ML19014A270
| 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 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
(1:00 p.m.)
2 MODERATOR LOPAS: Hi, everybody. Good 3
afternoon. Welcome to the NRCs Webinar and Public 4
Meeting to Accept Comments on the staffs Evaluation 5
of Training and Experience Requirements for Different 6
Categories of Radiopharmaceuticals.
7 My name is Sarah Lopas and I am the project 8
manager for the staffs evaluation, and Im also going 9
to be giving a portion of todays presentation, and 10 facilitating.
11 Im joined here by Maryann Ayoade who is 12 a health physicist on the NRCs Medical Radiation Safety 13 Team. And she is a technical lead on the training and 14 experience evaluation.
15 And also with me is Chris Einberg. And 16 Chris is the chief of the Medical Safety and Events 17 Assessment Branch in the Office of Nuclear Material 18 Safety and Safeguards.
19 So for folks that are here today, thank 20 you for signing in. I appreciate that. You have those 21 handouts. I also want to welcome the folks on the phone 22 and joining us via the webinar.
23 And lets move on to the next slide here.
24
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So today for our agenda Chris is going to 1
give a quick welcome. Im going to follow Chris with 2
some leading information.
3 We are on Slide 3 right now for folks that 4
may be following along on the slides, maybe not 5
necessarily using the webinar.
6 Then Maryann and I will do the NRC 7
presentation. And then were going to open it up for 8
your comments. And well answer your questions as we 9
can. So theres plenty of time for comments. Theres 10 only a few people here in the room and there are about 11 20 or so of you on the phone. So thanks for calling 12 in, we appreciate you.
13 All right. So I think at this point I will 14 hand it over to Chris to give us our welcome.
15 MR. EINBERG: Okay, thank you, Sarah.
16 Good afternoon, everyone. Thank you for 17 taking the time to attend todays meeting, the folks 18 in person here at the NRC, and remotely via the bridge 19 line in the webinar.
20 Todays meeting is the third of the four 21 comment acceptance meetings that the NRC will be 22 conducting in our training and experience requirements 23 evaluations. The purpose of todays meeting is 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 twofold:
1 To provide background information on the 2
NRC staffs planned evaluation of developing tailored 3
training and experience requirements for administering 4
different categories of radiopharmaceuticals for which 5
a written directive is required in accordance with our 6
regulations in 10 CFR Part 35, which are our regulations 7
for Medical Use of Byproduct Material; and Subpart E 8
under Part 35, which covers Unsealed Byproduct 9
Material-Written Directive Required.
10 And most importantly, to listen to and 11 record your comments on this evaluation.
12 The comments we receive from the medical 13 community, the agreement states, and other stakeholders 14 are critical to the NRC staffs decision making on 15 whether our existing training and experience 16 requirements should be revised. If you do not provide 17 your comments today, we encourage you to participate 18 in one of our future comment meetings in January, or 19 submit written comments using regulations.gov by 20 January 29th, 2019.
21 Later in the presentation we will cover 22 how you can submit your written comments.
23 And now Ill hand the presentation back 24
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to Sarah Lopas.
1 MODERATOR LOPAS: Okay, just some quick 2
general meeting information.
3 I do just want to note for the folks in 4
the room the bathrooms are out the door to the left 5
and kind of around. And if we have to evacuate for 6
any reason, just follow us. Well probably head out 7
the way we came in, or there is also an emergency exit 8
over just past the bathrooms. Follow us, yes. Weve 9
got you. Trust your regulators, well guide you.
10 So if youre on the phone and logged into 11 the webinar, I do have some handouts uploaded for you, 12 the same handouts that are here in the room. So that 13 is the information paper that the staff published back 14 in late August 2018, the Federal Register notice that 15 opened up this 3-month comment period, and I also have 16 todays slides. So you can download all of those from 17 the handouts.
18 If you are on the phone and you are having 19 issues with your webinar, our slides are posted on our 20 public meeting notice. A link to our slides is included 21 in the reminder email that went out at about 12:00 p.m.
22 Eastern today. And the slides are also on the NRCs 23 T&E Evaluation webpage. So theres a few places to 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 get to the slides if you want to follow along if you 1
cant get into the webinar for some reason.
2 Lets see, what else do we have here? So 3
today were going to be referring to T&E a lot, training 4
and experience. Authorized users will often be 5
referred to as AUs. And todays meeting is being 6
transcribed by a court reporter. They are on the phone 7
with us. And we have, which I think was mentioned by 8
Tara, our Operator, but were recording this call as 9
well just as a backup. But I just want to make sure 10 everybodys aware of that.
11 So all of your comments today will be 12 captured accurately by the court reporter. And 13 comments that you speak today are given the same weight 14 as comments that you submit written. And you can, you 15 know, feel free, you dont have to resubmit your 16 comments but you certainly can. So they all have the 17 same weight.
18 All right. At this point were going to 19 go to Slide 7. And thats where Im going to ask Maryann 20 to take over for us.
21 MS. AYOADE: Great. Thank you, Sarah.
22 Today I will be presenting information on 23 an overview of the regulations on training and 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 experience for radiopharmaceuticals requiring a 1
written directive; some background on the related 2
stakeholder concerns received for this evaluation; and 3
NRCs efforts on the evaluation thus far.
4 So the current regulations on training and 5
experience for radiopharmaceuticals requiring a 6
written directive are under 10 CFR Part 35, Subpart 7
E. These training and experience requirements provide 8
three pathways that a physician may be authorized to 9
administer radiopharmaceuticals that require a written 10 directive.
11 A physician can be authorized to administer 12 these radiopharmaceuticals if they are certified by 13 a medical specialty board whose certification process 14 is recognized by the NRC or an agreement state.
15 A physician can also be authorized if they 16 satisfy the training and experience requirements via 17 an alternate pathway, which includes the completion 18 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 19 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 20 training in the relevant topic areas, as listed in the 21 regulations, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work 22 experience in the relevant areas, as listed in the 23 regulations.
24
9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I hope you guys can hear me better now.
1 Ill try to speak up a little bit more.
2 A physician can also be authorized if they 3
have been previously identified as an authorized user 4
on an NRC or agreement state license or permit.
5 And so this training and experience 6
evaluation is focused on the ultimate pathways. And 7
the NRC staff are looking into what tailored training 8
and experience requirements for limited administration 9
of certain categories of radiopharmaceuticals would 10 look like. And that is what we will be referring to 11 as a limited authorized user status.
12 Next slide.
13 So in Subpart E there are four sections 14 that pertain to training and experience requirements.
15 The first section is under 10 CFR 35.390 for training 16 for the use of all radiopharmaceuticals in Subpart E, 17 all of which require a written directive.
18 The second is under 10 CFR 35.392 for 19 training for oral administration of sodium iodide 20 iodine 131 requiring a written directive in quantities 21 less than or equal to 33 millicuries.
22 The third is under 10 CFR 35.394 for 23 training for oral administration of sodium iodide 24
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 iodine 131 requiring a written directive in quantities 1
greater than 33 millicuries.
2 And the fourth section is in 10 CFR 35.396 3
for training for parenteral administration of any 4
radiopharmaceuticals requiring a written directive.
5 So I want to point out that all these 6
sections of training and experience, including the 7
pathways for experienced authorized users already 8
listed on the license, it includes the pathways for 9
experienced authorized users that are already listed 10 on the license.
11 Also, all the sections except 10 CFR 35.396 12 include training and experience under the board 13 certification and alternate pathways. However, 10 CFR 14 35.396 is for training exclusively under the alternate 15 pathways, and it is written for the radiation 16 oncologists that are looking to become authorized 17 users. And they can do this by completing some 18 additional hours of training and experience.
19 I also want to point out that the alternate 20 training pathway under 10 CFR 35.392 and.394 is for 21 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 22 classroom and lab training. And that is relevant to 23 the type of uses for which they are seeking to be 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 authorized. Whereas the alternate training pathways 1
under 10 CFR 390 is for the physician to successfully 2
complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, which 3
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 4
training.
5 Next slide.
6 This slide provides some background 7
information on stakeholder concerns received related 8
to the training and experience requirements.
9 Since the revisions to the training and 10 experience requirements in 2002, and again in 2005, 11 stakeholders have raised concerns about the effects 12 of some of the requirements on patient access to certain 13 radiopharmaceuticals.
14 Specifically, some stakeholders have 15 asserted that the 700-hour requirement in 10 CFR 35.390 16 is overly burdensome for physicians who are not 17 certified by a medical specialty board, and that the 18 extensive requirements have resulted in a shortage of 19 authorized users, which thereby limits patients access 20 to radiopharmaceuticals.
21 As a result, in 2015 and 16, in separate 22 efforts the NRC staff as well as the NRCs Advisory 23 Committee on the Medical Uses of Isotopes, also known 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 as the ACMUI, independently reviewed the training and 1
experience requirements for the medical uses authorized 2
under Subpart E. Specifically, NRC staff reviewed the 3
regulatory basis and the comments that were received 4
on past rulemakings related to the medical use of 5
byproduct materials, and did not identify any new 6
information that would call into question the basis 7
of this existing requirements.
8 As a result, the NRC staff did not propose 9
any changes to the regulations at the time. And the 10 NRC staff is continuing to work with the ACMUI in its 11 ongoing training and experience evaluation efforts.
12 Next slide.
13 So as part of the Staff Requirements 14 Memorandum dated August 17, 2017 -- and that is publicly 15 available in ADAMS via the hyperlink that is referenced 16 on this slide -- the Commission directed the NRC staff 17 to evaluate whether it makes sense to establish tailored 18 training and experience requirements for different 19 categories of radiopharmaceuticals; evaluate how those 20 categories should be determined, such as by risk, polled 21 by T&E cards, or by delivery methods; to evaluate what 22 the appropriate training and experience requirements 23 should be for each category; and to evaluate whether 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 those requirements should be based on hours of training 1
and experience or focused more on competency.
2 Next slide.
3 In response to the Commission direction, 4
the NRC staff solicited feedback from some medical and 5
regulatory stakeholders in April and May of 2018. And 6
that evaluation, including the NRC staffs analysis 7
and feedback received of the training and experience 8
requirements in Subpart E of 10 CFR Part 35 was 9
documented in an NRC SECY paper, SECY-18-0084.
10 The result of the evaluation concluded that 11 it may be feasible to establish tailored training and 12 experience requirements with different categories of 13 radiopharmaceuticals, and to create a means of 14 authorizing the administration of certain categories 15 of radiopharmaceuticals such as the Alimited authorized 16 user@ status.
17 It also concluded that there are viable 18 options for creating a competency-based approach to 19 demonstrate acceptable training and experience 20 requirements for a limited authorized user status.
21 But, however, the staff does need to conduct more 22 extensive outreach for stakeholders in the medical 23 community, to the medical community, to the agreement 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 states, and to other members of the public before making 1
any recommendations to the Commission.
2 And this is what brings us to our current 3
evaluation today.
4 So now I will hand over back to Sarah who 5
will discuss our current evaluation efforts and how 6
you can participate.
7 MODERATOR LOPAS: Thanks, Maryann. And 8
I just want to note that the SECY that Maryann was just 9
talking about on Slide 11, thats one of the handouts 10 thats attached to your webinar.
11 So next slide is Slide 12. And the end 12 of evaluation will be a paper that were going to send 13 up to our 5-member Commission. In this paper theyre 14 going to document our reasoning recommending no changes 15 to our current T&E regulations or, if we do recommend 16 changes, we will lay out our reasoning for those changes 17 and we will also add a rulemaking plan into that paper 18 as well.
19 So this is a very simplified diagram of 20 information that were going to consider in our 21 development of the recommendation to the Commission.
22 The diagram illustrates why the comment period is so 23 important. And thats because in large part the 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 feedback that we received is on -- that we received 1
on those questions that we asked in the Federal Register 2
notice is going to help us inform our recommendation 3
to the Commission.
4 Other important feedback will come from 5
our coordination with our co-regulator, the agreement 6
states, and the Advisory Committee on the Medical Uses 7
of Isotopes, ACMUI.
8 So in addition to the input that we received 9
from the public and the medical stakeholders, the 10 agreement states, and the ACMUI, the staff is also going 11 to look at patient access. Weve been working on 12 mapping facilities where they offer 35.300 therapies 13 in the United States. And right now we just have access 14 to NRC licensees for that data. But we do plan to go 15 out for a voluntary data request from the agreement 16 states to ask them if they can provide us that 17 information, if they have it, in kind of an easily 18 accessible form as well.
19 We use a web-based licensing database 20 system to maintain our licenses, so we are able to kind 21 of pull that information from our WBL system to help 22 us map that information. So working on that right now.
23 And the next thing that were going to start 24
16 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 looking at is were going to be looking at medical and 1
radiation safety events to determine if any of those 2
have a nexus to training and experience. So were just 3
starting that effort as well.
4 Then and were also going to start working 5
on reaching out to some international community to talk 6
to them about what kind of regulations they have for 7
training and experience.
8 So its important to note that if the staff 9
does end up recommending some sort of rulemaking that 10 we would document it in a rulemaking plan. And the 11 Commission would then proceed to vote on that rulemaking 12 plan. And that would determine whether or not the staff 13 would proceed with another Part 35 rulemaking effort.
14 And if rulemaking is recommended and 15 approved by the Commission -- and then approved by the 16 Commission, that would start the NRCs extensive 17 rulemaking process. And I am highlighting this process 18 because I think its important so that everybody 19 understands where we are in this process, you know, 20 were at the information gathering stage, you know, 21 were not in a rulemaking right now. This is, you know, 22 before we even make a determination about rulemaking.
23 The next slide is Slide 13.
24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This is the Federal Register Notice slide.
1 The Federal Register notice was published on Monday, 2
October 29th. It can be accessed at this link here.
3 You could just also do a Google search of 83 FR 54380.
4 Its also, of course, attached to your webinar too 5
as a handout. Easy enough.
6 So it announced the date of the federal 7
-- of the comment period, which ends January 29. And 8
its talking about public meetings that weve had to 9
date. We had one in November, one in December. We 10 have this one today. And then we have one final webinar 11 on January 22nd. That will be a morning webinar, 10:00 12 a.m. Eastern time, just to kind of change things up 13 because weve been doing most of these in the afternoon.
14 But, yes, and that will be a webinar only, 15 no, no in-person meeting just a webinar.
16 But most importantly, the Federal Register 17 notice asked a series of questions that we were really 18 interested in getting input on. So Im just going to 19 quickly read through these questions on the next few 20 slides just so you can understand, get a general context 21 of what we were, information that we were looking to 22 gain from comments from everybody. And note that when 23 we do open it up for comments we can go back through 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 these questions. So were just going to read through 1
them right now.
2 So Slide 14.
3 The first set of questions was asking about 4
tailored training and experience requirements. So are 5
the current pathways for obtaining AU status reasonable 6
and accessible? And are they adequate for protecting 7
public health and safety?
8 Should the NRC develop a new tailored T&E 9
pathway? And what would be the appropriate way to 10 categorize radiopharmaceuticals for tailored T&E 11 requirements? What would be those appropriate 12 requirements?
13 Should the fundamental T&E required of 14 physicians seeking limited AU status need to have the 15 same fundamental T&E required of physicians seeking 16 full AU status?
17 And how should the requirements for this 18 fundamental community be structured for a specific 19 category of radiopharmaceuticals?
20 On the next slide we have Section B, which 21 is talking about the NRCs recognition of medical 22 specialty boards.
23 And the current boards in our current 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 process is located on the NRCs Medical Toolkit Website.
1 But our questions are:
2 What boards other than those already 3
recognized by the NRC could be considered for 4
recognition for medical uses under 10 CFR 35.300?
5 And, are the current NRC medical specialty 6
board recognition criteria sufficient? If not, what 7
additional criteria should the NRC use?
8 Section C is getting to patient access 9
again. And we have heard some comments on patient 10 access.
11 So weve been asking, we ask is there a 12 shortage in the number of AUs for medical uses under 13 10 CFR 35.300? If so, is the shortage associated with 14 the use of a specific radiopharmaceutical?
15 Are there certain geographic areas with 16 an inadequate number of AUs?
17 Do current NRC regulations on AU T&E 18 requirements unnecessarily limit patient access to 19 procedures involving radiopharmaceuticals?
20 And, do current NRC regulations on AU T&E 21 requirements unnecessarily limit research and 22 development in nuclear medicine?
23 And then Section D was kind of asking 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 generally about the NRCs training and experience 1
requirements overall. And these questions are 2
broader:
3 Should the NRC regulate the T&E of 4
physicians for medical uses?
5 Are there requirements in the NRCs T&E 6
regulatory framework for physicians that are non-safety 7
related?
8 And, how can the NRC transform its 9
regulatory approach for T&E while still ensuring that 10 adequate protection is maintained for workers, the 11 public, patients, and human research subjects?
12 So those are the questions. Clearly, you 13 know, were not limited, your comments are not limited 14 to just those questions. We are asking that written 15 comments come in by January 29th, 2019. The easiest 16 way to submit them is via regulations.gov.
17 This is the direct link to submit your 18 comments, but if you go to regs.gov and you just type 19 in ANRC-2018-0230" in the search bar it will pop right 20 up and it says, Comment now! So you can either upload 21 your comments with a.pdf or you can type directly in 22 the text box. Theres a couple ways to do it.
23 If you have any issues with submitting your 24
21 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 comments that way, feel free to just email me directly, 1
or email Maryann. We will make sure it gets on the 2
docket for you. Thats not a problem.
3 All the comments that we do receive and 4
our transcript are posted on regulations.gov, but 5
theres a lag for those getting posted. Its a few 6
days, so you wont see your comment immediately. It 7
will take a few days for it to pop up. But rest assured 8
we will receive it.
9 Our comments are also going to be posted 10 to ADAMS, of course, our user-friendly Agency-wide 11 Documents Access and Management System.
12 And we are, of course, going to consider 13 all of your comments, and were going to summarize them, 14 and were going to bin them and summarize them and 15 organize them. Well create kind of a comment report, 16 comment summary report that well put out that will 17 accompany our SECY paper. So, you know, this is not 18 a rulemaking so we arent going to be responding back 19 to individual comments.
20 And then we have one more public comment 21 meeting, which I mentioned. Thats on the 22nd, 22 January 22nd, 10:00 a.m. - 12:00 p.m. Eastern Time.
23 And this is a webinar only.
24
22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Slide 20 are our next steps.
1 So the public comment period ends on 2
January 29th, as I mentioned.
3 Were going to continue the evaluation of 4
the comments as they come in. Were going to finish 5
our work with our additional information regarding 6
patient access and trying to map these facilities and 7
figuring out how many AUs there are.
8 Conducting that additional research about 9
international benchmarking, and looking at medical, 10 medical events.
11 And then the ACMUI Subcommittee on Training 12 and Experience is going to provide their report to us 13 on March 8. So there will be a public teleconference 14 on that report probably sometime later in March. So 15 we will, we will notice that on our public meeting notice 16 and send notice of that meeting on our medical listserv.
17 So if youre not on our medical listserv, get on that.
18 So well be looking, looking forward to 19 that input from the ACMUI.
20 And then later on in the process, after 21 we come up with our draft paper, we will be providing 22 that to the agreement states and the ACMUI for them 23 to review the draft paper ahead of time and to provide 24
23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 their input and comments on that paper.
1 We will take their comments in, you know, 2
revise the paper as needed, and finalize it and give 3
it to the Commission in the fall of 2019.
4 And so for more information you can, of 5
course, contact myself or Maryann. Im more kind of 6
the project manager person. If you have more kind of 7
process questions, thats for me. If you have more 8
regulations type questions, technical questions, 9
contact Maryann. Shes our technical lead.
10 Our website, I am striving to maintain the 11 website with, you know, our meeting summaries, links 12 to the transcripts for past meetings, things like that.
13 So thats the T&E website.
14 Of course the T&E docket on 15 regulations.gov, that will, that will show everybodys 16 comments, so you can see what people have submitted 17 so far if youre interested in that.
18 And with that, thats the end of our 19 presentation. So finished up pretty quickly, 1:25.
20 I want to -- well start here with comments in the room.
21 Everybody has to use a microphone. So I can run this 22 mic to you if you want to use this mic, or youre welcome 23 to use the podium mic if youd like to use the podium.
24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Just turn it on.
1 And, so folks on the phone, just go ahead 2
and press star-1 and that will let Tara know, our 3
operator, that youre going to need your line unmuted.
4 And Im just going to ask that everybody 5
start by introducing yourself. If you have an 6
affiliation, great. You dont need to state your 7
affiliation. And just speak slowly and clearly and 8
into a microphone so that everybody can hear you on 9
the phone.
10 Were starting with a comment in the room.
11 MS. TOMLINSON: Cindy Tomlinson with 12 ASTRO. Okay, sorry. Cindy Tomlinson with ASTRO. Can 13 you, can you expand a little more on your work with 14 the Agreement States to get some of the census data 15 in terms of your timeline? So will that be done in 16 time for the ACMUI to review it or do you mean to have 17 it done in time for the paper to be done?
18 Im just curious as to where you are, what 19 the time frame is.
20 MODERATOR LOPAS: It will probably be, it 21 will definitely not probably be in time to help out 22 ACMUI. Its a voluntary request for data from the 23 agreement states.
24
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And this is Sarah Lopas speaking, for folks 1
on the phone.
2 And we have a letter that were preparing 3
to go out right now. Its kind of stuck in the process 4
because it requires Office of Management and Budget 5
Review and it is closed. So were stuck in the process.
6 We probably wont get that letter out -- I mean who 7
knows, right? -- once OMB opens back up I anticipate 8
it might be three to four weeks after that that the 9
letter would go out. And then typically we give the 10 Agreement States about 45 to 60 days to respond to 11 something like that. So it will be a little while.
12 MS. TOMLINSON: And so is your, is your 13 intent then to have this data in time then for the paper 14 to be sent up to the Commission?
15 MODERATOR LOPAS: Yeah. Oh, absolutely.
16 MS. TOMLINSON: Okay.
17 MODERATOR LOPAS: It will be in that, 18 whatever data we get from the states were going to, 19 were going to clean up and map and include it in the 20 paper to the Commission, absolutely.
21 MS. TOMLINSON: And will that data be --
22 obviously it will be public because it will be in the 23 memo to the Commission -- but will you make that data 24
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 public?
1 MODERATOR LOPAS: We will be making the 2
maps public.
3 As far as any Excel files or anything like 4
that that we get from the states, we had not planned 5
to make that public.
6 MS. TOMLINSON: And by maps -- Im sorry 7
to --
8 MODERATOR LOPAS: Yeah sure. No. Yeah.
9 MS. TOMLINSON: Im just trying to 10 understand because this is something that we are, were 11 concerned about --
12 MODERATOR LOPAS: Yes.
13 MS. TOMLINSON: -- in terms of this 14 argument that there arent enough physicians.
15 MODERATOR LOPAS: Right.
16 MS. TOMLINSON: Im trying to understand 17 if there is something maybe we can do.
18 And so -- but so the maps are they going 19 to be just, like, a map of the United States with some 20 pin drops on there saying numbers?
21 MODERATOR LOPAS: So right now -- Ill tell 22 you what we have for our maps that weve done so far 23 for the NRC, for the non-agreement states. Its maps 24
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of States. And it is literally just a pinpoint.
1 And what we are, you know, and what we are 2
doing is for -- so we have main facility locations.
3 And we -- were going to put the number of 35.300 AUs.
4 That number is going to be next to the dot. You will 5
see at that particular location there might be five 6
35.300 AUs there.
7 There are some satellite locations 8
associated with some of those licensees. We dont know 9
how many 35.300 for those locations. We do know that 10 that use is certified, that satellite location is 11 authorized to use 35.300 materials, we just dont know 12 how many AUs they might have at that particular 13 location.
14 So, yeah, youre just going to see --
15 MS. TOMLINSON: Okay.
16 MODERATOR LOPAS: -- dots on a map.
17 MS. TOMLINSON: Thank you. So if its, 18 lets just say no likely source here in this area --
19 MODERATOR LOPAS: Yes.
20 MS. TOMLINSON: -- and its INOVA, and you 21 know that INOVA has, whatever, 10 authorized users under 22 35.390, but one of them might work in, you know, the 23 Fairfax Hospital, one might be at Fair Oaks, and one 24
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 might be at wherever else, thats not going to be 1
included? Its just going to be the big total --
2 MODERATOR LOPAS: Right.
3 MS. TOMLINSON: -- because of the way 4
satellites work?
5 MODERATOR LOPAS: Right. Exactly.
6 We will have, we are going to put it over 7
population data.
8 MS. TOMLINSON: Okay. Youre using 9
census data?
10 MODERATOR LOPAS: Yeah. So we have, 11 unfortunately we only have 2010 data. Right? But it 12 will kind of, its kind of the map is sort of shaded 13 to show population density.
14 MS. TOMLINSON: Okay, great. Thank you.
15 MODERATOR LOPAS: Yep.
16 MS. AYOADE: This is Maryann from the NRC.
17 Cindy, the question is to Cindy from ASTRO.
18 If for some reason based on what we shared with you 19 today you guys have, you know, any other information 20 or things that you think might be useful to use, please 21 feel free to share --
22 MS. TOMLINSON: Okay.
23 MS. AYOADE: -- with us. Thank you.
24
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MODERATOR LOPAS: All right. Folks on the 1
phone, touch star-1. Were going to go for another 2
comment in the room here and then well open it up to 3
the, well check in on the phones. So star-1 and get 4
in line.
5 MR. GUASTELLA: This is on, correct?
6 Hi. Michael Guastella. Im the 7
Executive Director of the Council on Radionuclides and 8
Radiopharmaceuticals. And I want to thank you for the 9
opportunity today to provide public comment.
10 It is CORARs position that the current 11 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> training and experience alternate pathway 12 for physicians who want to become authorized users to 13 safely administer patient-ready alpha, beta, and 14 beta/gamma emitting isotopes, and we kind of refer to 15 those as the non-imaging radiotherapy doses, and we 16 believe the requirements right now are excessive.
17 In answer to one of the questions, Sarah, 18 that you actually had put up a little while ago -- should 19 the NRC develop a new tailored training and experience 20 pathway for physicians? -- CORAR does believe that the 21 NRC should develop a new tailored training and 22 experience pathway for specialists such as medical 23 oncologists, hematologists, and urologists.
24
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The new pathway should provide the training 1
and experience necessary to safely administer these 2
non-imaging radiotherapies with consideration to 3
several factors.
4 One, the limited role in handling these 5
radionuclides which would be dispensed and delivered 6
to them in patient-ready doses from licensed nuclear 7
pharmacies, dispensed by nuclear pharmacists, licensed 8
nuclear pharmacists. Or, as were starting to see, 9
received directly from the manufacturer in a 10 patient-ready dose container.
11 The limited role does not include, if you 12 will, the full range of activity in handling byproduct 13 material such as molybdenum technetium generators; 14 preparing, compounding, and dispensing radioactive 15 drugs; administering a wide variety of radionuclides 16 requiring written directives; interpreting nuclear 17 medicine scans; learning about imaging equipment; 18 understanding imaging quality and assurance; and other 19 important clinical skills necessary to ensure safe and 20 comprehensive care in the nuclear medicine department.
21 All these things roll into the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 22 currently.
23 Other factors for consideration include 24
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the radiological safety profiles or 1
radiopharmaceuticals containing the alpha, beta, and 2
beta/gamma emitting isotopes. These, again, are the 3
non-imaging radiotherapy doses.
4 And, finally, physician experience and 5
training in handling toxic, non-radioactive chemical 6
therapies such as cytotoxic chemotherapy imaging.
7 And why is this important? At least from, 8
from our perspective, interested medical oncologists, 9
hematologists, and urologists who wish to become 10 limited authorized users through a potential 11 needs-tailored training experience pathway will have 12 the opportunity to provide improved continuity care 13 for their patients.
14 For example, this will be very important 15 for an oncologist who wishes to closely monitor a 16 patients response to a non-imaging radiotherapy 17 treatment and quickly treat any condition or 18 complication. These clinical efforts would be 19 hampered if the patient was required to travel for 20 treatment due to an AU shortage in the geographic area 21 where the patient lives, and where he or she is receiving 22 ongoing cancer treatment.
23 Thank you very much.
24
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MODERATOR LOPAS: Thank you.
1 Tara, can I check in on the phone, has 2
anybody pressed star-1?
3 OPERATOR: Yes. We do have a comment or 4
question from Scott.
5 Your line is open.
6 MR. DEGENHARDT: Yeah, thank you. My name 7
is Scott Degenhardt. I am a nuclear medicine advanced 8
associate here in Omaha, Nebraska. I am speaking as 9
an individual. I know theres been several comments 10 that have been submitted in the comments section, but 11 I did want to bring this up to the group, too.
12 I am proposing that nuclear medicine 13 advanced associates be considered for authorized user 14 designation. And for those of you who are unfamiliar 15 with the nuclear medicine advanced associates 16 profession, or NMAA, we are credentialed, board 17 certified mid-level providers in nuclear medicine.
18 We do function under the supervision of a physician.
19 I guess for those of, for those of you who 20 are a little unfamiliar with the program. So the 21 program is a Masters level program which includes 22 graduate level didactic course work and then also a 23 24-month clinical internship designed after a nuclear 24
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 medicine residency. The NMAA student during that 1
24-month internship learns under the guidance of a, 2
you know, a nuclear medicine physician or a radiologist, 3
very similar again to a nuclear medicine residency.
4 And with that being said, authorized user 5
training and education will not be compromised. Upon 6
the completion of the program the NMAA graduate meets 7
all qualifications required under 10 CFR 35.390 to 8
become authorized users.
9 So I guess thats just a very brief and 10 condensed statement about what a nuclear medicine 11 advanced associate is and our proposal. But I guess 12 some key points are, is that throughout healthcare we 13 have seen mid-level providers improve patient access, 14 efficiency, healthcare costs, and overall patient care.
15 And I believe the nuclear medicine advanced associate 16 would be no different in the field of nuclear medicine.
17 Again, we are mid-level providers, credentialed, and 18 board certified.
19 The way our program is set up, again, we 20 would be able to address current and future authorized 21 user needs throughout the country. The didactic course 22 work is done remotely, while the clinical internship 23 is done locally at the facilities that the student is 24
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 practicing at. We wouldnt compromise the current 1
training and education set forth by the NRC. And 2
ultimately we could improve overall patient safety and 3
care while addressing the authorized user needs.
4 So I guess at that I am free to answer any 5
questions or receive any comments.
6 MS. AYOADE: Thank you, Scott. This is 7
Maryann Ayoade from NRC. I just want to clarify again 8
your comments.
9 So youre saying that NRC should consider 10 nuclear medicine technologists to be approved as 11 authorized users in our licenses. If that wasnt your 12 comment, feel free to clarify.
13 But also just wanted to point out we have 14 received some comments also for NRC to consider 15 non-physicians to be listed as authorized, as 16 authorized users. Specifically we received comments 17 on the nuclear medicine technologists as well.
18 MR. DEGENHARDT: Yes. Its not nuclear 19 medicine technologists, it would be the NMAAs, the 20 nuclear medicine advanced associates, those who have 21 undergone that, that program, that training and 22 education. So not technologists but the, again, the 23 nuclear medicine advanced associates.
24
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS. AYOADE: Okay, thank you.
1 MR. DEGENHARDT: Yes. No, thank you.
2 MODERATOR LOPAS: Okay. Tara, is there 3
anybody else on the line? Star-2 for folks on the line.
4 And you can also, if you have a short 5
comment or a question, feel free to submit it via the 6
webinar question function. I can read it aloud for 7
you if you would feel more comfortable typing something.
8 Is there anybody on the line, Tara?
9 OPERATOR: Yes. Richard, your line is 10 open.
11 MR. SISKA: Hi. My name is Richard Siska.
12 I am a nuclear medicine advanced associate and a 13 radiation safety officer in Rolla, Missouri. And Id 14 like to kind of piggyback a little bit off what Scott 15 has said.
16 And to clarify, maybe give us a little 17 perspective on where the NMAA sits at the mid-level.
18 It would be akin to a nurse practitioner as opposed 19 to a nurse. So these are people that have undergone 20 not only undergraduate work but have obtained a Masters 21 Degree in graduate work and post-graduate certification 22 through a certification board.
23 In my commenting, too, through the website 24
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Im attaching some documentation that may help further 1
for your information-gathering process that also would 2
include a content outline of the examination process 3
that NMAAs must undergo following their being awarded 4
the degree of Masters of Imaging Sciences.
5 What this does, I think, is twofold.
6 First, it utilizes a group of professionals or upcoming 7
professionals in the mid-level studies that are peer 8
into nuclear medicine. So these people were nuclear 9
medicine technologists in the beginning, so theyve 10 had all the physics training. They are familiar with 11 the biochemistry of radiopharmaceuticals. They have 12 had experience in hot labs. They have had experience 13 in radiopharmacies because thats part of the training 14 requirement. They understand the physics.
15 And although theyre not physicists, they 16 do a lot of basic training in a lot of the components 17 that physicists would do, but just not to that extent.
18 Add onto that the extra components that 19 a graduate degree person, someone who has had 20 experience, not only the training of a nuclear medicine 21 technologist, the years of experience as a nuclear 22 medicine technologist, but then going back and 23 receiving extra course work much akin to a residency 24
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that a physician would receive, just on a smaller scale.
1 And put that extra education and experience on top 2
of that, and thats what a nuclear medicine advanced 3
associate is.
4 So they would be able to provide a pure 5
understanding of what radiopharmaceuticals are. And 6
one of the previous comments had aligned it to, you 7
know, chemotoxicity. And its a good analogy but its 8
not quite the same thing because radioactivity, of 9
course, is a different animal.
10 So, you know, keeping those types of people 11 with those kind of experiences and that kind of 12 education would prevent the NRC from having to change 13 the requirements as far as training and experience, 14 which I think, you know, when we look around and were 15 looking at accreditation agencies which are separate 16 from the NRC, were seeing stricter regulations on other 17 radiation safety activities. So its kind of 18 counterintuitive to reduce training and experience on 19 activities that are actually using radioactive 20 therapies that are changing the biochemistry of someone 21 internally and reducing the requirements of radiation 22 safety and experience on that. So to me its a little 23 confusing.
24
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 But I just wanted to add that comment.
1 Thank you.
2 MODERATOR LOPAS: All right. I 3
appreciate that Mr. Siska. Thank you.
4 Tara, is there another commenter on the 5
phone?
6 OPERATOR: Yes. David, your line is open.
7 MR. BURPEE: Hi. Im Dave Burpee with 8
Bayer Pharmaceuticals. I work with Xofigo. And this 9
week the SNMMI issued an editorial in their journal.
10 And I want to make a comment about how I strongly 11 disagree with this editorial.
12 Its main initiative was to state that the 13 NRC is taking on this initiative to raise money through 14 increasing or having more authorized user licensing 15 fees. In my experience theres no such thing as a AU 16 licensing fee. Certainly there are monies from 17 applications for amendments to grants but Ive got to 18 believe that thats an incredibly small fraction of 19 the NRCs budget.
20 From my perspective this is all about 21 improving patient care. And I applaud the NRC for 22 reviewing and taking on this important need.
23 I manage ten states currently. And there 24
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 are tremendous AU availability difficulties that are 1
restricting patient care with these important 2
radiotherapies. In the last quarter alone I saw four 3
cases where there was no authorized user for years at 4
these four institutions, and thats just in the last 5
quarter in my part of the country, okay.
6 Theres many other authorized user 7
problems in the case of the large cities and the rural 8
areas. Many, many patients arent in the right network 9
to get treated at the local hospital. Many physician 10 groups and hospital groups dont play in the same 11 sandbox together and they compete. And, therefore, 12 the patients are forced to travel to get treated versus 13 going to their local hospital. Were talking hours 14 of travel with men who are sick. And its a pretty 15 tough situation.
16 So this is rather ubiquitous. And I, 17 again, applaud the NRC for taking this on.
18 In your mapping effort, I applaud that.
19 I think its going to be helpful. But if theres any 20 way of understanding who is actually treating, thats 21 one of the big problems. There might be authorized 22 users at XYZ hospital but theyre not treating for 23 various reasons from -- and, again, similar situations 24
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to overall prejudice about not wanting to use that type 1
of therapy.
2 So good luck on that. And I wish you luck 3
to help try to understand that because their license 4
is good they may not actually be treating and, 5
therefore, the community is not being served.
6 Seven hundred hours would limit all of 7
these options, if that was the only criteria for 8
defining an authorized user. So we applaud the effort 9
to look further at options. And thats what this is 10 all about is giving patients options to improve the 11 patient care.
12 So, finally, we would like from Bayers 13 perspective to allow limited licenses for interested 14 physicians competing with -- limited licensing for 15 interested physicians after completing 16 product-specific manufacturer-provided training. And 17 this should improve patient care.
18 And we thank you again for the reference.
19 Im finished. Thank you.
20 MODERATOR LOPAS: Okay, thank you.
21 OPERATOR: We show no further questions 22 or comments on the phone.
23 MODERATOR LOPAS: Okay, thank you, Tara.
24
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Were going to hear from Chris.
1 MR. EINBERG: Yes. This is Chris Einberg.
2 Thank you for bringing up the issue of how the NRC 3
is funded. And just want to provide a little 4
clarification there regarding that fact.
5 The NRC is not a self-funded agency. We 6
are funded by the Congress with the requirement that 7
we recover 90 percent of our budget through fees 8
assessed to licensees and applicants. This money is 9
returned to the U.S. Treasury, the General Fund, and 10 therefore reimburses the taxpayers for services 11 provided by the NRC civilian industry.
12 The fees do not directly benefit the 13 agency. Furthermore, the NRC issues licenses to 14 facilities and not individual physicians or authorized 15 users as the commenter indicated. This allows 16 physicians to be listed on the license and authorized 17 users -- or, Im sorry -- this allows physicians to 18 be listed on a license and authorized to use radioactive 19 material under that license.
20 Increasing the number of authorized user 21 physicians at already NRC-licensed facilities does not 22 affect the fees that the NRC receives. Although 23 increasing the number of facilities would increase the 24
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 fees that the NRC receives, NRC would have a 1
proportionate amount of additional work, in essence 2
additional inspections, enforcement, licensing 3
actions, including renewals and amendments.
4 The licensees are billed an application 5
fee under 10 CFR Part 170 and an annual fee which factors 6
in costs for material users, license renewals, 7
amendments, and inspections, under 10 CFR Part 171.
8 As such, the NRC does not have a direct incentive to 9
add new licensees.
10 MODERATOR LOPAS: Thank you, Chris. I 11 appreciate that clarification.
12 Okay, were going to go back to the room 13 here. Folks on the phone, again, you can press star-1 14 at any time and well check back in on the phone. But 15 lets go to the room here.
16 MR. WITKOWSKI: John Witkowski, President 17 of UPPI.
18 MODERATOR LOPAS: Would you please speak 19 right into the microphone. Thank you.
20 MR. WITKOWSKI: We wanted to read a 21 prepared statement for the training and authorizing 22 of authorized users.
23 UPPI sincerely appreciates the Nuclear 24
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Regulatory Commission re-engaging in efforts to 1
determine how access to medical isotopes can be expanded 2
and the Commissions outreach to seek diverse opinions 3
on the training and education required for authorized 4
users. We believe that this is a very important issue 5
and that the NRC can help to expand access to vital 6
medical tests and treatments while maintaining safety.
7 On behalf of UPPIs 83 independent 8
commercial nuclear pharmacies, leading nonprofit 9
academic medical center radiopharmacies across the 10 country which are focused on delivering prepared 11 radiopharmaceuticals, diagnostic molecular imaging, 12 and therapeutic patient care needs, we are pleased to 13 offer comments to assist the NRC in evaluating how to 14 expand access to these vital services.
15 Specifically, UPPI urges the NRC to 16 consider building upon and expanding successful dual 17 authorized user programs by teaming of an authorized 18 user nuclear pharmacist and a limited trained medical 19 oncologist in alpha and beta radiotherapies. This 20 would enable the expansion of the availability of 21 treatments and ensure that a highly trained authorized 22 user is present to ensure patient radiation safety.
23 Since the pharmacy community has played 24
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 an important role in ensuring patient safety, 1
centralized nuclear pharmacies handle the preparation 2
and dose burden for hospitals and diagnostic imaging 3
centers by dispensing and delivering just-in-time 4
radiopharmaceutical doses for patients in molecular 5
imaging and therapy.
6 UPPI members dispense 8,000 7
patient-specific doses each day. The U.S. imaging 8
community orders 50,000 patient doses daily. Across 9
the country 300 nuclear pharmacies cover metro, 10 suburban, and rural areas. Nuclear pharmacists have 11 the responsibility to deliver these individually 12 prescribed and calibrated patient-specific doses to 13 the hospitals and imaging centers.
14 The expertise and dedication of the nuclear 15 pharmacists in delivery safe patient procedures ensure 16 the safe handling of the radioactive material since 17 back in the 1970s when the Board of Pharmacy Specialties 18 began its first specialty examination in nuclear 19 pharmacy in 1978. At that time the industry created 20 and adopted self-governance, safety, and handling 21 standards and training. That training continues to 22 develop and supplements the federal and state 23 requirements that are also necessary for nuclear 24
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 pharmacist licensing.
1 We believe that there is a role for nuclear 2
pharmacists to play in this case as well. And we 3
sincerely appreciate the NRC considering utilizing 4
nuclear pharmacists to expand access.
5 Expanding patient needs for 6
radiotherapeutic use of alpha and beta measures is clear 7
and will continue to grow. Not only does there appear 8
to be a geographic imbalance of authorized users that 9
disadvantages rural patient populations, but the 10 prospect of new systemic radiotherapies and the new 11 and more advanced effective treatment options has grown 12 since the petition by pharmaceuticals in 2015 to 13 reevaluate the access to such treatment.
14 New biological approaches to utilizing 15 alpha and beta radionuclides continue to expand as new 16 therapies for prostate, breast, and other cancers are 17 developed. Administering these advanced treatments 18 will create a need for more authorized users.
19 This will put more demand on the current 20 roster of authorized users. And the NRC is smart in 21 seeking to understand future demand and utilization 22 of authorized users, anticipating when and how the 23 demand for authorized users will increase, and 24
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 proactively assessing the current pathways for training 1
and experience to meet future patient needs.
2 UPPI believes that an expanded alternative 3
pathway for training and education in the radiotherapy 4
utilization of alpha and beta measures is appropriate 5
and necessary to allow patient access to these 6
treatments, especially in rural areas. The 7
radiopharmacy as partner between manufacturers and 8
hospitals is the source of the majority of the patient 9
doses for diagnostic imaging and therapy. Nuclear 10 pharmacists have authorized user training and 11 experience and authorized user nuclear pharmacists can 12 deliver fair amounts of care.
13 The nuclear pharmacist authorized users 14 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 15 the radiation safety and protection requirements for 16 handling alpha and beta radiopharmaceuticals.
17 Specifically, there are many similarities to physician 18 AU training in regard to understanding the drugs, the 19 physiological action, and patient outcomes, along with 20 the patient and environmental safety in handling and 21 use of radioactive material.
22 For example, the 200-hour formal training 23 includes a myriad of topics related to radiation safety 24
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 as outlined in 10 CFR 35.55, Training for Nuclear 1
Pharmacists, which includes radiation physics and 2
instrumentation, radiation protection, chemistry of 3
byproduct material for medical use, radiation biology, 4
performing checks for proper operation of instruments.
5 Theres another description here, but its 6
also to determine activity of dosages and, if 7
appropriate, instruments used to measure alpha and beta 8
emitting radionuclides, using administrative controls 9
to avoid medical events in the administration of 10 byproduct materials, using procedures to prevent and 11 minimize radioactive contamination, and using proper 12 decontamination procedures.
13 In other words, the training and experience 14 expertise that a nuclear pharmacist receives to become 15 authorized users is similar to the training received 16 by physicians, and the Nuclear Safety Act section would 17 be even more rigorous than the training that the 18 physician receives.
19 Because nuclear pharmacists receive 20 similar training as doctors with regards to nuclear 21 safety that enable nuclear pharmacists to become 22 authorized users, UPPI believes that there is a way 23 for the NRC to expand access to radiopharmaceuticals 24
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 without sacrificing patient safety by establishing an 1
alternative pathway for expansion of an authorized user 2
whos administering alpha and beta radiotherapy through 3
the use of team of authorized users. That will ensure 4
the fully trained authorized user at one site to ensure 5
patient and environmental safety and the safe handling 6
of all nuclear materials, and will not sacrifice those 7
requirements but would also significantly expand the 8
number and reach of treatment options for patients.
9 This dispensing of the therapeutic doses 10 by the nuclear pharmacist has already been established 11 by the nuclear pharmacy working with the drug 12 manufacturer. Specifically, there are approximately 13 1,200 practicing nuclear pharmacist authorized users 14 through the U.S., and they are widely geographically 15 distributed.
16 For example, UPPI has members in urban 17 areas like New York and Philadelphia, but also has 18 members that cover the whole state of Florida and 19 significant parts of West Texas. This proposal would 20 expand the reach of these therapies to rural and 21 underserved areas where medical oncologists keep 22 treatment sites. Patient care and compliance with 23 successful therapeutic injections would be achieved.
24
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UPPI envisions that the team established 1
under the proposal would consider -- would consist of 2
a nuclear pharmacist authorized user on site who would 3
cover the radiation safety aspects of the procedure, 4
while a limited trained medical oncologist authorized 5
user, one that possesses lesser hours of training than 6
700, would be present for the injection or infusion 7
of the therapy and the patient care and treatment.
8 A single course was developed years ago 9
with limited training of physicians for nuclear 10 cardiology. The training hours address radiation 11 safety and protection of the patient. Under this dual 12 authorized user proposal the onsite nuclear pharmacist 13 would provide radiation safety and radiation protection 14 while the limited trained authorized user medical 15 oncologist would follow proper radiation safety 16 procedures and would care for the patient during and 17 after the dose administration.
18 UPPI believes a limited trained physician 19 teamed with a nuclear pharmacist would satisfy the NRCs 20 concern for safety and care of the patient in alpha 21 and beta radiotheranostics.
22 Tailored T&E has already been successfully 23 integrated in several practice areas, notably the use 24
50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of Y-90 microspheres in interventional radiology and 1
with brachytherapy prostate implantation with 2
radioactive seeds. UPPI has a number of members that 3
engage in this process and would be pleased to work 4
with the NRC to provide feedback to evaluate potential 5
changes to training and education.
6 This successful engagement provides a good 7
template for the NRC to evaluate as the Commission 8
considers its proposal.
9 In conclusion, UPPI urges the NRC to 10 consider implementing a dual authorized user approach 11 for alpha and beta emitters that enables an authorized 12 user nuclear pharmacist to team with a limited trained 13 medical oncologist. This approach, which has already 14 been utilized to provide some additional treatment 15 options for patients would significantly expand the 16 patient access to these important services without 17 sacrificing patient safety or requiring a complex 18 system of different training levels for the 19 administration of different treatments. As the NRC 20 has indicated they may already be contemplating.
21 We understand that this proposal could 22 create training changes for an alternative pathway for 23 training and education. And UPPI stands ready to work 24
51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 with the NRC and other professionals to evaluate and 1
fulfill those needs.
2 Thank you very much for your consideration 3
to this alternative. We look forward to answering any 4
questions that you may have.
5 MODERATOR LOPAS: All right, thank you 6
very much.
7 Any questions? All right, thank you.
8 Tara, can I check in on the phone? If 9
theres anyone on the phone, star-1 to make a comment 10 or ask a question.
11 OPERATOR: Yes. We do have a comment or 12 question from Johannes. Your line is open.
13 MODERATOR LOPAS: Hello. Are you there?
14 DR. CZERNIN: Johannes Czernin.
15 MODERATOR LOPAS: Hi. Can you speak up 16 a little bit? And could you spell your name because 17 its a little unclear.
18 DR. CZERNIN: C-Z-E-R-N-I-N.
19 MODERATOR LOPAS: Okay.
20 DR. CZERNIN: Can you hear me?
21 MODERATOR LOPAS: Yes.
22 DR. CZERNIN: So my first comment would 23 be that there is a complete mix-up between therapeutic 24
52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 and diagnostic applications. When the gentleman talks 1
about nuclear cardiology and the radiotherapy he 2
completely mixed up.
3 But one issue is providing diagnostic 4
services with the therapeutic services.
5 The second one, training to become a 6
competent radiologic therapy or radionuclide therapy 7
expert it usually takes about five years in civilized 8
countries in Europe, Australia, Asia.
9 We have a situation here where pretty much 10 everyone can start treatment. My question for the 11 gentleman would be why wouldnt you propose that 12 pharmacies can provide immunotherapy services if 13 radiopharmacies can provide radionuclide therapy 14 services?
15 The second question for the gentleman would 16 be how would you deal with any radiation spill if you, 17 for instance, start treating patients with incontinent 18 patients, prostate cancer patients with nuclear tuned 19 treatment in an oncology office? How would you do this?
20 How is this done?
21 But the most important thing is this is 22 like karaoke amateur hour. These are untrained people 23 who try to start treating cancer patients. Its the 24
53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 most grotesque proposal that Ive ever heard.
1 And with that Im shutting up. Thank you.
2 MODERATOR LOPAS: Okay, thank you.
3 All right, Tara, do we have another 4
commenter on the phone?
5 OPERATOR: There are no other comments or 6
questions on the phone at this time.
7 MODERATOR LOPAS: All right. If you will 8
press star-1 or you can submit a question or comment 9
on, on the webinar using the webinar software.
10 Do we have anybody else in the room that 11 wants to speak right now? I can run the mic to you 12 if you dont feel like necessarily getting up?
13 No? Okay.
14 All right. So Im going to quickly maybe 15 while were waiting for folks if they want to make 16 additional comments, Im going to just run through I 17 have done meeting summaries from the meetings that weve 18 had in the past. We had one on November 14th and one 19 on December 11th. And the NRC publishes meeting 20 summaries within 30 days after each public meeting.
21 So Im just going to run through some of the opinions 22 and ideas and comments that we heard during those 23 previous meetings.
24
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And as I mentioned in the presentation, 1
if you go to regulations.gov and you search the NRC, 2
its going to be Docket Number U10, which is 3
NRC-2018-0230, you can see the comments, the written 4
comments that folks have submitted so far if youre 5
interested in seeing what people are sending to us thus 6
far.
7 So first of all, we have heard some strong 8
opposition to any reduction in teaming requirements 9
in 10 CFR 35.390; weve heard that the current 10 requirements are appropriate, that they protect the 11 safety of patients, the public, and practitioners; and 12 weve also heard that new, new therapies that are coming 13 down the pipeline are getting increasingly complex and 14 so they would require even more training perhaps than, 15 than maybe, you know, than maybe less.
16 We have heard that changing the regulations 17 and requirements could just create confusion and 18 complexity for licensees, for the NRC, and for agreement 19 states.
20 We have heard that in opposition to 21 reducing any T&E that we have to consider the 22 physicians background in the fundamentals of radiation 23 protection and radiation physics, and that training 24
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 in radiation sciences cant simply be counted in hours, 1
especially if this is, if working with radioactive 2
materials is not part of the physicians regular job 3
duties.
4 So additional comments that weve heard 5
is some commenters have strongly supported tailored 6
team requirements, citing that we already do this for, 7
for sodium iodide administration in 35.392 and.394.
8 And commenters have supported doing this for 9
potentially other categories and classes of drugs, 10 radiopharmaceuticals.
11 They thought that, you know, for 12 administration of radiopharmaceuticals that are 13 relatively safe in their unit dose agents that they 14 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 15 burdensome and not warranted.
16 Other comments we heard about, we heard 17 some opposition again, and opposition was stated that 18 if we lowered training and experience requirements 19 or lessened them that we could adversely affect the 20 field of nuclear medicine in general, that it wouldnt 21 encourage people to dedicate, you know, their practice 22 to that field. And potentially research and 23 development would suffer.
24
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Im going to move on to our next meeting 1
summary. Lets see.
2 We have heard many comments about patient 3
access, and particularly in rural areas theres an 4
issue. There was a note that, theres a shortage of 5
physicians in general in rural areas and that, you know, 6
we dont expect that thered be any difference between 7
the shortage of physicians and shortage of AUs. You 8
know, theres probably similar shortage of AUs in rural 9
areas, if not worse for AUs.
10 We have heard, and then we did hear in our 11 last meeting there was some more strong opposition to 12 kind of opening up the AU to non-physicians, that there 13 was opposition to that.
14 Im going -- I do have one comment here 15 on the webinar. Okay, I did get a request for me to 16 repeat the docket number for T&E. So the docket number, 17 Im going to pull it up on the, on the slides as well.
18 But it is NRC-2018-0230. Its right here.
19 So if you go to regulations.gov and you 20 search NRC-2018-0230 that will bring you to the 21 regulations.gov docket where it will list all the 22 comments that we received so far, written comments.
23 And we also are posting transcripts as they become 24
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 available.
1 So star-1 on the phone. Does anybody, 2
anybody in the room have any additional comments before 3
we go back to the phone?
4 Sure.
5 MR. GUASTELLA: This is Michael Guastella 6
again at CORAR. I think the question, I believe in 7
the ACMUI report they did comment on the safety profile 8
and history of the radiotherapy.
9 Has NRC taken into consideration that that 10 safety profile, that broad safety profile includes 11 individuals that have been grandfathered in prior to 12 the 2002 final rule? I dont know if youve ever kind 13 of taken a look at that. It may be too granular, but 14 I think its, its something to consider.
15 Thank you.
16 MS. AYOADE: Yes. Thank you for your 17 comment, question. We have not taken that into account 18 but, as you said, its something for us to consider.
19 MODERATOR LOPAS: Okay. All right, Tara, 20 are there any comments on the phone?
21 OPERATOR: Vicki LaRue, your line is open.
22 MS. LaRUE: Thank you. My name is Vicki 23 LaRue. I am a nuclear medicine advanced associate in 24
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Denver, Colorado. And I just wanted to reiterate a 1
couple of points that were made by my colleagues. And 2
that is the goal of the nuclear medicine advanced 3
associates, which is the nuclear medicine physician 4
extender, is to extend the services and expertise of 5
our nuclear medicine physicians and nuclear 6
radiologists while ensuring that they retain control 7
of complex clinical decisions.
8 And basically as a medical specialty in 9
general, we are trained by these physicians to perform 10 as they would perform in specific clinical scenarios.
11 So I just wanted to reiterate the fact that 12 as physician extenders we are always working under the 13 supervision of physician authorized users.
14 And that is my main goal. Thank you so 15 much.
16 MODERATOR LOPAS: All right. Thank you, 17 Vicki.
18 Star-1 on the phone. Tara, is there 19 anybody else?
20 OPERATOR: Shaemus Gleason, your line is 21 open.
22 MR. GLEASON: Thank you very much. And 23 thank you to the NRC staff for allowing us to comment 24
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 on this recent proposal.
1 Id like to just refer the staff back to 2
a letter that Bayer sent to the NRC in response to this 3
initiative 11 July, 2018. In the interests of time 4
Im not going to go through every point and subpoint 5
in there but I just want to kind of talk a little bit 6
about the appeal and how we spent a lot of time running 7
an effort developing a distribution model that we feel 8
is safe administration.
9 That distribution model is distributing 10 a product that has limited injection site reactions 11 and limited adverse events associated with the therapy.
12 These patients are dosed every four weeks and are 13 immediately releasable patients.
14 And in spite of all of this, and in spite 15 of the fact that we have over 1,000 sites up and treating 16 patients to this day, in the market research that we 17 provided to the NRC it shows that one of the largest 18 issues we have is availability of nuclear medicine 19 physicians to do these therapies, and also hesitation 20 on the patients side that they dont want to go to 21 another physician.
22 So taking these things into account we 23 really appreciate the opportunity to comment on this.
24
60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And I just wanted to kind of share that and kind of 1
refer you back to the documents on 11 July, 2018, which 2
I think are, you know, eliminates a lot of these issues 3
that were talked about today.
4 So thank you for your time.
5 MODERATOR LOPAS: Yes. That was Shane, 6
was that your name? Sheamus?
7 MR. GLEASON: Yes, its Sheamus Gleason.
8 And Im the head of Global Radiopharmaceutical 9
Strategic Operations at Bayer.
10 MODERATOR LOPAS: Excellent. Excellent, 11 thank you, Sheamus. I appreciate that.
12 MR. GLEASON: No problem. No problem.
13 OPERATOR: The next question or comment 14 comes from Johannes. The line is open.
15 DR. CZERNIN: Its Johannes Czernin again.
16 I completely understand why industry is 17 pushing for that. My comments to some other prior 18 comments that were made about kind of the needs 19 assessment are that we did the analyses and actually 20 came up, using data from Europe, that you need about 21 150 theranostics centers in the United States, number 22 one.
23 Secondly, if you talk about highly 24
61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 specialized theranostics clinics, they are not 1
different from highly specialized oncology centers or 2
transplant centers. Nobody of sound mind would place 3
them all over the country. This is not the best way 4
to do medicine. Medicine should be left to 5
well-trained experts.
6 And what is proposed here is a completely 7
dumbing down of a very complex, interactive, 8
collaborative effort among many disciplines to provide 9
best patient care.
10 And, again, if you suggest the 11 radiopharmacies can do that, then why not pharmacies 12 doing chemotherapy.
13 Thats it.
14 MODERATOR LOPAS: Okay. Thank you, 15 Johannes.
16 Tara, do we have another comment or 17 question on the phone?
18 OPERATOR: We show no further comments or 19 questions at this time.
20 MODERATOR LOPAS: Okay. All right, folks 21 on the phone, star-1. We will go for a few minutes 22 long. But this will not be your last chance to get 23 in comments. Clearly we have another webinar January 24
62 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 22nd. Thats a Tuesday. Its at 10:00 a.m. Eastern 1
time, so its early for folks not on the East Coast.
2 And we also, you know, we do encourage folks 3
to submit comments, too, on the docket written. I mean, 4
of course we have your comments transcribed today but 5
its always, it is nice to get written comments as well 6
because it really allows us to carefully evaluate those, 7
too. So those can be done by regulations.gov.
8 And if you have any issues on 9
regulations.gov, please just email me. And Ill put 10 my contact information up again.
11 So star-1 on the phone. Do we have any 12 last comments here in the room?
13 All right. Donna-Beth Howe. Donna, Ill 14 bring -- Dona-Beth, Ill bring the microphone to you.
15 DR. HOWE: This is Donna-Beth Howe with 16 the Nuclear Regulatory Commission. And I would just 17 like to get a little bit of clarification on some of 18 the things weve heard today.
19 One is the proposal from UPI -- UPPI to 20 have the authorized nuclear pharmacists working in 21 coordination with a limited authorized user. I 22 understand that commercial nuclear pharmacies 23 distribute radiopharmaceuticals to rural areas. But 24
63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 those are people transporting doses. Do you have 1
enough nuclear pharmacists to send your nuclear 2
pharmacists to each rural physician or location to be 3
active in the dispensing and the administration of the 4
radiopharmaceuticals?
5 MR. WITKOWSKI: To respond to your 6
question, I think conceivably its not going to be every 7
medical oncologist in the country whos going to try 8
to get limited authorized user status. The comments 9
from the call is that were not going to put up a 10 radiotheranostics suite in the nuclear pharmacy and 11 have the patient and doctor come there, but were 12 looking at the nuclear pharmacists. And, yes, we do 13 have enough staff to be able -- of nuclear pharmacists 14 to go onsite.
15 The therapies could be scheduled for a 16 single day of the week and it could be scheduled all 17 at the one time. But go to the site that would be 18 licensed. And potentially it could be the suite within 19 chemotherapy that could be licensed by the agreement 20 state or the NRC.
21 And the team there, the doctor would inject 22 the dose, take care of the patient. He would have an 23 understanding of the radionuclide and all these 24
64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 radiation safety aspects. And the nuclear pharmacist 1
who would dispense the individual dose in the nuclear 2
pharmacy without any complaint, and handle any type 3
of radiation safety and contamination issues, is there 4
to address that should it occur at the site.
5 Additionally, and in some areas, you could 6
have a health physicist come to help in monitoring the 7
patient. And obviously these patients would require 8
health physicists in order to keep compliance with the 9
regulations that the NRC requires on patient dose 10 recording and disposal rates and such.
11 We believe that this is not going to be 12 a widespread number of sites, that it will be areas 13 that have not been served but could be reached. A 14 nuclear pharmacist could, with the staff and our nuclear 15 pharmacist then would go on site. They would probably 16 take the does on site and work with the physician for 17 the injection.
18 DR. HOWE: Thank you. And I have one 19 question for the individual I think on the phone with 20 the advanced degree for the technologists and the 21 intermediate between the physicians and the 22 technologists.
23 We currently have at the NRC a program that 24
65 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 is widespread which is the mobile nuclear medicine where 1
you have a authorized user physician and the 2
pharmaceutical goes out in a van and the technologist 3
will help administer it at the site.
4 Your, the last commenter commented is that 5
this advanced intermediate person would operate under 6
the supervision of a physician authorized user. So 7
could you possibly comment on how this would differ 8
between what youre proposing and what we currently 9
have for a mobile nuclear medicine type license?
10 MODERATOR LOPAS: Okay, Donna-Beth, lets 11 see if any of the commenters -- so I believe that was 12 Vicki spoke up about that. We also had I believe Scott.
13 And, Scott, if youd jump back on the line, 14 Id love to have the spelling of your last name.
15 And we also have Richard Siska.
16 So I dont know if Vicki, Scott, or Richard 17 would want to potentially respond to Dr. Howe. So, 18 Tara, let me know if any, if either of those three press 19 star-1 to respond.
20 OPERATOR: I do have Johannes, Scott, and 21 Vicki who are waiting to speak. Which one would you 22 like first?
23 MODERATOR LOPAS: Well start with Scott 24
66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 and go to Vicki, and then we can go to Johannes.
1 OPERATOR: And we just had Richard as well 2
join.
3 MODERATOR LOPAS: All right.
4 OPERATOR: So, Scott, your line is open.
5 MR. DEGENHARDT: Yeah, thank you.
6 And I, I did hear most of that question.
7 I apologize, but what our program or what our 8
profession is, is again we started off as nuclear 9
medicine technologists, highly trained nuclear 10 medicine technologists who have advanced their 11 education or our education to a, you know, to a mid-level 12 status.
13 We, you know, we have the graduate level 14 didactic course work. We have a clinical internship 15 under a nuclear physician or radiologist, 24 months 16 worth of education where we study in depth radiation 17 protection, radiation biology, physics, in addition 18 to just overall patient care to function as a mid-level 19 provider, again, in this field.
20 Where we could benefit in the healthcare 21 setting is I currently work for a oncology practice 22 here in Omaha, and as our -- we have our radioactive 23 materials license, we do radiotherapy, you know, with 24
67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Xofigo, a 1-minute administration, pretty cut and dry.
1 You know, little time as far as the administration 2
and the complexity of administration goes.
3 Now that we have seen the emergence of 4
Lutathera here in the U.S., you know, its a little 5
bit more of a complex administration. You know, 6
45-minute injection. And thats tying up our 7
authorized user and our physicians, you know, that 8
entirety. And, you know, theyre unavailable for other 9
patient care, unavailable to dictate, you know, other 10 studies during that time as their time is dedicated 11 to that patient.
12 Where a mid-level provider could certainly 13 benefit, you know, with an authorized user status or 14 limited authorized user status, again functioning under 15 the supervision of that, that physician, you know, they 16 could be that onsite provider there with that patient 17 to free up the physicians for other, other work, other 18 patients to, you know, improve patient access and, 19 honestly, improve overall patient care and safety.
20 I would like to hear what Vicki and Richard 21 would have to say about that as well. But I hope that 22 answers the question, and I appreciate the opportunity.
23 My name, again, Scott Degenhardt, 24
68 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 D-E-G-E-N-H-A-R-D-T.
1 MODERATOR LOPAS: Im sorry, could you 2
spell that one more time? I just missed that. I 3
apologize, Scott.
4 MR. DEGENHARDT: No problem. Degenhardt 5
is D-E-G-E-N-H-A-R-D-T.
6 MODERATOR LOPAS: Okay, excellent.
7 All right, thank you. Okay, lets go to, 8
well go to, over to Vicki, then Richard. And, 9
Johannes, I know you are on the line. So, Vicki, well 10 hear from Vicki next.
11 Tara, is Vicki still on the line?
12 MS. LaRUE: Yes, Im here.
13 OPERATOR: Vicki, your line is open.
14 MS. LaRUE: Okay. Can you all hear me?
15 MODERATOR LOPAS: We can, yes.
16 MS. LaRUE: Okay, great.
17 If Im understanding the question 18 correctly from Dr. Howe, I believe if in a mobile service 19 where maybe an authorized user is listed on a diagnostic 20 prescription and then the technologist, say, injects 21 the tracer, thats very commonplace for any, for any 22 nuclear medicine department or for any nuclear medicine 23 radiopharmaceutical injection.
24
69 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I think what we can do as physician 1
extenders is under the supervision of the physician 2
authorized user, and functioning as an authorized user, 3
we extend the services of the therapeutic authorized 4
user and be the physical proxy.
5 As staff had mentioned previously, this 6
is logistically challenging for our authorized users, 7
our therapeutic physicians to either leave the 8
department, leave the reading room. And even if its 9
going across campus or going up to the 15th floor, this 10 is kind of non-productive time for them if there isnt 11 a clinical emergency. Naturally, the physicians take 12 care of all the complex clinical decisions of this.
13 Thus, the physical proxy being the 14 physicians extender, as we have been trained by these 15 physicians, then we can hopefully take a little bit 16 of burden off of them. And whether its going up to 17 the 15th floor or across campus or across town, then 18 we can certainly extend the services of the nuclear 19 medicine physician or nuclear radiologist by being a 20 physical proxy and, again, being the physician 21 extender. This is the model. We see it in almost every 22 other medical specialty of physicians using extenders.
23 So hopefully that answers the question.
24
70 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MODERATOR LOPAS: Thank you, Vicki.
1 And, Richard Siska, are you still on the 2
line, Richard?
3 MR. SISKA: Yes, I am.
4 MODERATOR LOPAS: Anything to add?
5 MR. SISKA: I think, well, I think Vicki 6
pretty much answered the question head on.
7 Just to give an analogy, when you go to 8
your doctors office now sometimes you wont see your 9
physician, youre going to see a nurse practitioner.
10 You might see a couple of different people. You might 11 see a nurses aide, a nurse, and then the nurse 12 practitioner.
13 And what the nurse practitioner is is what 14 Vicki explained is the proxy for the physician. So 15 the physician does supervise but its a broad scope 16 of supervision. They dont have to be in the room.
17 They may not be in the building. They may not even 18 be in the same town. But theyre working in a 19 collaborative effort.
20 This is more of the design of what the 21 nuclear medicine advanced associate is. The 22 technologists do have authorized duties to inject 23 radiopharmaceuticals under the license and supervision 24
71 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of an authorized user, whereas the NMAA could do that 1
as a proxy, like, Vicki mentioned, in a different 2
location being placed on a license that is, for 3
instance, in a rural area.
4 Im in an area that is two hours from a 5
pharmacy. I dont know if my pharmacies would have 6
licensed pharmacists to come up and sit with patients 7
on a daily or even, you know, weekly basis to do all 8
the duties that a technologist, an NMAA, and a licensed 9
pharmacist could do when you could have one person doing 10 that thats already working in that facility.
11 So to me this is kind of the role that the 12 NMAA was created for. And this would help expand our 13 duties and keep that, you know, the job duties of nuclear 14 medicine within the nuclear medicine realm. Because, 15 as other pure nuclear medicine people, I kind of think 16 its been watered down over time. And just because 17 things have happened in the past that have allowed other 18 entities to come into nuclear medicine doesnt mean 19 that they were great ideas.
20 So I, I just reiterate what Vicki and Scott 21 have said.
22 MODERATOR LOPAS: All right. Thank you, 23 Richard.
24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Donna-Beth, do you have any more questions?
1 Okay.
2 All right, is Dr. Czernin still on the line, 3
Tara?
4 OPERATOR: Yes. Your line is open?
5 DR. CZERNIN: Just a few comments.
6 First of all, I have great respect for all 7
the training levels but its not the Regulatory 8
Commissions purview to decide who can practice what 9
kind of medicine. These are therapeutic, not 10 diagnostic. The highest volume of patients will be 11 prostate cancer patients within two to three years.
12 Okay.
13 Prostate cancer patients, 50 percent of 14 them will be incontinent. If you treat them with 15 radionuclides in an oncology office you will have 16 contaminations resulting, very often shutdown of rooms 17 for a certain time or period to decontaminate it.
18 So how are you going to manage that in the 19 oncology office? Its not the work flow of an oncology 20 office. It will take enormous amount of time. And 21 oncologists, by the way, are not trained even if you 22 make them authorized users, to know what they are doing 23 with radioactive treatment. Thats number one.
24
73 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The second one is I have, again, great 1
respect for all the comments, but treating patients 2
for physicians is always productive time. You may come 3
from that kind of radiology offices where you just look 4
at images.
5 Nuclear medicine comes from internal 6
medicine. And to say that we waste our time by treating 7
physicians is again a complete misrepresentation of 8
what we do in our jobs. So I would really, I really 9
urge you to respect appropriate training, competence, 10 and unique treatments for properly trained experts.
11 MODERATOR LOPAS: Okay, thank you.
12 All right, star-1 on the phone for any 13 additional comments. And we will get started to close 14 out.
15 I want to check back in the room if there 16 are any additional comments in the room?
17 Okay, Tara, Im going to check on the phone 18 one last time for any additional comments.
19 OPERATOR: We do have two. We do have two 20 commentators. Aria, your line is open.
21 DR. RAZMARIA: Hi. This is Aria Razmaria 22 speaking on behalf of training in nuclear medicine.
23 I just wanted to raise the topic about 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 advanced nuclear medicine associates. Its important 1
that physician extenders are going to be in future of 2
nuclear medicine. But I think the discussion here is 3
about authorized users under whom advanced nuclear 4
medicine associates are going to be working. The 5
changes that have been discussed here really are, you 6
know, how the treatment -- the training requirements 7
are going to look like for these providers.
8 If you look at the 10 CFR Part 35.300 it 9
starts with Aphysicians who.@ But this discussion is 10 about physicians and the requirements for their 11 training.
12 And, again, the point was brought up that 13 nuclear medicine advanced associates are going to be 14 practicing under supervision of nuclear physicians or 15 nuclear radiologists. But, again, the changes that 16 are happening or being discussed are pointing out that, 17 for example, a family medicine physician could obtain 18 authorized user status, an ophthalmologist could be 19 able to obtain authorized user status by just having 20 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, two weeks of training.
21 So this is, again, this is going to be a 22 lot of responsibility thats going to be transferred 23 to nuclear medicine advanced associates. And the 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 authorized user might not be a nuclear physician or 1
a nuclear radiologist.
2 So this is youre going to have to bear 3
that in mind when youre kind of looking for therapies 4
that are highly -- high side effect profiles, for 5
example, nuclear therapies. Imagine the patient goes 6
into a cardiac crisis. Its just then a matter of 7
saying the dose at the bedside and have it injected 8
like a Xofigo. By the way, Xofigo has other kind of 9
consideration of -- intensive therapy planning, what 10 succession of therapy, its just not a matter of giving 11 a dose but its a lot of thinking and clinical 12 consideration in terms of dosing and dosimetry.
13 But I can just imagine for nuclear therapy 14 a patient goes into cardiac crisis, whos going to be 15 there who -- are you going to have this authorized user 16 linkage -- authorized user that has not, you know, come 17 across a side effect profile of such therapies, 18 radioligand therapies.
19 Just bear in mind the discussions here, 20 there are two different topics, the importance of 21 nuclear medicine advanced associate and their future 22 role in nuclear medicine -- to dilute training for 23 authorized user -- another word for physicians who are 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 going to be responsible directly for what therapies 1
are being administered.
2 And, again, I dont want to be in the 3
position of a nuclear medicine advanced associate that 4
runs into a very dangerous complication and who has, 5
for example, a family physician or an ophthalmologist 6
or internal medicine specialist who has never seen such 7
complications that these therapies can have and have 8
to resort to look for help from someone who doesnt 9
have that experience or that level of training.
10 So just bringing that to your attention.
11 This is a discussion here youre having is about 12 physicians who are going to be authorized users who 13 have the responsibility, the ultimate responsibility 14 what complications those therapies going to have.
15 Thank you.
16 MODERATOR LOPAS: All right. Thank you, 17 Dr. Razmaria.
18 Tara, there was another comment?
19 OPERATOR: David, your line is open.
20 MR. BURPEE: Hi. Thank you again.
21 And just to put some perspective to the 22 physicians good concerns about an authorized user and 23 the extent of training that obviously they have compared 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to other who might not have as much.
1 I want to just paint a picture about how 2
the real world works in that in my ten states that I 3
manage the authorized users write the written 4
directive, consult with the patient, and thats really 5
about all they do.
6 The team that they work with is just as 7
responsible and does a great job. And theres been 8
no problems whatsoever.
9 So a team consists, of course, of the 10 radiation safety officers, the radiopharmacist who 11 prepares unit doses, the certified nuclear med techs, 12 the hospital clinic administrators who are responsible 13 with the licenses, and the regulatory people. They, 14 they certainly are an important part of the team that 15 makes all this happen in a very efficient and compliant 16 way.
17 Radium is being used widely in our patient 18 centers. And even in the worst case scenarios its 19 very, very easy for them to handle. And theyre 20 certainly prepared and its certainly a part of their 21 license to be ready to be prepared for any kind of 22 contingency, like a patient who might be incontinent.
23 For the radium, thats an interesting 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 situation in the product really isnt coming out in 1
urine, one, and it doesnt go past the outer layer of 2
dead cells on your skin. Its easily cleaned up with 3
your radcons, and a piece of paper clearly takes care 4
of any kind of situation. You can continue to use the 5
room because the alpha doesnt go past the piece of 6
paper.
7 So theres many levels here of concern.
8 And I think its important to understand which isotope 9
and therapies were talking about as we look at what 10 kind of level of training and experience we need.
11 So thank you.
12 MODERATOR LOPAS: Okay, thank you. And 13 that was David Burpee; correct?
14 MR. BURPEE: It is.
15 MODERATOR LOPAS: Okay, excellent.
16 Okay, star-1 on the phone. Tara, do we 17 have any additional comments on the phone?
18 OPERATOR: Yes. We do have another 19 comment from Johannes.
20 MODERATOR LOPAS: Okay.
21 DR. CZERNIN: Sorry for talking again.
22 It is absolutely true that this is a team effort. I 23 completely agree with the previous comments. The 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 question is only whether the commentator is aware that 1
before the directive is scheduled or the order is 2
scheduled a whole hour, 45 minutes in treatment centers 3
is spent by designing the appropriate treatment, 4
understanding whether its appropriate, and delivering 5
the correct treatment.
6 I also appreciate very much the informative 7
comments on alpha radiation. Thats, of course, 8
helpful for me to understand. But please keep in mind 9
theranostics clinics will then be run by authorized 10 users who have no idea about lutetium within a 11 relatively short time frame. And they have no idea 12 about any other therapeutic isotopes, side effects, 13 combination issues, and so on and so forth.
14 So picking Xofigo is pretty easy. But are 15 you really then limiting authorized users to just doing 16 Xofigo? Or wouldnt you, if your patients want to go 17 to a place where people really know what they are doing, 18 they are part of an integrated care team that manages 19 the patient, and dont have a pseudo-authorized user 20 just to make your, you know, make an argument that the 21 treatment is now more accessible for patients.
22 How do you make the argument for transplant 23 patients? How do you make the argument for major 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 surgery centers? How do you make the argument for chemo 1
and immunotherapy? Its just really picking and 2
choosing an argument for reasons that can only be 3
probably commercial.
4 MODERATOR LOPAS: Okay, thank you, Dr.
5 Czernin. Tara, do we have another comment on the phone?
6 OPERATOR: There are no other comments or 7
questions at this time.
8 MODERATOR LOPAS: Okay. All right, going 9
to do last call in the room for additional comments 10 in the room? Okay, hearing none, we are going to, I 11 think, close out the meeting. We will have another 12 webinar January 22nd, 10:00 a.m. The registration 13 information is on the NRC Public Meeting Website. If 14 you Google ANRC public meetings@ the meeting schedule 15 page pops right up and you should be able to find our 16 January 22nd training and experience evaluation public 17 meeting.
18 I want to thank everybody for participating 19 today. We had really great comments and a dialog, and 20 we appreciate everybodys taking their time to dial 21 in to the webinar on the bridge line and for folks to 22 come in person. We appreciate it.
23 So with that, have a great afternoon, 24
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 everybody. Thank you so much.
1 (Whereupon, the above-entitled matter went 2
off the record at 2:37 p.m.
3 4