ML19014A270

Transcript Meeting to Accept Comments on the Nrc'S Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals January 10, 2019, Pages 1-81

ML19014A270
Person / Time
Issue date:	01/10/2019
From:	NRC/NMSS/DMSST/MSEB
To:
Sarah Lopas 301-415-6360
References
NRC-0054
Download: ML19014A270 (82)

Text

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Public Meeting To Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals Docket Number: NRC-2018-0230 Location: Public Meeting at NRC Headquarters in Rockville, MD, and Webinar Date: January 10, 2019 Work Order No.: NRC-0054 Pages 1-81 NEAL R. GROSS AND CO., INC.

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

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

1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

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PUBLIC MEETING TO ACCEPT COMMENTS ON THE NRCS EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS

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THURSDAY, JANUARY 10, 2019

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PUBLIC MEETING

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The Public Meeting convened at 1:00 p.m.,

Sarah Lopas, Moderator, presiding.

PRESENT:

SARAH LOPAS, NMSS/MSST/MSEB MARYANN AYOADE, NMSS/MSST/MSEB CHRISTIAN EINBERG, NMSS/MSST/MSEB DONNA-BETH HOWE, NMSS/MSST/MSEB NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 TABLE OF CONTENTS Welcome and Introduction...........................4 Review Agenda and Ground Rules.....................5 Presentation on the NRCs T&E Evaluation...........7 Public Comments...................................23 Adjourn...........................................78 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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3 1 P R O C E E D I N G S 2 (1:00 p.m.)

3 MODERATOR LOPAS: Hi, everybody. Good 4 afternoon. Welcome to the NRCs Webinar and Public 5 Meeting to Accept Comments on the staffs Evaluation 6 of Training and Experience Requirements for Different 7 Categories of Radiopharmaceuticals.

8 My name is Sarah Lopas and I am the project 9 manager for the staffs evaluation, and Im also going 10 to be giving a portion of todays presentation, and 11 facilitating.

12 Im joined here by Maryann Ayoade who is 13 a health physicist on the NRCs Medical Radiation Safety 14 Team. And she is a technical lead on the training and 15 experience evaluation.

16 And also with me is Chris Einberg. And 17 Chris is the chief of the Medical Safety and Events 18 Assessment Branch in the Office of Nuclear Material 19 Safety and Safeguards.

20 So for folks that are here today, thank 21 you for signing in. I appreciate that. You have those 22 handouts. I also want to welcome the folks on the phone 23 and joining us via the webinar.

24 And lets move on to the next slide here.

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4 1 So today for our agenda Chris is going to 2 give a quick welcome. Im going to follow Chris with 3 some leading information.

4 We are on Slide 3 right now for folks that 5 may be following along on the slides, maybe not 6 necessarily using the webinar.

7 Then Maryann and I will do the NRC 8 presentation. And then were going to open it up for 9 your comments. And well answer your questions as we 10 can. So theres plenty of time for comments. Theres 11 only a few people here in the room and there are about 12 20 or so of you on the phone. So thanks for calling 13 in, we appreciate you.

14 All right. So I think at this point I will 15 hand it over to Chris to give us our welcome.

16 MR. EINBERG: Okay, thank you, Sarah.

17 Good afternoon, everyone. Thank you for 18 taking the time to attend todays meeting, the folks 19 in person here at the NRC, and remotely via the bridge 20 line in the webinar.

21 Todays meeting is the third of the four 22 comment acceptance meetings that the NRC will be 23 conducting in our training and experience requirements 24 evaluations. The purpose of todays meeting is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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5 1 twofold:

2 To provide background information on the 3 NRC staffs planned evaluation of developing tailored 4 training and experience requirements for administering 5 different categories of radiopharmaceuticals for which 6 a written directive is required in accordance with our 7 regulations in 10 CFR Part 35, which are our regulations 8 for Medical Use of Byproduct Material; and Subpart E 9 under Part 35, which covers Unsealed Byproduct 10 Material-Written Directive Required.

11 And most importantly, to listen to and 12 record your comments on this evaluation.

13 The comments we receive from the medical 14 community, the agreement states, and other stakeholders 15 are critical to the NRC staffs decision making on 16 whether our existing training and experience 17 requirements should be revised. If you do not provide 18 your comments today, we encourage you to participate 19 in one of our future comment meetings in January, or 20 submit written comments using regulations.gov by 21 January 29th, 2019.

22 Later in the presentation we will cover 23 how you can submit your written comments.

24 And now Ill hand the presentation back NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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6 1 to Sarah Lopas.

2 MODERATOR LOPAS: Okay, just some quick 3 general meeting information.

4 I do just want to note for the folks in 5 the room the bathrooms are out the door to the left 6 and kind of around. And if we have to evacuate for 7 any reason, just follow us. Well probably head out 8 the way we came in, or there is also an emergency exit 9 over just past the bathrooms. Follow us, yes. Weve 10 got you. Trust your regulators, well guide you.

11 So if youre on the phone and logged into 12 the webinar, I do have some handouts uploaded for you, 13 the same handouts that are here in the room. So that 14 is the information paper that the staff published back 15 in late August 2018, the Federal Register notice that 16 opened up this 3-month comment period, and I also have 17 todays slides. So you can download all of those from 18 the handouts.

19 If you are on the phone and you are having 20 issues with your webinar, our slides are posted on our 21 public meeting notice. A link to our slides is included 22 in the reminder email that went out at about 12:00 p.m.

23 Eastern today. And the slides are also on the NRCs 24 T&E Evaluation webpage. So theres a few places to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 get to the slides if you want to follow along if you 2 cant get into the webinar for some reason.

3 Lets see, what else do we have here? So 4 today were going to be referring to T&E a lot, training 5 and experience. Authorized users will often be 6 referred to as AUs. And todays meeting is being 7 transcribed by a court reporter. They are on the phone 8 with us. And we have, which I think was mentioned by 9 Tara, our Operator, but were recording this call as 10 well just as a backup. But I just want to make sure 11 everybodys aware of that.

12 So all of your comments today will be 13 captured accurately by the court reporter. And 14 comments that you speak today are given the same weight 15 as comments that you submit written. And you can, you 16 know, feel free, you dont have to resubmit your 17 comments but you certainly can. So they all have the 18 same weight.

19 All right. At this point were going to 20 go to Slide 7. And thats where Im going to ask Maryann 21 to take over for us.

22 MS. AYOADE: Great. Thank you, Sarah.

23 Today I will be presenting information on 24 an overview of the regulations on training and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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8 1 experience for radiopharmaceuticals requiring a 2 written directive; some background on the related 3 stakeholder concerns received for this evaluation; and 4 NRCs efforts on the evaluation thus far.

5 So the current regulations on training and 6 experience for radiopharmaceuticals requiring a 7 written directive are under 10 CFR Part 35, Subpart 8 E. These training and experience requirements provide 9 three pathways that a physician may be authorized to 10 administer radiopharmaceuticals that require a written 11 directive.

12 A physician can be authorized to administer 13 these radiopharmaceuticals if they are certified by 14 a medical specialty board whose certification process 15 is recognized by the NRC or an agreement state.

16 A physician can also be authorized if they 17 satisfy the training and experience requirements via 18 an alternate pathway, which includes the completion 19 of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including a 20 minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory 21 training in the relevant topic areas, as listed in the 22 regulations, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work 23 experience in the relevant areas, as listed in the 24 regulations.

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9 1 I hope you guys can hear me better now.

2 Ill try to speak up a little bit more.

3 A physician can also be authorized if they 4 have been previously identified as an authorized user 5 on an NRC or agreement state license or permit.

6 And so this training and experience 7 evaluation is focused on the ultimate pathways. And 8 the NRC staff are looking into what tailored training 9 and experience requirements for limited administration 10 of certain categories of radiopharmaceuticals would 11 look like. And that is what we will be referring to 12 as a limited authorized user status.

13 Next slide.

14 So in Subpart E there are four sections 15 that pertain to training and experience requirements.

16 The first section is under 10 CFR 35.390 for training 17 for the use of all radiopharmaceuticals in Subpart E, 18 all of which require a written directive.

19 The second is under 10 CFR 35.392 for 20 training for oral administration of sodium iodide 21 iodine 131 requiring a written directive in quantities 22 less than or equal to 33 millicuries.

23 The third is under 10 CFR 35.394 for 24 training for oral administration of sodium iodide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 iodine 131 requiring a written directive in quantities 2 greater than 33 millicuries.

3 And the fourth section is in 10 CFR 35.396 4 for training for parenteral administration of any 5 radiopharmaceuticals requiring a written directive.

6 So I want to point out that all these 7 sections of training and experience, including the 8 pathways for experienced authorized users already 9 listed on the license, it includes the pathways for 10 experienced authorized users that are already listed 11 on the license.

12 Also, all the sections except 10 CFR 35.396 13 include training and experience under the board 14 certification and alternate pathways. However, 10 CFR 15 35.396 is for training exclusively under the alternate 16 pathways, and it is written for the radiation 17 oncologists that are looking to become authorized 18 users. And they can do this by completing some 19 additional hours of training and experience.

20 I also want to point out that the alternate 21 training pathway under 10 CFR 35.392 and .394 is for 22 the physician to successfully complete 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of 23 classroom and lab training. And that is relevant to 24 the type of uses for which they are seeking to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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11 1 authorized. Whereas the alternate training pathways 2 under 10 CFR 390 is for the physician to successfully 3 complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, which 4 includes the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory 5 training.

6 Next slide.

7 This slide provides some background 8 information on stakeholder concerns received related 9 to the training and experience requirements.

10 Since the revisions to the training and 11 experience requirements in 2002, and again in 2005, 12 stakeholders have raised concerns about the effects 13 of some of the requirements on patient access to certain 14 radiopharmaceuticals.

15 Specifically, some stakeholders have 16 asserted that the 700-hour requirement in 10 CFR 35.390 17 is overly burdensome for physicians who are not 18 certified by a medical specialty board, and that the 19 extensive requirements have resulted in a shortage of 20 authorized users, which thereby limits patients access 21 to radiopharmaceuticals.

22 As a result, in 2015 and 16, in separate 23 efforts the NRC staff as well as the NRCs Advisory 24 Committee on the Medical Uses of Isotopes, also known NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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12 1 as the ACMUI, independently reviewed the training and 2 experience requirements for the medical uses authorized 3 under Subpart E. Specifically, NRC staff reviewed the 4 regulatory basis and the comments that were received 5 on past rulemakings related to the medical use of 6 byproduct materials, and did not identify any new 7 information that would call into question the basis 8 of this existing requirements.

9 As a result, the NRC staff did not propose 10 any changes to the regulations at the time. And the 11 NRC staff is continuing to work with the ACMUI in its 12 ongoing training and experience evaluation efforts.

13 Next slide.

14 So as part of the Staff Requirements 15 Memorandum dated August 17, 2017 -- and that is publicly 16 available in ADAMS via the hyperlink that is referenced 17 on this slide -- the Commission directed the NRC staff 18 to evaluate whether it makes sense to establish tailored 19 training and experience requirements for different 20 categories of radiopharmaceuticals; evaluate how those 21 categories should be determined, such as by risk, polled 22 by T&E cards, or by delivery methods; to evaluate what 23 the appropriate training and experience requirements 24 should be for each category; and to evaluate whether NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 those requirements should be based on hours of training 2 and experience or focused more on competency.

3 Next slide.

4 In response to the Commission direction, 5 the NRC staff solicited feedback from some medical and 6 regulatory stakeholders in April and May of 2018. And 7 that evaluation, including the NRC staffs analysis 8 and feedback received of the training and experience 9 requirements in Subpart E of 10 CFR Part 35 was 10 documented in an NRC SECY paper, SECY-18-0084.

11 The result of the evaluation concluded that 12 it may be feasible to establish tailored training and 13 experience requirements with different categories of 14 radiopharmaceuticals, and to create a means of 15 authorizing the administration of certain categories 16 of radiopharmaceuticals such as the Alimited authorized 17 user@ status.

18 It also concluded that there are viable 19 options for creating a competency-based approach to 20 demonstrate acceptable training and experience 21 requirements for a limited authorized user status.

22 But, however, the staff does need to conduct more 23 extensive outreach for stakeholders in the medical 24 community, to the medical community, to the agreement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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14 1 states, and to other members of the public before making 2 any recommendations to the Commission.

3 And this is what brings us to our current 4 evaluation today.

5 So now I will hand over back to Sarah who 6 will discuss our current evaluation efforts and how 7 you can participate.

8 MODERATOR LOPAS: Thanks, Maryann. And 9 I just want to note that the SECY that Maryann was just 10 talking about on Slide 11, thats one of the handouts 11 thats attached to your webinar.

12 So next slide is Slide 12. And the end 13 of evaluation will be a paper that were going to send 14 up to our 5-member Commission. In this paper theyre 15 going to document our reasoning recommending no changes 16 to our current T&E regulations or, if we do recommend 17 changes, we will lay out our reasoning for those changes 18 and we will also add a rulemaking plan into that paper 19 as well.

20 So this is a very simplified diagram of 21 information that were going to consider in our 22 development of the recommendation to the Commission.

23 The diagram illustrates why the comment period is so 24 important. And thats because in large part the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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15 1 feedback that we received is on -- that we received 2 on those questions that we asked in the Federal Register 3 notice is going to help us inform our recommendation 4 to the Commission.

5 Other important feedback will come from 6 our coordination with our co-regulator, the agreement 7 states, and the Advisory Committee on the Medical Uses 8 of Isotopes, ACMUI.

9 So in addition to the input that we received 10 from the public and the medical stakeholders, the 11 agreement states, and the ACMUI, the staff is also going 12 to look at patient access. Weve been working on 13 mapping facilities where they offer 35.300 therapies 14 in the United States. And right now we just have access 15 to NRC licensees for that data. But we do plan to go 16 out for a voluntary data request from the agreement 17 states to ask them if they can provide us that 18 information, if they have it, in kind of an easily 19 accessible form as well.

20 We use a web-based licensing database 21 system to maintain our licenses, so we are able to kind 22 of pull that information from our WBL system to help 23 us map that information. So working on that right now.

24 And the next thing that were going to start NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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16 1 looking at is were going to be looking at medical and 2 radiation safety events to determine if any of those 3 have a nexus to training and experience. So were just 4 starting that effort as well.

5 Then and were also going to start working 6 on reaching out to some international community to talk 7 to them about what kind of regulations they have for 8 training and experience.

9 So its important to note that if the staff 10 does end up recommending some sort of rulemaking that 11 we would document it in a rulemaking plan. And the 12 Commission would then proceed to vote on that rulemaking 13 plan. And that would determine whether or not the staff 14 would proceed with another Part 35 rulemaking effort.

15 And if rulemaking is recommended and 16 approved by the Commission -- and then approved by the 17 Commission, that would start the NRCs extensive 18 rulemaking process. And I am highlighting this process 19 because I think its important so that everybody 20 understands where we are in this process, you know, 21 were at the information gathering stage, you know, 22 were not in a rulemaking right now. This is, you know, 23 before we even make a determination about rulemaking.

24 The next slide is Slide 13.

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17 1 This is the Federal Register Notice slide.

2 The Federal Register notice was published on Monday, 3 October 29th. It can be accessed at this link here.

4 You could just also do a Google search of 83 FR 54380.

5 Its also, of course, attached to your webinar too 6 as a handout. Easy enough.

7 So it announced the date of the federal 8 -- of the comment period, which ends January 29. And 9 its talking about public meetings that weve had to 10 date. We had one in November, one in December. We 11 have this one today. And then we have one final webinar 12 on January 22nd. That will be a morning webinar, 10:00 13 a.m. Eastern time, just to kind of change things up 14 because weve been doing most of these in the afternoon.

15 But, yes, and that will be a webinar only, 16 no, no in-person meeting just a webinar.

17 But most importantly, the Federal Register 18 notice asked a series of questions that we were really 19 interested in getting input on. So Im just going to 20 quickly read through these questions on the next few 21 slides just so you can understand, get a general context 22 of what we were, information that we were looking to 23 gain from comments from everybody. And note that when 24 we do open it up for comments we can go back through NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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18 1 these questions. So were just going to read through 2 them right now.

3 So Slide 14.

4 The first set of questions was asking about 5 tailored training and experience requirements. So are 6 the current pathways for obtaining AU status reasonable 7 and accessible? And are they adequate for protecting 8 public health and safety?

9 Should the NRC develop a new tailored T&E 10 pathway? And what would be the appropriate way to 11 categorize radiopharmaceuticals for tailored T&E 12 requirements? What would be those appropriate 13 requirements?

14 Should the fundamental T&E required of 15 physicians seeking limited AU status need to have the 16 same fundamental T&E required of physicians seeking 17 full AU status?

18 And how should the requirements for this 19 fundamental community be structured for a specific 20 category of radiopharmaceuticals?

21 On the next slide we have Section B, which 22 is talking about the NRCs recognition of medical 23 specialty boards.

24 And the current boards in our current NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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19 1 process is located on the NRCs Medical Toolkit Website.

2 But our questions are:

3 What boards other than those already 4 recognized by the NRC could be considered for 5 recognition for medical uses under 10 CFR 35.300?

6 And, are the current NRC medical specialty 7 board recognition criteria sufficient? If not, what 8 additional criteria should the NRC use?

9 Section C is getting to patient access 10 again. And we have heard some comments on patient 11 access.

12 So weve been asking, we ask is there a 13 shortage in the number of AUs for medical uses under 14 10 CFR 35.300? If so, is the shortage associated with 15 the use of a specific radiopharmaceutical?

16 Are there certain geographic areas with 17 an inadequate number of AUs?

18 Do current NRC regulations on AU T&E 19 requirements unnecessarily limit patient access to 20 procedures involving radiopharmaceuticals?

21 And, do current NRC regulations on AU T&E 22 requirements unnecessarily limit research and 23 development in nuclear medicine?

24 And then Section D was kind of asking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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20 1 generally about the NRCs training and experience 2 requirements overall. And these questions are 3 broader:

4 Should the NRC regulate the T&E of 5 physicians for medical uses?

6 Are there requirements in the NRCs T&E 7 regulatory framework for physicians that are non-safety 8 related?

9 And, how can the NRC transform its 10 regulatory approach for T&E while still ensuring that 11 adequate protection is maintained for workers, the 12 public, patients, and human research subjects?

13 So those are the questions. Clearly, you 14 know, were not limited, your comments are not limited 15 to just those questions. We are asking that written 16 comments come in by January 29th, 2019. The easiest 17 way to submit them is via regulations.gov.

18 This is the direct link to submit your 19 comments, but if you go to regs.gov and you just type 20 in ANRC-2018-0230" in the search bar it will pop right 21 up and it says, Comment now! So you can either upload 22 your comments with a .pdf or you can type directly in 23 the text box. Theres a couple ways to do it.

24 If you have any issues with submitting your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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21 1 comments that way, feel free to just email me directly, 2 or email Maryann. We will make sure it gets on the 3 docket for you. Thats not a problem.

4 All the comments that we do receive and 5 our transcript are posted on regulations.gov, but 6 theres a lag for those getting posted. Its a few 7 days, so you wont see your comment immediately. It 8 will take a few days for it to pop up. But rest assured 9 we will receive it.

10 Our comments are also going to be posted 11 to ADAMS, of course, our user-friendly Agency-wide 12 Documents Access and Management System.

13 And we are, of course, going to consider 14 all of your comments, and were going to summarize them, 15 and were going to bin them and summarize them and 16 organize them. Well create kind of a comment report, 17 comment summary report that well put out that will 18 accompany our SECY paper. So, you know, this is not 19 a rulemaking so we arent going to be responding back 20 to individual comments.

21 And then we have one more public comment 22 meeting, which I mentioned. Thats on the 22nd, 23 January 22nd, 10:00 a.m. - 12:00 p.m. Eastern Time.

24 And this is a webinar only.

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22 1 Slide 20 are our next steps.

2 So the public comment period ends on 3 January 29th, as I mentioned.

4 Were going to continue the evaluation of 5 the comments as they come in. Were going to finish 6 our work with our additional information regarding 7 patient access and trying to map these facilities and 8 figuring out how many AUs there are.

9 Conducting that additional research about 10 international benchmarking, and looking at medical, 11 medical events.

12 And then the ACMUI Subcommittee on Training 13 and Experience is going to provide their report to us 14 on March 8. So there will be a public teleconference 15 on that report probably sometime later in March. So 16 we will, we will notice that on our public meeting notice 17 and send notice of that meeting on our medical listserv.

18 So if youre not on our medical listserv, get on that.

19 So well be looking, looking forward to 20 that input from the ACMUI.

21 And then later on in the process, after 22 we come up with our draft paper, we will be providing 23 that to the agreement states and the ACMUI for them 24 to review the draft paper ahead of time and to provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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23 1 their input and comments on that paper.

2 We will take their comments in, you know, 3 revise the paper as needed, and finalize it and give 4 it to the Commission in the fall of 2019.

5 And so for more information you can, of 6 course, contact myself or Maryann. Im more kind of 7 the project manager person. If you have more kind of 8 process questions, thats for me. If you have more 9 regulations type questions, technical questions, 10 contact Maryann. Shes our technical lead.

11 Our website, I am striving to maintain the 12 website with, you know, our meeting summaries, links 13 to the transcripts for past meetings, things like that.

14 So thats the T&E website.

15 Of course the T&E docket on 16 regulations.gov, that will, that will show everybodys 17 comments, so you can see what people have submitted 18 so far if youre interested in that.

19 And with that, thats the end of our 20 presentation. So finished up pretty quickly, 1:25.

21 I want to -- well start here with comments in the room.

22 Everybody has to use a microphone. So I can run this 23 mic to you if you want to use this mic, or youre welcome 24 to use the podium mic if youd like to use the podium.

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24 1 Just turn it on.

2 And, so folks on the phone, just go ahead 3 and press star-1 and that will let Tara know, our 4 operator, that youre going to need your line unmuted.

5 And Im just going to ask that everybody 6 start by introducing yourself. If you have an 7 affiliation, great. You dont need to state your 8 affiliation. And just speak slowly and clearly and 9 into a microphone so that everybody can hear you on 10 the phone.

11 Were starting with a comment in the room.

12 MS. TOMLINSON: Cindy Tomlinson with 13 ASTRO. Okay, sorry. Cindy Tomlinson with ASTRO. Can 14 you, can you expand a little more on your work with 15 the Agreement States to get some of the census data 16 in terms of your timeline? So will that be done in 17 time for the ACMUI to review it or do you mean to have 18 it done in time for the paper to be done?

19 Im just curious as to where you are, what 20 the time frame is.

21 MODERATOR LOPAS: It will probably be, it 22 will definitely not probably be in time to help out 23 ACMUI. Its a voluntary request for data from the 24 agreement states.

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25 1 And this is Sarah Lopas speaking, for folks 2 on the phone.

3 And we have a letter that were preparing 4 to go out right now. Its kind of stuck in the process 5 because it requires Office of Management and Budget 6 Review and it is closed. So were stuck in the process.

7 We probably wont get that letter out -- I mean who 8 knows, right? -- once OMB opens back up I anticipate 9 it might be three to four weeks after that that the 10 letter would go out. And then typically we give the 11 Agreement States about 45 to 60 days to respond to 12 something like that. So it will be a little while.

13 MS. TOMLINSON: And so is your, is your 14 intent then to have this data in time then for the paper 15 to be sent up to the Commission?

16 MODERATOR LOPAS: Yeah. Oh, absolutely.

17 MS. TOMLINSON: Okay.

18 MODERATOR LOPAS: It will be in that, 19 whatever data we get from the states were going to, 20 were going to clean up and map and include it in the 21 paper to the Commission, absolutely.

22 MS. TOMLINSON: And will that data be --

23 obviously it will be public because it will be in the 24 memo to the Commission -- but will you make that data NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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26 1 public?

2 MODERATOR LOPAS: We will be making the 3 maps public.

4 As far as any Excel files or anything like 5 that that we get from the states, we had not planned 6 to make that public.

7 MS. TOMLINSON: And by maps -- Im sorry 8 to --

9 MODERATOR LOPAS: Yeah sure. No. Yeah.

10 MS. TOMLINSON: Im just trying to 11 understand because this is something that we are, were 12 concerned about --

13 MODERATOR LOPAS: Yes.

14 MS. TOMLINSON: -- in terms of this 15 argument that there arent enough physicians.

16 MODERATOR LOPAS: Right.

17 MS. TOMLINSON: Im trying to understand 18 if there is something maybe we can do.

19 And so -- but so the maps are they going 20 to be just, like, a map of the United States with some 21 pin drops on there saying numbers?

22 MODERATOR LOPAS: So right now -- Ill tell 23 you what we have for our maps that weve done so far 24 for the NRC, for the non-agreement states. Its maps NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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27 1 of States. And it is literally just a pinpoint.

2 And what we are, you know, and what we are 3 doing is for -- so we have main facility locations.

4 And we -- were going to put the number of 35.300 AUs.

5 That number is going to be next to the dot. You will 6 see at that particular location there might be five 7 35.300 AUs there.

8 There are some satellite locations 9 associated with some of those licensees. We dont know 10 how many 35.300 for those locations. We do know that 11 that use is certified, that satellite location is 12 authorized to use 35.300 materials, we just dont know 13 how many AUs they might have at that particular 14 location.

15 So, yeah, youre just going to see --

16 MS. TOMLINSON: Okay.

17 MODERATOR LOPAS: -- dots on a map.

18 MS. TOMLINSON: Thank you. So if its, 19 lets just say no likely source here in this area --

20 MODERATOR LOPAS: Yes.

21 MS. TOMLINSON: -- and its INOVA, and you 22 know that INOVA has, whatever, 10 authorized users under 23 35.390, but one of them might work in, you know, the 24 Fairfax Hospital, one might be at Fair Oaks, and one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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28 1 might be at wherever else, thats not going to be 2 included? Its just going to be the big total --

3 MODERATOR LOPAS: Right.

4 MS. TOMLINSON: -- because of the way 5 satellites work?

6 MODERATOR LOPAS: Right. Exactly.

7 We will have, we are going to put it over 8 population data.

9 MS. TOMLINSON: Okay. Youre using 10 census data?

11 MODERATOR LOPAS: Yeah. So we have, 12 unfortunately we only have 2010 data. Right? But it 13 will kind of, its kind of the map is sort of shaded 14 to show population density.

15 MS. TOMLINSON: Okay, great. Thank you.

16 MODERATOR LOPAS: Yep.

17 MS. AYOADE: This is Maryann from the NRC.

18 Cindy, the question is to Cindy from ASTRO.

19 If for some reason based on what we shared with you 20 today you guys have, you know, any other information 21 or things that you think might be useful to use, please 22 feel free to share --

23 MS. TOMLINSON: Okay.

24 MS. AYOADE: -- with us. Thank you.

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29 1 MODERATOR LOPAS: All right. Folks on the 2 phone, touch star-1. Were going to go for another 3 comment in the room here and then well open it up to 4 the, well check in on the phones. So star-1 and get 5 in line.

6 MR. GUASTELLA: This is on, correct?

7 Hi. Michael Guastella. Im the 8 Executive Director of the Council on Radionuclides and 9 Radiopharmaceuticals. And I want to thank you for the 10 opportunity today to provide public comment.

11 It is CORARs position that the current 12 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> training and experience alternate pathway 13 for physicians who want to become authorized users to 14 safely administer patient-ready alpha, beta, and 15 beta/gamma emitting isotopes, and we kind of refer to 16 those as the non-imaging radiotherapy doses, and we 17 believe the requirements right now are excessive.

18 In answer to one of the questions, Sarah, 19 that you actually had put up a little while ago -- should 20 the NRC develop a new tailored training and experience 21 pathway for physicians? -- CORAR does believe that the 22 NRC should develop a new tailored training and 23 experience pathway for specialists such as medical 24 oncologists, hematologists, and urologists.

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30 1 The new pathway should provide the training 2 and experience necessary to safely administer these 3 non-imaging radiotherapies with consideration to 4 several factors.

5 One, the limited role in handling these 6 radionuclides which would be dispensed and delivered 7 to them in patient-ready doses from licensed nuclear 8 pharmacies, dispensed by nuclear pharmacists, licensed 9 nuclear pharmacists. Or, as were starting to see, 10 received directly from the manufacturer in a 11 patient-ready dose container.

12 The limited role does not include, if you 13 will, the full range of activity in handling byproduct 14 material such as molybdenum technetium generators; 15 preparing, compounding, and dispensing radioactive 16 drugs; administering a wide variety of radionuclides 17 requiring written directives; interpreting nuclear 18 medicine scans; learning about imaging equipment; 19 understanding imaging quality and assurance; and other 20 important clinical skills necessary to ensure safe and 21 comprehensive care in the nuclear medicine department.

22 All these things roll into the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 23 currently.

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31 1 the radiological safety profiles or 2 radiopharmaceuticals containing the alpha, beta, and 3 beta/gamma emitting isotopes. These, again, are the 4 non-imaging radiotherapy doses.

5 And, finally, physician experience and 6 training in handling toxic, non-radioactive chemical 7 therapies such as cytotoxic chemotherapy imaging.

8 And why is this important? At least from, 9 from our perspective, interested medical oncologists, 10 hematologists, and urologists who wish to become 11 limited authorized users through a potential 12 needs-tailored training experience pathway will have 13 the opportunity to provide improved continuity care 14 for their patients.

15 For example, this will be very important 16 for an oncologist who wishes to closely monitor a 17 patients response to a non-imaging radiotherapy 18 treatment and quickly treat any condition or 19 complication. These clinical efforts would be 20 hampered if the patient was required to travel for 21 treatment due to an AU shortage in the geographic area 22 where the patient lives, and where he or she is receiving 23 ongoing cancer treatment.

24 Thank you very much.

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32 1 MODERATOR LOPAS: Thank you.

2 Tara, can I check in on the phone, has 3 anybody pressed star-1?

4 OPERATOR: Yes. We do have a comment or 5 question from Scott.

6 Your line is open.

7 MR. DEGENHARDT: Yeah, thank you. My name 8 is Scott Degenhardt. I am a nuclear medicine advanced 9 associate here in Omaha, Nebraska. I am speaking as 10 an individual. I know theres been several comments 11 that have been submitted in the comments section, but 12 I did want to bring this up to the group, too.

13 I am proposing that nuclear medicine 14 advanced associates be considered for authorized user 15 designation. And for those of you who are unfamiliar 16 with the nuclear medicine advanced associates 17 profession, or NMAA, we are credentialed, board 18 certified mid-level providers in nuclear medicine.

19 We do function under the supervision of a physician.

20 I guess for those of, for those of you who 21 are a little unfamiliar with the program. So the 22 program is a Masters level program which includes 23 graduate level didactic course work and then also a 24 24-month clinical internship designed after a nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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33 1 medicine residency. The NMAA student during that 2 24-month internship learns under the guidance of a, 3 you know, a nuclear medicine physician or a radiologist, 4 very similar again to a nuclear medicine residency.

5 And with that being said, authorized user 6 training and education will not be compromised. Upon 7 the completion of the program the NMAA graduate meets 8 all qualifications required under 10 CFR 35.390 to 9 become authorized users.

10 So I guess thats just a very brief and 11 condensed statement about what a nuclear medicine 12 advanced associate is and our proposal. But I guess 13 some key points are, is that throughout healthcare we 14 have seen mid-level providers improve patient access, 15 efficiency, healthcare costs, and overall patient care.

16 And I believe the nuclear medicine advanced associate 17 would be no different in the field of nuclear medicine.

18 Again, we are mid-level providers, credentialed, and 19 board certified.

20 The way our program is set up, again, we 21 would be able to address current and future authorized 22 user needs throughout the country. The didactic course 23 work is done remotely, while the clinical internship 24 is done locally at the facilities that the student is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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34 1 practicing at. We wouldnt compromise the current 2 training and education set forth by the NRC. And 3 ultimately we could improve overall patient safety and 4 care while addressing the authorized user needs.

5 So I guess at that I am free to answer any 6 questions or receive any comments.

7 MS. AYOADE: Thank you, Scott. This is 8 Maryann Ayoade from NRC. I just want to clarify again 9 your comments.

10 So youre saying that NRC should consider 11 nuclear medicine technologists to be approved as 12 authorized users in our licenses. If that wasnt your 13 comment, feel free to clarify.

14 But also just wanted to point out we have 15 received some comments also for NRC to consider 16 non-physicians to be listed as authorized, as 17 authorized users. Specifically we received comments 18 on the nuclear medicine technologists as well.

19 MR. DEGENHARDT: Yes. Its not nuclear 20 medicine technologists, it would be the NMAAs, the 21 nuclear medicine advanced associates, those who have 22 undergone that, that program, that training and 23 education. So not technologists but the, again, the 24 nuclear medicine advanced associates.

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35 1 MS. AYOADE: Okay, thank you.

2 MR. DEGENHARDT: Yes. No, thank you.

3 MODERATOR LOPAS: Okay. Tara, is there 4 anybody else on the line? Star-2 for folks on the line.

5 And you can also, if you have a short 6 comment or a question, feel free to submit it via the 7 webinar question function. I can read it aloud for 8 you if you would feel more comfortable typing something.

9 Is there anybody on the line, Tara?

10 OPERATOR: Yes. Richard, your line is 11 open.

12 MR. SISKA: Hi. My name is Richard Siska.

13 I am a nuclear medicine advanced associate and a 14 radiation safety officer in Rolla, Missouri. And Id 15 like to kind of piggyback a little bit off what Scott 16 has said.

17 And to clarify, maybe give us a little 18 perspective on where the NMAA sits at the mid-level.

19 It would be akin to a nurse practitioner as opposed 20 to a nurse. So these are people that have undergone 21 not only undergraduate work but have obtained a Masters 22 Degree in graduate work and post-graduate certification 23 through a certification board.

24 In my commenting, too, through the website NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 Im attaching some documentation that may help further 2 for your information-gathering process that also would 3 include a content outline of the examination process 4 that NMAAs must undergo following their being awarded 5 the degree of Masters of Imaging Sciences.

6 What this does, I think, is twofold.

7 First, it utilizes a group of professionals or upcoming 8 professionals in the mid-level studies that are peer 9 into nuclear medicine. So these people were nuclear 10 medicine technologists in the beginning, so theyve 11 had all the physics training. They are familiar with 12 the biochemistry of radiopharmaceuticals. They have 13 had experience in hot labs. They have had experience 14 in radiopharmacies because thats part of the training 15 requirement. They understand the physics.

16 And although theyre not physicists, they 17 do a lot of basic training in a lot of the components 18 that physicists would do, but just not to that extent.

19 Add onto that the extra components that 20 a graduate degree person, someone who has had 21 experience, not only the training of a nuclear medicine 22 technologist, the years of experience as a nuclear 23 medicine technologist, but then going back and 24 receiving extra course work much akin to a residency NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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37 1 that a physician would receive, just on a smaller scale.

2 And put that extra education and experience on top 3 of that, and thats what a nuclear medicine advanced 4 associate is.

5 So they would be able to provide a pure 6 understanding of what radiopharmaceuticals are. And 7 one of the previous comments had aligned it to, you 8 know, chemotoxicity. And its a good analogy but its 9 not quite the same thing because radioactivity, of 10 course, is a different animal.

11 So, you know, keeping those types of people 12 with those kind of experiences and that kind of 13 education would prevent the NRC from having to change 14 the requirements as far as training and experience, 15 which I think, you know, when we look around and were 16 looking at accreditation agencies which are separate 17 from the NRC, were seeing stricter regulations on other 18 radiation safety activities. So its kind of 19 counterintuitive to reduce training and experience on 20 activities that are actually using radioactive 21 therapies that are changing the biochemistry of someone 22 internally and reducing the requirements of radiation 23 safety and experience on that. So to me its a little 24 confusing.

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38 1 But I just wanted to add that comment.

2 Thank you.

3 MODERATOR LOPAS: All right. I 4 appreciate that Mr. Siska. Thank you.

5 Tara, is there another commenter on the 6 phone?

7 OPERATOR: Yes. David, your line is open.

8 MR. BURPEE: Hi. Im Dave Burpee with 9 Bayer Pharmaceuticals. I work with Xofigo. And this 10 week the SNMMI issued an editorial in their journal.

11 And I want to make a comment about how I strongly 12 disagree with this editorial.

13 Its main initiative was to state that the 14 NRC is taking on this initiative to raise money through 15 increasing or having more authorized user licensing 16 fees. In my experience theres no such thing as a AU 17 licensing fee. Certainly there are monies from 18 applications for amendments to grants but Ive got to 19 believe that thats an incredibly small fraction of 20 the NRCs budget.

21 From my perspective this is all about 22 improving patient care. And I applaud the NRC for 23 reviewing and taking on this important need.

24 I manage ten states currently. And there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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39 1 are tremendous AU availability difficulties that are 2 restricting patient care with these important 3 radiotherapies. In the last quarter alone I saw four 4 cases where there was no authorized user for years at 5 these four institutions, and thats just in the last 6 quarter in my part of the country, okay.

7 Theres many other authorized user 8 problems in the case of the large cities and the rural 9 areas. Many, many patients arent in the right network 10 to get treated at the local hospital. Many physician 11 groups and hospital groups dont play in the same 12 sandbox together and they compete. And, therefore, 13 the patients are forced to travel to get treated versus 14 going to their local hospital. Were talking hours 15 of travel with men who are sick. And its a pretty 16 tough situation.

17 So this is rather ubiquitous. And I, 18 again, applaud the NRC for taking this on.

19 In your mapping effort, I applaud that.

20 I think its going to be helpful. But if theres any 21 way of understanding who is actually treating, thats 22 one of the big problems. There might be authorized 23 users at XYZ hospital but theyre not treating for 24 various reasons from -- and, again, similar situations NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 to overall prejudice about not wanting to use that type 2 of therapy.

3 So good luck on that. And I wish you luck 4 to help try to understand that because their license 5 is good they may not actually be treating and, 6 therefore, the community is not being served.

7 Seven hundred hours would limit all of 8 these options, if that was the only criteria for 9 defining an authorized user. So we applaud the effort 10 to look further at options. And thats what this is 11 all about is giving patients options to improve the 12 patient care.

13 So, finally, we would like from Bayers 14 perspective to allow limited licenses for interested 15 physicians competing with -- limited licensing for 16 interested physicians after completing 17 product-specific manufacturer-provided training. And 18 this should improve patient care.

19 And we thank you again for the reference.

20 Im finished. Thank you.

21 MODERATOR LOPAS: Okay, thank you.

22 OPERATOR: We show no further questions 23 or comments on the phone.

24 MODERATOR LOPAS: Okay, thank you, Tara.

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41 1 Were going to hear from Chris.

2 MR. EINBERG: Yes. This is Chris Einberg.

3 Thank you for bringing up the issue of how the NRC 4 is funded. And just want to provide a little 5 clarification there regarding that fact.

6 The NRC is not a self-funded agency. We 7 are funded by the Congress with the requirement that 8 we recover 90 percent of our budget through fees 9 assessed to licensees and applicants. This money is 10 returned to the U.S. Treasury, the General Fund, and 11 therefore reimburses the taxpayers for services 12 provided by the NRC civilian industry.

13 The fees do not directly benefit the 14 agency. Furthermore, the NRC issues licenses to 15 facilities and not individual physicians or authorized 16 users as the commenter indicated. This allows 17 physicians to be listed on the license and authorized 18 users -- or, Im sorry -- this allows physicians to 19 be listed on a license and authorized to use radioactive 20 material under that license.

21 Increasing the number of authorized user 22 physicians at already NRC-licensed facilities does not 23 affect the fees that the NRC receives. Although 24 increasing the number of facilities would increase the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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42 1 fees that the NRC receives, NRC would have a 2 proportionate amount of additional work, in essence 3 additional inspections, enforcement, licensing 4 actions, including renewals and amendments.

5 The licensees are billed an application 6 fee under 10 CFR Part 170 and an annual fee which factors 7 in costs for material users, license renewals, 8 amendments, and inspections, under 10 CFR Part 171.

9 As such, the NRC does not have a direct incentive to 10 add new licensees.

11 MODERATOR LOPAS: Thank you, Chris. I 12 appreciate that clarification.

13 Okay, were going to go back to the room 14 here. Folks on the phone, again, you can press star-1 15 at any time and well check back in on the phone. But 16 lets go to the room here.

17 MR. WITKOWSKI: John Witkowski, President 18 of UPPI.

19 MODERATOR LOPAS: Would you please speak 20 right into the microphone. Thank you.

21 MR. WITKOWSKI: We wanted to read a 22 prepared statement for the training and authorizing 23 of authorized users.

24 UPPI sincerely appreciates the Nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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43 1 Regulatory Commission re-engaging in efforts to 2 determine how access to medical isotopes can be expanded 3 and the Commissions outreach to seek diverse opinions 4 on the training and education required for authorized 5 users. We believe that this is a very important issue 6 and that the NRC can help to expand access to vital 7 medical tests and treatments while maintaining safety.

8 On behalf of UPPIs 83 independent 9 commercial nuclear pharmacies, leading nonprofit 10 academic medical center radiopharmacies across the 11 country which are focused on delivering prepared 12 radiopharmaceuticals, diagnostic molecular imaging, 13 and therapeutic patient care needs, we are pleased to 14 offer comments to assist the NRC in evaluating how to 15 expand access to these vital services.

16 Specifically, UPPI urges the NRC to 17 consider building upon and expanding successful dual 18 authorized user programs by teaming of an authorized 19 user nuclear pharmacist and a limited trained medical 20 oncologist in alpha and beta radiotherapies. This 21 would enable the expansion of the availability of 22 treatments and ensure that a highly trained authorized 23 user is present to ensure patient radiation safety.

24 Since the pharmacy community has played NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 an important role in ensuring patient safety, 2 centralized nuclear pharmacies handle the preparation 3 and dose burden for hospitals and diagnostic imaging 4 centers by dispensing and delivering just-in-time 5 radiopharmaceutical doses for patients in molecular 6 imaging and therapy.

7 UPPI members dispense 8,000 8 patient-specific doses each day. The U.S. imaging 9 community orders 50,000 patient doses daily. Across 10 the country 300 nuclear pharmacies cover metro, 11 suburban, and rural areas. Nuclear pharmacists have 12 the responsibility to deliver these individually 13 prescribed and calibrated patient-specific doses to 14 the hospitals and imaging centers.

15 The expertise and dedication of the nuclear 16 pharmacists in delivery safe patient procedures ensure 17 the safe handling of the radioactive material since 18 back in the 1970s when the Board of Pharmacy Specialties 19 began its first specialty examination in nuclear 20 pharmacy in 1978. At that time the industry created 21 and adopted self-governance, safety, and handling 22 standards and training. That training continues to 23 develop and supplements the federal and state 24 requirements that are also necessary for nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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45 1 pharmacist licensing.

2 We believe that there is a role for nuclear 3 pharmacists to play in this case as well. And we 4 sincerely appreciate the NRC considering utilizing 5 nuclear pharmacists to expand access.

6 Expanding patient needs for 7 radiotherapeutic use of alpha and beta measures is clear 8 and will continue to grow. Not only does there appear 9 to be a geographic imbalance of authorized users that 10 disadvantages rural patient populations, but the 11 prospect of new systemic radiotherapies and the new 12 and more advanced effective treatment options has grown 13 since the petition by pharmaceuticals in 2015 to 14 reevaluate the access to such treatment.

15 New biological approaches to utilizing 16 alpha and beta radionuclides continue to expand as new 17 therapies for prostate, breast, and other cancers are 18 developed. Administering these advanced treatments 19 will create a need for more authorized users.

20 This will put more demand on the current 21 roster of authorized users. And the NRC is smart in 22 seeking to understand future demand and utilization 23 of authorized users, anticipating when and how the 24 demand for authorized users will increase, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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46 1 proactively assessing the current pathways for training 2 and experience to meet future patient needs.

3 UPPI believes that an expanded alternative 4 pathway for training and education in the radiotherapy 5 utilization of alpha and beta measures is appropriate 6 and necessary to allow patient access to these 7 treatments, especially in rural areas. The 8 radiopharmacy as partner between manufacturers and 9 hospitals is the source of the majority of the patient 10 doses for diagnostic imaging and therapy. Nuclear 11 pharmacists have authorized user training and 12 experience and authorized user nuclear pharmacists can 13 deliver fair amounts of care.

14 The nuclear pharmacist authorized users 15 possess 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and education to satisfy 16 the radiation safety and protection requirements for 17 handling alpha and beta radiopharmaceuticals.

18 Specifically, there are many similarities to physician 19 AU training in regard to understanding the drugs, the 20 physiological action, and patient outcomes, along with 21 the patient and environmental safety in handling and 22 use of radioactive material.

23 For example, the 200-hour formal training 24 includes a myriad of topics related to radiation safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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47 1 as outlined in 10 CFR 35.55, Training for Nuclear 2 Pharmacists, which includes radiation physics and 3 instrumentation, radiation protection, chemistry of 4 byproduct material for medical use, radiation biology, 5 performing checks for proper operation of instruments.

6 Theres another description here, but its 7 also to determine activity of dosages and, if 8 appropriate, instruments used to measure alpha and beta 9 emitting radionuclides, using administrative controls 10 to avoid medical events in the administration of 11 byproduct materials, using procedures to prevent and 12 minimize radioactive contamination, and using proper 13 decontamination procedures.

14 In other words, the training and experience 15 expertise that a nuclear pharmacist receives to become 16 authorized users is similar to the training received 17 by physicians, and the Nuclear Safety Act section would 18 be even more rigorous than the training that the 19 physician receives.

20 Because nuclear pharmacists receive 21 similar training as doctors with regards to nuclear 22 safety that enable nuclear pharmacists to become 23 authorized users, UPPI believes that there is a way 24 for the NRC to expand access to radiopharmaceuticals NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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48 1 without sacrificing patient safety by establishing an 2 alternative pathway for expansion of an authorized user 3 whos administering alpha and beta radiotherapy through 4 the use of team of authorized users. That will ensure 5 the fully trained authorized user at one site to ensure 6 patient and environmental safety and the safe handling 7 of all nuclear materials, and will not sacrifice those 8 requirements but would also significantly expand the 9 number and reach of treatment options for patients.

10 This dispensing of the therapeutic doses 11 by the nuclear pharmacist has already been established 12 by the nuclear pharmacy working with the drug 13 manufacturer. Specifically, there are approximately 14 1,200 practicing nuclear pharmacist authorized users 15 through the U.S., and they are widely geographically 16 distributed.

17 For example, UPPI has members in urban 18 areas like New York and Philadelphia, but also has 19 members that cover the whole state of Florida and 20 significant parts of West Texas. This proposal would 21 expand the reach of these therapies to rural and 22 underserved areas where medical oncologists keep 23 treatment sites. Patient care and compliance with 24 successful therapeutic injections would be achieved.

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49 1 UPPI envisions that the team established 2 under the proposal would consider -- would consist of 3 a nuclear pharmacist authorized user on site who would 4 cover the radiation safety aspects of the procedure, 5 while a limited trained medical oncologist authorized 6 user, one that possesses lesser hours of training than 7 700, would be present for the injection or infusion 8 of the therapy and the patient care and treatment.

9 A single course was developed years ago 10 with limited training of physicians for nuclear 11 cardiology. The training hours address radiation 12 safety and protection of the patient. Under this dual 13 authorized user proposal the onsite nuclear pharmacist 14 would provide radiation safety and radiation protection 15 while the limited trained authorized user medical 16 oncologist would follow proper radiation safety 17 procedures and would care for the patient during and 18 after the dose administration.

19 UPPI believes a limited trained physician 20 teamed with a nuclear pharmacist would satisfy the NRCs 21 concern for safety and care of the patient in alpha 22 and beta radiotheranostics.

23 Tailored T&E has already been successfully 24 integrated in several practice areas, notably the use NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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50 1 of Y-90 microspheres in interventional radiology and 2 with brachytherapy prostate implantation with 3 radioactive seeds. UPPI has a number of members that 4 engage in this process and would be pleased to work 5 with the NRC to provide feedback to evaluate potential 6 changes to training and education.

7 This successful engagement provides a good 8 template for the NRC to evaluate as the Commission 9 considers its proposal.

10 In conclusion, UPPI urges the NRC to 11 consider implementing a dual authorized user approach 12 for alpha and beta emitters that enables an authorized 13 user nuclear pharmacist to team with a limited trained 14 medical oncologist. This approach, which has already 15 been utilized to provide some additional treatment 16 options for patients would significantly expand the 17 patient access to these important services without 18 sacrificing patient safety or requiring a complex 19 system of different training levels for the 20 administration of different treatments. As the NRC 21 has indicated they may already be contemplating.

22 We understand that this proposal could 23 create training changes for an alternative pathway for 24 training and education. And UPPI stands ready to work NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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51 1 with the NRC and other professionals to evaluate and 2 fulfill those needs.

3 Thank you very much for your consideration 4 to this alternative. We look forward to answering any 5 questions that you may have.

6 MODERATOR LOPAS: All right, thank you 7 very much.

8 Any questions? All right, thank you.

9 Tara, can I check in on the phone? If 10 theres anyone on the phone, star-1 to make a comment 11 or ask a question.

12 OPERATOR: Yes. We do have a comment or 13 question from Johannes. Your line is open.

14 MODERATOR LOPAS: Hello. Are you there?

15 DR. CZERNIN: Johannes Czernin.

16 MODERATOR LOPAS: Hi. Can you speak up 17 a little bit? And could you spell your name because 18 its a little unclear.

19 DR. CZERNIN: C-Z-E-R-N-I-N.

20 MODERATOR LOPAS: Okay.

21 DR. CZERNIN: Can you hear me?

22 MODERATOR LOPAS: Yes.

23 DR. CZERNIN: So my first comment would 24 be that there is a complete mix-up between therapeutic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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52 1 and diagnostic applications. When the gentleman talks 2 about nuclear cardiology and the radiotherapy he 3 completely mixed up.

4 But one issue is providing diagnostic 5 services with the therapeutic services.

6 The second one, training to become a 7 competent radiologic therapy or radionuclide therapy 8 expert it usually takes about five years in civilized 9 countries in Europe, Australia, Asia.

10 We have a situation here where pretty much 11 everyone can start treatment. My question for the 12 gentleman would be why wouldnt you propose that 13 pharmacies can provide immunotherapy services if 14 radiopharmacies can provide radionuclide therapy 15 services?

16 The second question for the gentleman would 17 be how would you deal with any radiation spill if you, 18 for instance, start treating patients with incontinent 19 patients, prostate cancer patients with nuclear tuned 20 treatment in an oncology office? How would you do this?

21 How is this done?

22 But the most important thing is this is 23 like karaoke amateur hour. These are untrained people 24 who try to start treating cancer patients. Its the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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53 1 most grotesque proposal that Ive ever heard.

2 And with that Im shutting up. Thank you.

3 MODERATOR LOPAS: Okay, thank you.

4 All right, Tara, do we have another 5 commenter on the phone?

6 OPERATOR: There are no other comments or 7 questions on the phone at this time.

8 MODERATOR LOPAS: All right. If you will 9 press star-1 or you can submit a question or comment 10 on, on the webinar using the webinar software.

11 Do we have anybody else in the room that 12 wants to speak right now? I can run the mic to you 13 if you dont feel like necessarily getting up?

14 No? Okay.

15 All right. So Im going to quickly maybe 16 while were waiting for folks if they want to make 17 additional comments, Im going to just run through I 18 have done meeting summaries from the meetings that weve 19 had in the past. We had one on November 14th and one 20 on December 11th. And the NRC publishes meeting 21 summaries within 30 days after each public meeting.

22 So Im just going to run through some of the opinions 23 and ideas and comments that we heard during those 24 previous meetings.

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54 1 And as I mentioned in the presentation, 2 if you go to regulations.gov and you search the NRC, 3 its going to be Docket Number U10, which is 4 NRC-2018-0230, you can see the comments, the written 5 comments that folks have submitted so far if youre 6 interested in seeing what people are sending to us thus 7 far.

8 So first of all, we have heard some strong 9 opposition to any reduction in teaming requirements 10 in 10 CFR 35.390; weve heard that the current 11 requirements are appropriate, that they protect the 12 safety of patients, the public, and practitioners; and 13 weve also heard that new, new therapies that are coming 14 down the pipeline are getting increasingly complex and 15 so they would require even more training perhaps than, 16 than maybe, you know, than maybe less.

17 We have heard that changing the regulations 18 and requirements could just create confusion and 19 complexity for licensees, for the NRC, and for agreement 20 states.

21 We have heard that in opposition to 22 reducing any T&E that we have to consider the 23 physicians background in the fundamentals of radiation 24 protection and radiation physics, and that training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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55 1 in radiation sciences cant simply be counted in hours, 2 especially if this is, if working with radioactive 3 materials is not part of the physicians regular job 4 duties.

5 So additional comments that weve heard 6 is some commenters have strongly supported tailored 7 team requirements, citing that we already do this for, 8 for sodium iodide administration in 35.392 and .394.

9 And commenters have supported doing this for 10 potentially other categories and classes of drugs, 11 radiopharmaceuticals.

12 They thought that, you know, for 13 administration of radiopharmaceuticals that are 14 relatively safe in their unit dose agents that they 15 thought that 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training would be overly 16 burdensome and not warranted.

17 Other comments we heard about, we heard 18 some opposition again, and opposition was stated that 19 if we lowered training and experience requirements 20 or lessened them that we could adversely affect the 21 field of nuclear medicine in general, that it wouldnt 22 encourage people to dedicate, you know, their practice 23 to that field. And potentially research and 24 development would suffer.

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56 1 Im going to move on to our next meeting 2 summary. Lets see.

3 We have heard many comments about patient 4 access, and particularly in rural areas theres an 5 issue. There was a note that, theres a shortage of 6 physicians in general in rural areas and that, you know, 7 we dont expect that thered be any difference between 8 the shortage of physicians and shortage of AUs. You 9 know, theres probably similar shortage of AUs in rural 10 areas, if not worse for AUs.

11 We have heard, and then we did hear in our 12 last meeting there was some more strong opposition to 13 kind of opening up the AU to non-physicians, that there 14 was opposition to that.

15 Im going -- I do have one comment here 16 on the webinar. Okay, I did get a request for me to 17 repeat the docket number for T&E. So the docket number, 18 Im going to pull it up on the, on the slides as well.

19 But it is NRC-2018-0230. Its right here.

20 So if you go to regulations.gov and you 21 search NRC-2018-0230 that will bring you to the 22 regulations.gov docket where it will list all the 23 comments that we received so far, written comments.

24 And we also are posting transcripts as they become NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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57 1 available.

2 So star-1 on the phone. Does anybody, 3 anybody in the room have any additional comments before 4 we go back to the phone?

5 Sure.

6 MR. GUASTELLA: This is Michael Guastella 7 again at CORAR. I think the question, I believe in 8 the ACMUI report they did comment on the safety profile 9 and history of the radiotherapy.

10 Has NRC taken into consideration that that 11 safety profile, that broad safety profile includes 12 individuals that have been grandfathered in prior to 13 the 2002 final rule? I dont know if youve ever kind 14 of taken a look at that. It may be too granular, but 15 I think its, its something to consider.

16 Thank you.

17 MS. AYOADE: Yes. Thank you for your 18 comment, question. We have not taken that into account 19 but, as you said, its something for us to consider.

20 MODERATOR LOPAS: Okay. All right, Tara, 21 are there any comments on the phone?

22 OPERATOR: Vicki LaRue, your line is open.

23 MS. LaRUE: Thank you. My name is Vicki 24 LaRue. I am a nuclear medicine advanced associate in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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58 1 Denver, Colorado. And I just wanted to reiterate a 2 couple of points that were made by my colleagues. And 3 that is the goal of the nuclear medicine advanced 4 associates, which is the nuclear medicine physician 5 extender, is to extend the services and expertise of 6 our nuclear medicine physicians and nuclear 7 radiologists while ensuring that they retain control 8 of complex clinical decisions.

9 And basically as a medical specialty in 10 general, we are trained by these physicians to perform 11 as they would perform in specific clinical scenarios.

12 So I just wanted to reiterate the fact that 13 as physician extenders we are always working under the 14 supervision of physician authorized users.

15 And that is my main goal. Thank you so 16 much.

17 MODERATOR LOPAS: All right. Thank you, 18 Vicki.

19 Star-1 on the phone. Tara, is there 20 anybody else?

21 OPERATOR: Shaemus Gleason, your line is 22 open.

23 MR. GLEASON: Thank you very much. And 24 thank you to the NRC staff for allowing us to comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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59 1 on this recent proposal.

2 Id like to just refer the staff back to 3 a letter that Bayer sent to the NRC in response to this 4 initiative 11 July, 2018. In the interests of time 5 Im not going to go through every point and subpoint 6 in there but I just want to kind of talk a little bit 7 about the appeal and how we spent a lot of time running 8 an effort developing a distribution model that we feel 9 is safe administration.

10 That distribution model is distributing 11 a product that has limited injection site reactions 12 and limited adverse events associated with the therapy.

13 These patients are dosed every four weeks and are 14 immediately releasable patients.

15 And in spite of all of this, and in spite 16 of the fact that we have over 1,000 sites up and treating 17 patients to this day, in the market research that we 18 provided to the NRC it shows that one of the largest 19 issues we have is availability of nuclear medicine 20 physicians to do these therapies, and also hesitation 21 on the patients side that they dont want to go to 22 another physician.

23 So taking these things into account we 24 really appreciate the opportunity to comment on this.

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60 1 And I just wanted to kind of share that and kind of 2 refer you back to the documents on 11 July, 2018, which 3 I think are, you know, eliminates a lot of these issues 4 that were talked about today.

5 So thank you for your time.

6 MODERATOR LOPAS: Yes. That was Shane, 7 was that your name? Sheamus?

8 MR. GLEASON: Yes, its Sheamus Gleason.

9 And Im the head of Global Radiopharmaceutical 10 Strategic Operations at Bayer.

11 MODERATOR LOPAS: Excellent. Excellent, 12 thank you, Sheamus. I appreciate that.

13 MR. GLEASON: No problem. No problem.

14 OPERATOR: The next question or comment 15 comes from Johannes. The line is open.

16 DR. CZERNIN: Its Johannes Czernin again.

17 I completely understand why industry is 18 pushing for that. My comments to some other prior 19 comments that were made about kind of the needs 20 assessment are that we did the analyses and actually 21 came up, using data from Europe, that you need about 22 150 theranostics centers in the United States, number 23 one.

24 Secondly, if you talk about highly NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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61 1 specialized theranostics clinics, they are not 2 different from highly specialized oncology centers or 3 transplant centers. Nobody of sound mind would place 4 them all over the country. This is not the best way 5 to do medicine. Medicine should be left to 6 well-trained experts.

7 And what is proposed here is a completely 8 dumbing down of a very complex, interactive, 9 collaborative effort among many disciplines to provide 10 best patient care.

11 And, again, if you suggest the 12 radiopharmacies can do that, then why not pharmacies 13 doing chemotherapy.

14 Thats it.

15 MODERATOR LOPAS: Okay. Thank you, 16 Johannes.

17 Tara, do we have another comment or 18 question on the phone?

19 OPERATOR: We show no further comments or 20 questions at this time.

21 MODERATOR LOPAS: Okay. All right, folks 22 on the phone, star-1. We will go for a few minutes 23 long. But this will not be your last chance to get 24 in comments. Clearly we have another webinar January NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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62 1 22nd. Thats a Tuesday. Its at 10:00 a.m. Eastern 2 time, so its early for folks not on the East Coast.

3 And we also, you know, we do encourage folks 4 to submit comments, too, on the docket written. I mean, 5 of course we have your comments transcribed today but 6 its always, it is nice to get written comments as well 7 because it really allows us to carefully evaluate those, 8 too. So those can be done by regulations.gov.

9 And if you have any issues on 10 regulations.gov, please just email me. And Ill put 11 my contact information up again.

12 So star-1 on the phone. Do we have any 13 last comments here in the room?

14 All right. Donna-Beth Howe. Donna, Ill 15 bring -- Dona-Beth, Ill bring the microphone to you.

16 DR. HOWE: This is Donna-Beth Howe with 17 the Nuclear Regulatory Commission. And I would just 18 like to get a little bit of clarification on some of 19 the things weve heard today.

20 One is the proposal from UPI -- UPPI to 21 have the authorized nuclear pharmacists working in 22 coordination with a limited authorized user. I 23 understand that commercial nuclear pharmacies 24 distribute radiopharmaceuticals to rural areas. But NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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63 1 those are people transporting doses. Do you have 2 enough nuclear pharmacists to send your nuclear 3 pharmacists to each rural physician or location to be 4 active in the dispensing and the administration of the 5 radiopharmaceuticals?

6 MR. WITKOWSKI: To respond to your 7 question, I think conceivably its not going to be every 8 medical oncologist in the country whos going to try 9 to get limited authorized user status. The comments 10 from the call is that were not going to put up a 11 radiotheranostics suite in the nuclear pharmacy and 12 have the patient and doctor come there, but were 13 looking at the nuclear pharmacists. And, yes, we do 14 have enough staff to be able -- of nuclear pharmacists 15 to go onsite.

16 The therapies could be scheduled for a 17 single day of the week and it could be scheduled all 18 at the one time. But go to the site that would be 19 licensed. And potentially it could be the suite within 20 chemotherapy that could be licensed by the agreement 21 state or the NRC.

22 And the team there, the doctor would inject 23 the dose, take care of the patient. He would have an 24 understanding of the radionuclide and all these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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64 1 radiation safety aspects. And the nuclear pharmacist 2 who would dispense the individual dose in the nuclear 3 pharmacy without any complaint, and handle any type 4 of radiation safety and contamination issues, is there 5 to address that should it occur at the site.

6 Additionally, and in some areas, you could 7 have a health physicist come to help in monitoring the 8 patient. And obviously these patients would require 9 health physicists in order to keep compliance with the 10 regulations that the NRC requires on patient dose 11 recording and disposal rates and such.

12 We believe that this is not going to be 13 a widespread number of sites, that it will be areas 14 that have not been served but could be reached. A 15 nuclear pharmacist could, with the staff and our nuclear 16 pharmacist then would go on site. They would probably 17 take the does on site and work with the physician for 18 the injection.

19 DR. HOWE: Thank you. And I have one 20 question for the individual I think on the phone with 21 the advanced degree for the technologists and the 22 intermediate between the physicians and the 23 technologists.

24 We currently have at the NRC a program that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 is widespread which is the mobile nuclear medicine where 2 you have a authorized user physician and the 3 pharmaceutical goes out in a van and the technologist 4 will help administer it at the site.

5 Your, the last commenter commented is that 6 this advanced intermediate person would operate under 7 the supervision of a physician authorized user. So 8 could you possibly comment on how this would differ 9 between what youre proposing and what we currently 10 have for a mobile nuclear medicine type license?

11 MODERATOR LOPAS: Okay, Donna-Beth, lets 12 see if any of the commenters -- so I believe that was 13 Vicki spoke up about that. We also had I believe Scott.

14 And, Scott, if youd jump back on the line, 15 Id love to have the spelling of your last name.

16 And we also have Richard Siska.

17 So I dont know if Vicki, Scott, or Richard 18 would want to potentially respond to Dr. Howe. So, 19 Tara, let me know if any, if either of those three press 20 star-1 to respond.

21 OPERATOR: I do have Johannes, Scott, and 22 Vicki who are waiting to speak. Which one would you 23 like first?

24 MODERATOR LOPAS: Well start with Scott NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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66 1 and go to Vicki, and then we can go to Johannes.

2 OPERATOR: And we just had Richard as well 3 join.

4 MODERATOR LOPAS: All right.

5 OPERATOR: So, Scott, your line is open.

6 MR. DEGENHARDT: Yeah, thank you.

7 And I, I did hear most of that question.

8 I apologize, but what our program or what our 9 profession is, is again we started off as nuclear 10 medicine technologists, highly trained nuclear 11 medicine technologists who have advanced their 12 education or our education to a, you know, to a mid-level 13 status.

14 We, you know, we have the graduate level 15 didactic course work. We have a clinical internship 16 under a nuclear physician or radiologist, 24 months 17 worth of education where we study in depth radiation 18 protection, radiation biology, physics, in addition 19 to just overall patient care to function as a mid-level 20 provider, again, in this field.

21 Where we could benefit in the healthcare 22 setting is I currently work for a oncology practice 23 here in Omaha, and as our -- we have our radioactive 24 materials license, we do radiotherapy, you know, with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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67 1 Xofigo, a 1-minute administration, pretty cut and dry.

2 You know, little time as far as the administration 3 and the complexity of administration goes.

4 Now that we have seen the emergence of 5 Lutathera here in the U.S., you know, its a little 6 bit more of a complex administration. You know, 7 45-minute injection. And thats tying up our 8 authorized user and our physicians, you know, that 9 entirety. And, you know, theyre unavailable for other 10 patient care, unavailable to dictate, you know, other 11 studies during that time as their time is dedicated 12 to that patient.

13 Where a mid-level provider could certainly 14 benefit, you know, with an authorized user status or 15 limited authorized user status, again functioning under 16 the supervision of that, that physician, you know, they 17 could be that onsite provider there with that patient 18 to free up the physicians for other, other work, other 19 patients to, you know, improve patient access and, 20 honestly, improve overall patient care and safety.

21 I would like to hear what Vicki and Richard 22 would have to say about that as well. But I hope that 23 answers the question, and I appreciate the opportunity.

24 My name, again, Scott Degenhardt, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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68 1 D-E-G-E-N-H-A-R-D-T.

2 MODERATOR LOPAS: Im sorry, could you 3 spell that one more time? I just missed that. I 4 apologize, Scott.

5 MR. DEGENHARDT: No problem. Degenhardt 6 is D-E-G-E-N-H-A-R-D-T.

7 MODERATOR LOPAS: Okay, excellent.

8 All right, thank you. Okay, lets go to, 9 well go to, over to Vicki, then Richard. And, 10 Johannes, I know you are on the line. So, Vicki, well 11 hear from Vicki next.

12 Tara, is Vicki still on the line?

13 MS. LaRUE: Yes, Im here.

14 OPERATOR: Vicki, your line is open.

15 MS. LaRUE: Okay. Can you all hear me?

16 MODERATOR LOPAS: We can, yes.

17 MS. LaRUE: Okay, great.

18 If Im understanding the question 19 correctly from Dr. Howe, I believe if in a mobile service 20 where maybe an authorized user is listed on a diagnostic 21 prescription and then the technologist, say, injects 22 the tracer, thats very commonplace for any, for any 23 nuclear medicine department or for any nuclear medicine 24 radiopharmaceutical injection.

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69 1 I think what we can do as physician 2 extenders is under the supervision of the physician 3 authorized user, and functioning as an authorized user, 4 we extend the services of the therapeutic authorized 5 user and be the physical proxy.

6 As staff had mentioned previously, this 7 is logistically challenging for our authorized users, 8 our therapeutic physicians to either leave the 9 department, leave the reading room. And even if its 10 going across campus or going up to the 15th floor, this 11 is kind of non-productive time for them if there isnt 12 a clinical emergency. Naturally, the physicians take 13 care of all the complex clinical decisions of this.

14 Thus, the physical proxy being the 15 physicians extender, as we have been trained by these 16 physicians, then we can hopefully take a little bit 17 of burden off of them. And whether its going up to 18 the 15th floor or across campus or across town, then 19 we can certainly extend the services of the nuclear 20 medicine physician or nuclear radiologist by being a 21 physical proxy and, again, being the physician 22 extender. This is the model. We see it in almost every 23 other medical specialty of physicians using extenders.

24 So hopefully that answers the question.

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70 1 MODERATOR LOPAS: Thank you, Vicki.

2 And, Richard Siska, are you still on the 3 line, Richard?

4 MR. SISKA: Yes, I am.

5 MODERATOR LOPAS: Anything to add?

6 MR. SISKA: I think, well, I think Vicki 7 pretty much answered the question head on.

8 Just to give an analogy, when you go to 9 your doctors office now sometimes you wont see your 10 physician, youre going to see a nurse practitioner.

11 You might see a couple of different people. You might 12 see a nurses aide, a nurse, and then the nurse 13 practitioner.

14 And what the nurse practitioner is is what 15 Vicki explained is the proxy for the physician. So 16 the physician does supervise but its a broad scope 17 of supervision. They dont have to be in the room.

18 They may not be in the building. They may not even 19 be in the same town. But theyre working in a 20 collaborative effort.

21 This is more of the design of what the 22 nuclear medicine advanced associate is. The 23 technologists do have authorized duties to inject 24 radiopharmaceuticals under the license and supervision NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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71 1 of an authorized user, whereas the NMAA could do that 2 as a proxy, like, Vicki mentioned, in a different 3 location being placed on a license that is, for 4 instance, in a rural area.

5 Im in an area that is two hours from a 6 pharmacy. I dont know if my pharmacies would have 7 licensed pharmacists to come up and sit with patients 8 on a daily or even, you know, weekly basis to do all 9 the duties that a technologist, an NMAA, and a licensed 10 pharmacist could do when you could have one person doing 11 that thats already working in that facility.

12 So to me this is kind of the role that the 13 NMAA was created for. And this would help expand our 14 duties and keep that, you know, the job duties of nuclear 15 medicine within the nuclear medicine realm. Because, 16 as other pure nuclear medicine people, I kind of think 17 its been watered down over time. And just because 18 things have happened in the past that have allowed other 19 entities to come into nuclear medicine doesnt mean 20 that they were great ideas.

21 So I, I just reiterate what Vicki and Scott 22 have said.

23 MODERATOR LOPAS: All right. Thank you, 24 Richard.

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72 1 Donna-Beth, do you have any more questions?

2 Okay.

3 All right, is Dr. Czernin still on the line, 4 Tara?

5 OPERATOR: Yes. Your line is open?

6 DR. CZERNIN: Just a few comments.

7 First of all, I have great respect for all 8 the training levels but its not the Regulatory 9 Commissions purview to decide who can practice what 10 kind of medicine. These are therapeutic, not 11 diagnostic. The highest volume of patients will be 12 prostate cancer patients within two to three years.

13 Okay.

14 Prostate cancer patients, 50 percent of 15 them will be incontinent. If you treat them with 16 radionuclides in an oncology office you will have 17 contaminations resulting, very often shutdown of rooms 18 for a certain time or period to decontaminate it.

19 So how are you going to manage that in the 20 oncology office? Its not the work flow of an oncology 21 office. It will take enormous amount of time. And 22 oncologists, by the way, are not trained even if you 23 make them authorized users, to know what they are doing 24 with radioactive treatment. Thats number one.

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73 1 The second one is I have, again, great 2 respect for all the comments, but treating patients 3 for physicians is always productive time. You may come 4 from that kind of radiology offices where you just look 5 at images.

6 Nuclear medicine comes from internal 7 medicine. And to say that we waste our time by treating 8 physicians is again a complete misrepresentation of 9 what we do in our jobs. So I would really, I really 10 urge you to respect appropriate training, competence, 11 and unique treatments for properly trained experts.

12 MODERATOR LOPAS: Okay, thank you.

13 All right, star-1 on the phone for any 14 additional comments. And we will get started to close 15 out.

16 I want to check back in the room if there 17 are any additional comments in the room?

18 Okay, Tara, Im going to check on the phone 19 one last time for any additional comments.

20 OPERATOR: We do have two. We do have two 21 commentators. Aria, your line is open.

22 DR. RAZMARIA: Hi. This is Aria Razmaria 23 speaking on behalf of training in nuclear medicine.

24 I just wanted to raise the topic about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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74 1 advanced nuclear medicine associates. Its important 2 that physician extenders are going to be in future of 3 nuclear medicine. But I think the discussion here is 4 about authorized users under whom advanced nuclear 5 medicine associates are going to be working. The 6 changes that have been discussed here really are, you 7 know, how the treatment -- the training requirements 8 are going to look like for these providers.

9 If you look at the 10 CFR Part 35.300 it 10 starts with Aphysicians who.@ But this discussion is 11 about physicians and the requirements for their 12 training.

13 And, again, the point was brought up that 14 nuclear medicine advanced associates are going to be 15 practicing under supervision of nuclear physicians or 16 nuclear radiologists. But, again, the changes that 17 are happening or being discussed are pointing out that, 18 for example, a family medicine physician could obtain 19 authorized user status, an ophthalmologist could be 20 able to obtain authorized user status by just having 21 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, two weeks of training.

22 So this is, again, this is going to be a 23 lot of responsibility thats going to be transferred 24 to nuclear medicine advanced associates. And the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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75 1 authorized user might not be a nuclear physician or 2 a nuclear radiologist.

3 So this is youre going to have to bear 4 that in mind when youre kind of looking for therapies 5 that are highly -- high side effect profiles, for 6 example, nuclear therapies. Imagine the patient goes 7 into a cardiac crisis. Its just then a matter of 8 saying the dose at the bedside and have it injected 9 like a Xofigo. By the way, Xofigo has other kind of 10 consideration of -- intensive therapy planning, what 11 succession of therapy, its just not a matter of giving 12 a dose but its a lot of thinking and clinical 13 consideration in terms of dosing and dosimetry.

14 But I can just imagine for nuclear therapy 15 a patient goes into cardiac crisis, whos going to be 16 there who -- are you going to have this authorized user 17 linkage -- authorized user that has not, you know, come 18 across a side effect profile of such therapies, 19 radioligand therapies.

20 Just bear in mind the discussions here, 21 there are two different topics, the importance of 22 nuclear medicine advanced associate and their future 23 role in nuclear medicine -- to dilute training for 24 authorized user -- another word for physicians who are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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76 1 going to be responsible directly for what therapies 2 are being administered.

3 And, again, I dont want to be in the 4 position of a nuclear medicine advanced associate that 5 runs into a very dangerous complication and who has, 6 for example, a family physician or an ophthalmologist 7 or internal medicine specialist who has never seen such 8 complications that these therapies can have and have 9 to resort to look for help from someone who doesnt 10 have that experience or that level of training.

11 So just bringing that to your attention.

12 This is a discussion here youre having is about 13 physicians who are going to be authorized users who 14 have the responsibility, the ultimate responsibility 15 what complications those therapies going to have.

16 Thank you.

17 MODERATOR LOPAS: All right. Thank you, 18 Dr. Razmaria.

19 Tara, there was another comment?

20 OPERATOR: David, your line is open.

21 MR. BURPEE: Hi. Thank you again.

22 And just to put some perspective to the 23 physicians good concerns about an authorized user and 24 the extent of training that obviously they have compared NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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77 1 to other who might not have as much.

2 I want to just paint a picture about how 3 the real world works in that in my ten states that I 4 manage the authorized users write the written 5 directive, consult with the patient, and thats really 6 about all they do.

7 The team that they work with is just as 8 responsible and does a great job. And theres been 9 no problems whatsoever.

10 So a team consists, of course, of the 11 radiation safety officers, the radiopharmacist who 12 prepares unit doses, the certified nuclear med techs, 13 the hospital clinic administrators who are responsible 14 with the licenses, and the regulatory people. They, 15 they certainly are an important part of the team that 16 makes all this happen in a very efficient and compliant 17 way.

18 Radium is being used widely in our patient 19 centers. And even in the worst case scenarios its 20 very, very easy for them to handle. And theyre 21 certainly prepared and its certainly a part of their 22 license to be ready to be prepared for any kind of 23 contingency, like a patient who might be incontinent.

24 For the radium, thats an interesting NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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78 1 situation in the product really isnt coming out in 2 urine, one, and it doesnt go past the outer layer of 3 dead cells on your skin. Its easily cleaned up with 4 your radcons, and a piece of paper clearly takes care 5 of any kind of situation. You can continue to use the 6 room because the alpha doesnt go past the piece of 7 paper.

8 So theres many levels here of concern.

9 And I think its important to understand which isotope 10 and therapies were talking about as we look at what 11 kind of level of training and experience we need.

12 So thank you.

13 MODERATOR LOPAS: Okay, thank you. And 14 that was David Burpee; correct?

15 MR. BURPEE: It is.

16 MODERATOR LOPAS: Okay, excellent.

17 Okay, star-1 on the phone. Tara, do we 18 have any additional comments on the phone?

19 OPERATOR: Yes. We do have another 20 comment from Johannes.

21 MODERATOR LOPAS: Okay.

22 DR. CZERNIN: Sorry for talking again.

23 It is absolutely true that this is a team effort. I 24 completely agree with the previous comments. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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79 1 question is only whether the commentator is aware that 2 before the directive is scheduled or the order is 3 scheduled a whole hour, 45 minutes in treatment centers 4 is spent by designing the appropriate treatment, 5 understanding whether its appropriate, and delivering 6 the correct treatment.

7 I also appreciate very much the informative 8 comments on alpha radiation. Thats, of course, 9 helpful for me to understand. But please keep in mind 10 theranostics clinics will then be run by authorized 11 users who have no idea about lutetium within a 12 relatively short time frame. And they have no idea 13 about any other therapeutic isotopes, side effects, 14 combination issues, and so on and so forth.

15 So picking Xofigo is pretty easy. But are 16 you really then limiting authorized users to just doing 17 Xofigo? Or wouldnt you, if your patients want to go 18 to a place where people really know what they are doing, 19 they are part of an integrated care team that manages 20 the patient, and dont have a pseudo-authorized user 21 just to make your, you know, make an argument that the 22 treatment is now more accessible for patients.

23 How do you make the argument for transplant 24 patients? How do you make the argument for major NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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80 1 surgery centers? How do you make the argument for chemo 2 and immunotherapy? Its just really picking and 3 choosing an argument for reasons that can only be 4 probably commercial.

5 MODERATOR LOPAS: Okay, thank you, Dr.

6 Czernin. Tara, do we have another comment on the phone?

7 OPERATOR: There are no other comments or 8 questions at this time.

9 MODERATOR LOPAS: Okay. All right, going 10 to do last call in the room for additional comments 11 in the room? Okay, hearing none, we are going to, I 12 think, close out the meeting. We will have another 13 webinar January 22nd, 10:00 a.m. The registration 14 information is on the NRC Public Meeting Website. If 15 you Google ANRC public meetings@ the meeting schedule 16 page pops right up and you should be able to find our 17 January 22nd training and experience evaluation public 18 meeting.

19 I want to thank everybody for participating 20 today. We had really great comments and a dialog, and 21 we appreciate everybodys taking their time to dial 22 in to the webinar on the bridge line and for folks to 23 come in person. We appreciate it.

24 So with that, have a great afternoon, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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81 1 everybody. Thank you so much.

2 (Whereupon, the above-entitled matter went 3 off the record at 2:37 p.m.

4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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