ML19029B476

Transcript of Public (Webinar) to Accept Comments on the Nrc'S Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals, January 22, 2019, Pages 1-74

ML19029B476
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Issue date:	01/22/2019
From:	Sarah Lopas NRC/NMSS/DMSST/MSEB
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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 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 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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

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3 1 P-R-O-C-E-E-D-I-N-G-S 2 (10:02 a.m.)

3 MS. LOPAS: Hi, everybody, good morning.

4 Welcome to the Nuclear Regulatory Commission's 5 webinar to accept comments on the Staff's evaluation 6 of training and experience requirements for different 7 categories of radiopharmaceuticals.

8 This is our last of four public 9 meetings/webinars that we've had on this topic. And 10 I want to remind everybody that our comment period 11 ends a week from today on Tuesday, January 29th.

12 My name is Sarah Lopas and I'm a member 13 of the NRC's Medical Radiation Safety Team, which is 14 part of the Medical Safety and Events Assessment 15 Branch in the NRCs Office of Nuclear Materials Safety 16 and Safeguard.

17 I'm the project manager for the NRCs 18 training experience evaluation and I'll be 19 facilitating today's webinar and giving part of the 20 presentation.

21 And here to help me out is Maryann Ayoade, 22 who is a health physicist in the NRCs Medical 23 Radiation Safety Team. And she is the technical lead 24 on the training and experience evaluation. So 25 Maryann will be giving part of the presentation as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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4 1 well.

2 We have a short agenda for today's 3 webinar. I'll just be going over some basic 4 information about the webinar and then Maryann and I 5 will go through 15 slides that will cover background 6 information on the NRCs evaluation on training 7 experience evaluations, we're going to discuss the 8 Federal Register notice that was published on October 9 29 and then we're going to cover how you can provide 10 your written comments by that January 29th deadline, 11 if you would like to provide written comments.

12 Then we're going to open up the phone 13 lines to take your comments and any kind of process-14 type questions you have. And you can also submit 15 questions or comments via the webinar software. I'll 16 keep an eye on that.

17 The purpose of today's webinar is 18 twofold. It's to provide you background information 19 on the staff's planned evaluation of developing 20 tailored training and experience requirements for 21 administering different categories of 22 radiopharmaceuticals, for which a written directive 23 is required.

24 And that's in accordance with your 25 regulations in 10 CFR Part 35. And those are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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5 1 regulations for medical use of byproduct material.

2 And specifically, under Subpart E, of 3 Part 35, which covers unsealed byproduct material 4 written directive required.

5 And most importantly, the reason why 6 we're here is to listen to and record your comments 7 on the evaluation. So, the comments that we received 8 from the medical community, the agreement states and 9 other stakeholders, are critical to our decision 10 making on whether our existing training and 11 experience requirements should be revised.

12 And so, if you don't provide comments 13 today, orally over the phone, just please make sure 14 you get them in. You get your written comments in 15 by regulations.gov by January 29th. That due date.

16 And I'll be going over how you can do 17 that a couple more slides from now.

18 So, for general webinar information 19 today, I want to note that if you aren't logged into 20 the webinar that's okay, there's a couple ways to get 21 our slides. You can either go to our public meeting 22 schedule web page and that provides-if you find 23 today's meeting, which should be one of the top 24 meetings listed-there's a link to our slides.

25 If you go to the NRCs T&E website, if NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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6 1 you just Google NRC training and experience 2 evaluation, that will bring up our T&E website.

3 And there's a link to today's slides if you scroll 4 down the page and look for today's meeting as well.

5 So, there is a couple of ways to get to 6 our slides if you're just listening in without the 7 webinar.

8 Today we're going to be discussing our 9 evaluation of training experience requirements for 10 certain categories of radiopharmaceuticals. We're 11 likely going to refer to them as, training experience, 12 as T&E for short. And also, we tend to refer to 13 authorized users, which are those physicians who are 14 authorized to administer radiopharmaceuticals, as 15 AUs.

16 So those are some terms that you'll hear 17 today.

18 And today's webinar is being transcribed 19 by a court reporter. And a full transcript of this 20 webinar will be publicly available in about a week 21 and a half or so. Or maybe we might try to get it 22 turned around a little bit quicker before the comment 23 deadline. I'll try to do that for you all.

24 And it's going to be available in the 25 NRC's agencywide Documents Access and Management NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 System, that's ADAMS. And I'll be posting a link to 2 this transcript on the NRC's training and experience 3 website. It will also go up on regulations.gov too.

4 And you can find all of the transcripts 5 that we have for our past three public meetings on 6 that T&E website as well. And also on 7 regulations.gov.

8 On regulations.gov, under our docket 9 (NRC-2018-0230), there is a category called 10 supporting documents. And that's where I've listed 11 the meeting summaries and transcripts, if you're 12 interested in what people have said during past 13 meetings.

14 And I do want to say that all the comments 15 that are spoken here today will make it on our docket 16 since they are being transcribed. And that oral and 17 written comments have equal weight. So if you don't, 18 if you've spoken your mind today and you don't feel 19 like typing it in or sending it by regulations.gov 20 afterwards, that's perfectly fine because we will get 21 it today.

22 So, right now everybody is in listen only 23 mode. And as Cedric mentioned, when Maryann and I 24 finish the presentation, that's when I'll be opening 25 the phone lines. And all you have to do is press NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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8 1 star-1.

2 And I'll remind everybody that you do 3 need to make sure that you introduce yourself and 4 clearly state your name. And if it's a tricky name, 5 maybe spell it out for our court reporter. That's 6 vitally important so we know who is saying what.

7 So now I'm going to hand the presentation 8 over to Maryann so she can talk about our T&E 9 regulations and give you some background.

10 MS. AYOADE: Great, thank you, Sarah.

11 Good morning, everyone.

12 Today I will be presenting information on 13 an overview of the regulations on training and 14 experience for radiopharmaceuticals requirement and 15 directive, some background on the related stakeholder 16 concerns received for this evaluation and the NRC's 17 efforts on the evaluation thus far.

18 So, the current regulations on training 19 and experience for radiopharmaceuticals requiring a 20 written directive, are under 10 CFR Part 35, Subpart 21 E. These training and experience requirements 22 provide three pathways that a physician may be 23 authorized to administer radiopharmaceuticals that 24 require written directives.

25 A physician can be authorized to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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9 1 administer these radiopharmaceuticals if they are 2 certified by a medical specialty board. This 3 certification process is recognized by the NRC or an 4 agreement state.

5 A physician can also be authorized if 6 they've satisfied the training requirements via an 7 ultimate pathway, which includes the completion of 8 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including a 9 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 10 training in relevant topic areas as listed in the 11 regulation. And 500 hours of supervised work 12 experience in the relevant areas as listed in the 13 regulations.

14 A physician can also be authorized if 15 they have been previously identified as an authorized 16 user on an NRC or agreement state license or permit.

17 So, this training and experience 18 evaluation is focused on the alternate pathways. And 19 the NRC staff are looking into what tailored training 20 and experience requirements, for limited 21 administration of certain categories of 22 radiopharmaceuticals would look like. And that is 23 what we will be referring to as an admitted authorized 24 user status.

25 Next slide. In Subpart E, there are four NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 sections that pertain to training and experience 2 requirements.

3 The first section is under 10 CFR 35.390, 4 for training for the use of all radiopharmaceuticals 5 in Subpart E. All of which require a written 6 directive.

7 The second is under 10 CFR 35.392, the 8 training for oral administration of sodium iodide, I-9 131. Requiring a writing directive in quantities 10 less than or equal to 33 millicuries.

11 The third is under 10 CFR 35.394, for 12 training for oral administration of sodium iodide, I-13 131. Requiring the writing directive in quantities 14 greater than 33 millicuries.

15 And the fourth section is in 10 CFR 16 35.396, for training for the parenteral 17 administration of any radiopharmaceuticals requiring 18 the written directive.

19 I want to point out that all of these 20 sections of training and experience, include the 21 pathways for an experienced authorized user that is 22 already listed on a license. Also, all the sections, 23 except for 10 CFR 35.396, include training and 24 experience under the board certification and ultimate 25 pathways.

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11 1 However, 10 CFR 35.396 is for training 2 exclusively under the ultimate pathways. And it is 3 really for the radiation oncologist that are looking 4 to become authorized users. And they can do this by 5 completing some additional hours of training and 6 experience.

7 I also want to point out that ultimate 8 training pathways, under 10 CFR 35.392 and 394, is 9 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 /> 10 of classroom and lab training that is relevant to the 11 type of use for which they are seeking to be 12 authorized.

13 Whereas, ultimate training pathways, 14 under 10 CFR 35.390, is for the physician to 15 successfully complete 700 hours of training and 16 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 17 laboratory training.

18 Next slide. So, this slide provides 19 background information on stakeholder concerns that 20 have been received related to these training and 21 experience requirements.

22 Since the revision to the training and 23 experience requirements in 2002, and again in 2005, 24 stakeholders have raised concerns about the effects 25 of some of the requirements on patient access to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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12 1 certain therapy related pharmaceuticals.

2 Specifically, some of the stakeholders 3 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 4 CFR 35.390, is overly burdensome for physicians that 5 are not certified by a medical specialty board and 6 that the extensive requirements have resulted in a 7 shortage of authorized users. Which thereby limits 8 patients access to radiopharmaceuticals.

9 As a result, in 2015 and in 2016, in 10 separate efforts to NRC Staff and the NRC's Advisory 11 Committee on the medical uses of isotopes, also known 12 as the ACMUI, independently reviewed the training and 13 experience requirements for the medical uses 14 authorizes under Subpart E.

15 Specifically, the NRC Staff has reviewed 16 the regulatory basis and comments received on past 17 rulemaking related to the medical use of byproduct 18 materials and did not identify any new information 19 that will call into question the basis of the existing 20 requirements.

21 As a result, the NRC Staff did not 22 disclose any changes to the regulations at the time.

23 And the NRC Staff is continuing to work with the ACMUI 24 in this ongoing training and experience evaluation 25 effort.

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13 1 Next slide. As part of the Staff 2 requirements memorandum dated August 17, 2017, and 3 that is publicly available in ADAMS via the hyperlink 4 that is referenced on this slide, the Commission 5 directed the NRC Staff to evaluate whether it makes 6 sense to establish tailored training and experience 7 requirements for different categories of 8 radiopharmaceuticals. It also evaluates how this 9 category should be determined.

10 So, such as the risk posed by 11 radionuclides or by delivery method. It also 12 evaluates what the training and experience 13 requirements would be for each category and to 14 evaluate whether those requirements should be based 15 on hours of training and experience or focus more on 16 competency.

17 Next slide. In response to the 18 Commission direction, the NRC Staff obtained feedback 19 from some medical and regulatory stakeholders in 20 April and May of 2018.

21 That evaluation, including the NRC Staff 22 analysis and the feedback that was received of the 23 training and experience requirements in Subpart E of 24 10 CFR Part 35, was documented in an NRC SECY paper, 25 which is the SECY-18-0084.

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14 1 The results of that evaluation concluded 2 that it may be feasible to establish tailored training 3 and experience requirements, for different categories 4 of radiopharmaceuticals and to create a means of 5 authorizing the administration of certain categories 6 of radiopharmaceuticals, which is the limited 7 authorized user status.

8 It also concluded that there are viable 9 options for creating a competency-based approach to 10 demonstrate accessible training and experience for a 11 limited authorized user status. But, however, the 12 Staff does need to conduct more extensive outreach to 13 stakeholders in the medical community, to the 14 agreement states and to other members of the public, 15 before making a recommendation to the Commission.

16 And that is what brings us to our current 17 evaluation to date. I will now hand it back over to 18 Sarah, who will discuss our current evaluation 19 efforts and how you can participate. Next slide.

20 MS. LOPAS: Thank you, Maryann. So, the 21 end product of the NRC Staff's evaluation will be a 22 paper that we're going to send to our five-member 23 Commission.

24 And that paper is going to document the 25 results of our evaluation. Which would either be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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15 1 maybe recommending no changes or recommending some 2 options for potential changes.

3 And, if we do recommend some options, we 4 will also have to accompany that paper with a 5 rulemaking plan.

6 On this slide, we're on Slide 11 now, 7 this is a simplified diagram of the information that 8 we're going to consider in our development of a 9 recommendation to the Commission. The diagram 10 illustrates why this comment period is so important 11 to this effort because, in large part, the feedback 12 that we receive on the questions that we've asked in 13 our Federal Register notice, are going to inform our 14 recommendation to the Commission.

15 And other important feedback will come 16 from our coordination with our co-regulators, the 17 Agreement States, and the NRC Advisory's Committee on 18 the Medical Uses of Isotopes, ACMUI as Maryann had 19 mentioned earlier.

20 In addition to the inputs we receive 21 from--

22 (Technical interference) 23 MS. LOPAS: -- the Agreements States and 24 the ACMUI, the NRC Staff is also examining the issue 25 of patient access. So, we are currently attempting NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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16 1 to map NRC licensees that are licensed to use 10 CFR 2 Part 35.300 materials.

3 These are licensee facilities that could 4 potentially offer these therapeutic 5 radiopharmaceuticals. So, we're going to be mapping 6 those. And there will be a series of maps of the 7 individual states for the data that we have.

8 The NRC only has access currently to non-9 agreement states - - our licensees. And those are 10 about 13 states at the moment.

11 We are planning to issue a voluntary 12 request for information to the Agreement States for 13 their information on --

14 (Technical interference) 15 MS. LOPAS: -- for these therapies as 16 well. So that would hopefully give us a little bit 17 more complete of a picture of the --

18 (Technical interference) 19 MS. LOPAS: -- United States, depending 20 on how many Agreement States are able to respond back 21 to us and help us out with this data.

22 I will note that we are stuck a little 23 bit right now with that request. That voluntary 24 request to the Agreement States. It does need to be 25 reviewed and approved by the Office of Management and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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17 1 Budget.

2 And the Office of Management and Budget 3 is closed due to the partial Government shutdown.

4 So, at the moment, we're kind of stuck. But I would 5 hope that that letter would go out to the Agreement 6 States --

7 (Technical interference) 8 MS. LOPAS: -- maybe two to four weeks 9 after the partial shutdown ends and --

10 (Technical interference) 11 MS. LOPAS: -- everything goes back up.

12 The other things that the staff is going 13 to look at are - - we're reviewing our training and 14 experience requirements in other countries in an 15 effort to benchmark what other, what the 16 international community is doing with regard to 17 training and experience.

18 And then we also are reviewing - - doing 19 an extensive review of recent medical events in our 20 NMED database. The Nuclear Materials Events 21 Database. NMED is our database that covers events 22 with nuclear materials - - to see if any medical 23 events have a nexus to training and experience.

24 So, we have to dig a little deeper into 25 those events to see if we can get to a root cause of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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18 1 training and experience. So, those are the two 2 additional things that we're looking at. Three 3 additional things we're looking at.

4 In addition to evaluating your comments 5 --

6 (Technical interference) 7 MS. LOPAS: -- and what we hear from the 8 ACMUI and the Agreement States.

9 So, it's important to --

10 (Technical interference) 11 MS. LOPAS: -- is to our regulations, 12 that we would need to document, again, document that 13 in a rule making plan. And then our Commission would 14 the proceed to vote on that rulemaking plan.

15 And that would determine whether or not 16 we would move forward with another Part 35 rulemaking 17 effort. And if rulemaking is recommended and the 18 Commission approves it, that would then start our 19 extensive rulemaking process that many people are 20 familiar with.

21 And I am highlighting where we are in 22 this process so everybody understands where we are.

23 And where we are is that we're still in the 24 information gathering phase. We --

25 (Technical interference)

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19 1 MS. LOPAS: -- kept in mind, you know, 2 we're really at the beginning of this. And until we 3 really get all, until the public comment period ends 4 and we get everybody's comments in and we get a chance 5 to really digest them and we hear from the agreement 6 states --

7 (Technical interference) 8 MS. LOPAS: -- a path forward yet. So, 9 I just wanted to highlight that.

10 Next slide, Slide 12, covers our Federal 11 Register notice. So, that was published back on 12 Monday, October 29th. The Federal Register notice 13 can be accessed by this link.

14 And I also want to point out that there 15 are some handouts attached to the webinar. So, if 16 you click on the little handouts button on your 17 webinar, you'll see, I believe, a copy of these slides 18 that you can download if you want.

19 I have the SECY paper that Maryann 20 referenced from last August --

21 (Technical interference) 22 MS. LOPAS: -- And I also have a copy of 23 the Federal Register notice. So you can download all 24 of those documents from the --

25 (Technical interference)

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20 1 MS. LOPAS: -- webinar. So, the Federal 2 Register announced the comment period. It ends on, 3 a week from a today on Tuesday, January 29th.

4 And most importantly, the Federal 5 Register notice asks a series of questions on which 6 the NRC would like specific input on from the medical 7 community.

8 So, I'm going to read through those 9 questions in the next four slides just to give 10 everybody some context of kind of the information 11 that we're looking for.

12 But then, we will be opening it up to 13 public comments after I'm done here in a couple of 14 minutes. So, we can certainly walk through the 15 questions later on or however we want to do it, so, 16 don't worry, I'm just going to read through the 17 comments now, or the questions now, to put some 18 context into what we're looking to get.

19 So, Slide 13, here we are. Questions in 20 the FRN.

21 So, Part A was asking about tailored 22 training and experience. And these aren't all of our 23 questions so that's why I do encourage you to read 24 through the whole FRN, there's a lot of subparts to 25 these questions --

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21 1 (Technical interference) 2 MS. LOPAS: -- You can review the FRN 3 that I've attached to the webinar and read through 4 them maybe during the comment portion of todays 5 meeting.

6 Question 1. Are the current pathways for 7 obtaining AU status reasonable and accessible, are 8 they adequate for protecting public health and 9 safety?

10 Question 2. Should the NRC develop a new 11 tailored T&E pathway? What would be the appropriate 12 way to categorize radiopharmaceuticals for tailored 13 T&E requirements?

14 Question 3. Should the fundamental T&E 15 required of physicians seeking limited AU status need 16 to have the same fundamental T&E required of 17 physicians seeking full AU status?

18 Question 4. How should the requirements 19 for this fundamental T&E be structured for a specific 20 category of radiopharmaceuticals?

21 Slide 14 goes over the NRCs recognition 22 of medical specialty force. And if you Google NRC 23 medical licensee toolkit, these procedures for 24 recognizing the medical specialty boards are on that 25 medical licensee toolkit website. But, what boards, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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22 1 other than those already recognized from the NRC, 2 could be considered for recognition for medical uses 3 under 10 CFR 35.300. And those other boards are, 4 American, or the boards that we currently recognize 5 are, American Board on Nuclear Medicine, American 6 Board of Radiology, American Osteopathic Board of 7 Radiology, Certification Board of Nuclear 8 Endocrinology.

9 And two, are the current NRC medical 10 specialty board recognition criteria sufficient? If 11 not, what additional criteria should the NRC use?

12 Slide 15 goes over the patient access --

13 (Technical interference) 14 MS. LOPAS: -- perspective of folks that 15 may or may not be impacted by our regulations on 16 patient access.

17 So, is there a shortage in the number of 18 AUs for medical uses under 10 CFR 35.300? If so, is 19 the shortage associated with the use of a specific 20 radiopharmaceutical?

21 Are there certain geographic areas with 22 an inadequate number of AUs?

23 Do current NRC regulations on AU T&E 24 requirements unnecessarily limit patient access to 25 procedures involving radiopharmaceuticals?

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23 1 And, do current NRC regulations on AU T&E 2 requirements unnecessarily limit research and 3 development in nuclear medicine?

4 And we have gotten some feedback or 5 questions about, why is the NRC asking --

6 (Technical interference) 7 MS. LOPAS: -- this? And I would answer 8 that and say that, you know, we are interested in the 9 perspective of folks that are out there doing this -

10 what are the impacts that people are noticing with 11 regard to patient access?

12 You know, we have heard from some 13 physicians that, No, there is no patient access issue, 14 there are plenty of AUs out there. And then we've 15 heard from some other industry folks saying, yes, 16 we're having hard time finding AUs.

17 So, that's the kind of feedback that we'd 18 like to hear. And that's why we thought it was 19 important to include in the FRN.

20 And then Slide 16 are questions, just 21 general questions about the NRC's training and 22 experience regulations as a whole. These are kind 23 of in an effort to, for us to kind of maybe look 24 transformatively at our medical regulations with 25 regard to training and experience.

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24 1 So, Question 1. Should the NRC regulate 2 the T&E of physicians for medical uses?

3 Are there requirements in the NRC's T&E 4 regulatory framework for physicians that are 5 non-safety related?

6 And how can the NRC transform its 7 regulatory approach for T&E while still ensuring that 8 adequate protection is maintained for workers, the 9 general public, patients, and human research 10 subjects?

11 So, those are all the questions. And 12 like I said, there's multiple sub-questions 13 underneath each one of these questions, so I really 14 encourage you to check out the Federal Register 15 notice.

16 So, this slide just gives you the 17 important details about submitting your written 18 comments. So, like I mentioned, January 29th, one 19 week from today at 11:59 p.m., the regs.gov portal 20 will stop accepting comments.

21 So, how do you submit comments to 22 regulations.gov? Well, you simply just go to 23 www.regulations.gov and there's a search bar will 24 popup right at the top and you just type in, NRC-25 2018-0230.

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25 1 And that will just bring you right to the 2 T&E page, docket page. And it's very self-3 explanatory on submitting comments.

4 This is also, that second bullet there on 5 the side is just the direct link to submit comments, 6 so that will get you there as well.

7 I do want to note that, let's see, last 8 Friday regulations.gov, I think, went down for about 9 half a day. You could not access anything on 10 regulations.gov.

11 And it was related to the Government 12 shutdown affecting a portion of the Environment 13 Protection Agency, which actually manages 14 regulations.gov. But it is back up and running.

15 It did come back up and running about, I 16 don't know, half way through the day on Friday. And 17 I've been told, I've been assured that it should 18 remain up and running through the rest of the comment 19 period, through January 29th.

20 Now, if you have any issues at all with 21 submitting your comments by regulations.gov, if you 22 go to log on and you can't get to it, it's shutdown 23 for some reason, you can email your comments to me or 24 Maryann. That is no problem, that's perfectly 25 acceptable.

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26 1 And that's going to be the work around if 2 for some reason regulations.gov shutdowns anytime 3 between now and January 29th. But I've been checking 4 regulations.gov a few times a day, every day because 5 I'm nervous about about it, and it's so far so good.

6 Except for that one Friday. Or, I think it was 7 Thursday that it actually went down.

8 So, my contact information and Maryann's 9 contact information will be in the slide, the next 10 slide, so you'll see that. But I just want to make 11 sure that everybody knows that emailing your comments 12 to me is a perfectly fine option if regulations.gov 13 isn't working.

14 I do want to note that when you submit 15 your comment on regulations.gov, you're not going to 16 see it posted right away. It takes a few weeks.

17 But I will, I promise you that we are 18 getting it so don't worry. It sends you a little 19 confirmation that your comment has been received.

20 And we receive them.

21 It just takes a, we have an internal 22 administration, an admin type process where we have 23 to pull it down off the regulations.gov, put it into 24 our ADAMS system, so your comments will also be in 25 ADAMS, and then we re-post it back on regulations.gov.

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27 1 So that's why it takes a little bit longer.

2 At the end of the comment period, so we're 3 going to be compiling all the comments, organizing 4 them, reviewing them and we'll be summarizing them.

5 And we'll be putting together a nice summary report 6 that will be attached to the paper that we send to 7 the Commission. And the summary report will 8 summarize everything we've heard from everybody.

9 And I do want to note that because this 10 is not a rulemaking, so we aren't going to responding 11 individually to comments, the comments are simply to 12 inform us. So we aren't going to be responding back 13 to your comments.

14 Okay, next slide is Slide 18. These are 15 just next steps, so this is just a basic outline.

16 So the comment period ends on January 17 29th. And then in February and March we're going to 18 be evaluating your comments, reviewing that 19 additional information that I talked about.

20 You know, conducting the patient access, 21 doing the patient access maps, looking at 22 international benchmarking and accepting medical and 23 radiation safety events. We'll be looking forward 24 to getting a draft report from the ACMUI subcommittee 25 on T&E, so hopefully we'll get that in mid-February NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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28 1 or so.

2 I will encourage folks to check out the 3 T&E website. And if you aren't signed up for the 4 NRC's medical Listserv please do that as well. We 5 will be having a public teleconference with the ACMUI 6 to discuss their draft subcommittee report on T&E.

7 So that may really be of interest for 8 many of you that has been on these webinars. So, 9 keep an eye out for that. It will be on our website.

10 It will be on the NRC's public meeting 11 website. It will be noted there. And also, a note 12 will go out via our medical Listserv about when that's 13 going to be happening and how you can participate in 14 that.

15 And then, once we do our draft paper, the 16 ACMUI and the agreement states will both get to review 17 that draft paper and send us back their comments.

18 There will be another ACMUI teleconference on their 19 comments on our draft sometime in the summer.

20 So, again, you would just keep an eye out 21 on the medical Listserv and the websites to see when 22 that is going to happen.

23 And then we will finalize our paper and 24 hopefully deliver it to the Commission sometime in 25 the fall. The Fall of 2019. So that's our general NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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29 1 schedule.

2 So, for more information, next slide, 3 Slide 19. I really encourage you to visit the T&E 4 website there. Like I said, the regulations.gov 5 page, that docket page, that shows everybody's 6 comments that they've submitted to date.

7 So if you're interested in reading 8 through some comments that people have sent in so 9 far. I also have been posting the meeting summaries 10 and transcripts there.

11 And then of course, if you have any 12 questions, you can contact me at sarah.lopas@nrc.gov.

13 As the PM I kind of can talk you through the more 14 process type questions.

15 But I encourage you to reach out to 16 Maryann Ayoade. She is the technical lead on the 17 project, so regulation type questions or have some 18 technical questions, she is who you should go to.

19 And that's it for our presentation. So, 20 before we open up the phones, I just want to remind 21 everybody that, again, we're being transcribed by the 22 court reporter so we can accurate comments for our 23 T&E docket, so please being by introducing yourself.

24 Maybe spell your name if you think it's a tricky name.

25 And speak clear.

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30 1 You can press star-1 at any point, so 2 just go ahead and press star-1 if you already want to 3 jump in. And then you are also free to submit your 4 questions and comments via the chat function or the 5 question function on the webinar. I'll keep an eye 6 on that. And I can certainly read those aloud for 7 you.

8 So, star-1 on the phone. And I'll just 9 go to Cedric, if you can just let us know if anybody 10 pops on the line?

11 THE OPERATOR: Sure. And also, if you'd 12 like to ask a question, please remember to un-mute 13 your phone and record your name clearly when prompted.

14 MS. LOPAS: Star-1 for any questions or 15 comments.

16 THE OPERATOR: I'm currently showing no 17 questions in queue.

18 MS. LOPAS: All right, everybody, this 19 is your last, this is your last time to shine in 20 public, so, if you want to get on the line and tell 21 us how you feel, this is it. Otherwise make sure you 22 do submit your comments by regulations.gov. Your 23 written comments that is, by January 29th.

24 So, just press star-1. Or if you're a 25 little shy, you can type it into the webinar, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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31 1 I'll read it aloud.

2 THE OPERATOR: And our first question 3 comes from Ben Greenspan. Your line is open.

4 DR. GREENSPAN: Thank you very much. My 5 name is Dr. Ben Greenspan and I'm representing myself.

6 The bottom line of my comments is that I 7 think the NRC should not make a separate category for 8 authorized users for people who haven't gone through 9 approved board certification process and should not 10 reduce the requirements.

11 I think that physicians need to master 12 not only the previously submitted curriculum 13 submitted by the SNMMI, and I know there's also 14 curriculum by the ACMUI, and the number of other 15 features that I think I'll send in writing. I don't 16 want to read all this here.

17 But I think it's important for authorized 18 users to have the full range of competency no matter 19 which agents they are using. And there's going to 20 be a whole range of agents in the future with all 21 sort of different types of features and 22 characteristics and risk factors and so on.

23 And it's also important to understand the 24 radiation safety aspects and logistics of how we 25 receive these radiopharmaceuticals and how they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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32 1 dispose of waste and all that.

2 I also wanted to say I do not know of any 3 evidence that there is an insufficient number of 4 authorized users. Nuclear medicine physicians are 5 authorized users, many nuclear radiologists are 6 authorized users and many radiation oncologists are 7 authorized users.

8 And I don't think, as a patient access 9 problem, I think the major issue here is that many 10 medical oncologists are not referring patients for 11 these procedures. And now they want to give them 12 themselves without any training, and I think that's 13 really unacceptable.

14 Another thing, another point I wanted to 15 make is, that I think competency is a better way to 16 provide documentation of expertise rather than the 17 number of hours. And there are a number of ways to 18 do that.

19 One is certification by the appropriate 20 boards, with maintenance of certification. Another 21 is accreditation of the programs that these people 22 are involved with, the departments of nuclear 23 medicine and radiation oncology or whatever.

24 And certification can be accomplished by 25 board exams, such as from the ABNM or the ABR.

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33 1 Accreditation can be accomplished, and that can be 2 setup very easily.

3 And then you could also actually setup 4 proficiency testing, which would really be a good way 5 to assess the department and the qualifications and 6 expertise of the physicians.

7 And with that I think I'll quit, and I'll 8 send in some comments in writing. Thank you.

9 MS. LOPAS: All right, thank you, Dr.

10 Greenspan, I appreciate you calling in.

11 DR. GREENSPAN: Thank you.

12 MS. LOPAS: Okay. Cedric, do you have 13 anybody else on the line?

14 THE OPERATOR: Yes. The next question 15 comes from Ralph Lieto. Your line is open.

16 MS. LOPAS: Ralph.

17 MR. LIETO: Yes, thank you. My name is 18 Ralph Lieto, I'm representing myself. My question 19 for NRC Staff, in light of this big shutdown and your 20 proposed timeline that was in the slides, is this 21 timeline taking into account the delays due to the 22 shutdown or is the timeline is likely going to be 23 shifted back a little bit?

24 Because it seems like, in light of this 25 shutdown and then your attempts to get additional NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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34 1 information, it looks like it's overly optimistic.

2 MS. LOPAS: That's a good question, 3 Ralph. This is Sarah Lopas.

4 So, this timeline doesn't account for the 5 shutdown impacting us at all. At the moment, I don't 6 see the partial shutdown affecting us. You know, the 7 NRC is fully funded.

8 Like I said, the only thing that kind of 9 is, that were being affected right now by the shutdown 10 is the Office of Management and Budget needs to review 11 our letter to the Agreement States for that voluntary 12 information requests going out to them.

13 I don't anticipate that delay impacting 14 our overall schedule to be honest. So, we will of 15 course keep you posted.

16 The other thing that I think is minutia, 17 that I don't think really applies to much, but the 18 Office of the Federal Register is shutdown at the 19 moment. It is affecting our, the only thing I can 20 think of is it is affecting our ability, we have to 21 register, we have to notice to the Federal Register 22 when we're going to have an ACMUI public meeting, and 23 I might check with, I have a lawyer here in the room.

24 We must notice in the Federal Register 25 notice before we can have that meeting? I'm asking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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35 1 somebody in our room.

2 MR. IRVIN: So, this is Ian Irvin with 3 the Office of General Counsel. I got to admit, that's 4 with another attorney --

5 MS. LOPAS: Okay. Yes.

6 MR. IRVIN: -- counsel, with what most 7 be noticed in the Federal Register.

8 MS. LOPAS: Yes.

9 MR. IRVIN: But we have received some new 10 guidance --

11 MS. LOPAS: Okay.

12 MR. IRVIN: -- about what we can publish 13 in the Federal Register.

14 MS. LOPAS: Okay.

15 MR. IRVIN: And we're still reviewing it.

16 We just received that.

17 MS. LOPAS: Yes. So, Ralph, I'll be 18 honest, I have to, if for some reason we were -- we 19 have to notice that ACMUI, A-C-M-U-I, public meeting, 20 public teleconference, ideally 15 days ahead of the 21 meeting.

22 You can, under extenuating circumstances, 23 do it like ten days or so ahead and note it's because 24 of shutdown or whatever.

25 MR. LIETO: Okay.

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36 1 MS. LOPAS: If for some reason that backs 2 up that meeting, that public teleconference, that 3 might back us up a little bit. So, I can just say 4 stay tuned. If there's a delay it would be a very 5 minor delay. So, does that help?

6 MR. LIETO: Yes. I'm just really 7 concerned in the data that's going to be obtained 8 from just NRC states alone. Not that that data is 9 problematic, but I think it's not going to provide a 10 typical cross section of the AUs that are out there 11 because of the potential states that are non-12 agreement.

13 So, I think it would be tremendously 14 valuable for the NRC to obtain as much Agreement State 15 information that they're willing to provide.

16 MS. LOPAS: Yes, I would agree with that.

17 Yes. Okay, do you have any other additional 18 questions or comments, Ralph?

19 MR. LIETO: Not at this time. I'm going 20 to be providing written comments also. But I echo 21 many of the comments that Dr. Greenspan provided in 22 that I think the current T&E is an acceptable 23 methodology for assuring that the AUs are, have 24 appropriate training and experience.

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37 1 think that you have mentioned in your introductory 2 about the investigation, deeper investigation of 3 medical events in the NMED database. And I have a 4 lot of, shall I say, take it with a large grain of 5 salt that that's going to be of any value.

6 I think if you look at the ACMUI comments 7 from their own reviews annually of the NMED events 8 involving medical events. That the data there is 9 inconsistent across the states. Including the NRC 10 investigations.

11 And I was involved with these for about 12 eight years with the ACMUI. And this was a big 13 complaint that the information and investigation of 14 these events are sometimes very superficial. And 15 it's not standardized across the Agreement States 16 themselves, even relative to the NRC.

17 And I have never seen a medical event 18 reported, in the years that I have reviewed it, where 19 training experience was identified as a major cause 20 of a major contributing cause.

21 So, I am a little concerned that the NRC 22 is going to, "delve deeper" to find out if there are 23 medical events that have training and experience, 24 when that isn't even not reported in the events to 25 date. I would think that that would be a major thing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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38 1 if an investigator found that in one of the states.

2 And even sort of anecdotally again, some 3 of the most highly publicized medical events over the 4 last 20 years that the NRC has been involved with, 5 training and experience was never identified as a 6 major cause.

7 So, with that I'll let other people 8 comment. Thank you for your time.

9 MS. LOPAS: Yes, thank you. Okay, star-10 1 to make a comment or ask a question or you can also 11 type a short comment or short question in your webinar 12 using your webinar software.

13 Cedric, do we have anybody else on the 14 line that would like to have their line open?

15 THE OPERATOR: Yes. The next question 16 come from Jeffrey Siegel. Your line is open.

17 MR. SIEGEL: Good morning. Thank you 18 for having this -- sorry?

19 MS. LOPAS: Good morning. Sorry.

20 MR. SIEGEL: Good morning. Thank you 21 for having this webinar and inviting comments.

22 Just a brief history before I begin with 23 my comments. I've submitted written comments on the 24 website, and I'm waiting for them to appear. It's 25 been two weeks. But I understand it takes a while.

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39 1 Historically there was great reason for 2 there to be lots of T&E for physicians because most 3 agents were not supplied as a unit dosage, they had 4 to be manipulated. And hundreds of millicuries and 5 a wide variety of agents were given. And this was a 6 new field.

7 And, the T&E requirements, from 8 historical aspects, are not necessarily germane to 9 today's supplied agents.

10 Also, as I understand it, T&E 11 regulations, for medical use, are only for, if 12 justified by radiation risk to patients. They have 13 nothing to do with the practice of medicine.

14 So what I'd like to say is that, first of 15 all, the FRN is talking about radiopharmaceuticals 16 categories, I think that's wrong. I think it should 17 be for specific radiopharmaceuticals. Because, 18 within a given category, not all agents pose the same 19 risk.

20 So, now for my comments. Currently 21 physicians are not free to attend limited used 22 authorization for any given radiopharmaceuticals, 23 regardless of its safety profile, as they must contain 24 full AU status pursuant to 35.390.

25 This of course is not true for limited NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 use authorization which is available for sodium 2 iodide. Since a physician would undoubtedly choose 3 the ultimately pathway pursuant to 392 or 394, since 4 much fewer T&E AUs are required.

5 The pathways for obtaining AU status 6 pursuant to 390 are therefore not reasonable since 7 physician desiring limited AU status for another 8 radiopharmaceutical, even if it possesses radiation 9 safety risk than oral sodium iodide, are required to 10 have the same T&E as physicians seeking full AU 11 status.

12 Tailoring, therefore, should be based on 13 use of this specific agent, not an entire category.

14 As I said, since not all radiopharmaceuticals, in any 15 given category, pose the same radiation risk.

16 And when we're talking about categories, 17 how many are there? 390 has four dosage categories.

18 The first two are all sodium iodide. Not categories 19 at all, just specific agents.

20 The last two are for parenteral 21 administration of any beta emitter or photon emitting 22 radionuclide with a photon energy less than 150 keV 23 or parenteral administration or other 24 radiopharmaceutical.

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41 1 category only pertains to those two categories. And 2 that's all that's currently codified.

3 So there are three choices. Specific 4 radiopharmaceuticals in these last two categories 5 should either be placed into their own requirements, 6 such as a new codified 10 CFR 35.395, if their 7 radiation safety profiles justify it or reduce T&E 8 that is appropriate and sufficient to protect 9 workers, the general public, patients, et cetera or, 10 two, they should be regulated under 35.1000 or, 11 lastly, they should remain lumped together as is.

12 Unless the first two choices are 13 implemented, the ability to attain limited AU status 14 is justified, would be entirely ruled out. NRC 15 already believes limited AU status is justified, at 16 least for oral sodium iodide.

17 NRC therefore needs to objectively, not 18 suggestively, assess the associated risks for a given 19 radiopharmaceuticals. Such an assessment should 20 include, how is it supplied, its ease of 21 administration, the intended administered activity, 22 half-life and purity, radio contaminate levels, root 23 of elimination from the body, waste disposal, 24 potential dose to others, potential for internal 25 contamination and patient release issues.

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42 1 Unless this assessment is not done, it 2 cannot be entirely regulated appropriately and the 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> necessary for ensuring safety cannot be done.

4 Reducing T&E requirements for specific 5 agents will undoubtedly increase the complexity of 6 regulatory oversight. But when justified, should be 7 of minor concern as it would be a more risk informed 8 approach and is great benefits to patients and their 9 treating physicians.

10 Restricting patients access to and 11 ability to use an FDA approved and commercially 12 available agent by imposing unwarranted and unduly 13 burden to community regulations that may not be 14 reflective of the radiation risks involved, is 15 detrimental to them and their patients.

16 Conflicts with NRC guidelines of minimizing 17 intrusion into medical judgement, as the medical use 18 policy statements say, only when justified by 19 radiation risks will such requirements be imposed, 20 and such an approach is most assuredly not risk 21 informed.

22 I thank you for listening to my comments.

23 Thank you.

24 MS. LOPAS: All right, thank you, Mr.

25 Siegel. All right, Cedric, do we have another NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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43 1 commenter on the line? Star-1 to get your line un-2 muted.

3 THE OPERATOR: Sure. Next question and 4 comment comes from Michele Panichi. Thank you, your 5 line is open.

6 MS. PANICHI: Good morning. How are you 7 guys doing?

8 MS. LOPAS: Good morning. Great.

9 MS. PANICHI: So, I'm going to have to 10 respectfully disagree with Dr. Siegel. I know Jeff 11 very well. He's very respected and I respect his 12 opinion.

13 However, I believe that we should not 14 change our training T&E requirements. These are 15 relatively dangerous radiopharmaceuticals that we're 16 talking about. They have long half-life's, they're 17 alpha and beta emitters.

18 And there's a reason why a written 19 directive is required. We don't consider this, you 20 know, a diagnostic 140 keV, six hour half-life kind 21 of isotope.

22 Industry is pushing primarily to sell 23 their products. That being said, they want industry 24 people to proctor physicians for this. Big mistake.

25 As soon as you allow somebody other than NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 a current authorized user in that category to oversee, 2 you're opening up a large can of worms.

3 In the previous webinar there was a 4 pharmacist who said that pharmacists require an 5 authorized nuclear needs 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />. Well, that's 6 not quite an accurate statement.

7 If you read the training requirements for 8 that, the 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> is to get a board certification 9 exam acknowledged by the NRC.

10 And the idea is that a nuclear pharmacist 11 can oversee radiation safety for an authorized user 12 is also not feasible. If you want to talk about a 13 shortage of physicians, there's a huge shortage of 14 nuclear pharmacists.

15 I dare say, there is a whole lot less 16 fewer nuclear pharmacists than there are authorized 17 users.

18 I don't believe there is a shortage of 19 authorized users out there. I believe that every 20 radiologist, and that radiation oncologist, now they 21 have the opportunity to become authorized users.

22 I believe the people, the physicians who 23 are pushing this, the MDECs and sometimes the 24 urologists, they're more self-serving than we would 25 like to see in a physician group. They need, want NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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45 1 to keep their patients in their practice. It has 2 nothing to do with the availability of an authorized 3 user.

4 And that's about it. I will be also 5 submitting my comments in writing. And that's about 6 it. Thank you.

7 MS. LOPAS: All right, thank you. Okay, 8 star-1 to have Cedric un-mute your line for you.

9 star-1. Cedric, do we have somebody up next?

10 THE OPERATOR: Yes. We have a follow-up 11 with Jeffrey Siegel. Your line is open.

12 MR. SIEGEL: Hi, since my name was 13 mentioned I must respectfully disagree with Michelle, 14 of course. Because, objectivity is what's required.

15 We can't just say, all agents are equally 16 hazardous because they are not. And if we're going 17 to follow that all radiation is risky, ALARA and LNT, 18 which I believe is not true at all, then that would 19 be true.

20 But I think we owe it to the patients and 21 the physicians and the community and everybody, to 22 have an objective assessment of each agent. And the 23 level of risk it involves. Thanks.

24 MS. LOPAS: Okay, thank you, Dr. Siegel.

25 Okay, star-1 to get in on the conversation. Cedric, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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46 1 do we have anybody else in line?

2 THE OPERATOR: None currently.

3 MS. LOPAS: Okay. All right, everybody 4 star-1. We will hang on for a few minutes, but I 5 want to, let's see.

6 I'm going to go, I pulled up on the 7 webinar some of the questions, the more detailed 8 questions under A. Tailored training and experience 9 requirements.

10 You know, Dr. Siegel had mentioned that 11 he didn't think it was appropriate to categorize state 12 radiopharmaceuticals that may be, such as by their 13 type of radiation admission or characteristics 14 because not all, may be drugs within those admission 15 categories, are the same.

16 So, some other options that were 17 suggested in the FRN was to characterize 18 radiopharmaceuticals by similar delivery methods.

19 Whether it's oral, parenteral.

20 Of course, the radiation characteristics 21 or emission, alpha, beta, gamma, low-energy photon.

22 Or similar preparation methods, such as patient ready 23 doses or a combination of that.

24 So that's something that we're looking to 25 get comments on. And, Cedric, you can just interrupt NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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47 1 me.

2 THE OPERATOR: Sure. We do have David 3 Burpee that's on.

4 MS. LOPAS: Okay.

5 THE OPERATOR: Your line is open.

6 MR. Burpee: Good morning, everyone, 7 thank you for this opportunity and for all the good 8 comments.

9 As far as enough authorized users, I 10 think the key word is really treating authorized users 11 that have the ability to.

12 I witness, as I manage ten states for 13 license and compliance for Xofigo, numerous scenarios 14 where patients cannot be treated at even very large 15 institutions, typically due to infighting between 16 authorized users who could be treating.

17 There's a very large place in north 18 Chicago with 400 beds for four years, fought between 19 authorized users as to who could have the privileges 20 at that institution, and therefore they didn't treat 21 at all. That story is fairly ubiquitous. And it 22 goes in many directions.

23 For example, another large group needed 24 to have preceptorships and they solicited another 25 group to do that and at the end of the day the other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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48 1 group decided they were competition and wouldn't sign 2 the attestation forms, and so no one was able to treat 3 at those institutions.

4 The rural situation is acute in that 5 there are not enough out there to help cover all these 6 places. And therefore in general, all these 7 scenarios require the men to travel. Men were sick 8 and don't want to travel typically.

9 So, we do need to look at how we can have 10 more options for being an authorized user.

11 I think something dawned on me recently 12 that I think is germane to this in that, if you look 13 at alpha emitters, there has never been any formal 14 trading for authorized users with alpha emitters.

15 They are very unique.

16 And Dr. Siegel's comments are right on 17 the money, that there are certainly incredibly 18 differently qualities to those products compared to 19 all beta emitters and every other types of therapy 20 that has been out there.

21 So, thanks for those considerations and 22 for this time.

23 MS. LOPAS: Sure.

24 THE OPERATOR: Thank you. We have an 25 additional comment with Ben Greenspan. Your line is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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49 1 open.

2 DR. GREENSPAN: Thank you. This is Ben 3 Greenspan. I am a nuclear medicine physician and 4 radiologist and I wanted to make some comments 5 regarding some of the comments we just had.

6 First of all, I think, while there may be 7 different lists of various, of these therapeutic 8 radiopharmaceuticals, they're still potentially 9 dangerous. And I also think that many of them will 10 be given in combination. So we may give alpha 11 emitters and beta emitters with patients to various 12 cancers.

13 And therefore, the alpha's user who is 14 treating these patients really needs to know the full 15 range of the basic science and clinical expertise to 16 handle all this.

17 In terms of various physicians, I have 18 great respect for the clinical abilities of medical 19 oncologist, and urologists, but I don't think they 20 should be treating these patients by themselves.

21 I don't think they have the requisite 22 background in radiation sciences and, if they 23 actually wanted to get it all and spend whatever time 24 it took to come up to the same level as a nuclear 25 medicine physicians and radiation oncologist, then NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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50 1 that's fine. But I doubt any of them would.

2 As far as authorized users and patient 3 access, I'm not aware of too many places having these 4 kinds of logistical issues with infighting. I guess 5 some of them do but I don't think that's a huge issue.

6 In terms of rural areas, I don't think, 7 I think patients realize they have to travel if 8 they're in a rural area. For just about everything 9 beyond simple things.

10 So, if they want coronary bypass surgery, 11 they're not going to get it by the surgeon who does 12 one a year, they're going to go to a major medical 13 center and get one by an expert. And the same should 14 be true for treating with radiopharmaceuticals.

15 They have potential risks if they're 16 misused or there are problems. And these should be 17 provided by experts who know what they're doing, and 18 I think patients realize that. Thank you very much.

19 MS. LOPAS: Okay, thank you, Dr.

20 Greenspan. Press star-1, again, if you want to get 21 in on the conversation.

22 I do have one question from the webinar 23 that I'm going to read aloud. So there was a question 24 about whether or not the NRC has been conducting any 25 outreach to the referring visits physician NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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51 1 communities, such as medical oncology, et cetera, for 2 input on this.

3 And we did send out, back when the FRN 4 first went out, we did send out the FRN and ask them 5 to provide questions to about 100 different 6 stakeholder groups. And so, a lot of the stakeholder 7 groups included, let's see, kind of professional 8 societies for urologists, for cardiologists, for 9 medical oncology.

10 So, we did do some attempt at outreach in 11 that matter. I don't know if any of those are support 12 to be on our medical Listserv, but we did reach out 13 to the professional societies. And hopefully that 14 those groups put the word out to their membership 15 that this is something that we are looking at.

16 We also, and I can't remember off hand 17 right now, but we did publish short little 18 advertisement type articles, less than one page or 19 so, kind of in a number of journals. Not medical 20 journals per say but kind of like newsletter monthly, 21 sort of either online or printed newsletters, for a 22 number of organizations just alerting them to these 23 public meetings and our effort and our FRN questions.

24 We did do a fair amount of outreach to 25 what we think would be those communities, those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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52 1 referring physician communities. So, thank you for 2 that question, that's a good one.

3 Because we, exactly, we'd like to hear 4 from those folks as well. This is what they want to 5 be getting into.

6 Okay, Cedric, do we have anybody else on 7 the line?

8 THE OPERATOR: None currently in the 9 queue.

10 MS. LOPAS: Okay. All right, star-1 or, 11 again, submit a question or comment via the webinar, 12 we're happy to go that route.

13 Maryann and I attended recently, just 14 this past weekend, on Thursday through Saturday, 15 Maryann and I attended the Society for Nuclear 16 Medicine and Molecular Imaging, their mid-winter 17 meeting, which was in Palm Springs, which was very 18 nice. But we got a lot of good feedback from the 19 folks attending that meeting.

20 And I know some of you are on the line 21 that we saw there, so thank you for calling in and 22 we're definitely looking forward to your written 23 comments as well.

24 star-1. And, Cedric, just let me know 25 is anybody pops on the line.

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53 1 THE OPERATOR: Okay.

2 MS. LOPAS: So, Question 5 here on the 3 tailored training and experience requirements.

4 Question 5 gets into, if we were to create 5 tailored T&E categories, what should those specific 6 requirements include for the classroom and lab 7 training?

8 How many hours, what should be covered 9 under that classroom and lab training, what topics?

10 The work experience, we asked exactly, we 11 heard some comments about whether or not the 12 pharmaceutical manufacturers should be able to 13 provide the preceptor attestation. That's one of our 14 questions we'd like feedback on.

15 And the competency, we have been hearing 16 some feedback on competency that we, the NRC, should 17 look into whether or not we could move our regs to 18 evaluate competency rather than just straight hours 19 of T&E. So, those are some of our questions in our 20 Federal Register notice.

21 Also, some questions on who should 22 establish and administer these curriculums on an 23 examination. And also, how often should AU 24 competency be periodically assessed?

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54 1 recent myths of training and so that's important to 2 think about too. Should it be a number of cases 3 every year or so that the physician AUs are required 4 to maintain their competency or are required to 5 maintain that AU certification?

6 So these are all good things to think 7 about.

8 THE OPERATOR: Excuse me, Sarah, we do 9 have a question. Miguel de la Guardia, your line is 10 open.

11 MR. DE LA GUARDIA: Hi, this is Miguel 12 de la Guardia and I am the RSO at Cook Children's 13 Medical Center in Fort Worth. And we are one of the 14 major trading centers for neuroblastoma using iodine-15 131 MIBG.

16 First, I want to echo Jeffrey Siegel's 17 comments. I think they're spot on.

18 But next I also want to concur with the 19 comments of the lack of authorized users. There are 20 plenty of authorized users for diagnostics but for 21 therapy is very difficult.

22 Right now we only have two authorized 23 users here that can actually administer diamygadia 24 (phonetic). And sometimes it's very difficult to 25 schedule these treatments based on their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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55 1 availability.

2 And as far as rural areas, we are very 3 keenly aware of that because we get patients from all 4 over the place. If you go west of Fort Worth, where 5 we are, there is nothing as far as being able to treat 6 these patients until you get to Arizona or California.

7 So, there is a critical shortage out there of 8 physicians that can do therapies.

9 Now, I do know that nuclear medicine, we 10 would like hold on to as much as we can, but prior 11 experience shows that when other groups get involved, 12 such as the endocrinologist or cardiology, which 13 actually launched nuclear cardiology made, basically 14 saved nuclear medicine in many respects, I think that 15 having a pathway for other physicians to be able to 16 do these treatments will be very helpful.

17 Especially now that most of the therapies 18 can be obtained from a nuclear pharmacy as a unit 19 dose and you don't have to manipulate the product 20 onsite.

21 So I want to thank you for the opportunity 22 to commenting and for sponsoring this webinar. Thank 23 you.

24 MS. LOPAS: Yes, thank you.

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56 1 or comments.

2 MS. LOPAS: Okay, thank you. Okay, and 3 I will maybe, just to kind of spur some conversation, 4 the last public meeting we had was on January 10th.

5 And during that meeting we got some unique ideas 6 submitted by a comment.

7 One was to allow to open up the AU status 8 to non-physicians. So, including maybe authorized 9 nuclear pharmacists. Also maybe including some 10 advance trained technologist.

11 We specifically got comments from nuclear 12 medicine advance associates who undergo, you know, 13 who have been technologist for many, many years and 14 then they go on to continue their training with two 15 years of a master's program and then they do a nuclear 16 medicine kind of internship or they kind of, they 17 kind of call it analogous to a residency. They 18 offered up, they thought that potentially they could 19 be considered for AU status.

20 So, we, at the NRC, even though our 21 questions in FRN are kind of very specific, we are 22 open to hearing any ideas on how, if we do think, you 23 know, if you do think that's there's a patient access 24 issue on how we can improve that situation.

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57 1 comments on whether you think it would be a good idea 2 to allow certain categories of folks practicing in 3 this medicine field to become AUs. Right now, in the 4 Part 35 regulations an authorized user is only 5 defined, can only be a physician, a dentist or a 6 podiatrist.

7 So obviously the majority of our AUs are 8 physicians. And so, we did get some comments that 9 maybe we should consider expanding that definition of 10 authorized user.

11 So, star-1 to provide any additional oral 12 comments.

13 THE OPERATOR: We do have an additional 14 comment with Michelle Panichi. Your line is open.

15 MS. PANICHI: Oh my goodness.

16 (Laughter) 17 MS. PANICHI: This is a tough one. So, 18 let us not forget these are prescription medications.

19 So, they have to be prescribed by a physician.

20 As much as I would like to say, as a 21 nuclear med tech, that I am equally qualified as a 22 nuclear medicine physician, I am not.

23 I also have the honor of being the RSO at 24 nuclear pharmacies, and I can confidentially tell you 25 that the majority of nuclear pharmacists that I have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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58 1 met should not be prescribing these medications.

2 Remember, this is not just administering.

3 I have no problem with a nuclear med tech 4 administering a radiotherapy, with an authorized user 5 in place. A lot of times it is simply passing a 6 pill, injecting a patient.

7 But that's not what requires the AU 8 status, it's the prescribing of these medications.

9 And they are prescription drugs.

10 So, an NMAA or a nuclear med tech, even 11 a nuclear pharmacist, they're not in the practice of 12 prescribing pharmaceuticals. Thanks.

13 MS. LOPAS: Yes, thank you.

14 THE OPERATOR: Another addition question 15 or comment comes from Ralph Lieto. Your line is 16 open.

17 MR. LIETO: Thank you. I also would like 18 to echo Michelle's comments that I think that these 19 suggestions of non-physicians becoming authorized 20 users basically would turn the NRCs whole regulatory 21 framework upside down.

22 If you allowed this for therapeutic 23 radiopharmaceuticals, you are opening up a literal 24 Pandora's Box where you could have other specialists, 25 you could have an RSO making a case that they oversee NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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59 1 all this and probably supervises as much as the AU 2 does, the operations of radiation safety in these 3 aspects, making a case for them to be the "AU."

4 Which I think is absolutely abhorrent as 5 a medical physicist and radiation safety officer. I 6 think that, like I said, this is just a very, very 7 bad thought process for suggesting this.

8 And if the NRC would be considering this, 9 you basically would undermine the whole intent of 10 having a physician involved with not only the 11 therapeutic aspect of it, but also the diagnostic 12 imaging aspect of it.

13 As Michelle pointed out, the AU is not 14 just involved with overseeing the administration, but 15 supervising all aspects of receipt, patient 16 assessment, administration and follow-up. And they 17 are the best persons for this.

18 And I think my objections as a 19 technologist and a nuclear pharmacist would be, a pun 20 intended, just a set of nuclear land mines for the 21 NRC.

22 I do have another comment that, regarding 23 your previous slide. I think it was on Item 5 where 24 you, the NRC uses the word competency.

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60 1 connotations to different groups. The ACMUI, over 2 the years, has addressed this several times in the 3 definition, or excuse me, the description of the 4 preceptor attestation.

5 And I think NRC should stay away from 6 that term because competency is more than just an 7 assessment of the understanding and having a 8 requisite knowledge to perform the supervisory 9 aspects of the radiopharmaceuticals that the 10 applicant is applying for.

11 It's maybe just a, maybe a pet peeve of 12 whatever, but I think competency, as used in this 13 slide, is not what you're really trying to evaluate.

14 I think what you want to know is, did the training 15 and experience that the individuals get can reassess 16 that that training and experience contains the 17 requisites body of knowledge that they need to 18 function independently in supervising these types of 19 radiopharmaceuticals. Thank you for the comment.

20 MS. LOPAS: Okay, thank you.

21 THE OPERATOR: We have a follow-up with 22 Miguel. Your line is open.

23 MR. DE LA GUARDIA: Thank you for taking 24 my follow-up. I'm not sure if I was clear on my 25 comments.

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61 1 I am a nuclear medicine technologist, but 2 I am not in favor of nuclear medicine technologists 3 prescribing. That is not part of our scope of 4 practice.

5 Also, similarly, I think in almost every 6 state here in the United States, pharmacist are not 7 allowed to prescribe most medications. So, that 8 would require a change completely in pharmacy 9 practice.

10 I know in some other countries, 11 pharmacist can prescribe, but commonly that's not 12 true here in the United States. So, when I was 13 talking about authorized user, I'm talking about 14 physician authorized users. Thank you.

15 MS. LOPAS: Yes, thank you, Miguel. And 16 I didn't mean to imply that you were suggesting that, 17 I was just stating that in our previous meeting on 18 January 10th, we had received some comments along 19 those lines about potentially, the NRC should 20 potentially consider opening up AU status to some 21 non-physicians. So, understood. Understood.

22 THE OPERATOR: Thank you. And the next 23 question, comment comes from Scott Degenhardt. Your 24 line is open.

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62 1 my name is Scott Degenhardt. I am actually a nuclear 2 medicine advance associate speaking on behalf of 3 myself here.

4 I just want to clarify what a nuclear 5 medicine advance associate is. While one time, at 6 one time we were technologists, we're actually mid-7 level providers in the field of nuclear medicine.

8 Again, yes, we were technologists at one 9 point, but we have gone through a two to three year 10 additional schooling at the master's level where we 11 have didactic course work, but we also undergo a 24 12 month internship under the supervision of a 13 physician, most under a radiologist or a nuclear 14 physician.

15 Where we, at the end of the program, are 16 actually, we meet all training requirements for what 17 is currently asked of, of an authorized user. So, 18 we wouldn't, you know, if the NRC would consider the 19 nuclear medicine advance associate for authorized 20 user status, we wouldn't be compromising training and 21 education, the current training and education 22 requirements.

23 But I guess I just wanted to clarify that 24 we are not technologist, we're actually mid-level 25 providers in the field of nuclear medicine. Almost NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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63 1 every other field in the healthcare industry has mid-2 level providers that do prescribe drugs, under the 3 supervision of a physician. And that's the model 4 that we were proposing there.

5 The nuclear medicine advance associate 6 would be working under the supervision of an 7 authorized user, again, just as that physician 8 extender alongside them.

9 I guess, any other questions I'm happy to 10 answer but I just wanted to clarify that. Thank you.

11 MS. LOPAS: Yes, thank you, Scott. Thank 12 you for that clarification.

13 THE OPERATOR: Our next question or 14 comment comes from Ben Greenspan. Your line is open.

15 DR. GREENSPAN: Thank you. This is Ben 16 Greenspan again, I'm a nuclear medicine physician and 17 radiologist and I wanted to make some comments.

18 First of all, I agree with Ralph Lieto's 19 comments. Regarding Scott's comments just now, I 20 agree pretty much.

21 I mean, these NMAAs, the Nuclear Medicine 22 Advanced Associates, are technologists who have had 23 an extra two plus years of training and are certainly 24 expert in radiation safety. And in other aspects of 25 dealing with radiopharmaceuticals.

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64 1 But they're not physicians. And if they 2 were given AU status, they still have to, I would 3 think they'd still have to work under an authorized 4 user, under a physician. And I don't see how that 5 adds anything.

6 I think they could certainly help with 7 the process of treating a patient, and they could 8 certainly give the radiopharmaceuticals, most of 9 which would be given parenteral, but they still have 10 to work under an authorized user, i.e. under a 11 physician. And I think that would be most 12 appropriate.

13 On the other hand, I really do think 14 that's a very good program and I'd like to see it 15 expand and have more technologists, nuclear medicine 16 technologists, go into those programs. I think it 17 helps the field.

18 Mid-level providers, as these people are 19 seen throughout medicine now and they are physician 20 extenders, and I think they would help nuclear 21 medicine practice. Including in radionuclide 22 therapy. Thank you.

23 MS. LOPAS: All right, thank you.

24 THE OPERATOR: Thank you. And our next 25 question, comment comes from Rachel Semon. Your line NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 is open.

2 MS. SEMON: Thank you. Can you hear me 3 okay?

4 MS. LOPAS: Yes, we can.

5 MS. SEMON: Okay, great. I appreciate 6 the opportunity to comment. I'm really not going to 7 comment one way or the other as to which direction 8 this should go, in terms of T&E, but I did want to, 9 for the record, provide some feedback regarding 10 pharmacy and the practice of pharmacy and that there 11 certainly is precedent outside of the nuclear 12 medicine, or the nuclear medicine world, where 13 pharmacist do have provider status.

14 It is quite often you will see this 15 actually in medical oncology. There is board 16 certifications based on specialty. So, I am a board 17 certified nuclear pharmacist.

18 I could say today I would not be 19 comfortable being in a AU, a full AU, overseeing 20 patient management. It's certainly something to 21 consider moving forward. Perhaps in conjunction 22 within the nuclear medicine department.

23 And we talk about potential shortage of 24 AUs. And what I know that I have seen historically, 25 is that the current RVU model tends to provide some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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66 1 barrier to a nuclear medicine physician being torn 2 between the requirements of reading images, the 3 diagnostic portion versus having to spend 30 minutes 4 to an hour with a patient for therapy.

5 And so, perhaps there is something here 6 that could help facilitate patient access and ease 7 the requirements of time spent, et cetera, in the 8 future.

9 But just for the record, I wanted to say 10 that provider status is not, there is a precedent for 11 provider status outside of nuclear medicine, 12 particularly in medical oncology. And there are 13 pharmacists who have limited prescribing rights as 14 well.

15 Typically, it is under the supervision of 16 a physician. So I think there is some room here.

17 Maybe not immediately, but not to be close minded 18 with that. That's it, thank you so much.

19 MS. LOPAS: Great, thank you. And, 20 Cedric, do we have anybody else? star-1 if you want 21 to get in on the conversation, get your comments 22 transcribed to go on the record.

23 THE OPERATOR: None currently in the 24 queue, but, again, press star-1.

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67 1 so, I will say that, related to that comment that we 2 just heard, we have had some comments submitted that 3 the NRC should be open to the idea of, maybe not 4 necessarily making an authorized nuclear pharmacist 5 an AU, but maybe some sort of requirement or new 6 regulatory requirement for an alternate, an alternate 7 pathway of having a limited authorized user physician 8 teamed with a authorized nuclear pharmacist.

9 That authorized nuclear pharmacist 10 undergo extensive training and, per our requirements, 11 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 12 nuclear pharmacist.

13 So, if you teamed an authorized nuclear 14 pharmacist with perhaps a limited trained authorized 15 user physician, that you would still be meeting the 16 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.

17 Because you'd have those two individuals working 18 together.

19 So that was one comment that we received 20 on the January 10th meeting. That's a little bit 21 different from just suggesting that authorized 22 nuclear pharmacists should be considered for AU 23 status.

24 Okay, we're going to -- anybody else on 25 the line, Cedric?

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68 1 THE OPERATOR: Yes. Ralph Lieto, your 2 line is open.

3 MS. LOPAS: Okay, Ralph.

4 MR. LIETO: Yes, Sarah. I'm glad you 5 brought that subject up. I had heard about this but 6 I was wondering if this was something the NRC was 7 seriously going to consider or not.

8 Again, I think this is something that 9 would basically set the licensee up for a lot of 10 potential problems. Because, it's my understanding 11 of this proposal that you would have a centralized 12 nuclear pharmacist teamed with a limited AU that would 13 be onsite, something to that nature.

14 And to me this is matched with two chiefs 15 with no Indians.

16 I think that these types of situations 17 you need, with therapeutic radiopharmaceuticals, a 18 person that's signing the written directive needs to 19 be in AU. And that AU has to be responsible for the 20 proper management of that radiopharmaceutical, to 21 that patient.

22 This dual AU, that would be fine as long 23 as everything goes great, but what happens if 24 something goes wrong, okay, and there's a medical 25 event or there's a problem with the patient or the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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69 1 assay at the site.

2 You can't have this dual AU 3 geographically separated and expect that it's not 4 just going to create further problems. And 5 especially from the aspect of supervision, which is 6 something that the NRC takes quite seriously. And 7 not just in the diagnostic side but even more so on 8 the therapeutic side.

9 And I think this dual AU is, again, just 10 fraught with all kinds of potential problems that's 11 going to place the licensee, who's going to be the 12 management, in a lot more potential problems of trying 13 to resolve this.

14 Because the nuclear pharmacist is going 15 to be offsite at, and operating under a different 16 license than the administration. Just so many things 17 that add up to, that this is just a very, very poor 18 idea.

19 MS. LOPAS: Okay. Yes, and I think to 20 clarify, now, I haven't received the written comments 21 on this, on this particular idea yet. They have not 22 been submitted yet.

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70 1 to the limited AU position site for a day of 2 treatments, right. So they would be paired together 3 physically, during an administration.

4 So, that's just a clarification from what 5 I recall from the January 10th meeting. But yes, if 6 you have any follow-up on that, Ralph, go right ahead.

7 MR. LIETO: I would just say that, if you 8 have an AU that's onsite to administer it, then you 9 wouldn't need the nuclear pharmacist to be present.

10 MS. LOPAS: Right.

11 MR. LIETO: I think it just, again, I 12 think it kind of goes back that, what are you trying 13 to sell here. And it is not anything that is going 14 to improve the radiation safety management 15 supervision at the site where the, where all the work 16 is going to be done.

17 MS. LOPAS: Okay, thank you, Ralph. Does 18 anybody else have a comment? star-1 or feel free to 19 type one via the webinar software, I can read it 20 aloud.

21 Okay, I'm just going to give it another 22 minute or so. I do appreciate everybody calling in 23 today and taking the time.

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71 1 appreciate you guys taking the time to do and it means 2 a lot to the NRC. And we do really, we're going to 3 really examine everybody's input.

4 Whether you've spoken on one of these 5 meetings or, and/or when you send it in, send in the 6 written, your written comments.

7 And I just want to remind folks, you have 8 until January 29th, end of that day, to get your 9 comments in. That's a week from today. It's a 10 Tuesday.

11 Try to use regulations.gov if you can.

12 And if you're encountering any difficulties or at all 13 concerned, I'm happy to take your comments via email.

14 And, again, my email is in the slides here. It's 15 sarah.lopas@nrc.gov. So either myself or Maryann 16 will take your comments via email, that's fine too.

17 And, I don't know, Cedric, can I check in 18 on the phone one last time?

19 THE OPERATOR: No questions or comments.

20 MS. LOPAS: Okay. I think that's it.

21 And Dr. Siegel, I will say, I think you had noted 22 that you're waiting for your comments to get up on 23 regs.gov.

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72 1 should be on regulations.gov shortly.

2 But there is a number of kind of 3 rulemakings and other efforts going on at the agency 4 and we only have a few administrative staff that kind 5 of handle the processing of all the comments that we 6 receive from the public on all of our projects. So, 7 I apologize for the delay, I know that's difficult.

8 But I'm going to reach out to our folks and see if 9 they can expedite some of the processing on regs.gov.

10 So, Maryann, do you have any follow-ups?

11 MS. AYOADE: Yes, Sarah, I was waiting 12 for everybody to provide their comments. Just to add 13 to and clarify Ralph Lieto's comment on competency.

14 Thank you for bringing that up.

15 I just wanted to, as you have recognized 16 the sensitivity with the word competency and the 17 misunderstanding that it could come about from that.

18 And so, with the new rule, I just wanted to point out 19 that with attestation statement, it replaced the text 20 that used to formally say, attestation demonstrate 21 that the individual has achieved a level of competency 22 to function independently.

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73 1 duties. So thank you for bringing that up.

2 Now, when this evaluation started, it was 3 still with the former regulations. The new rule 4 become effective last Monday, January 14th, at the 5 NRC licensees.

6 And so, just a, I just wanted to bring it 7 to your awareness that you recognized that. And 8 thank you for bringing that up.

9 MS. LOPAS: Okay, thanks, Maryann. And 10 on the NRC's medical toolkit licensee, or medical 11 licensee toolkit website, Maryann, I think there is 12 a page that's dedicated to the Part 35 rule changes 13 that just went into effect, is that right?

14 MS. AYOADE: That's correct. And if you 15 even just go to, if you Google the 10 CFR 35 16 regulations, they are now updated with the new rule.

17 So, if you can't find it in our medical use toolkit, 18 if you just Google 10 CFR 35 to get into the new rule, 19 it's updated with the new rule.

20 MS. LOPAS: Right. And I think the 21 slides from some public meetings that we had on the 22 Part 35, the new rule changes, those are also on the 23 medical licensee toolkit website I believe.

24 So those are available for people to pull 25 up the PDF of slides if they just want to see an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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74 1 overview. Although it's about a 96 slide overview, 2 but it's an overview.

3 Okay. Cedric, do we have any other final 4 comments on the line?

5 THE OPERATOR: No questions in queue.

6 MS. LOPAS: Okay. All right, Maryann, 7 is there anything else?

8 MS. AYOADE: No, that's it.

9 MS. LOPAS: Okay. All right, everybody, 10 January 29th, deadline to get your comments in. But 11 Maryann and I are here for your questions and comments 12 before, and after that date obviously. Please keep 13 checking out our website that I have the slide up on 14 right now for any updates.

15 And if you are signed up to receive our 16 medical Listserv emails that's great. If not, do 17 that. I suggest doing that because that's a good way 18 to stay informed of all the NRC's medical regulations 19 and news and all that good stuff.

20 All right, thank you so much for your 21 time today and that will be the end of our meeting.

22 THE OPERATOR: Thank you, and that 23 concludes today's conference. You may all disconnect 24 at this time. Speakers, you may standby for post-25 conference.

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75 1 (Whereupon, the above-entitled matter 2 went off the record at 11:35 a.m.)

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