ML19029B476
| ML19029B476 | |
| Person / Time | |
|---|---|
| Issue date: | 01/22/2019 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | |
| Sarah Lopas 301-415-6360 | |
| References | |
| NRC-0055 | |
| Download: ML19029B476 (76) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Meeting (Webinar) to Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals Docket Number:
(n/a)
Location:
Webinar Date:
Tuesday, January 22, 2019 Work Order No.:
NRC-0055 Pages 1-74 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
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PUBLIC MEETING (WEBINAR) TO ACCEPT COMMENTS ON THE NRC'S EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
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- TUESDAY, JANUARY 22, 2019
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The meeting was held via webinar at 10:00 a.m. Eastern Time.
PRESENTERS FROM THE NRC:
MARYANN AYOADE, NMSS, MSST, MSEB SARAH LOPAS, NMSS, MSST, MSEB
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CONTENTS Page Welcome and Introduction Sarah Lopas..................................4 Review Agenda and Ground rules Sarah Lopas..................................6 Presentation on the NRC's T&E Evaluation Maryann Ayoade...............................9 Sarah Lopas.................................15 Questions & Comments..............................30 Adjourn...........................................74
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P-R-O-C-E-E-D-I-N-G-S 1
(10:02 a.m.)
2 MS. LOPAS: Hi, everybody, good morning.
3 Welcome to the Nuclear Regulatory Commission's 4
webinar to accept comments on the Staff's evaluation 5
of training and experience requirements for different 6
categories of radiopharmaceuticals.
7 This is our last of four public 8
meetings/webinars that we've had on this topic. And 9
I want to remind everybody that our comment period 10 ends a week from today on Tuesday, January 29th.
11 My name is Sarah Lopas and I'm a member 12 of the NRC's Medical Radiation Safety Team, which is 13 part of the Medical Safety and Events Assessment 14 Branch in the NRCs Office of Nuclear Materials Safety 15 and Safeguard.
16 I'm the project manager for the NRCs 17 training experience evaluation and I'll be 18 facilitating today's webinar and giving part of the 19 presentation.
20 And here to help me out is Maryann Ayoade, 21 who is a health physicist in the NRCs Medical 22 Radiation Safety Team. And she is the technical lead 23 on the training and experience evaluation. So 24 Maryann will be giving part of the presentation as 25
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 well.
1 We have a short agenda for today's 2
webinar. I'll just be going over some basic 3
information about the webinar and then Maryann and I 4
will go through 15 slides that will cover background 5
information on the NRCs evaluation on training 6
experience evaluations, we're going to discuss the 7
Federal Register notice that was published on October 8
29 and then we're going to cover how you can provide 9
your written comments by that January 29th deadline, 10 if you would like to provide written comments.
11 Then we're going to open up the phone 12 lines to take your comments and any kind of process-13 type questions you have. And you can also submit 14 questions or comments via the webinar software. I'll 15 keep an eye on that.
16 The purpose of today's webinar is 17 twofold. It's to provide you background information 18 on the staff's planned evaluation of developing 19 tailored training and experience requirements for 20 administering different categories of 21 radiopharmaceuticals, for which a written directive 22 is required.
23 And that's in accordance with your 24 regulations in 10 CFR Part 35. And those are 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 regulations for medical use of byproduct material.
1 And specifically, under Subpart E, of 2
Part 35, which covers unsealed byproduct material 3
written directive required.
4 And most importantly, the reason why 5
we're here is to listen to and record your comments 6
on the evaluation. So, the comments that we received 7
from the medical community, the agreement states and 8
other stakeholders, are critical to our decision 9
making on whether our existing training and 10 experience requirements should be revised.
11 And so, if you don't provide comments 12 today, orally over the phone, just please make sure 13 you get them in. You get your written comments in 14 by regulations.gov by January 29th. That due date.
15 And I'll be going over how you can do 16 that a couple more slides from now.
17 So, for general webinar information 18 today, I want to note that if you aren't logged into 19 the webinar that's okay, there's a couple ways to get 20 our slides. You can either go to our public meeting 21 schedule web page and that provides-if you find 22 today's meeting, which should be one of the top 23 meetings listed-there's a link to our slides.
24 If you go to the NRCs T&E website, if 25
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 you just Google NRC training and experience 1
evaluation, that will bring up our T&E website.
2 And there's a link to today's slides if you scroll 3
down the page and look for today's meeting as well.
4 So, there is a couple of ways to get to 5
our slides if you're just listening in without the 6
webinar.
7 Today we're going to be discussing our 8
evaluation of training experience requirements for 9
certain categories of radiopharmaceuticals. We're 10 likely going to refer to them as, training experience, 11 as T&E for short. And also, we tend to refer to 12 authorized users, which are those physicians who are 13 authorized to administer radiopharmaceuticals, as 14 AUs.
15 So those are some terms that you'll hear 16 today.
17 And today's webinar is being transcribed 18 by a court reporter. And a full transcript of this 19 webinar will be publicly available in about a week 20 and a half or so. Or maybe we might try to get it 21 turned around a little bit quicker before the comment 22 deadline. I'll try to do that for you all.
23 And it's going to be available in the 24 NRC's agencywide Documents Access and Management 25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 System, that's ADAMS. And I'll be posting a link to 1
this transcript on the NRC's training and experience 2
website. It will also go up on regulations.gov too.
3 And you can find all of the transcripts 4
that we have for our past three public meetings on 5
that T&E website as well.
And also on 6
regulations.gov.
7 On regulations.gov, under our docket 8
there is a
category called 9
supporting documents. And that's where I've listed 10 the meeting summaries and transcripts, if you're 11 interested in what people have said during past 12 meetings.
13 And I do want to say that all the comments 14 that are spoken here today will make it on our docket 15 since they are being transcribed. And that oral and 16 written comments have equal weight. So if you don't, 17 if you've spoken your mind today and you don't feel 18 like typing it in or sending it by regulations.gov 19 afterwards, that's perfectly fine because we will get 20 it today.
21 So, right now everybody is in listen only 22 mode. And as Cedric mentioned, when Maryann and I 23 finish the presentation, that's when I'll be opening 24 the phone lines. And all you have to do is press 25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 star-1.
1 And I'll remind everybody that you do 2
need to make sure that you introduce yourself and 3
clearly state your name. And if it's a tricky name, 4
maybe spell it out for our court reporter. That's 5
vitally important so we know who is saying what.
6 So now I'm going to hand the presentation 7
over to Maryann so she can talk about our T&E 8
regulations and give you some background.
9 MS. AYOADE: Great, thank you, Sarah.
10 Good morning, everyone.
11 Today I will be presenting information on 12 an overview of the regulations on training and 13 experience for radiopharmaceuticals requirement and 14 directive, some background on the related stakeholder 15 concerns received for this evaluation and the NRC's 16 efforts on the evaluation thus far.
17 So, the current regulations on training 18 and experience for radiopharmaceuticals requiring a 19 written directive, are under 10 CFR Part 35, Subpart 20 E. These training and experience requirements 21 provide three pathways that a physician may be 22 authorized to administer radiopharmaceuticals that 23 require written directives.
24 A
physician can be authorized to 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 administer these radiopharmaceuticals if they are 1
certified by a medical specialty board. This 2
certification process is recognized by the NRC or an 3
agreement state.
4 A physician can also be authorized if 5
they've satisfied the training requirements via an 6
ultimate pathway, which includes the completion of 7
700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including a 8
minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> in classroom and laboratory 9
training in relevant topic areas as listed in the 10 regulation. And 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work 11 experience in the relevant areas as listed in the 12 regulations.
13 A physician can also be authorized if 14 they have been previously identified as an authorized 15 user on an NRC or agreement state license or permit.
16 So, this training and experience 17 evaluation is focused on the alternate pathways. And 18 the NRC staff are looking into what tailored training 19 and experience requirements, for limited 20 administration of certain categories of 21 radiopharmaceuticals would look like. And that is 22 what we will be referring to as an admitted authorized 23 user status.
24 Next slide. In Subpart E, there are four 25
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 sections that pertain to training and experience 1
requirements.
2 The first section is under 10 CFR 35.390, 3
for training for the use of all radiopharmaceuticals 4
in Subpart E. All of which require a written 5
directive.
6 The second is under 10 CFR 35.392, the 7
training for oral administration of sodium iodide, I-8 131. Requiring a writing directive in quantities 9
less than or equal to 33 millicuries.
10 The third is under 10 CFR 35.394, for 11 training for oral administration of sodium iodide, I-12 131. Requiring the writing directive in quantities 13 greater than 33 millicuries.
14 And the fourth section is in 10 CFR 15 35.396, for training for the parenteral 16 administration of any radiopharmaceuticals requiring 17 the written directive.
18 I want to point out that all of these 19 sections of training and experience, include the 20 pathways for an experienced authorized user that is 21 already listed on a license. Also, all the sections, 22 except for 10 CFR 35.396, include training and 23 experience under the board certification and ultimate 24 pathways.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 However, 10 CFR 35.396 is for training 1
exclusively under the ultimate pathways. And it is 2
really for the radiation oncologist that are looking 3
to become authorized users. And they can do this by 4
completing some additional hours of training and 5
experience.
6 I also want to point out that ultimate 7
training pathways, under 10 CFR 35.392 and 394, is 8
for the physicians to successfully complete 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> 9
of classroom and lab training that is relevant to the 10 type of use for which they are seeking to be 11 authorized.
12
- Whereas, ultimate training
- pathways, 13 under 10 CFR 35.390, is for the physician to 14 successfully complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and 15 experience, which includes 300 hours0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br /> of classroom and 16 laboratory training.
17 Next slide. So, this slide provides 18 background information on stakeholder concerns that 19 have been received related to these training and 20 experience requirements.
21 Since the revision to the training and 22 experience requirements in 2002, and again in 2005, 23 stakeholders have raised concerns about the effects 24 of some of the requirements on patient access to 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 certain therapy related pharmaceuticals.
1 Specifically, some of the stakeholders 2
have asserted that the 700 hour0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> requirements in 10 3
CFR 35.390, is overly burdensome for physicians that 4
are not certified by a medical specialty board and 5
that the extensive requirements have resulted in a 6
shortage of authorized users. Which thereby limits 7
patients access to radiopharmaceuticals.
8 As a result, in 2015 and in 2016, in 9
separate efforts to NRC Staff and the NRC's Advisory 10 Committee on the medical uses of isotopes, also known 11 as the ACMUI, independently reviewed the training and 12 experience requirements for the medical uses 13 authorizes under Subpart E.
14 Specifically, the NRC Staff has reviewed 15 the regulatory basis and comments received on past 16 rulemaking related to the medical use of byproduct 17 materials and did not identify any new information 18 that will call into question the basis of the existing 19 requirements.
20 As a result, the NRC Staff did not 21 disclose any changes to the regulations at the time.
22 And the NRC Staff is continuing to work with the ACMUI 23 in this ongoing training and experience evaluation 24 effort.
25
13 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Next slide. As part of the Staff 1
requirements memorandum dated August 17, 2017, and 2
that is publicly available in ADAMS via the hyperlink 3
that is referenced on this slide, the Commission 4
directed the NRC Staff to evaluate whether it makes 5
sense to establish tailored training and experience 6
requirements for different categories of 7
radiopharmaceuticals. It also evaluates how this 8
category should be determined.
9 So, such as the risk posed by 10 radionuclides or by delivery method. It also 11 evaluates what the training and experience 12 requirements would be for each category and to 13 evaluate whether those requirements should be based 14 on hours of training and experience or focus more on 15 competency.
16 Next slide.
In response to the 17 Commission direction, the NRC Staff obtained feedback 18 from some medical and regulatory stakeholders in 19 April and May of 2018.
20 That evaluation, including the NRC Staff 21 analysis and the feedback that was received of the 22 training and experience requirements in Subpart E of 23 10 CFR Part 35, was documented in an NRC SECY paper, 24 which is the SECY-18-0084.
25
14 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 results of that evaluation concluded 1
that it may be feasible to establish tailored training 2
and experience requirements, for different categories 3
of radiopharmaceuticals and to create a means of 4
authorizing the administration of certain categories 5
of radiopharmaceuticals, which is the limited 6
authorized user status.
7 It also concluded that there are viable 8
options for creating a competency-based approach to 9
demonstrate accessible training and experience for a 10 limited authorized user status. But, however, the 11 Staff does need to conduct more extensive outreach to 12 stakeholders in the medical community, to the 13 agreement states and to other members of the public, 14 before making a recommendation to the Commission.
15 And that is what brings us to our current 16 evaluation to date. I will now hand it back over to 17 Sarah, who will discuss our current evaluation 18 efforts and how you can participate. Next slide.
19 MS. LOPAS: Thank you, Maryann. So, the 20 end product of the NRC Staff's evaluation will be a 21 paper that we're going to send to our five-member 22 Commission.
23 And that paper is going to document the 24 results of our evaluation. Which would either be 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 maybe recommending no changes or recommending some 1
options for potential changes.
2 And, if we do recommend some options, we 3
will also have to accompany that paper with a 4
rulemaking plan.
5 On this slide, we're on Slide 11 now, 6
this is a simplified diagram of the information that 7
we're going to consider in our development of a 8
recommendation to the Commission. The diagram 9
illustrates why this comment period is so important 10 to this effort because, in large part, the feedback 11 that we receive on the questions that we've asked in 12 our Federal Register notice, are going to inform our 13 recommendation to the Commission.
14 And other important feedback will come 15 from our coordination with our co-regulators, the 16 Agreement States, and the NRC Advisory's Committee on 17 the Medical Uses of Isotopes, ACMUI as Maryann had 18 mentioned earlier.
19 In addition to the inputs we receive 20 from--
21 (Technical interference) 22 MS. LOPAS: -- the Agreements States and 23 the ACMUI, the NRC Staff is also examining the issue 24 of patient access. So, we are currently attempting 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to map NRC licensees that are licensed to use 10 CFR 1
Part 35.300 materials.
2 These are licensee facilities that could 3
potentially offer these therapeutic 4
radiopharmaceuticals. So, we're going to be mapping 5
those. And there will be a series of maps of the 6
individual states for the data that we have.
7 The NRC only has access currently to non-8 agreement states - - our licensees. And those are 9
about 13 states at the moment.
10 We are planning to issue a voluntary 11 request for information to the Agreement States for 12 their information on --
13 (Technical interference) 14 MS. LOPAS: -- for these therapies as 15 well. So that would hopefully give us a little bit 16 more complete of a picture of the --
17 (Technical interference) 18 MS. LOPAS: -- United States, depending 19 on how many Agreement States are able to respond back 20 to us and help us out with this data.
21 I will note that we are stuck a little 22 bit right now with that request. That voluntary 23 request to the Agreement States. It does need to be 24 reviewed and approved by the Office of Management and 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Budget.
1 And the Office of Management and Budget 2
is closed due to the partial Government shutdown.
3 So, at the moment, we're kind of stuck. But I would 4
hope that that letter would go out to the Agreement 5
States --
6 (Technical interference) 7 MS. LOPAS: -- maybe two to four weeks 8
after the partial shutdown ends and --
9 (Technical interference) 10 MS. LOPAS: -- everything goes back up.
11 The other things that the staff is going 12 to look at are - - we're reviewing our training and 13 experience requirements in other countries in an 14 effort to benchmark what
- other, what the 15 international community is doing with regard to 16 training and experience.
17 And then we also are reviewing - - doing 18 an extensive review of recent medical events in our 19 NMED database.
The Nuclear Materials Events 20 Database. NMED is our database that covers events 21 with nuclear materials - - to see if any medical 22 events have a nexus to training and experience.
23 So, we have to dig a little deeper into 24 those events to see if we can get to a root cause of 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 training and experience. So, those are the two 1
additional things that we're looking at. Three 2
additional things we're looking at.
3 In addition to evaluating your comments 4
5 (Technical interference) 6 MS. LOPAS: -- and what we hear from the 7
ACMUI and the Agreement States.
8 So, it's important to --
9 (Technical interference) 10 MS. LOPAS: -- is to our regulations, 11 that we would need to document, again, document that 12 in a rule making plan. And then our Commission would 13 the proceed to vote on that rulemaking plan.
14 And that would determine whether or not 15 we would move forward with another Part 35 rulemaking 16 effort. And if rulemaking is recommended and the 17 Commission approves it, that would then start our 18 extensive rulemaking process that many people are 19 familiar with.
20 And I am highlighting where we are in 21 this process so everybody understands where we are.
22 And where we are is that we're still in the 23 information gathering phase. We --
24 (Technical interference) 25
19 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. LOPAS: -- kept in mind, you know, 1
we're really at the beginning of this. And until we 2
really get all, until the public comment period ends 3
and we get everybody's comments in and we get a chance 4
to really digest them and we hear from the agreement 5
states --
6 (Technical interference) 7 MS. LOPAS: -- a path forward yet. So, 8
I just wanted to highlight that.
9 Next slide, Slide 12, covers our Federal 10 Register notice. So, that was published back on 11 Monday, October 29th. The Federal Register notice 12 can be accessed by this link.
13 And I also want to point out that there 14 are some handouts attached to the webinar. So, if 15 you click on the little handouts button on your 16 webinar, you'll see, I believe, a copy of these slides 17 that you can download if you want.
18 I have the SECY paper that Maryann 19 referenced from last August --
20 (Technical interference) 21 MS. LOPAS: -- And I also have a copy of 22 the Federal Register notice. So you can download all 23 of those documents from the --
24 (Technical interference) 25
20 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. LOPAS: -- webinar. So, the Federal 1
Register announced the comment period. It ends on, 2
a week from a today on Tuesday, January 29th.
3 And most importantly, the Federal 4
Register notice asks a series of questions on which 5
the NRC would like specific input on from the medical 6
community.
7 So, I'm going to read through those 8
questions in the next four slides just to give 9
everybody some context of kind of the information 10 that we're looking for.
11 But then, we will be opening it up to 12 public comments after I'm done here in a couple of 13 minutes. So, we can certainly walk through the 14 questions later on or however we want to do it, so, 15 don't worry, I'm just going to read through the 16 comments now, or the questions now, to put some 17 context into what we're looking to get.
18 So, Slide 13, here we are. Questions in 19 the FRN.
20 So, Part A was asking about tailored 21 training and experience. And these aren't all of our 22 questions so that's why I do encourage you to read 23 through the whole FRN, there's a lot of subparts to 24 these questions --
25
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 (Technical interference) 1 MS. LOPAS: -- You can review the FRN 2
that I've attached to the webinar and read through 3
them maybe during the comment portion of todays 4
meeting.
5 Question 1. Are the current pathways for 6
obtaining AU status reasonable and accessible, are 7
they adequate for protecting public health and 8
safety?
9 Question 2. Should the NRC develop a new 10 tailored T&E pathway? What would be the appropriate 11 way to categorize radiopharmaceuticals for tailored 12 T&E requirements?
13 Question 3. Should the fundamental T&E 14 required of physicians seeking limited AU status need 15 to have the same fundamental T&E required of 16 physicians seeking full AU status?
17 Question 4. How should the requirements 18 for this fundamental T&E be structured for a specific 19 category of radiopharmaceuticals?
20 Slide 14 goes over the NRCs recognition 21 of medical specialty force. And if you Google NRC 22 medical licensee toolkit, these procedures for 23 recognizing the medical specialty boards are on that 24 medical licensee toolkit website. But, what boards, 25
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 other than those already recognized from the NRC, 1
could be considered for recognition for medical uses 2
under 10 CFR 35.300. And those other boards are, 3
American, or the boards that we currently recognize 4
are, American Board on Nuclear Medicine, American 5
Board of Radiology, American Osteopathic Board of 6
Radiology, Certification Board of Nuclear 7
Endocrinology.
8 And two, are the current NRC medical 9
specialty board recognition criteria sufficient? If 10 not, what additional criteria should the NRC use?
11 Slide 15 goes over the patient access --
12 (Technical interference) 13 MS. LOPAS: -- perspective of folks that 14 may or may not be impacted by our regulations on 15 patient access.
16 So, is there a shortage in the number of 17 AUs for medical uses under 10 CFR 35.300? If so, is 18 the shortage associated with the use of a specific 19 radiopharmaceutical?
20 Are there certain geographic areas with 21 an inadequate number of AUs?
22 Do current NRC regulations on AU T&E 23 requirements unnecessarily limit patient access to 24 procedures involving radiopharmaceuticals?
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And, do current NRC regulations on AU T&E 1
requirements unnecessarily limit research and 2
development in nuclear medicine?
3 And we have gotten some feedback or 4
questions about, why is the NRC asking --
5 (Technical interference) 6 MS. LOPAS: -- this? And I would answer 7
that and say that, you know, we are interested in the 8
perspective of folks that are out there doing this --
9 what are the impacts that people are noticing with 10 regard to patient access?
11 You know, we have heard from some 12 physicians that, No, there is no patient access issue, 13 there are plenty of AUs out there. And then we've 14 heard from some other industry folks saying, yes, 15 we're having hard time finding AUs.
16 So, that's the kind of feedback that we'd 17 like to hear. And that's why we thought it was 18 important to include in the FRN.
19 And then Slide 16 are questions, just 20 general questions about the NRC's training and 21 experience regulations as a whole. These are kind 22 of in an effort to, for us to kind of maybe look 23 transformatively at our medical regulations with 24 regard to training and experience.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So, Question 1. Should the NRC regulate 1
the T&E of physicians for medical uses?
2 Are there requirements in the NRC's T&E 3
regulatory framework for physicians that are 4
non-safety related?
5 And how can the NRC transform its 6
regulatory approach for T&E while still ensuring that 7
adequate protection is maintained for workers, the 8
general
- public, patients, and human research 9
subjects?
10 So, those are all the questions. And 11 like I
- said, there's multiple sub-questions 12 underneath each one of these questions, so I really 13 encourage you to check out the Federal Register 14 notice.
15 So, this slide just gives you the 16 important details about submitting your written 17 comments. So, like I mentioned, January 29th, one 18 week from today at 11:59 p.m., the regs.gov portal 19 will stop accepting comments.
20 So, how do you submit comments to 21 regulations.gov? Well, you simply just go to 22 www.regulations.gov and there's a search bar will 23 popup right at the top and you just type in, NRC-24 2018-0230.
25
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 that will just bring you right to the 1
T&E page, docket page. And it's very self-2 explanatory on submitting comments.
3 This is also, that second bullet there on 4
the side is just the direct link to submit comments, 5
so that will get you there as well.
6 I do want to note that, let's see, last 7
Friday regulations.gov, I think, went down for about 8
half a day. You could not access anything on 9
regulations.gov.
10 And it was related to the Government 11 shutdown affecting a portion of the Environment 12 Protection
- Agency, which actually manages 13 regulations.gov. But it is back up and running.
14 It did come back up and running about, I 15 don't know, half way through the day on Friday. And 16 I've been told, I've been assured that it should 17 remain up and running through the rest of the comment 18 period, through January 29th.
19 Now, if you have any issues at all with 20 submitting your comments by regulations.gov, if you 21 go to log on and you can't get to it, it's shutdown 22 for some reason, you can email your comments to me or 23 Maryann. That is no problem, that's perfectly 24 acceptable.
25
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 And that's going to be the work around if 1
for some reason regulations.gov shutdowns anytime 2
between now and January 29th. But I've been checking 3
regulations.gov a few times a day, every day because 4
I'm nervous about about it, and it's so far so good.
5 Except for that one Friday. Or, I think it was 6
Thursday that it actually went down.
7 So, my contact information and Maryann's 8
contact information will be in the slide, the next 9
slide, so you'll see that. But I just want to make 10 sure that everybody knows that emailing your comments 11 to me is a perfectly fine option if regulations.gov 12 isn't working.
13 I do want to note that when you submit 14 your comment on regulations.gov, you're not going to 15 see it posted right away. It takes a few weeks.
16 But I will, I promise you that we are 17 getting it so don't worry. It sends you a little 18 confirmation that your comment has been received.
19 And we receive them.
20 It just takes a, we have an internal 21 administration, an admin type process where we have 22 to pull it down off the regulations.gov, put it into 23 our ADAMS system, so your comments will also be in 24 ADAMS, and then we re-post it back on regulations.gov.
25
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 So that's why it takes a little bit longer.
1 At the end of the comment period, so we're 2
going to be compiling all the comments, organizing 3
them, reviewing them and we'll be summarizing them.
4 And we'll be putting together a nice summary report 5
that will be attached to the paper that we send to 6
the Commission. And the summary report will 7
summarize everything we've heard from everybody.
8 And I do want to note that because this 9
is not a rulemaking, so we aren't going to responding 10 individually to comments, the comments are simply to 11 inform us. So we aren't going to be responding back 12 to your comments.
13 Okay, next slide is Slide 18. These are 14 just next steps, so this is just a basic outline.
15 So the comment period ends on January 16 29th. And then in February and March we're going to 17 be evaluating your
- comments, reviewing that 18 additional information that I talked about.
19 You know, conducting the patient access, 20 doing the patient access
- maps, looking at 21 international benchmarking and accepting medical and 22 radiation safety events. We'll be looking forward 23 to getting a draft report from the ACMUI subcommittee 24 on T&E, so hopefully we'll get that in mid-February 25
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 or so.
1 I will encourage folks to check out the 2
T&E website. And if you aren't signed up for the 3
NRC's medical Listserv please do that as well. We 4
will be having a public teleconference with the ACMUI 5
to discuss their draft subcommittee report on T&E.
6 So that may really be of interest for 7
many of you that has been on these webinars. So, 8
keep an eye out for that. It will be on our website.
9 It will be on the NRC's public meeting 10 website. It will be noted there. And also, a note 11 will go out via our medical Listserv about when that's 12 going to be happening and how you can participate in 13 that.
14 And then, once we do our draft paper, the 15 ACMUI and the agreement states will both get to review 16 that draft paper and send us back their comments.
17 There will be another ACMUI teleconference on their 18 comments on our draft sometime in the summer.
19 So, again, you would just keep an eye out 20 on the medical Listserv and the websites to see when 21 that is going to happen.
22 And then we will finalize our paper and 23 hopefully deliver it to the Commission sometime in 24 the fall. The Fall of 2019. So that's our general 25
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 schedule.
1 So, for more information, next slide, 2
Slide 19. I really encourage you to visit the T&E 3
website there. Like I said, the regulations.gov 4
page, that docket page, that shows everybody's 5
comments that they've submitted to date.
6 So if you're interested in reading 7
through some comments that people have sent in so 8
far. I also have been posting the meeting summaries 9
and transcripts there.
10 And then of course, if you have any 11 questions, you can contact me at sarah.lopas@nrc.gov.
12 As the PM I kind of can talk you through the more 13 process type questions.
14 But I encourage you to reach out to 15 Maryann Ayoade. She is the technical lead on the 16 project, so regulation type questions or have some 17 technical questions, she is who you should go to.
18 And that's it for our presentation. So, 19 before we open up the phones, I just want to remind 20 everybody that, again, we're being transcribed by the 21 court reporter so we can accurate comments for our 22 T&E docket, so please being by introducing yourself.
23 Maybe spell your name if you think it's a tricky name.
24 And speak clear.
25
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 You can press star-1 at any point, so 1
just go ahead and press star-1 if you already want to 2
jump in. And then you are also free to submit your 3
questions and comments via the chat function or the 4
question function on the webinar. I'll keep an eye 5
on that. And I can certainly read those aloud for 6
you.
7 So, star-1 on the phone. And I'll just 8
go to Cedric, if you can just let us know if anybody 9
pops on the line?
10 THE OPERATOR: Sure. And also, if you'd 11 like to ask a question, please remember to un-mute 12 your phone and record your name clearly when prompted.
13 MS. LOPAS: Star-1 for any questions or 14 comments.
15 THE OPERATOR: I'm currently showing no 16 questions in queue.
17 MS. LOPAS: All right, everybody, this 18 is your last, this is your last time to shine in 19 public, so, if you want to get on the line and tell 20 us how you feel, this is it. Otherwise make sure you 21 do submit your comments by regulations.gov. Your 22 written comments that is, by January 29th.
23 So, just press star-1. Or if you're a 24 little shy, you can type it into the webinar, and 25
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 I'll read it aloud.
1 THE OPERATOR: And our first question 2
comes from Ben Greenspan. Your line is open.
3 DR. GREENSPAN: Thank you very much. My 4
name is Dr. Ben Greenspan and I'm representing myself.
5 The bottom line of my comments is that I 6
think the NRC should not make a separate category for 7
authorized users for people who haven't gone through 8
approved board certification process and should not 9
reduce the requirements.
10 I think that physicians need to master 11 not only the previously submitted curriculum 12 submitted by the SNMMI, and I know there's also 13 curriculum by the ACMUI, and the number of other 14 features that I think I'll send in writing. I don't 15 want to read all this here.
16 But I think it's important for authorized 17 users to have the full range of competency no matter 18 which agents they are using. And there's going to 19 be a whole range of agents in the future with all 20 sort of different types of features and 21 characteristics and risk factors and so on.
22 And it's also important to understand the 23 radiation safety aspects and logistics of how we 24 receive these radiopharmaceuticals and how they 25
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 dispose of waste and all that.
1 I also wanted to say I do not know of any 2
evidence that there is an insufficient number of 3
authorized users. Nuclear medicine physicians are 4
authorized users, many nuclear radiologists are 5
authorized users and many radiation oncologists are 6
authorized users.
7 And I don't think, as a patient access 8
problem, I think the major issue here is that many 9
medical oncologists are not referring patients for 10 these procedures. And now they want to give them 11 themselves without any training, and I think that's 12 really unacceptable.
13 Another thing, another point I wanted to 14 make is, that I think competency is a better way to 15 provide documentation of expertise rather than the 16 number of hours. And there are a number of ways to 17 do that.
18 One is certification by the appropriate 19 boards, with maintenance of certification. Another 20 is accreditation of the programs that these people 21 are involved with, the departments of nuclear 22 medicine and radiation oncology or whatever.
23 And certification can be accomplished by 24 board exams, such as from the ABNM or the ABR.
25
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 Accreditation can be accomplished, and that can be 1
setup very easily.
2 And then you could also actually setup 3
proficiency testing, which would really be a good way 4
to assess the department and the qualifications and 5
expertise of the physicians.
6 And with that I think I'll quit, and I'll 7
send in some comments in writing. Thank you.
8 MS. LOPAS: All right, thank you, Dr.
9 Greenspan, I appreciate you calling in.
10 DR. GREENSPAN: Thank you.
11 MS. LOPAS: Okay. Cedric, do you have 12 anybody else on the line?
13 THE OPERATOR: Yes. The next question 14 comes from Ralph Lieto. Your line is open.
15 MS. LOPAS: Ralph.
16 MR. LIETO: Yes, thank you. My name is 17 Ralph Lieto, I'm representing myself. My question 18 for NRC Staff, in light of this big shutdown and your 19 proposed timeline that was in the slides, is this 20 timeline taking into account the delays due to the 21 shutdown or is the timeline is likely going to be 22 shifted back a little bit?
23 Because it seems like, in light of this 24 shutdown and then your attempts to get additional 25
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 information, it looks like it's overly optimistic.
1 MS. LOPAS: That's a good question, 2
Ralph. This is Sarah Lopas.
3 So, this timeline doesn't account for the 4
shutdown impacting us at all. At the moment, I don't 5
see the partial shutdown affecting us. You know, the 6
NRC is fully funded.
7 Like I said, the only thing that kind of 8
is, that were being affected right now by the shutdown 9
is the Office of Management and Budget needs to review 10 our letter to the Agreement States for that voluntary 11 information requests going out to them.
12 I don't anticipate that delay impacting 13 our overall schedule to be honest. So, we will of 14 course keep you posted.
15 The other thing that I think is minutia, 16 that I don't think really applies to much, but the 17 Office of the Federal Register is shutdown at the 18 moment. It is affecting our, the only thing I can 19 think of is it is affecting our ability, we have to 20 register, we have to notice to the Federal Register 21 when we're going to have an ACMUI public meeting, and 22 I might check with, I have a lawyer here in the room.
23 We must notice in the Federal Register 24 notice before we can have that meeting? I'm asking 25
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 somebody in our room.
1 MR. IRVIN: So, this is Ian Irvin with 2
the Office of General Counsel. I got to admit, that's 3
with another attorney --
4 MS. LOPAS: Okay. Yes.
5 MR. IRVIN: -- counsel, with what most 6
be noticed in the Federal Register.
7 MS. LOPAS: Yes.
8 MR. IRVIN: But we have received some new 9
guidance --
10 MS. LOPAS: Okay.
11 MR. IRVIN: -- about what we can publish 12 in the Federal Register.
13 MS. LOPAS: Okay.
14 MR. IRVIN: And we're still reviewing it.
15 We just received that.
16 MS. LOPAS: Yes. So, Ralph, I'll be 17 honest, I have to, if for some reason we were -- we 18 have to notice that ACMUI, A-C-M-U-I, public meeting, 19 public teleconference, ideally 15 days ahead of the 20 meeting.
21 You can, under extenuating circumstances, 22 do it like ten days or so ahead and note it's because 23 of shutdown or whatever.
24 MR. LIETO: Okay.
25
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 MS. LOPAS: If for some reason that backs 1
up that meeting, that public teleconference, that 2
might back us up a little bit. So, I can just say 3
stay tuned. If there's a delay it would be a very 4
minor delay. So, does that help?
5 MR. LIETO: Yes. I'm just really 6
concerned in the data that's going to be obtained 7
from just NRC states alone. Not that that data is 8
problematic, but I think it's not going to provide a 9
typical cross section of the AUs that are out there 10 because of the potential states that are non-11 agreement.
12 So, I think it would be tremendously 13 valuable for the NRC to obtain as much Agreement State 14 information that they're willing to provide.
15 MS. LOPAS: Yes, I would agree with that.
16 Yes. Okay, do you have any other additional 17 questions or comments, Ralph?
18 MR. LIETO: Not at this time. I'm going 19 to be providing written comments also. But I echo 20 many of the comments that Dr. Greenspan provided in 21 that I think the current T&E is an acceptable 22 methodology for assuring that the AUs are, have 23 appropriate training and experience.
24 I will make one anecdotal comment, and I 25
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 think that you have mentioned in your introductory 1
about the investigation, deeper investigation of 2
medical events in the NMED database. And I have a 3
lot of, shall I say, take it with a large grain of 4
salt that that's going to be of any value.
5 I think if you look at the ACMUI comments 6
from their own reviews annually of the NMED events 7
involving medical events. That the data there is 8
inconsistent across the states. Including the NRC 9
investigations.
10 And I was involved with these for about 11 eight years with the ACMUI. And this was a big 12 complaint that the information and investigation of 13 these events are sometimes very superficial. And 14 it's not standardized across the Agreement States 15 themselves, even relative to the NRC.
16 And I have never seen a medical event 17 reported, in the years that I have reviewed it, where 18 training experience was identified as a major cause 19 of a major contributing cause.
20 So, I am a little concerned that the NRC 21 is going to, "delve deeper" to find out if there are 22 medical events that have training and experience, 23 when that isn't even not reported in the events to 24 date. I would think that that would be a major thing 25
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 if an investigator found that in one of the states.
1 And even sort of anecdotally again, some 2
of the most highly publicized medical events over the 3
last 20 years that the NRC has been involved with, 4
training and experience was never identified as a 5
major cause.
6 So, with that I'll let other people 7
comment. Thank you for your time.
8 MS. LOPAS: Yes, thank you. Okay, star-9 1 to make a comment or ask a question or you can also 10 type a short comment or short question in your webinar 11 using your webinar software.
12 Cedric, do we have anybody else on the 13 line that would like to have their line open?
14 THE OPERATOR: Yes. The next question 15 come from Jeffrey Siegel. Your line is open.
16 MR. SIEGEL: Good morning. Thank you 17 for having this -- sorry?
18 MS. LOPAS: Good morning. Sorry.
19 MR. SIEGEL: Good morning. Thank you 20 for having this webinar and inviting comments.
21 Just a brief history before I begin with 22 my comments. I've submitted written comments on the 23 website, and I'm waiting for them to appear. It's 24 been two weeks. But I understand it takes a while.
25
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 Historically there was great reason for 1
there to be lots of T&E for physicians because most 2
agents were not supplied as a unit dosage, they had 3
to be manipulated. And hundreds of millicuries and 4
a wide variety of agents were given. And this was a 5
new field.
6
- And, the T&E requirements, from 7
historical aspects, are not necessarily germane to 8
today's supplied agents.
9
- Also, as I
understand it, T&E 10 regulations, for medical use, are only for, if 11 justified by radiation risk to patients. They have 12 nothing to do with the practice of medicine.
13 So what I'd like to say is that, first of 14 all, the FRN is talking about radiopharmaceuticals 15 categories, I think that's wrong. I think it should 16 be for specific radiopharmaceuticals. Because, 17 within a given category, not all agents pose the same 18 risk.
19 So, now for my comments. Currently 20 physicians are not free to attend limited used 21 authorization for any given radiopharmaceuticals, 22 regardless of its safety profile, as they must contain 23 full AU status pursuant to 35.390.
24 This of course is not true for limited 25
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 use authorization which is available for sodium 1
iodide. Since a physician would undoubtedly choose 2
the ultimately pathway pursuant to 392 or 394, since 3
much fewer T&E AUs are required.
4 The pathways for obtaining AU status 5
pursuant to 390 are therefore not reasonable since 6
physician desiring limited AU status for another 7
radiopharmaceutical, even if it possesses radiation 8
safety risk than oral sodium iodide, are required to 9
have the same T&E as physicians seeking full AU 10 status.
11 Tailoring, therefore, should be based on 12 use of this specific agent, not an entire category.
13 As I said, since not all radiopharmaceuticals, in any 14 given category, pose the same radiation risk.
15 And when we're talking about categories, 16 how many are there? 390 has four dosage categories.
17 The first two are all sodium iodide. Not categories 18 at all, just specific agents.
19 The last two are for parenteral 20 administration of any beta emitter or photon emitting 21 radionuclide with a photon energy less than 150 keV 22 or parenteral administration or other 23 radiopharmaceutical.
24 Therefore, this authorization for a given 25
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 category only pertains to those two categories. And 1
that's all that's currently codified.
2 So there are three choices. Specific 3
radiopharmaceuticals in these last two categories 4
should either be placed into their own requirements, 5
such as a new codified 10 CFR 35.395, if their 6
radiation safety profiles justify it or reduce T&E 7
that is appropriate and sufficient to protect 8
workers, the general public, patients, et cetera or, 9
two, they should be regulated under 35.1000 or, 10 lastly, they should remain lumped together as is.
11 Unless the first two choices are 12 implemented, the ability to attain limited AU status 13 is justified, would be entirely ruled out. NRC 14 already believes limited AU status is justified, at 15 least for oral sodium iodide.
16 NRC therefore needs to objectively, not 17 suggestively, assess the associated risks for a given 18 radiopharmaceuticals. Such an assessment should 19
- include, how is it
- supplied, its ease of 20 administration, the intended administered activity, 21 half-life and purity, radio contaminate levels, root 22 of elimination from the body, waste disposal, 23 potential dose to others, potential for internal 24 contamination and patient release issues.
25
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 Unless this assessment is not done, it 1
cannot be entirely regulated appropriately and the 2
hours necessary for ensuring safety cannot be done.
3 Reducing T&E requirements for specific 4
agents will undoubtedly increase the complexity of 5
regulatory oversight. But when justified, should be 6
of minor concern as it would be a more risk informed 7
approach and is great benefits to patients and their 8
treating physicians.
9 Restricting patients access to and 10 ability to use an FDA approved and commercially 11 available agent by imposing unwarranted and unduly 12 burden to community regulations that may not be 13 reflective of the radiation risks involved, is 14 detrimental to them and their patients.
15 Conflicts with NRC guidelines of minimizing 16 intrusion into medical judgement, as the medical use 17 policy statements say, only when justified by 18 radiation risks will such requirements be imposed, 19 and such an approach is most assuredly not risk 20 informed.
21 I thank you for listening to my comments.
22 Thank you.
23 MS. LOPAS: All right, thank you, Mr.
24 Siegel. All right, Cedric, do we have another 25
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 commenter on the line? Star-1 to get your line un-1 muted.
2 THE OPERATOR: Sure. Next question and 3
comment comes from Michele Panichi. Thank you, your 4
line is open.
5 MS. PANICHI: Good morning. How are you 6
guys doing?
7 MS. LOPAS: Good morning. Great.
8 MS. PANICHI: So, I'm going to have to 9
respectfully disagree with Dr. Siegel. I know Jeff 10 very well. He's very respected and I respect his 11 opinion.
12 However, I believe that we should not 13 change our training T&E requirements. These are 14 relatively dangerous radiopharmaceuticals that we're 15 talking about. They have long half-life's, they're 16 alpha and beta emitters.
17 And there's a reason why a written 18 directive is required. We don't consider this, you 19 know, a diagnostic 140 keV, six hour half-life kind 20 of isotope.
21 Industry is pushing primarily to sell 22 their products. That being said, they want industry 23 people to proctor physicians for this. Big mistake.
24 As soon as you allow somebody other than 25
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 a current authorized user in that category to oversee, 1
you're opening up a large can of worms.
2 In the previous webinar there was a 3
pharmacist who said that pharmacists require an 4
authorized nuclear needs 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />. Well, that's 5
not quite an accurate statement.
6 If you read the training requirements for 7
that, the 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> is to get a board certification 8
exam acknowledged by the NRC.
9 And the idea is that a nuclear pharmacist 10 can oversee radiation safety for an authorized user 11 is also not feasible. If you want to talk about a 12 shortage of physicians, there's a huge shortage of 13 nuclear pharmacists.
14 I dare say, there is a whole lot less 15 fewer nuclear pharmacists than there are authorized 16 users.
17 I don't believe there is a shortage of 18 authorized users out there. I believe that every 19 radiologist, and that radiation oncologist, now they 20 have the opportunity to become authorized users.
21 I believe the people, the physicians who 22 are pushing this, the MDECs and sometimes the 23 urologists, they're more self-serving than we would 24 like to see in a physician group. They need, want 25
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 to keep their patients in their practice. It has 1
nothing to do with the availability of an authorized 2
user.
3 And that's about it. I will be also 4
submitting my comments in writing. And that's about 5
it. Thank you.
6 MS. LOPAS: All right, thank you. Okay, 7
star-1 to have Cedric un-mute your line for you.
8 star-1. Cedric, do we have somebody up next?
9 THE OPERATOR: Yes. We have a follow-up 10 with Jeffrey Siegel. Your line is open.
11 MR. SIEGEL: Hi, since my name was 12 mentioned I must respectfully disagree with Michelle, 13 of course. Because, objectivity is what's required.
14 We can't just say, all agents are equally 15 hazardous because they are not. And if we're going 16 to follow that all radiation is risky, ALARA and LNT, 17 which I believe is not true at all, then that would 18 be true.
19 But I think we owe it to the patients and 20 the physicians and the community and everybody, to 21 have an objective assessment of each agent. And the 22 level of risk it involves. Thanks.
23 MS. LOPAS: Okay, thank you, Dr. Siegel.
24 Okay, star-1 to get in on the conversation. Cedric, 25
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 do we have anybody else in line?
1 THE OPERATOR: None currently.
2 MS. LOPAS: Okay. All right, everybody 3
star-1. We will hang on for a few minutes, but I 4
want to, let's see.
5 I'm going to go, I pulled up on the 6
webinar some of the questions, the more detailed 7
questions under A. Tailored training and experience 8
requirements.
9 You know, Dr. Siegel had mentioned that 10 he didn't think it was appropriate to categorize state 11 radiopharmaceuticals that may be, such as by their 12 type of radiation admission or characteristics 13 because not all, may be drugs within those admission 14 categories, are the same.
15 So, some other options that were 16 suggested in the FRN was to characterize 17 radiopharmaceuticals by similar delivery methods.
18 Whether it's oral, parenteral.
19 Of course, the radiation characteristics 20 or emission, alpha, beta, gamma, low-energy photon.
21 Or similar preparation methods, such as patient ready 22 doses or a combination of that.
23 So that's something that we're looking to 24 get comments on. And, Cedric, you can just interrupt 25
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 me.
1 THE OPERATOR: Sure. We do have David 2
Burpee that's on.
3 MS. LOPAS: Okay.
4 THE OPERATOR: Your line is open.
5 MR. Burpee: Good morning, everyone, 6
thank you for this opportunity and for all the good 7
comments.
8 As far as enough authorized users, I 9
think the key word is really treating authorized users 10 that have the ability to.
11 I witness, as I manage ten states for 12 license and compliance for Xofigo, numerous scenarios 13 where patients cannot be treated at even very large 14 institutions, typically due to infighting between 15 authorized users who could be treating.
16 There's a very large place in north 17 Chicago with 400 beds for four years, fought between 18 authorized users as to who could have the privileges 19 at that institution, and therefore they didn't treat 20 at all. That story is fairly ubiquitous. And it 21 goes in many directions.
22 For example, another large group needed 23 to have preceptorships and they solicited another 24 group to do that and at the end of the day the other 25
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 group decided they were competition and wouldn't sign 1
the attestation forms, and so no one was able to treat 2
at those institutions.
3 The rural situation is acute in that 4
there are not enough out there to help cover all these 5
places. And therefore in general, all these 6
scenarios require the men to travel. Men were sick 7
and don't want to travel typically.
8 So, we do need to look at how we can have 9
more options for being an authorized user.
10 I think something dawned on me recently 11 that I think is germane to this in that, if you look 12 at alpha emitters, there has never been any formal 13 trading for authorized users with alpha emitters.
14 They are very unique.
15 And Dr. Siegel's comments are right on 16 the money, that there are certainly incredibly 17 differently qualities to those products compared to 18 all beta emitters and every other types of therapy 19 that has been out there.
20 So, thanks for those considerations and 21 for this time.
22 MS. LOPAS: Sure.
23 THE OPERATOR: Thank you. We have an 24 additional comment with Ben Greenspan. Your line is 25
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 open.
1 DR. GREENSPAN: Thank you. This is Ben 2
Greenspan. I am a nuclear medicine physician and 3
radiologist and I wanted to make some comments 4
regarding some of the comments we just had.
5 First of all, I think, while there may be 6
different lists of various, of these therapeutic 7
radiopharmaceuticals, they're still potentially 8
dangerous. And I also think that many of them will 9
be given in combination. So we may give alpha 10 emitters and beta emitters with patients to various 11 cancers.
12 And therefore, the alpha's user who is 13 treating these patients really needs to know the full 14 range of the basic science and clinical expertise to 15 handle all this.
16 In terms of various physicians, I have 17 great respect for the clinical abilities of medical 18 oncologist, and urologists, but I don't think they 19 should be treating these patients by themselves.
20 I don't think they have the requisite 21 background in radiation sciences and, if they 22 actually wanted to get it all and spend whatever time 23 it took to come up to the same level as a nuclear 24 medicine physicians and radiation oncologist, then 25
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 that's fine. But I doubt any of them would.
1 As far as authorized users and patient 2
access, I'm not aware of too many places having these 3
kinds of logistical issues with infighting. I guess 4
some of them do but I don't think that's a huge issue.
5 In terms of rural areas, I don't think, 6
I think patients realize they have to travel if 7
they're in a rural area. For just about everything 8
beyond simple things.
9 So, if they want coronary bypass surgery, 10 they're not going to get it by the surgeon who does 11 one a year, they're going to go to a major medical 12 center and get one by an expert. And the same should 13 be true for treating with radiopharmaceuticals.
14 They have potential risks if they're 15 misused or there are problems. And these should be 16 provided by experts who know what they're doing, and 17 I think patients realize that. Thank you very much.
18 MS.
LOPAS:
- Okay, thank
- you, Dr.
19 Greenspan. Press star-1, again, if you want to get 20 in on the conversation.
21 I do have one question from the webinar 22 that I'm going to read aloud. So there was a question 23 about whether or not the NRC has been conducting any 24 outreach to the referring visits physician 25
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 communities, such as medical oncology, et cetera, for 1
input on this.
2 And we did send out, back when the FRN 3
first went out, we did send out the FRN and ask them 4
to provide questions to about 100 different 5
stakeholder groups. And so, a lot of the stakeholder 6
groups included, let's see, kind of professional 7
societies for urologists, for cardiologists, for 8
medical oncology.
9 So, we did do some attempt at outreach in 10 that matter. I don't know if any of those are support 11 to be on our medical Listserv, but we did reach out 12 to the professional societies. And hopefully that 13 those groups put the word out to their membership 14 that this is something that we are looking at.
15 We also, and I can't remember off hand 16 right
- now, but we did publish short little 17 advertisement type articles, less than one page or 18 so, kind of in a number of journals. Not medical 19 journals per say but kind of like newsletter monthly, 20 sort of either online or printed newsletters, for a 21 number of organizations just alerting them to these 22 public meetings and our effort and our FRN questions.
23 We did do a fair amount of outreach to 24 what we think would be those communities, those 25
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 referring physician communities. So, thank you for 1
that question, that's a good one.
2 Because we, exactly, we'd like to hear 3
from those folks as well. This is what they want to 4
be getting into.
5 Okay, Cedric, do we have anybody else on 6
the line?
7 THE OPERATOR: None currently in the 8
queue.
9 MS. LOPAS: Okay. All right, star-1 or, 10 again, submit a question or comment via the webinar, 11 we're happy to go that route.
12 Maryann and I attended recently, just 13 this past weekend, on Thursday through Saturday, 14 Maryann and I attended the Society for Nuclear 15 Medicine and Molecular Imaging, their mid-winter 16 meeting, which was in Palm Springs, which was very 17 nice. But we got a lot of good feedback from the 18 folks attending that meeting.
19 And I know some of you are on the line 20 that we saw there, so thank you for calling in and 21 we're definitely looking forward to your written 22 comments as well.
23 star-1. And, Cedric, just let me know 24 is anybody pops on the line.
25
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 THE OPERATOR: Okay.
1 MS. LOPAS: So, Question 5 here on the 2
tailored training and experience requirements.
3 Question 5 gets into, if we were to create 4
tailored T&E categories, what should those specific 5
requirements include for the classroom and lab 6
training?
7 How many hours, what should be covered 8
under that classroom and lab training, what topics?
9 The work experience, we asked exactly, we 10 heard some comments about whether or not the 11 pharmaceutical manufacturers should be able to 12 provide the preceptor attestation. That's one of our 13 questions we'd like feedback on.
14 And the competency, we have been hearing 15 some feedback on competency that we, the NRC, should 16 look into whether or not we could move our regs to 17 evaluate competency rather than just straight hours 18 of T&E. So, those are some of our questions in our 19 Federal Register notice.
20 Also, some questions on who should 21 establish and administer these curriculums on an 22 examination. And also, how often should AU 23 competency be periodically assessed?
24 We have been getting some questions on 25
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 recent myths of training and so that's important to 1
think about too. Should it be a number of cases 2
every year or so that the physician AUs are required 3
to maintain their competency or are required to 4
maintain that AU certification?
5 So these are all good things to think 6
about.
7 THE OPERATOR: Excuse me, Sarah, we do 8
have a question. Miguel de la Guardia, your line is 9
open.
10 MR. DE LA GUARDIA: Hi, this is Miguel 11 de la Guardia and I am the RSO at Cook Children's 12 Medical Center in Fort Worth. And we are one of the 13 major trading centers for neuroblastoma using iodine-14 131 MIBG.
15 First, I want to echo Jeffrey Siegel's 16 comments. I think they're spot on.
17 But next I also want to concur with the 18 comments of the lack of authorized users. There are 19 plenty of authorized users for diagnostics but for 20 therapy is very difficult.
21 Right now we only have two authorized 22 users here that can actually administer diamygadia 23 (phonetic). And sometimes it's very difficult to 24 schedule these treatments based on their 25
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 availability.
1 And as far as rural areas, we are very 2
keenly aware of that because we get patients from all 3
over the place. If you go west of Fort Worth, where 4
we are, there is nothing as far as being able to treat 5
these patients until you get to Arizona or California.
6 So, there is a critical shortage out there of 7
physicians that can do therapies.
8 Now, I do know that nuclear medicine, we 9
would like hold on to as much as we can, but prior 10 experience shows that when other groups get involved, 11 such as the endocrinologist or cardiology, which 12 actually launched nuclear cardiology made, basically 13 saved nuclear medicine in many respects, I think that 14 having a pathway for other physicians to be able to 15 do these treatments will be very helpful.
16 Especially now that most of the therapies 17 can be obtained from a nuclear pharmacy as a unit 18 dose and you don't have to manipulate the product 19 onsite.
20 So I want to thank you for the opportunity 21 to commenting and for sponsoring this webinar. Thank 22 you.
23 MS. LOPAS: Yes, thank you.
24 THE OPERATOR: Still no further questions 25
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 or comments.
1 MS. LOPAS: Okay, thank you. Okay, and 2
I will maybe, just to kind of spur some conversation, 3
the last public meeting we had was on January 10th.
4 And during that meeting we got some unique ideas 5
submitted by a comment.
6 One was to allow to open up the AU status 7
to non-physicians. So, including maybe authorized 8
nuclear pharmacists. Also maybe including some 9
advance trained technologist.
10 We specifically got comments from nuclear 11 medicine advance associates who undergo, you know, 12 who have been technologist for many, many years and 13 then they go on to continue their training with two 14 years of a master's program and then they do a nuclear 15 medicine kind of internship or they kind of, they 16 kind of call it analogous to a residency. They 17 offered up, they thought that potentially they could 18 be considered for AU status.
19 So, we, at the NRC, even though our 20 questions in FRN are kind of very specific, we are 21 open to hearing any ideas on how, if we do think, you 22 know, if you do think that's there's a patient access 23 issue on how we can improve that situation.
24 So, that would include providing us 25
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 comments on whether you think it would be a good idea 1
to allow certain categories of folks practicing in 2
this medicine field to become AUs. Right now, in the 3
Part 35 regulations an authorized user is only 4
defined, can only be a physician, a dentist or a 5
podiatrist.
6 So obviously the majority of our AUs are 7
physicians. And so, we did get some comments that 8
maybe we should consider expanding that definition of 9
authorized user.
10 So, star-1 to provide any additional oral 11 comments.
12 THE OPERATOR: We do have an additional 13 comment with Michelle Panichi. Your line is open.
14 MS. PANICHI: Oh my goodness.
15 (Laughter) 16 MS. PANICHI: This is a tough one. So, 17 let us not forget these are prescription medications.
18 So, they have to be prescribed by a physician.
19 As much as I would like to say, as a 20 nuclear med tech, that I am equally qualified as a 21 nuclear medicine physician, I am not.
22 I also have the honor of being the RSO at 23 nuclear pharmacies, and I can confidentially tell you 24 that the majority of nuclear pharmacists that I have 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 met should not be prescribing these medications.
1 Remember, this is not just administering.
2 I have no problem with a nuclear med tech 3
administering a radiotherapy, with an authorized user 4
in place. A lot of times it is simply passing a 5
pill, injecting a patient.
6 But that's not what requires the AU 7
status, it's the prescribing of these medications.
8 And they are prescription drugs.
9 So, an NMAA or a nuclear med tech, even 10 a nuclear pharmacist, they're not in the practice of 11 prescribing pharmaceuticals. Thanks.
12 MS. LOPAS: Yes, thank you.
13 THE OPERATOR: Another addition question 14 or comment comes from Ralph Lieto. Your line is 15 open.
16 MR. LIETO: Thank you. I also would like 17 to echo Michelle's comments that I think that these 18 suggestions of non-physicians becoming authorized 19 users basically would turn the NRCs whole regulatory 20 framework upside down.
21 If you allowed this for therapeutic 22 radiopharmaceuticals, you are opening up a literal 23 Pandora's Box where you could have other specialists, 24 you could have an RSO making a case that they oversee 25
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 all this and probably supervises as much as the AU 1
does, the operations of radiation safety in these 2
aspects, making a case for them to be the "AU."
3 Which I think is absolutely abhorrent as 4
a medical physicist and radiation safety officer. I 5
think that, like I said, this is just a very, very 6
bad thought process for suggesting this.
7 And if the NRC would be considering this, 8
you basically would undermine the whole intent of 9
having a physician involved with not only the 10 therapeutic aspect of it, but also the diagnostic 11 imaging aspect of it.
12 As Michelle pointed out, the AU is not 13 just involved with overseeing the administration, but 14 supervising all aspects of
- receipt, patient 15 assessment, administration and follow-up. And they 16 are the best persons for this.
17 And I
think my objections as a
18 technologist and a nuclear pharmacist would be, a pun 19 intended, just a set of nuclear land mines for the 20 NRC.
21 I do have another comment that, regarding 22 your previous slide. I think it was on Item 5 where 23 you, the NRC uses the word competency.
24 I
think this has some different 25
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 connotations to different groups. The ACMUI, over 1
the years, has addressed this several times in the 2
definition, or excuse me, the description of the 3
preceptor attestation.
4 And I think NRC should stay away from 5
that term because competency is more than just an 6
assessment of the understanding and having a 7
requisite knowledge to perform the supervisory 8
aspects of the radiopharmaceuticals that the 9
applicant is applying for.
10 It's maybe just a, maybe a pet peeve of 11 whatever, but I think competency, as used in this 12 slide, is not what you're really trying to evaluate.
13 I think what you want to know is, did the training 14 and experience that the individuals get can reassess 15 that that training and experience contains the 16 requisites body of knowledge that they need to 17 function independently in supervising these types of 18 radiopharmaceuticals. Thank you for the comment.
19 MS. LOPAS: Okay, thank you.
20 THE OPERATOR: We have a follow-up with 21 Miguel. Your line is open.
22 MR. DE LA GUARDIA: Thank you for taking 23 my follow-up. I'm not sure if I was clear on my 24 comments.
25
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 I am a nuclear medicine technologist, but 1
I am not in favor of nuclear medicine technologists 2
prescribing. That is not part of our scope of 3
practice.
4 Also, similarly, I think in almost every 5
state here in the United States, pharmacist are not 6
allowed to prescribe most medications. So, that 7
would require a change completely in pharmacy 8
practice.
9 I
know in some other countries, 10 pharmacist can prescribe, but commonly that's not 11 true here in the United States. So, when I was 12 talking about authorized user, I'm talking about 13 physician authorized users. Thank you.
14 MS. LOPAS: Yes, thank you, Miguel. And 15 I didn't mean to imply that you were suggesting that, 16 I was just stating that in our previous meeting on 17 January 10th, we had received some comments along 18 those lines about potentially, the NRC should 19 potentially consider opening up AU status to some 20 non-physicians. So, understood. Understood.
21 THE OPERATOR: Thank you. And the next 22 question, comment comes from Scott Degenhardt. Your 23 line is open.
24 MR. DEGENHARDT: Yes, thank you. Yes, 25
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 my name is Scott Degenhardt. I am actually a nuclear 1
medicine advance associate speaking on behalf of 2
myself here.
3 I just want to clarify what a nuclear 4
medicine advance associate is. While one time, at 5
one time we were technologists, we're actually mid-6 level providers in the field of nuclear medicine.
7 Again, yes, we were technologists at one 8
point, but we have gone through a two to three year 9
additional schooling at the master's level where we 10 have didactic course work, but we also undergo a 24 11 month internship under the supervision of a
12 physician, most under a radiologist or a nuclear 13 physician.
14 Where we, at the end of the program, are 15 actually, we meet all training requirements for what 16 is currently asked of, of an authorized user. So, 17 we wouldn't, you know, if the NRC would consider the 18 nuclear medicine advance associate for authorized 19 user status, we wouldn't be compromising training and 20 education, the current training and education 21 requirements.
22 But I guess I just wanted to clarify that 23 we are not technologist, we're actually mid-level 24 providers in the field of nuclear medicine. Almost 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 every other field in the healthcare industry has mid-1 level providers that do prescribe drugs, under the 2
supervision of a physician. And that's the model 3
that we were proposing there.
4 The nuclear medicine advance associate 5
would be working under the supervision of an 6
authorized user, again, just as that physician 7
extender alongside them.
8 I guess, any other questions I'm happy to 9
answer but I just wanted to clarify that. Thank you.
10 MS. LOPAS: Yes, thank you, Scott. Thank 11 you for that clarification.
12 THE OPERATOR: Our next question or 13 comment comes from Ben Greenspan. Your line is open.
14 DR. GREENSPAN: Thank you. This is Ben 15 Greenspan again, I'm a nuclear medicine physician and 16 radiologist and I wanted to make some comments.
17 First of all, I agree with Ralph Lieto's 18 comments. Regarding Scott's comments just now, I 19 agree pretty much.
20 I mean, these NMAAs, the Nuclear Medicine 21 Advanced Associates, are technologists who have had 22 an extra two plus years of training and are certainly 23 expert in radiation safety. And in other aspects of 24 dealing with radiopharmaceuticals.
25
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 But they're not physicians. And if they 1
were given AU status, they still have to, I would 2
think they'd still have to work under an authorized 3
user, under a physician. And I don't see how that 4
adds anything.
5 I think they could certainly help with 6
the process of treating a patient, and they could 7
certainly give the radiopharmaceuticals, most of 8
which would be given parenteral, but they still have 9
to work under an authorized user, i.e. under a 10 physician. And I think that would be most 11 appropriate.
12 On the other hand, I really do think 13 that's a very good program and I'd like to see it 14 expand and have more technologists, nuclear medicine 15 technologists, go into those programs. I think it 16 helps the field.
17 Mid-level providers, as these people are 18 seen throughout medicine now and they are physician 19 extenders, and I think they would help nuclear 20 medicine practice.
Including in radionuclide 21 therapy. Thank you.
22 MS. LOPAS: All right, thank you.
23 THE OPERATOR: Thank you. And our next 24 question, comment comes from Rachel Semon. Your line 25
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 open.
1 MS. SEMON: Thank you. Can you hear me 2
okay?
3 MS. LOPAS: Yes, we can.
4 MS. SEMON: Okay, great. I appreciate 5
the opportunity to comment. I'm really not going to 6
comment one way or the other as to which direction 7
this should go, in terms of T&E, but I did want to, 8
for the record, provide some feedback regarding 9
pharmacy and the practice of pharmacy and that there 10 certainly is precedent outside of the nuclear 11 medicine, or the nuclear medicine world, where 12 pharmacist do have provider status.
13 It is quite often you will see this 14 actually in medical oncology. There is board 15 certifications based on specialty. So, I am a board 16 certified nuclear pharmacist.
17 I could say today I would not be 18 comfortable being in a AU, a full AU, overseeing 19 patient management. It's certainly something to 20 consider moving forward. Perhaps in conjunction 21 within the nuclear medicine department.
22 And we talk about potential shortage of 23 AUs. And what I know that I have seen historically, 24 is that the current RVU model tends to provide some 25
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 barrier to a nuclear medicine physician being torn 1
between the requirements of reading images, the 2
diagnostic portion versus having to spend 30 minutes 3
to an hour with a patient for therapy.
4 And so, perhaps there is something here 5
that could help facilitate patient access and ease 6
the requirements of time spent, et cetera, in the 7
future.
8 But just for the record, I wanted to say 9
that provider status is not, there is a precedent for 10 provider status outside of nuclear
- medicine, 11 particularly in medical oncology. And there are 12 pharmacists who have limited prescribing rights as 13 well.
14 Typically, it is under the supervision of 15 a physician. So I think there is some room here.
16 Maybe not immediately, but not to be close minded 17 with that. That's it, thank you so much.
18 MS. LOPAS: Great, thank you. And, 19 Cedric, do we have anybody else? star-1 if you want 20 to get in on the conversation, get your comments 21 transcribed to go on the record.
22 THE OPERATOR: None currently in the 23 queue, but, again, press star-1.
24 MS. LOPAS: So, this is Sarah again. And 25
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 so, I will say that, related to that comment that we 1
just heard, we have had some comments submitted that 2
the NRC should be open to the idea of, maybe not 3
necessarily making an authorized nuclear pharmacist 4
an AU, but maybe some sort of requirement or new 5
regulatory requirement for an alternate, an alternate 6
pathway of having a limited authorized user physician 7
teamed with a authorized nuclear pharmacist.
8 That authorized nuclear pharmacist 9
undergo extensive training and, per our requirements, 10 also require 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E, become an authorized 11 nuclear pharmacist.
12 So, if you teamed an authorized nuclear 13 pharmacist with perhaps a limited trained authorized 14 user physician, that you would still be meeting the 15 spirit of those 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience.
16 Because you'd have those two individuals working 17 together.
18 So that was one comment that we received 19 on the January 10th meeting. That's a little bit 20 different from just suggesting that authorized 21 nuclear pharmacists should be considered for AU 22 status.
23 Okay, we're going to -- anybody else on 24 the line, Cedric?
25
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 THE OPERATOR: Yes. Ralph Lieto, your 1
line is open.
2 MS. LOPAS: Okay, Ralph.
3 MR. LIETO: Yes, Sarah. I'm glad you 4
brought that subject up. I had heard about this but 5
I was wondering if this was something the NRC was 6
seriously going to consider or not.
7 Again, I think this is something that 8
would basically set the licensee up for a lot of 9
potential problems. Because, it's my understanding 10 of this proposal that you would have a centralized 11 nuclear pharmacist teamed with a limited AU that would 12 be onsite, something to that nature.
13 And to me this is matched with two chiefs 14 with no Indians.
15 I think that these types of situations 16 you need, with therapeutic radiopharmaceuticals, a 17 person that's signing the written directive needs to 18 be in AU. And that AU has to be responsible for the 19 proper management of that radiopharmaceutical, to 20 that patient.
21 This dual AU, that would be fine as long 22 as everything goes great, but what happens if 23 something goes wrong, okay, and there's a medical 24 event or there's a problem with the patient or the 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 assay at the site.
1 You can't have this dual AU 2
geographically separated and expect that it's not 3
just going to create further problems. And 4
especially from the aspect of supervision, which is 5
something that the NRC takes quite seriously. And 6
not just in the diagnostic side but even more so on 7
the therapeutic side.
8 And I think this dual AU is, again, just 9
fraught with all kinds of potential problems that's 10 going to place the licensee, who's going to be the 11 management, in a lot more potential problems of trying 12 to resolve this.
13 Because the nuclear pharmacist is going 14 to be offsite at, and operating under a different 15 license than the administration. Just so many things 16 that add up to, that this is just a very, very poor 17 idea.
18 MS. LOPAS: Okay. Yes, and I think to 19 clarify, now, I haven't received the written comments 20 on this, on this particular idea yet. They have not 21 been submitted yet.
22 But just from hearing from public 23 meetings, I think the idea that they're proposing is 24 that the authorized nuclear pharmacist would travel 25
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 to the limited AU position site for a day of 1
treatments, right. So they would be paired together 2
physically, during an administration.
3 So, that's just a clarification from what 4
I recall from the January 10th meeting. But yes, if 5
you have any follow-up on that, Ralph, go right ahead.
6 MR. LIETO: I would just say that, if you 7
have an AU that's onsite to administer it, then you 8
wouldn't need the nuclear pharmacist to be present.
9 MS. LOPAS: Right.
10 MR. LIETO: I think it just, again, I 11 think it kind of goes back that, what are you trying 12 to sell here. And it is not anything that is going 13 to improve the radiation safety management 14 supervision at the site where the, where all the work 15 is going to be done.
16 MS. LOPAS: Okay, thank you, Ralph. Does 17 anybody else have a comment? star-1 or feel free to 18 type one via the webinar software, I can read it 19 aloud.
20 Okay, I'm just going to give it another 21 minute or so. I do appreciate everybody calling in 22 today and taking the time.
23 And I know that many of you have called 24 in for a number of these meetings. So, I really 25
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 appreciate you guys taking the time to do and it means 1
a lot to the NRC. And we do really, we're going to 2
really examine everybody's input.
3 Whether you've spoken on one of these 4
meetings or, and/or when you send it in, send in the 5
written, your written comments.
6 And I just want to remind folks, you have 7
until January 29th, end of that day, to get your 8
comments in. That's a week from today. It's a 9
Tuesday.
10 Try to use regulations.gov if you can.
11 And if you're encountering any difficulties or at all 12 concerned, I'm happy to take your comments via email.
13 And, again, my email is in the slides here. It's 14 sarah.lopas@nrc.gov. So either myself or Maryann 15 will take your comments via email, that's fine too.
16 And, I don't know, Cedric, can I check in 17 on the phone one last time?
18 THE OPERATOR: No questions or comments.
19 MS. LOPAS: Okay. I think that's it.
20 And Dr. Siegel, I will say, I think you had noted 21 that you're waiting for your comments to get up on 22 regs.gov.
23 They are in ADAMS and I did see them come 24 through in my email, I think on Friday. So they 25
72 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 should be on regulations.gov shortly.
1 But there is a number of kind of 2
rulemakings and other efforts going on at the agency 3
and we only have a few administrative staff that kind 4
of handle the processing of all the comments that we 5
receive from the public on all of our projects. So, 6
I apologize for the delay, I know that's difficult.
7 But I'm going to reach out to our folks and see if 8
they can expedite some of the processing on regs.gov.
9 So, Maryann, do you have any follow-ups?
10 MS. AYOADE: Yes, Sarah, I was waiting 11 for everybody to provide their comments. Just to add 12 to and clarify Ralph Lieto's comment on competency.
13 Thank you for bringing that up.
14 I just wanted to, as you have recognized 15 the sensitivity with the word competency and the 16 misunderstanding that it could come about from that.
17 And so, with the new rule, I just wanted to point out 18 that with attestation statement, it replaced the text 19 that used to formally say, attestation demonstrate 20 that the individual has achieved a level of competency 21 to function independently.
22 That has been replaced
- with, the 23 individual has demonstrated the ability to function 24 independently to procure the radiation safety related 25
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 duties. So thank you for bringing that up.
1 Now, when this evaluation started, it was 2
still with the former regulations. The new rule 3
become effective last Monday, January 14th, at the 4
NRC licensees.
5 And so, just a, I just wanted to bring it 6
to your awareness that you recognized that. And 7
thank you for bringing that up.
8 MS. LOPAS: Okay, thanks, Maryann. And 9
on the NRC's medical toolkit licensee, or medical 10 licensee toolkit website, Maryann, I think there is 11 a page that's dedicated to the Part 35 rule changes 12 that just went into effect, is that right?
13 MS. AYOADE: That's correct. And if you 14 even just go to, if you Google the 10 CFR 35 15 regulations, they are now updated with the new rule.
16 So, if you can't find it in our medical use toolkit, 17 if you just Google 10 CFR 35 to get into the new rule, 18 it's updated with the new rule.
19 MS. LOPAS: Right. And I think the 20 slides from some public meetings that we had on the 21 Part 35, the new rule changes, those are also on the 22 medical licensee toolkit website I believe.
23 So those are available for people to pull 24 up the PDF of slides if they just want to see an 25
74 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 overview. Although it's about a 96 slide overview, 1
but it's an overview.
2 Okay. Cedric, do we have any other final 3
comments on the line?
4 THE OPERATOR: No questions in queue.
5 MS. LOPAS: Okay. All right, Maryann, 6
is there anything else?
7 MS. AYOADE: No, that's it.
8 MS. LOPAS: Okay. All right, everybody, 9
January 29th, deadline to get your comments in. But 10 Maryann and I are here for your questions and comments 11 before, and after that date obviously. Please keep 12 checking out our website that I have the slide up on 13 right now for any updates.
14 And if you are signed up to receive our 15 medical Listserv emails that's great. If not, do 16 that. I suggest doing that because that's a good way 17 to stay informed of all the NRC's medical regulations 18 and news and all that good stuff.
19 All right, thank you so much for your 20 time today and that will be the end of our meeting.
21 THE OPERATOR: Thank you, and that 22 concludes today's conference. You may all disconnect 23 at this time. Speakers, you may standby for post-24 conference.
25
75 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 (Whereupon, the above-entitled matter 1
went off the record at 11:35 a.m.)
2