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{{#Wiki_filter:1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION  
{{#Wiki_filter:Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
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PUBLIC MEETING TO ACCEPT COMMENTS ON THE NRC'S EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
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WEDNESDAY, NOVEMBER 14, 2018
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The meeting was conducted via teleconference, at 1:00 p.m., Sarah Lopas, Office of


Nuclear Material Safety and Safeguards, presiding.  
==Title:==
Public Meeting to Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals Docket Number:    NRC-2018-0230 Location:        Teleconference Date:            Wednesday, November 14, 2018 Work Order No.:  NRC-3995                          Pages 1-66 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433


NRC STAFF PRESENT:  
1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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PUBLIC MEETING TO ACCEPT COMMENTS ON THE NRC'S EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
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WEDNESDAY, NOVEMBER 14, 2018
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The      meeting          was      conducted        via teleconference, at 1:00 p.m., Sarah Lopas, Office of Nuclear Material Safety and Safeguards, presiding.
NRC STAFF PRESENT:
SARAH LOPAS, Project Manager, Office of Nuclear Material Safety and Safeguards MARYANN AYOADE, Health Physicist, Office of Nuclear Material Safety and Safeguards CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch, Office of Nuclear Material Safety and Safeguards NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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SARAH LOPAS, Project Manager, Office of Nuclear Material Safety and Safeguards MARYANN AYOADE, Health Physicist, Office of Nuclear Material Safety and Safeguards CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch, Office of Nuclear Material   
2 ALSO PRESENT:
DAVID CROWLEY, Radioactive Material Branch Manager, North Carolina Department of Health and Human Services MUNIR GHESANI, MD, FACNM, FACR, Society of Nuclear Medicine and Molecular Imaging RALPH LIETO, St. Joseph Mercy Health System AMIN MIRHADI, MD, Cedars-Sinai Medical Center ARIA RAZMARIA, MD, UCLA Medical Center JEFFRY SIEGEL NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 CONTENTS Call to Order and Opening Remarks..................4 Welcome and Introduction...........................5 Review Agenda and Ground Rules.....................7 Presentation on the NRC's T&E Evaluation...........9 Public Comments...................................27 Closing Remarks...................................65 Adjourn...........................................66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1                      P R O C E E D I N G S 2                                                          1:02 p.m.
3                  MS. LOPAS:        (presiding)      Hi, everybody.
4 Good afternoon.
5                  Welcome to the NRC's webinar to accept 6 comments on the Staff Evaluation of Training and 7 Experience Requirements for Different Categories of 8 Radiopharmaceuticals.
9                  My name is Sarah Lopas, and I am a member 10 of the NRC's Medical Radiation Safety Team, which is 11 part of the Medical Safety and Events Assessment Branch 12 and the NRC's Office of Nuclear Material Safety and 13 Safeguards.
14                  I'm the Project Manager for the NRC's 15 training      and  experience        evaluation,    and  I'll      be 16 facilitating today's webinar and, also, giving part 17 of the NRC's presentation.
18                  I'm joined here at NRC's Headquarters by 19 my manager, Chris Einberg, who is the Chief of the 20 Medical Safety and Events Assessment Branch.                      Also 21 joining us remotely via phone is another member of the 22 Medical Radiation Safety Team and the technical lead 23 on the training and experience evaluation, Maryann 24 Ayoade.        Maryann will be helping me with today's 25 presentation.
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5 1                  We have a short agenda for today's webinar.
2  In just a moment, my Branch Chief Chris will start 3 us out with a welcome and the purpose of today's meeting.
4  And then, myself and Maryann will go through about 5 15 slides that will cover background information on 6 the NRC's evaluation, and we will discuss The Federal 7 Register notice that was published on October 29th and 8 the questions that were contained in that Federal 9 Register notice.          And we will cover how you can also 10 provide written comments by the January 29th comment 11 deadline, if you would like to submit written comments.
12                  Then, we're going to go to the phone lines.
13  We'll open them up one by one, and we'll take your 14 comments on the record.
15                  And now, I'm going to ask Chris Einberg, 16 Chief of the Medical Safety and Events Assessment Branch 17 in the NRC's Office of Nuclear Material Safety and 18 Safeguards, to give a short welcome.
19                  MR. EINBERG:        Okay.      Thank you, Sarah.
20                  Good afternoon, everyone.              Thank you for 21 taking the time to attend today's webinar, which will 22 be the first of four comment acceptance meetings that 23 the      NRC  will  be  conducting        on    our training      and 24 experience requirements evaluation.
25                  The purpose of today's meeting is twofold:
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6 1  to provide background information on the NRC staff's 2 planned evaluation of developing tailored training and 3 experience requirements for administering different 4 categories of radiopharmaceuticals for which a written 5 directive      is    required,      in    accordance      with      our 6 regulations        in  10 CFR Part          35,      which  are      our 7 regulations for medical use of byproduct materials in 8 Subpart E under Part 35, which covers unsealed byproduct 9 material, written directive required.
10                  And most importantly, to listen to and 11 record your comments on the evaluation.                  The comments 12 that we receive from the medical community today, the 13 Agreement      States,    and    the    other      stakeholders      are 14 critical to the NRC staff's decision-making on whether 15 our existing training and experience requirements 16 should be revised.        If you do not provide your comments 17 today, we encourage you to participate in one of the 18 future comment meetings in December and January or 19 submit written comments using regulations.gov by the 20 January 29th, 2019 comment due date.                    Later in the 21 presentation, we will cover how you can submit your 22 written comments.
23                  And now, I'll hand the conversation back 24 to Sarah, who is going to provide some basic information 25 about today's webinar.
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7 1                    Sarah?
2                    MS. LOPAS:      Thanks, Chris.
3                    So, if there's anybody on the bridge line 4 that doesn't have the webinar up and running, or doesn't 5 have the slides in front of them, I just want to let 6 you know that you can go to the NRC's public meeting 7 website and you can find that by just Googling or going 8 to some other internet search.                  "NRC public meeting,"
9 search that term and kind of the first thing that pops 10 up is our website, our public meeting notice website.
11                    There, if you click on that link you pull 12 down, you'll find the meeting notice for this meeting.
13  If you click on "more" under that meeting notice and 14 look a little bit further, there is a link to the slides.
15  It will be a PDF file of what we're using today.                      So, 16 that's just a quick notice for everybody on the phone, 17 on the bridge line.
18                    So, today we're going to be discussing the 19 NRC's          evaluation      of      training        and  experience 20 requirements            for        certain            categories          of 21 radiopharmaceuticals.            We're going to often refer to 22 training and experience as "T&E" for short.                        And we 23 will often refer to authorized users -- that is, those 24 physicians          who    are    authorized          to  administer 25 radiopharmaceuticals -- as "AUs".
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8 1                  Today's webinar is being transcribed by 2 a court reporter.          And as Cedric, our operator, had 3 mentioned, this phone line is also being recorded.
4 So, we're having a double-fail option here.
5                  So, the full transcript of this webinar 6 is going to be publicly available in a few weeks, and 7 it will be on our NRC's Agencywide Documents Access 8 and Management System, or ADAMS, as we call it.                        And 9 I'll also be posting a link of that transcript to the 10 NRC's Training and Experience website, as well as 11 posting        it  to  the      docket      website      for  T&E      on 12 regulations.gov.
13                  All of the comments that you make today 14 will be captured on the docket.                    So, I'll be combing 15 through the transcript and pulling out your comments 16 for inclusion in our evaluation effort.                    So, if you 17 speak today, you do not need to then separately provide 18 those        written  comments        on    regulations.gov.            And 19 because it will be captured in the transcript, we will 20 have it on the record.          And it's important to note that 21 the full comments and written comments carry the same 22 weight.        There's no preferred way to submit your 23 comments.
24                  We'll    be    opening      the    phone  lines      for 25 comments        after  the      NRC    presentation      concludes.
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9 1 Everyone is in listen-only mode at the moment.                      But, 2 when it comes time to make a comment, you're just going 3 to press *1 on your phone pad.                  That's *1. And that 4 will let Cedric, who is the operator, know that you'll 5 need your line unmuted.
6                And now, I'm going to hand the presentation 7 over to my colleague, Health Physicist Maryann Ayoade, 8 so she can review the NRC's current T&E regulations 9 and      talk  about    why    the    NRC    is  conducting      this 10 evaluation.
11                Maryann?
12                MS. AYOADE:        Great.        Thank you, Sarah.
13                Today, I will be presenting information 14 on an overview of the regulations on training and 15 experience      requirements          for      radiopharmaceuticals 16 requiring      a  written      directive;          some  background 17 information      on  the    related      stakeholder    concerns 18 received, and the NRC's efforts on the evaluation thus 19 far.
20                The current regulations on training and 21 experience      for    radiopharmaceuticals            requiring        a 22 written directive are under 10 CFR Part 35, Subpart 23 E.      And these training and experience requirements 24 provide two pathways that a physician may be authorized 25 to administer radiopharmaceuticals that require a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 written directive.
2                  The first pathway is that a physician can 3 be authorized to administer these radiopharmaceuticals 4 if they are certified by a medical specialty board whose 5 certification process is recognized by the NRC or an 6 Agreement State.
7                  A physician can also be authorized, to 8 satisfy the training and experience requirements, by 9 an alternate pathway, which includes completion of 700 10 hours of training and experience, including a minimum 11 of 200 hours of classroom and laboratory training in 12 the relevant topic areas, as listed in the regulation, 13 and 500 hours of supervised work experience in the 14 relevant areas, as listed in the regulation.
15                  And a third path is that a physician can 16 also      be authorized      if    they    have    been previously 17 identified as an authorized user on an NRC or Agreement 18 State license or permit.
19                  This training and experience evaluation 20 is focused on the alternate pathway, and the NRC staff 21 are looking into what tailored training and experience 22 requirements for limited administration of certain 23 categories of radiopharmaceuticals would look like.
24 And that is what we will be referring to as a limited 25 authorized user status.
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11 1                Next slide.
2                In Subpart E there are four sections that 3 pertain to training and experience requirements.                      The 4 first is under 10 CFR 35.390, which is for training 5 for the use of already pharmaceuticals in Subpart E, 6 all of which require a written directive.
7                The second is under 10 CFR 35.392, which 8 is for training for oral administration of sodium 9 iodide, Iodide-131, requiring a written directive in 10 quantities less than or equal to 33 millicuries.
11                The third is under 10 CFR 35.394, which 12 is for training for oral administration of sodium 13 iodide, Iodide-131, requiring a written directive in 14 quantities greater than 33 millicuries.
15                And the fourth is in 10 CFR 35.396, which 16 is for training for parenteral administration of any 17 radiopharmaceutical requiring a written directive.
18                All  of    this    sections      of  training      and 19 experience      include    the      pathway      for  experienced 20 authorized users already listed on a license.                    All of 21 these sections, except 10 CFR 35.396, include training 22 and      experience  under    the    board      certification        and 23 alternate pathways.
24                And  so,    I    want    to    point  out      that 25 10 CFR 35.396 is for training that is exclusively under NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 the alternate pathways for radiation oncologists to 2 become authorized users by completing additional hours 3 of training and experience.
4                  I also want to point out that the alternate 5 training pathways under 10 CFR 35.392 and .394 are for 6 the physician to successfully complete 80 hours of 7 classroom and lab training that is relevant to the type 8 of use for which they are seeking to be authorized.
9 Whereas, the alternative pathway under 10 CFR 35.390 10 is for the physicians who successfully complete 700 11 hours of training and experience, which includes 200 12 hours of classroom and lab training.
13                  Next slide.
14                  This    slide      provides        some    background 15 information on stakeholder concerns received related 16 to training and experience requirements.                      So, since 17 the        revision    to    the      training        and    experience 18 requirements in 2002, and again in 2005, stakeholders 19 have raised concerns about the effects of some of the 20 requirements          on      patient        access        to    certain 21 radiopharmaceuticals.
22                  Specifically,        some      stakeholders        have 23 asserted that the 700-hour requirement in 10 CFR 35.390 24 is    overly    burdensome      for    physicians        who  are      not 25 certified by a medical specialty board, and that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 extensive requirements have resulted in a shortage of 2 authorized users, which, thereby, limits patient access 3 to radiopharmaceuticals.
4                As a result, in 2015 and 2017, in separate 5 efforts, the NRC staff and the NRCs Advisory Committee 6 on the Medical Uses of Isotopes, also known as ACMUI, 7 independently reviewed the training and experience 8 requirements for the medical uses authorized under 9 Subpart E.
10                Specifically,        NRC      staff  reviewed      the 11 regulatory    basis    and    comments        received  on    past 12 rulemaking related to the medical use of byproduct 13 materials and did not identify any new information that 14 would call into question the basis of the existing 15 requirements.
16                As a result, the NRC staff did not propose 17 any changes to the regulations at the time.                The NRC 18 staff is continuing to work with the ACMUI in its ongoing 19 training and experience evaluation effort.
20                Next slide.
21                As  part      of    the      Staff  Requirements 22 Memorandum dated August 17, 2017 - and that is publicly 23 available in ADAMS; there is a hyperlink reference here 24 - the Commission directed the NRC staff to evaluate 25 whether it makes sense to establish tailored training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 and experience requirements for different categories 2 of radiopharmaceuticals; how those categories should 3 be    determined,    such    as    by    risk      code,  by  use      of 4 radionuclides,        or    by    delivery        method;  what      the 5 appropriate training and experience requirements would 6 be for each category, and whether those requirements 7 should be based on hours of training and experience 8 or more focused on competency.
9                  Next slide.
10                  In response to the Commission direction, 11 the NRC staff solicited feedback from some medical and 12 regulatory stakeholders in April and May of 2018.                    That 13 evaluation, including the NRC staff analysis and the 14 feedback      received    of    the    training        and experience 15 requirements      in  Subpart        E  of    10 CFR Part    35,      is 16 documented in SECY-18-0084.
17                  And  the      results        of    that  evaluation 18 concluded that it may be feasible to establish tailored 19 training and experience requirements for different 20 categories of radiopharmaceuticals, and to create a 21 means of authorizing the administration of certain 22 categories of radiopharmaceuticals, such as the limited 23 authorized user status.
24                  The evaluation also concluded that there 25 are viable options for creating a competency-based NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 approach      to  demonstrate        acceptable        training      and 2 experience        for  limited        authorized        user  status.
3 However, the staff needs to conduct more extensive 4 outreach to stakeholders in the medical community, to 5 the Agreement States, and other members of the public, 6 before making a recommendation to the Commission.
7                  And  this      brings      us    to  our  current 8 evaluation to date.          I will now hand it back to Sarah, 9 who will discuss our current evaluation efforts and 10 how you can participate.
11                  Next slide.
12                  MS. LOPAS:      Thank you, Maryann.
13                  The end product of our evaluation will be 14 a paper that we will send out to our five-member 15 Commission.        That paper will either document our 16 reasoning for recommending no changes to our current 17 training and experience requirements or, if we do 18 recommend that changes to our T&E regulations are 19 warranted,      we  will      document      our    reasoning    in    a 20 rulemaking plan paper.
21                  This    is    a  simplified        diagram  of    the 22 information that we will consider in our development 23 of a recommendation to the Commission on whether changes 24 to our existing T&E requirements are warranted.                      This 25 diagram illustrates why this comment period is so NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 important to this effort.          Because, in large part, the 2 feedback that we receive on the questions that weve 3 asked in our Federal Register notice will inform our 4 recommendation to the Commission.                  Other important 5 feedback will come from our coordination with our 6 co-regulators, the Agreement States, and the NRCs 7 Advisory Committee on the Medical Uses of Isotopes, 8 ACMUI.
9                In addition to the input we receive from 10 the public, medical stakeholders, the Agreement States, 11 and the ACMUI, the NRC staff will also examine the issue 12 of patient access.      Our staff will attempt to determine 13 the number of current authorized users and their 14 geographic distribution across the United States.
15                Authorized user and associated geographic 16 data is not readily available.            So, the NRC staff will 17 be spending the next few months determining of this 18 dataset is achievable.
19                Staff    will      also    review    training      and 20 experience requirements in other countries, in an 21 effort to benchmark the U.S. against the international 22 medical regulation.        And staff will also do a review 23 of medical and radiation safety events to determine 24 if any have a nexus to training and experience.
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17 1 does end up recommending rulemaking, which we would, 2 again, document in a rulemaking plan, the Commission 3 would then proceed to vote on that rulemaking plan.
4 And that would determine whether or not the staff would 5 proceed with another Part 35 rulemaking effort.
6                  If    rulemaking          is      recommended,      and 7 subsequently approved by the Commission, that would 8 start the NRCs extensive rulemaking process.                  And Im 9 really highlighting this process information because 10 I think its important that everybody understands where 11 we are in this process.
12                  And where we are right now is that were 13 in      the  information-gathering              stage,  and      that 14 information we gather and the comments we receive are 15 going to help us determine whether a rulemaking to 16 address training and experience requirements is even 17 warranted.
18                  I hope many of you have read it by now, 19 but the NRC published a Federal Register notice on 20 Monday, October 29th.          The Federal Register notice can 21 be accessed by that link at the top of your slide, or 22 you can also just Google search the citation for the 23 Federal Register notice, which is 83 FR 54380.
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Safety and Safeguards
18 1 29th, 2019.      It also announced the dates for these public 2 webinars and meetings.            And in a couple of slides Ill 3 be talking about the additional meetings were having 4 after this one.
5                  But,    most      importantly,          The  Federal 6 Register notice asked a series of questions on which 7 we would like medical community stakeholder input.
8 Im going to read straight through the questions in 9 the next four slides, and Im just going to go straight 10 through them, just to provide an overall scope and 11 context of the information that were looking for.
12 But, when we get to the comment period in just a couple 13 of minutes, I am going to be kind of walking us through 14 the topical areas to try to gather your comments kind 15 of in an organized manner.                So, hold tight.          We are 16 going to read through the comments in the next slide.
17                  So, the first set of questions, Section 18 A in the FRN, extensively cover the crux of what were 19 evaluating, whether the NRC should create tailored 20 training      and  experience        requirements        for  certain 21 categories of radiopharmaceuticals.
22                  So, the questions are:
23                  Are the current pathways for obtaining AU 24 status reasonable and accessible?                    Are they adequate 25 for protecting public health and safety?
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2 ALSO PRESENT:
19 1                Should the NRC develop a new tailored T&E 2 pathway? What would be the appropriate way to categorize 3 radiopharmaceuticals for tailored T&E requirements?
DAVID CROWLEY, Radioactive Material Branch Manager, North Carolina Department of Health and Human  
4                Should the fundamental T&E required of 5 physicians seeking limited AU status need to have the 6 same fundamental T&E required of physicians seeking 7 full AU status?
8                And how should the requirements for this 9 fundamental T&E be structured for a specific category 10 of radiopharmaceuticals?
11                Section B, there are questions about the 12 NRCs recognition of medical specialty boards.                      And 13 those procedures for recognizing our medical specialty 14 boards are on our Medical Uses Licensee Toolkit website, 15 and the link is there on the slide.
16                But what boards other than those already 17 recognized    by  the    NRC    could      be considered      for 18 recognition for medical uses under 10 CFR 35.300?
19                Are the current NRC medical specialty board 20 recognition    criteria      sufficient?        If  not,      what 21 additional criteria should the NRC use?
22                The next topical area or set of questions 23 covers patient access.
24                So, is there a shortage of the number of 25 Aus for medical uses under 10 CFR 35.300?                If so, is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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20 1 that shortage associated with the use of a specific 2 radiopharmaceutical?
3                Are there certain geographic areas with 4 an inadequate number of Aus?
5                Do  current      NRC    regulations  on  AU    T&E 6 requirements unnecessarily limit patient access to 7 procedures involving radiopharmaceuticals?
8                And do current NRC regulations on AU T&E 9 requirements      unnecessarily          limit    research      and 10 development in nuclear medicine?
11                And then, the last set of questions we have, 12 they are a set of questions asking for general input 13 on the NRCs regulation of training and experience as 14 a whole.
15                So, should the NRC regulate the T&E of 16 physicians for medical uses?
17                Are there requirements in the NRCs T&E 18 regulatory framework for physicians that are non-safety 19 related?
20                How can the NRC transform its regulatory 21 approach for T&E while still ensuring that adequate 22 protection is maintained for workers, the general 23 public, patients, and human research subjects?
24                So, those are the questions that were 25 looking for your input on.          Ill be going through those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 questions when we get to the comment period in a second, 2 but it would be great if you could have the FRNO bin 3 and you can read through, because theres a lot of 4 sub-questions underneath those general questions that 5 I didn't want to laboriously read through.
6                  So, how can you submit your comments on 7 our evaluation and respond to all those questions?
8 Well, in addition to speaking during today's meeting, 9 and in any of the three future meetings that we have 10 planned,        you  can      submit        your    comments        via 11 regulations.gov.        And the link on this slide will take 12 you directly to the comment submissions form on the 13 T&E docket, which the docket ID is NRC-2018-0230.                    But 14 you can also just go to regulations.gov.                  Just type 15 in regulations.gov and it comes right up.                And you can 16 enter that docket, NRC-2018-0230, into the search bar 17 right at the top of that page, and it will bring you 18 right to our docket page.            Once you're in the comment 19 submission form, you can either type directly into the 20 form or you can upload a document like a Word or text 21 file or even a PDF.
22                  Here at the NRC I have immediate access 23 to        those  comments        that      are    submitted        via 24 regulations.gov, but I will warn everybody that there's 25 an internal administrative process here at the NRC.
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22 1 So, it takes a few weeks for those comments to become 2 publicly viewable on regulations.gov.                    So, don't panic 3 when you submit via regulations.gov and you go back 4 to see if you can find it if you can't find it.                            We 5 got it.        It's just it has to go into our ADAMS system 6 first, and then, it goes back up on the regulations.gov.
7  So, just to clarify, your comments will be publicly 8 available on regulations.gov and in ADAMS.
9                  If you encounter any issues at all when 10 you're submitting your comments via regulations.gov, 11 please contact me.          You can email me or call me.                  My 12 contact        information      will    be    at      the  end  of    this 13 presentation.
14                  And at the end of the public comment period, 15 we'll be compiling all the comments we received, both 16 written and oral, and we'll be publishing them in one 17 easily accessible comment report.                    Not only will that 18 comment report list all the comments out individually, 19 it will also summarize them.                And the comment report 20 will be available on the NRC T&E website, and I'll also 21 ensure that it gets posted to regulations.gov.                            And 22 I know that whatever recommendation paper that we 23 develop, it will heavily reference that comment report.
24                  I do want to point out that, because this 25 is in a rulemaking, and the purpose of collecting our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 comments is to help us inform our decision-making, we 2 will not be responding to individual comments or even 3 groups of binned comments.                So, that's an important 4 thing to note.
5                    This slide just details the additional 6 public meetings that we're going to be having on T&E 7 in December and January, before the comment period 8 closes out.        The meetings that are going to be held 9 on December 11th and January 10th, in addition to those 10 meetings          accessible          by      webinar      again        and 11 teleconference, those will also be open to in-person 12 attendance here at the NRC Headquarters in Rockville.
13  The      December    11th    meeting      will      be  held  in    the 14 Commission hearing room in our 1 White Flint Building, 15 and the Thursday, January 10th meeting will be held 16 on the ground floor conference room in our 3 White Flint 17 Building.
18                    And all the details that you need to 19 participate in those meetings, again, are on the NRC's 20 public meetings schedule website.                    And if you have any 21 questions, again, you can contact me.
22                    This slide shows our next steps, a basic 23 outline of our next steps, and the planned timeline 24 of our evaluation.            After the comment period ends on 25 January        29th,  the    NRC    will    begin      organizing      and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 evaluating the comments.                The NRC staff will also be 2 conducting        that  additional        research    that  I    noted 3 earlier        regarding      patient      access,    international 4 benchmarking, and assessing medical and radiation 5 safety events.
6                    The ACMUI Subcommittee on Training and 7 Experience will provide the NRC a report on their 8 findings        and    recommendations            regarding  the      T&E 9 requirements in the spring of 2019, and the staff will 10 consider        their    input      in    developing      their    draft 11 recommendation.
12                    Both the Agreement States and the ACMUI 13 will have an opportunity to provide comments on our 14 draft Commission paper, and the NRC will consider and 15 incorporate their comments into the final paper to the 16 Commission, which we have to finalize in early fall 17 2019.
18                    So, for more information and links to all 19 the documents that we mentioned today, like the SECY 20 paper from this past September or the Staff Requirements 21 Memorandum that caused us to do this evaluation in the 22 first place, please visit the NRC's Training and 23 Experience Evaluation website.                That's the link above.
24  It is housed under the NRC's Medical Licensee Toolkit 25 overall.        But we will be actively maintaining this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 website through the T&E effort.                  So, it's a good place 2 to go.
3                    Again,      you      can      also    go  to        the 4 regulations.gov docket for T&E.                    So, I will also be 5 putting public participation information on that.                        And 6 what's good about regulations.gov is that it will list 7 all the comments that we receive.                      So, you can look 8 at other folks' comments.
9                    And please reach out to me, Sarah Lopas, 10 as the Project Manager, if you have any kind of 11 process-type questions about the community effort.
12 And Maryann is your point of contact for your more 13 technical questions.
14                    So, with that, I'm going to get us into 15 the comment period phase of this.                      I do want to note 16 that you'll press *1 on your phone to make a comment.
17  And you can go ahead and press *1 now if you know you 18 already have something to say.                      That's great.        And 19 Cedric is just going to be going down the line and 20 unmuting lines as he receives those *1 requests.
21                    And so, we have plenty of time for comments 22 today.        We're scheduled to go to 3:00 p.m. Eastern, 23 but we can always go a little bit beyond that, if needed.
24                    And I do want to remind you that our court 25 reporter -- her name is Allegra -- she's on the phone, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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26 1 too.      She's transcribing everything we say today.                  So, 2 when we do unmute your phone, please remember to start 3 by introducing yourself.              If you have an affiliation 4 that you want to let us know about, you can certainly 5 include your affiliation.
6                  There aren't too many of us on the line.
7  I know we've got about 24 people on the webinar, which 8 is great, and there might be more people on the line.
9  But I do think that we will try to go through the topical 10 areas of the questions that we ask in the FRN, but I 11 do understand that many of you might just have a 12 statement that you want to just read right through.
13 And that's okay.        You don't need to try to break it 14 up.
15                  So, we'll just get started.                With that, 16 press *1 if you would like to make a comment.
17                  I have brought up on the webinar Section 18 A of the questions, and I have, of course, three 19 questions under Section A, under tailored training and 20 experience requirements.            Those are the topics asking 21 about:
22                  Are the current pathways for obtaining AU 23 status reasonable and accessible?                    Are they adequate 24 for protecting public health and safety?                    And then, 25 obviously, a big one, should the NRC develop new NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 tailored T&E pathways for a physician?
2                So, *1. Get something to drink; maybe get 3 some coffee.      And we can get started.
4                And, Cedric, just let me know whenever you 5 have anybody on the line to get going.
6                THE  OPERATOR:          Sure.      And  our    first 7 question or comment comes from Amin Mirhadi.
8                Your line is open.
9                DR. MIRHADI:        Thank you so much, Cedric.
10                Hi there.      My name is Dr. Amin Mirhadi.
11 I'm a radiation oncologist at Cedars-Sinai Medical 12 Center in Los Angeles.          I'm also the Vice Chair of the 13 American      Society      of    Radiation        Oncology's      NRC 14 Subcommittee.      And thank you for allowing me to provide 15 this statement on behalf of ASTRO, which is the acronym 16 for that.
17                ASTRO is the largest radiation oncology 18 society in the world with more than 10,000 members who 19 specialize in treating patients with radiation therapy.
20  As a leading organization in radiation oncology, 21 biology, and physics, the Society is dedicated to 22 improving patient care through education, clinical 23 practice,      advancement      of    science,      and  advocacy.
24 ASTRO's highest priority has always been ensuring 25 patients receive the safest, most effective treatments.
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28 1                  ASTRO is pleased that the NRC has invited 2 stakeholders        to  provide        input        on  training      and 3 experience        requirements        for      radiopharmaceuticals 4 through public meetings and written comments.                              We 5 strongly oppose any reduction in the T&E requirements 6 found in 10 CFR 35.390, training for use of unsealed 7 byproduct material for which a written directive is 8 required under the so-called "alternate pathway".
9                  ASTRO believes that the requirements found 10 in this section are appropriate.                      They protect the 11 safety of patients, the public, and practitioners, and 12 should not be diminished.
13                  Radiopharmaceuticals are highly effective 14 in treating cancer, with possible harmful effects to 15 both the patient and the public if not used correctly 16 under the supervision of the highly-trained physician.
17                  We are pleased in this report entitled 18 "Staff        Evaluation      of    Training          and  Experiment 19 Requirements for Administering Radiopharmaceuticals,"
20 that      the  NRC  staff      determined        that    the  current 21 requirement of 200 hours of classroom and laboratory 22 hours        prescribed    under      the    alternate      pathway      is 23 reasonable to acquire the fundamental knowledge that 24 an AU would need to administer any radiopharmaceutical.
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29 1 hours of work experience required, based on categories 2 of radiopharmaceuticals, will lead to confusion and 3 complexity, both for licensees as well as for the NRC 4 and Agreement States.
5                We  are    also      concerned    that  if      new 6 radiopharmaceuticals are approved for use that do not 7 fit clearly into one of the categories, that the NRC 8 will have to promulgate any additional regulations to 9 include the new agents, a process that could take time 10 to finalize, delaying patient access to potentially 11 lifesaving radiopharmaceuticals.
12                The rigorous T&E requirements contribute 13 to the excellent safety record of radiopharmaceuticals.
14  We believe that it is important that the person 15 administering        the          radiopharmaceuticals              is 16 appropriately trained in the safe handling, exposure 17 risk, and the management of side effects of radiation.
18                ASTRO looks forward to working with the 19 NRC as they continue deliberation and review on this 20 very important topic.          In addition, I want to close 21 by saying that ASTRO will submit more detailed written 22 comments by the end of the comment period.            And I really 23 appreciate the opportunity to speak to you guys today.
24                MS. LOPAS:        All right.      Thank you, Dr.
25 Mirhadi.
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30 1                  All right.        Cedric, do we have somebody 2 else on the line?
3                  Again, folks, press *1 to make a comment, 4 *1, and you can either focus on -- you could read a 5 statement, just like Dr. Mirhadi did, or you could focus 6 on kind of this first slide that I have up that talks 7 about questions 1, 2, and 3.
8                  Cedric?
9                  THE  OPERATOR:            I'm      showing  no      one 10 currently in queue.
11                  But, again, as another reminder, if you 12 would like to ask a question or make a comment, please 13 press *, then 1.        If you would like to withdraw that 14 question or comment, you may press *2.
15                  MS. LOPAS:      So, *1 to make a comment, *2 16 to change your mind.            I just learned something new.
17 Okay.
18                  All  right.        So,    I    can  move  through 19 different slides.        Again, we have three more meetings 20 on this.      My colleagues and I were determining what 21 was the best way to get comments from folks over the 22 phone line, and thought we would try walking through 23 some of the questions.            So, we're going to just play 24 around with that.        But we may change our comment format 25 in future meetings, just as an effort --
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31 1                  THE OPERATOR:        Sarah, we did have one that 2 came through.
3                  MS. LOPAS:      All right.          Let's go.
4                  THE OPERATOR:        All right.      Jeffry Siegel, 5 your line is open.
6                  MR. SIEGEL:          And thanks very much for 7 having this meeting.            I really appreciate it.
8                  My name is Jeffry Siegel.                  I've been 9 involved      in  reviewing        --    I    shouldn't    even      say 10 "reviewing" -- but involved in writing and publishing 11 about NRC requirements and regulations which have been 12 very good.
13                  And I figured I would want to start this 14 off with some controversy because I totally disagree 15 with the first speaker.
16                  First, a brief history relevant to the T&E 17 issue I think is in order.              Prior to the NRC revision 18 of Part 35 -- that is, pre-2002 -- only 80 hours of 19 T&E were required for the alternate pathway to obtain 20 AU status for therapeutic use, pursuant to 35.930 -- not 21 for the dyslexic, 930, not 390 -- and only I-131 use 22 was considered.          At the same time, diagnostic use, 23 pursuant to 35.920, required 700 hours.
24                  During    the    revision        of  Part  35,      NRC 25 modified, based on a risk-informed performance-based NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 approach, these requirements.                35.930 was replaced by 2 35.390, requiring 700 hours for the alternate pathway.
3  Eighty hours replaced the 700 hours, except for oral 4 sodium I-131 use.          Pursuant to 35.392 and .394, only 5 80 were, and still are, required for oral sodium 6 iodide-131 use.        Therefore, requirements have already 7 been tailored for a specific use via 392 and 394.                This 8 may be because the NRC was persuaded by endocrinologists 9 to maintain the 80 hours, and this was done 15 years 10 ago.        But, today, any physician desiring limited 11 authorization to use sodium iodide can do so with only 12 80 hours.
13                  Then, in 2006, a petition was submitted 14 to the NRC requesting the 700 hours be reduced to 80.
15  The NRC, of course, denied this petition, and it noted 16 that I-131 was considered to be less of a radiation 17 safety issue than the three agents in the petition; 18 namely, Quadramet, Bexxar, and Zevalin.                    And the 19 petition requested that med oncs and hematologists be 20 allowed to do this.
21                  NRC further believed that tailoring T&E 22 requirements, which, of course, they had already done 23 for sodium iodide, would increase the complexity of 24 regulatory oversight with no benefit to anyone.
25                  Now we skip forward to today.            Using a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 one-size-fits-all          regulatory            approach    is      not 2 beneficial        to      oral.                Oral    therapeutic 3 radiopharmaceuticals do not pose the same risk.                        So, 4 it follows that their use should not be subjected to, 5 and limited by, identical T&E requirements.                          This 6 contradicts the risk-informed approach NRC is using.
7                  If  a    physician        is      seeking  limited 8 authorization without any added flexibility for use 9 of a relatively safe agent, 700 hours is not warranted.
10  Requiring this number of hours, pursuant to 35.390, 11 for      limited  AU    status      conflates        a  single-use 12 requirement with the ability to administer all forms 13 of radionuclide therapy with unlimited flexibility, 14 which, by the way, of course, increases risks. Mandating 15 700 hours of training when it may not be necessary is, 16 indeed, burdensome to those physicians desiring to 17 attain AU status.
18                  And as an example, Xofigo-only usage.                  At 19 this point, I wanted to mention it because it is an 20 FDA-approved commercially-available therapeutic, and 21 physicians who want to incorporate this single agent 22 into their practice should be encouraged to do so if 23 they have been appropriately and sufficiently trained.
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34 1 as a unit dosage in a syringe, and unlike hundreds of 2 millicuries of sodium iodide, is of no external dose 3 concern.        And since it is excreted mainly in the feces, 4 it is not a likely source of internal contamination.
5  Further, the dose to others is so low that patient 6 release instructions are not even required, pursuant 7 to 35.75.        It must be pointed out that conventional 8 nuclear medicine equipment can be used to measure and 9 look for contamination, should it occur.
10                  So, in closing, NRC has already tailored 11 T&E requirements for the specific use of oral sodium 12 iodide.        So, the need for such tailoring requires no 13 further discussion, since it already has been done.
14 Therefore, a physician desiring to use Xofigo should 15 be able to attain limited AU status for Xofigo-only 16 usage if adequately trained to minimize any adverse 17 impact on public health and safety.
18                  Since the T&E requirements should reflect 19 the risk involved, and in the case of Xofigo-only use 20 this risk is much less than for oral sodium iodide, 21 only 80 hours of T&E, perhaps even less, should be 22 required.
23                  Thank you very much.                I realized what I 24 just was controversial, and this should kick off public 25 comment.        Thank you very much.
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35 1                MS. LOPAS:          All      right. Well,        we 2 appreciate all comments, controversial or not.                      And 3 I do like ones that kind of get discussion going.
4                So, *1 if you want to respond to that 5 comment or if you have some additional comments here 6 on Section A.
7                Cedric, do we have anybody else in the line?
8                THE OPERATOR:        Not at this time.
9                MS. LOPAS:      Okay.      All right. So, I have 10 up on the screen, in the webinar, if you're following 11 along on the webinar -- again, we've had some responses 12 back to should the T&E -- well, here's the question:
13  if we do develop tailored limited statuses, limited 14 AU statuses, should those folks go through the same 15 fundamental T&E required of physicians seeking full 16 AU status?    So, that was one question.
17                And the next slide, it kind of gets into 18 some of the nitty-gritty of what we're looking for.
19 We're looking for kind of, how should those fundamental 20 requirements    be    structured        for    these    specific 21 categories of radiopharmaceuticals?                And this is where 22 we're asking for questions like, what should these 23 requirements specifically include?                  Classroom and 24 laboratory training?        What topics under classroom and 25 laboratory training?        How many hours?        How many hours NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 of work experience?          And also, competency, how should 2 competency be evaluated?                  Should it be evaluated 3 through a written or practical examination or by an 4 independent examining committee?
5                  And let's see, what other questions do we 6 have      here?    We    have      questions        about  preceptor 7 attestation.        Should it be required for fundamental 8 T&E?
9                  So, you can check out that slide if anybody 10 has any comments on question 5.                And then, we also have 11 questions, which I've already received some feedback 12 in comments.        Should AU competency be periodically 13 assessed?        And if so, how should it be assessed and 14 how often, and by whom?
15                  So, there's a whole boatload of questions 16 to think about.
17                  Cedric, just let me know if anybody pops 18 on the line.
19                  *1 to make a comment; *2 if you change your 20 mind.
21                  THE OPERATOR:        Okay.      Will do.
22                  MS. LOPAS:      All right.        Thank you.
23                  And we can go ahead, since it is radio 24 silence a little bit, we don't need to stick with -- if 25 you have comments outside of those areas, those topical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37 1 areas, please feel free just to press *1 and share your 2 thoughts.      Like I said, we were just kind of exploring 3 how to best go through the comments on this, because 4 we do have a lot of questions in that Federal Register 5 notice.
6                So, Section B was recognition of medical 7 specialty boards by the NRC.            Are there any additional 8 boards that the NRC should be considering?
9                And question area C was on patient access.
10  This is a big one.        This is kind of the crux of some 11 of the arguments that we've been hearing that our 12 current regulations and requirements are so tough that 13 they're impacting patient access to these valuable 14 radiopharmaceuticals.          So, if anybody has any insight 15 on patient access, we would really be appreciative to 16 hear some of that.
17                THE OPERATOR:        I do have a caller in the 18 queue.
19                MS. LOPAS:      All right.
20                THE OPERATOR:        I did not catch their name.
21  I believe it was Munir.
22                Your line is open.
23                DR. GHESANI:          Yes.      Hi. This is Munir 24 Ghesani from SNMMI.
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38 1 point is that, if you are comparing training and 2 experience proportionate to somebody's background, you 3 have to keep in mind that there are certain basic 4 fundamentals          of    radiation        protection,    radiation 5 physics, and training in radiology sciences that cannot 6 be simply counted in number of hours.                    It goes with 7 what you are practicing day-in and day-out for years, 8 whether you're in the training or afterwards.
9                    So, a perfect example is understanding of 10 radiation physics, understanding of different types 11 of radioisotopes, and particles and non-particles of 12 many isotopes.          All of that is ingrained in the training 13 of radiologists or radiation oncologists and nuclear 14 medicine physicians.
15                    So, I would really caution the group by 16 just highlighting the point that, if somebody comes 17 from a field where none of this is part of their regular 18 training, and suddenly you are counting the number of 19 hours in which they can get that lab training and you 20 expect        them  to  get    a    full    understanding    of    the 21 radiation, I think it's an understatement.                    You have 22 to keep in mind that, for a radiology resident who spends 23 four years in learning it or a nuclear medicine 24 physician who spends three years after doing two years 25 of      preliminary      training,        all      of that  training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1 eventually allows somebody to become competent in not 2 only administering in an uncomplicated setting, but 3 should complications arise, being capable of handling 4 every potential scenario of that complication.
5                  So, while I really would like to caution 6 that this is something that really can't add the mark 7 in the number of hours of training.                    You have to keep 8 in consideration the background of their training as 9 well.
10                  Thank you for your attention.
11                  MS. LOPAS:          Okay.        Thank  you.        We 12 appreciate that input.
13                  Cedric, anybody else on the line?
14                  THE OPERATOR:         Not at this time.
15                  MS. LOPAS:        Okay.        *1, press *1, as a 16 reminder, to submit your comments.
17                  If you are on the webinar and you don't 18 feel        comfortable      speaking,        you      don't  want        to 19 necessarily speak aloud, you can submit a comment using 20 your webinar software.            If you want to do that under 21 the question function, I can read aloud your comment 22 for you, if you prefer that.              That's always an option, 23 too.
24                  So, I am pulling up on the webinar, I'm 25 going back to Section A again, because the last comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 was kind of in response to should these folks seeking 2 this limited AU status have the same fundamental 3 training as those with the full AU status.                  And that 4 last comment was basically saying, well, we shouldn't 5 be focusing just on hours; you have to consider a 6 physician's background.              You know, do they have a 7 background in this?          And if they're really coming in 8 with no background, there's something to consider here.
9                  We also have Section D, which is kind of 10 the more general questions on the NRC's T&E regulations 11 as a whole.      And I will give some background into this 12 question.
13                  The NRC has been looking at how we can 14 transform how we do things at the Agency, to continue 15 to evolve with the technologies around us.                  And, you 16 know, these questions are kind of in line with that.
17  How could the NRC transform its regulatory approach 18 for T&E?      So, we would be interested in hearing any 19 general comments about that as well.
20                  So, *1 if you have any comments for us.
21                  THE OPERATOR:          I'm showing no questions 22 or comments in the queue.
23                  MS. LOPAS:      All right.        Just a reminder 24 to press *1.
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41 1 to start from the top.                  And if we don't get any 2 comments --
3                  THE OPERATOR:        Excuse me.      I have one that 4 came through.
5                  MS. LOPAS:        Okay.        Great. Yes, good, 6 Cedric.
7                  THE OPERATOR:        They did not record their 8 name, but your line is open.
9                  MS. LOPAS:      Okay.        And just remember to 10 start by introducing yourself, please.
11                  MR. CROWLEY:          Good afternoon.        This is 12 Dave        Crowley  from      North     Carolina's    Radioactive 13 Materials Program.
14                  As an Agreement State program, I would just 15 like to say that what we do as regulators, and along 16 the lines of the training and experience for authorized 17 users, it is we want to do our utmost to protect the 18 health and safety of both the patient care side of 19 things, but also the occupational side of the house 20 as well.
21                  And this comment isn't so much to answer 22 any of your specific questions, but I do want to make 23 a request that in this process moving forward, to better 24 risk-inform how we proceed, that there be an evaluation 25 of all the medical events that have taken place.                      And NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 that would be a great tool for that, and looking at 2 some of the basis for the medical event rule itself 3 and the reporting of those events.
4                  Part of it is to learn whether or if it 5 was justified, that that would give us insight as to 6 whether training and experience was adequate or not 7 for various medical uses.                To my knowledge, I'm not 8 aware of an across-the-board review of all medical 9 events has taken place or not to evaluate that.                        But 10 I    would,    I  guess,      recommend        or    suggest  that      an 11 evaluation be done of all past medical events to see 12 if there is any correlation to the training experience, 13 either the pathways or the amount that the different 14 authorized users had that were related to those medical 15 events.
16                  And that's all.          Thank you.
17                  MS. LOPAS:      All right.          Thank you, Dave.
18                  And  actually,        I  have      a  question      for 19 Maryann.      Maryann, if you could take yourself off mute?
20  I have a question related to Dave's comment here, so 21 an NRC-imposed question.              You can thank me later for 22 it.
23                  But I am wondering, Maryann, does NMED have 24 that      information?        Would      it      have  the  kind      of 25 information for the doctor with how they're certified, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 whether they were certified under -- would we know how 2 they would be certified?            Is it something we could find 3 out in NMED?
4                  MS. AYOADE:        Hi, Sarah.
5                  So,  NMED    doesn't      always    provide    that 6 detailed of information.              But what I wanted to point 7 out was that part of what we're doing is additional 8 information gathering.          For this evaluation, for this 9 T&E, we're actually going to be looking at medical 10 events, just as you spoke about, to see if there's any 11 kind of correlation with what the causes are for the 12 medical event.      And then, we would look at the training 13 and experience of the users, if it involved any kind 14 of user error or type medical event.
15                  MS. LOPAS:        Okay.        Great. Thank you, 16 Maryann.      I appreciate that.
17                  MR. CROWLEY:        I don't know if I'm still 18 unmuted or not.
19                  MS. LOPAS:      No, you are -- yes, we can hear 20 you.
21                  MR. CROWLEY:        Okay.      Great.
22                  Yes, as far as the NMED data, I don't 23 believe there's a field to actually report which 24 training pathway AUs came from or even we try to avoid 25 personal      names  or    identifying          information    in    our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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44 1 reports that we provide.            But that is some information 2 that the states may have.              So, if you do a reference 3 through NMED, you might see that it falls back on 4 training being one of the underlying causes of the 5 event, and then, you can reach back out to those states 6 or whatever region had it take place, and maybe you'll 7 get some more info.
8                  Or even putting out a request to the states 9 to provide any known trends or observations that they've 10 made on that front.              But NMED, in and of itself, 11 probably        won't    just      lay      that      info    neatly, 12 unfortunately.
13                  MS. LOPAS:        Okay.        Great. Thank you, 14 Dave.        I appreciate that insight.            And, Maryann, thank 15 you.
16                  Okay, *1 if anybody has any comments kind 17 of related to that.
18                  Cedric, do we have anybody waiting in line 19 now?
20                  THE OPERATOR:        Yes.
21                  Ralph, your line is open.
22                  MR. LIETO:      Thank you.
23                  A  point      of    clarification        about      NMED 24 reports.        They are not available to the AU or to the 25 licensee.        And I've had a lot of experience in looking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 at specific NMED reports dealing with medical events, 2 and they do not indicate any training and experience 3 requirements as a part of the investigation, although 4 it's probably an interesting point to add.
5                But,    even    if    they      did  collect      that 6 information, an authorized user, a licensee, and RSO 7 does not have access to NMED reports.              This was an issue 8 that was brought up before the ACMUI last year, I believe 9 it was, about making these available to AUs and to 10 licensees. And the NRC denied making that availability 11 to those groups.      So, I think that's something, even 12 though the person before me had some good comments on, 13 right now the NRC is on record as not making that 14 information available.
15                Thank you.
16                MS. LOPAS:        Okay.      Hey, Ralph, are you 17 comfortable with providing your last name, your full 18 name?
19                MR. LIETO:        Oh, I'm sorry, Ralph Lieto.
20 I'm a medical physicist.
21                MS. LOPAS:      Oh, sorry, can you do that one 22 more time?    Your phone is going in and out.
23                MR. LIETO:      Ralph Lieto.
24                MS. LOPAS:      Ralph, okay.
25                MR. LIETO:      Got it?
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46 1                    MS. LOPAS:      All right.          Ralph Lieto.        All 2 right.        Thank you, Ralph.        We appreciate that.
3                    Okay. Cedric, do we have anybody else on 4 the line?
5                    THE OPERATOR:        Not at this time.
6                    MS. LOPAS:      Yes, I think we're having some 7 issues with the phone line on our end.                        But did you 8 say nobody is on the line right now, Cedric?
9                    THE OPERATOR:        Yes, not at this time.
10                    MS. LOPAS:      Okay.      Okay.      All right.        Let 11 me check my webinar real quick.
12                    I do have one, somebody who has submitted 13 a question.          So, I do have a question or a comment 14 submitted        that  says    --    and      this    is  from      Aria 15 Razmaria -- "The wording regarding patient access on 16 the      slide,    for    example,      geographic        distribution 17 question, are not mentioned in this detail in the FRN.
18  Will there be an update to The Federal Register 19 notice?"
20                    Okay. So, let me see what we're talking 21 about here.        "The wording regarding the patient access 22 on the slide" -- ah, okay.
23                    No. That's a good question.              So, let me 24 go back here and close out of here.
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47 1 would be looking at patient access, what the NRC will 2 be looking at in patient access?                      I'm wondering if 3 that's what you're talking about, where we don't go 4 into that detail in the FRN.
5                    That information was not included in the 6 FRN, kind of talking about how the NRC was going to 7 try      to    evaluate    patient      access.        That  was    just 8 information we provided in the slide to kind of go into 9 more detail about the NRC evaluation.                    So, no, we will 10 not be updating the FRN.
11                    But the question, we did get some feedback 12 that we were hoping -- well, not hoping -- we did get 13 some feedback that the NRC needed to be determining 14 these patient access questions, finding the answers 15 to these patient access questions.                      But we did want 16 to put these questions about patient access out to the 17 general public in the FRN, in case anybody did have 18 some insights on that.
19                    So, I am going to read through those 20 questions -- unless, Cedric, is there anybody that's 21 waiting to speak?
22                    THE OPERATOR:        No, not at this time.
23                    MS. LOPAS:        Okay.      So, patient access.
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48 1 thought we would also ask everybody in the FRN.
2                Question 1:        is there a shortage in the 3 number of AUs for medical uses under 10 CFR 35.300?
4 If so, is the shortage associated with the use of a 5 specific radiopharmaceutical?              Explain how.
6                Question 2:        are there certain geographic 7 areas with an inadequate number of AUs?            Identify these 8 areas.
9                Question 3:        do current NRC regulations 10 on AU T&E requirements unnecessarily limit patient 11 access to procedures involving radiopharmaceuticals?
12  Explain how.
13                And then, question 4:              do current NRC 14 regulations on AU T&E requirements unnecessarily limit 15 research and development in nuclear medicine?
16                So, those are the questions that we're 17 going to look into, but if folks on the line, and anybody 18 out there that's planning to comment, either in written 19 or in future meetings, has any input, we would love 20 to hear that.
21                So, press *1.
22                And if I didn't respond to that other 23 question adequately, you can feel free to write me 24 another question on the webinar clarifying, and I can 25 do my best.
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49 1                    Cedric, nothing?
2                    THE OPERATOR:          No questions.
3                    MS. LOPAS:        All right.          Okay. And so, 4 again, if you want to comment on something outside of 5 patient access, that's fine.                  We will open the lines 6 to any comments you have.
7                    But I think I will go back and see if I 8 can jog any comments on Section A.                    And again, Section 9 A of the FRN, this is covering the tailored training 10 and experience requirements.                  And this is really, you 11 know, the crux of what we're trying to evaluate here, 12 right?
13                    The general question:                are our current 14 pathways        for  obtaining        AU    status      reasonable      and 15 accessible?          And we have heard some varied responses 16 back on that.
17                    Are the current pathways for obtaining AU 18 status        adequate  for    protecting        public    health      and 19 safety?
20                    And should the NRC develop new tailored 21 T&E pathways for these physicians?                      If so, what would 22 be        the    appropriate          way      to      categorize        the 23 radiopharmaceuticals                for      those        tailored        T&E 24 requirements?            If not, explain why the regulation 25 should remain unchanged.
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50 1                  And  we      gave    some      examples    of      how 2 radiopharmaceuticals could be categorized, including 3 those with similar delivery methods, such as oral or 4 parenteral; the same type of radiation characteristics 5 or emissions, such as alpha, beta, gamma, low-energy 6 photons;      similar      preparation          methods,  such        as 7 patient-ready doses, or a combination of those.                    Maybe 8 there would be a category that would have a combination.
9                  So, those are some, just to kind of jog 10 people, those are kind of some ideas that we put in 11 the FRN.
12                  And *1 if you want to jump in and stop me 13 from talking.      That's how you do it.              Press *1.
14                  And I have one more question here on the 15 webinar I'm going to open up here.                Okay. That's just 16 somebody saying goodbye and thank you.
17                  All right.      And then, question 4 of Section 18 A:      should the fundamental T&E required of physicians 19 seeking limited AU status need to have the same 20 fundamental T&E required of physicians seeking full 21 AU status for all oral and parenteral administrations 22 under 10 CFR 35.300?
23                  *1 if you have any comments on any of those 24 questions.
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51 1 kind of gets into the specifics of requirements of 2 fundamental T&E, and it's how that fundamental T&E 3 should        be structured      for    specific    categories      of 4 radiopharmaceuticals.
5                  So, if anybody has any comments on that, 6 *1.
7                  THE OPERATOR:        Jeffry, your line is open.
8                  MR. SIEGEL:        Hi, Jeff Siegel again.          I'm 9 sorry for hogging this conversation, but --
10                  MS. LOPAS:      No, we're here.
11                  MR. SIEGEL:        Since you brought up again 12 full      authorization      versus      limited    authorization, 13 should it require the same T&E hours?                I would argue, 14 as I did in my opening, that that would not be 15 risk-informed.
16                  MS. LOPAS:      Right.
17                  MR. SIEGEL:        Right now, most people are 18 talking about their opinion.                  No studies have been 19 done, as somebody else was mentioning before, about 20 whether the T&E, whether it be 700 or 80, for the, I 21 would        say,  non-risk-informed          approach  to let      any 22 physician use hundreds of millicuries of I-131 is 23 adequate or not.          And I think the NRC needs to do a 24 little bit of homework.
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52 1 capable,      or  should      they    be      allowed  to use      an 2 FDA-approved commercially-available product if they 3 think it would help their patients if they were 4 adequately trained?            So, the question is, yes or no, 5 could a physician just pick a particular agent for his 6 practice, like a urologist who is treating prostate 7 cancer who says, "Ah, this is great.                  I would love to 8 give it to my patients."
9                  If they could with a reasonable T&E be able 10 to do that, as opposed to obtaining AU status based 11 on giving everything, which seems to me to be a non 12 sequitur, would the NRC agree or disagree that it would 13 be possible for a physician to medically use an FDA 14 commercially-available              product,        if  they      were 15 adequately trained?
16                  And that's what, I think, the issue at hand.
17  What would be the adequate training for a given 18 therapeutic which is administered based on receiving, 19 say, unit dosage, and all this interest in radiation 20 physics and radiation dosimetry, and all this other 21 stuff -- it's important, but moot to the single-user 22 physician.
23                  Thank you.
24                  MS. LOPAS:      So, I have a follow-up question 25 for you.        So, in question C, we asked, should the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 radiopharmaceutical manufacturer be able to provide 2 the preceptor attestation?          So, if, for instance, like 3 you're saying, a physician did want to pick one 4 particular drug and become -- you know, if there was 5 a way, a pathway to just being able to administer that 6 drug, I would be curious to hear your ideas for how 7 we would go about that, what that pathway would look 8 like, and if it would involve the manufacturer.
9                MR. SIEGEL:      Yes, well, I know if this was 10 approved, for example, under 35.1000, as opposed to 11 in an alternate pathway that was either 395 or 398, 12 because I don't think you can do it as part of 390, 13 I know that the manufacturer is allowed to give that 14 training for these micro seals, and it was so specified, 15 and I'm not saying it should or it shouldn't be.
16                All I'm saying is, a physician should be 17 able to, if it's deemed appropriate by experts in the 18 field who say, okay, this particular agent, no way it 19 requires 50 years of training and experience.          However, 20 this one, the way it's provided and the way it's 21 manufacturer supplied, because the manufacturer spent 22 a little bit of time coming up with a distribution model 23 that was safer than others -- so, I'm just saying it 24 should be looked at in a way that one could, then, 25 say -- and I agree with a lot of people who say that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Services MUNIR GHESANI, MD, FACNM, FACR, Society of Nuclear Medicine and Molecular Imaging RALPH LIETO, St. Joseph Mercy Health System
54 1 only people who are board-certified or have 18 years 2 of experience should be able to give even the simplest 3 unit dosage.
4                But, remember, medical oncologists, as an 5 example, give on a daily basis very potent, harmful 6 drugs, that is, chemotherapy drugs.                    They're very 7 skilled at doing that.        So, the only difference would 8 be in terms of what's in the syringe, and to figure 9 out what it is to do if there's a mishap.
10                I think it could easily be taken care of, 11 but that's up to you and people on the line and people 12 who are supplying comments as to what would be the 13 appropriate level of training, given an agent which 14 involves much less risk and it's easier to administer 15 than others in its class, as opposed to just saying 16 all oral, or oral/parenteral, or whatever.                        Just 17 something to think about.
18                MS. LOPAS:          Okay.        Thank  you.          I 19 appreciate that.
20                Does anybody have any comments kind of in 21 response to Jeff's comments or any comments on anything 22 in general?    Press *1.
23                Cedric, anybody on the line?
24                THE OPERATOR:        Showing no questions.
25                MS. LOPAS:      Okay.      All right. So, *1.
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AMIN MIRHADI, MD, Cedars-Sinai Medical Center
55 1                THE OPERATOR:        Ralph, your line is open.
2                MR. LIETO:      Thank you.
3                This is Ralph Lieto again.
4                And some of us here were talking about one 5 of the questions regarding the geographical issue and 6 patient access.      I think the NRC has already in their 7 introductory comments recognized that there's the need 8 for this information.
9                What would be, I think, of value to this 10 discussion when they're gathering this information, 11 assuming it's probably going to be by zip code or 12 something of that nature, if they could get the 13 distribution by the authorized used category -- in 14 other words, is it 390, 392, 394, or 396 for this 15 geographical distribution?              And I think that would 16 really go a long ways.          Because I think some of the 17 questions that I think -- or I should say the points 18 that Dr. Siegel has brought up regarding the physician 19 who wants the sort of limited use of a single modality 20 in a therapeutic application.
21                Thank you.
22                MS. LOPAS:      Okay.      Thank you.
23                Maryann, do you have anything that you want 24 to add with regard to how we would look at gathering 25 that dataset?
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ARIA RAZMARIA, MD, UCLA Medical Center  
56 1                  MS. AYOADE:        Hi, Sarah.
2                  Not really.        What Ralph said is something 3 that we're considering.            As we look at the authorized 4 users for 300 uses, we'll be able to look at the 5 different training categories that they're licensed 6 for.        So, we could get that information as well, in 7 addition to the distribution, like he said.
8                  MS. LOPAS:      Okay.      Thank you, Maryann.
9                  Okay.    *1 for any additional comments or 10 you can submit a question or comment for me to read 11 aloud via the webinar software.                    I can certainly do 12 that for you as well, if you would like to submit your 13 comments that way.
14                  THE OPERATOR:          Aria Razmaria, your line 15 is open.
16                  DR. RAZMARIA:        Hi. How are you?    This is 17 Aria Razmaria speaking.            I'm a Senior Nuclear Medicine 18 Resident at UCLA Medical Center.
19                  But I'm speaking on behalf of myself and, 20 also, on behalf of nuclear medicine, the nuclear medical 21 physician, on behalf of nuclear medicine training, both 22 in nuclear medicine programs and nuclear medicine and 23 biology programs.
24                  And I appreciate the NRC's request for 25 public comment.        It's an important topic, and there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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JEFFRY SIEGEL
57 1 are kind of soft processes that lend into this, again 2 reaching out to all different stakeholders in this 3 regard.
4                  One comment that we would like to make is 5 that being able to administer radiopharmaceuticals in 6 just the matter of a single dose being applied, and 7 to be able to do that.            It goes, also, along the line 8 of being able to enhance and encourage research in this 9 area.        People that are dedicated to one specific field 10 push        forward  and    contribute          to  developing      new 11 pharmaceuticals, radiopharmaceuticals, for different 12 applications.        So, in this regard, it's not just a 13 matter of application or administration, but also the 14 science and the developmental research that goes beyond 15 just having access to the application or administration 16 of these radiopharmaceuticals.
17                  Meaning that, as a body that is interested 18 and dedicated to the science of nuclear medicine, there 19 is a dire need in the U.S.              We see that all research, 20 almost the majority of research is coming from countries 21 outside of the U.S. in countries that have dedicated 22 programs        for  training.          And    there  is  a  body      of 23 physicians that are interested in the research and, 24 also, development of new avenues of therapy.
25                  So, just having a single limited authorized NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 CONTENTS Call to Order and Opening Remarks..................4
58 1 user      license  to    be    able      to      administer  certain 2 radiopharmaceuticals would not push the field forward 3 in the U.S. and contribute to further advancement of 4 the science of nuclear medicine.
5                  Thank    you      for    this      opportunity        to 6 contribute to the discussion.
7                  MS. LOPAS:      Yes.     Dr. Razmaria, can I ask 8 a follow-up question related to what you just said?
9                  DR. RAZMARIA:        Absolutely.
10                  MS. LOPAS:      So, related to one of the FRN 11 questions we have, do you think that the current regs, 12 do they have no effect on research and development in 13 nuclear medicine or are they adversely affecting it 14 because they're limiting the number of people that are 15 getting involved?          Or are you saying that, if we make 16 it easier for folks to just pick one category, that 17 you think that wouldn't do anything to help research 18 and development?
19                  DR. RAZMARIA:          Again, you actually are 20 facing a situation where I believe, actually, the 21 requirements that you are talking about, 700 hours, 22 if you calculate that, it would be four months of 23 training.       Whereas, again, based on the American Board 24 of Nuclear Medicine and the American Board of Radiology, 25 there's        a  good    understanding            that  that  is      not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Welcome and Introduction...........................5
59 1 sufficient, as programs have been developed sponsored 2 by the Board of Radiology and the Board of Nuclear 3 Medicine that perhaps included radiology and nuclear 4 medicine.         So,  there    is    understanding      that      that 5 requirement that you are talking about right now being 6 too much of training, which is just four months, it's 7 our understanding.
8                  I mean, what you are facing in the U.S.
9 is that people don't realize that to be able to advance 10 the research and science, we have to be dedicated; we 11 have to be understanding that just being able to read 12 one dose and that's it, the science is weak on that.
13  It's to be able to understand, okay, what other traces 14 are possible, what other avenues?                    So, it really can 15 be researched.
16                  Personally, you know, I have spent the time 17 to understand the question.             What you see in the nuclear 18 medicine, right now practiced in the U.S., the majority 19 are by radiologists, which they are very busy.                       They 20 have      to  cover  multiple        modalities.         And    to      my 21 understanding, radiologists, when I talk to them, they 22 really didn't sign up to do that, but what we are facing, 23 they are hiring from places like hospitals.
24                  College groups, they basically don't see 25 the need to having training in nuclear medicine, who NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Review Agenda and Ground Rules.....................7
60 1 have done the basics for four years, nothing but just 2 being able to understand what nuclear medicine is, 3 professional imaging as well as PET imaging.
4                    So, meaning, there is no time; there is 5 no encouragement to start these projects that are dear 6 to us, answering those specific questions that the field 7 needs.         That actually is happening, if you see across 8 the border, in Europe, all the developments.                         The 9 radiotherapists there are talking about the change in 10 requirements, because of all that are developed in 11 Europe, in Australia, in countries that have a strong 12 standing in nuclear medicine, with people who have spent 13 time not only just administering one single dose for 14 people to be able to create revenues, but who are 15 instructed in consultations, answering questions that 16 are not answered in the field.
17                    So,  these    are    physicians  that  we    are 18 mentioning right now in this discussion will have in 19 the future, how nuclear medicine that is practiced in 20 this country.         And again, there's a new generation of 21 trainees that are interested in taking this task or 22 taking these questions, who are dedicated and want to 23 do that.         And we need, if at all possible, to encourage 24 that, to enhance that.           Because, as mentioned, despite 25 the U.S. being the country where nuclear medicine was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Presentation on the NRC's T&E Evaluation...........9
61 1 invented, we're lagging behind internationally, behind 2 many other countries.          So, the rulemaking will have 3 a direct effect on that progress.
4                MS. LOPAS:          Okay.        All  right.        I 5 appreciate that insight.            Thank you.
6                Okay. Cedric, do you have anybody else 7 on the line?
8                *1, if anybody wants to respond in response 9 to what this Dr. Razmaria just spoke about or anything 10 else.
11                THE OPERATOR:        Showing no one in queue at 12 this time.
13                MS. LOPAS:      Okay.      Okay, folks, let's see.
14  So, we heard a little bit about the effect that this 15 can have on future R&D in nuclear medicine.             Maybe that 16 leads to specialty boards.           We got a couple of comments 17 in saying that maybe we don't need an alternative 18 pathway, that maybe it should just be these specialty 19 boards that are the only ones that can certify.
20                If anybody has any comments on that, press 21 *1, or any comments in general about the NRC's medical 22 specialty board recognition process.                 We're happy to 23 hear those, too.
24                The current boards right now that are 25 recognized at the NRC are the American Board of Nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Public Comments...................................27
62 1 Medicine, the American Board of Radiology, the American 2 Osteopathic Board of Radiology, and the Certification 3 Board of Nuclear Endocrinology.                 So, that's what we 4 have currently.
5                Are there other boards that we should be 6 considering?      Press *1 if you have any thoughts on that.
7                THE OPERATOR:          I'm showing no questions 8 or comments in queue at this time.
9                MS. LOPAS:      Okay.     Thank you.
10                All right.     And if folks have more general, 11 again, any more general comments on the NRC's T&E 12 regulations in general, I know we are happy to hear 13 those as well.
14                But I understand this is the first meeting.
15  There are three additional public comment meetings.
16  Like I said, the one in December, on December 11th 17 and the one on January 10th, those are in-person 18 meetings.     So, if anybody is in the area and wants to 19 travel, you can come on out and come attend one of those 20 meetings personally.         And both of those will also be 21 accessible via webinar and teleconference again.                     And 22 those will all be, again, transcribed and recorded.
23 And then, on January 22nd, we're going to have one final 24 webinar, and that will be about a week before the comment 25 period ends.     So, maybe comments will ramp up as we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Closing Remarks...................................65
63 1 move along.
2                  I have one, let's see, I have one comment 3 here      that  is  suggesting        certification      of  nuclear 4 cardiology.         I'm not seeing any other information 5 related to that.
6                  Mr. Johnson, if you want to hop on the line, 7 feel free.       *1 to hop on the line, if you want to expand 8 on your comment on certification of nuclear cardiology.
9  That would be helpful.         Otherwise, you can submit that 10 comment in writing as well.                 But I did receive that 11 comment via the webinar here.
12                  Okay. All right.         *1.
13                  MS. AYOADE:        This is Maryann.
14                  I'm not sure why the commenter just put 15 down      CBNC,  but    I'll    point      out    that  CBNC,      the 16 Certification Board for Nuclear Cardiology, who was 17 the best for training and imaging and localization 18 studies, which is under 10 CFR 35.200.                   And that's not 19 a subpart of this section of training and experience 20 that we're looking at.
21                  MS. LOPAS:            Okay.         That's      good 22 clarification.         Thank you, Maryann.             That's helpful.
23                  *1 if there's any additional comments.
24                  Cedric, do we have anybody on the line?
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Adjourn...........................................66
64 1 they withdrew the question.
2                MS. LOPAS:          All right.         *1 to ask a 3 question; *2 to change your mind.                 So, somebody got 4 the *2.
5                I've been doing these webinars for a few 6 years now, and I never knew *2 was an option.             So, that's 7 good to know.
8                Okay. All right.         Well, we're going to 9 give it a couple more minutes.                 But, if we continue 10 to have no comments, we will probably end the webinar 11 early.
12                So, *1.
13                I'm going to talk a little bit again about 14 the comment deadline for written comments.               If you want 15 to also submit written comments, you can submit written 16 comments via regulations.gov.               It's very easy.           And 17 the docket ID is NRC-2018-0230, and you just go to 18 regulations.gov and type that ID, that docket ID, right 19 in the search bar, and it will pop right up.             And there's 20 a little button that says, "Comment Now" on the 21 right-hand side, and it's very easy.
22                But, again, if you have any issues, I'm 23 going to put my contact information up again.                 You can 24 certainly contact myself or Maryann.                 If you have any 25 issues submitting comments via regulations.gov, I can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 P R O C E E D I N G S 1 1:02 p.m.
65 1 certainly help you out with that.               That's no problem.
2 MS. LOPAS:  (presiding)  Hi, everybody.
2               And *1 for any final comments for folks.
3 Good afternoon.
3               (No response.)
4 Welcome to the NRC's webinar to accept 5 comments on the Staff Evaluation of Training and 6 Experience Requirements for Different Categories of 7 Radiopharmaceuticals.
4               All right.          Cedric, I'm assuming it's 5 nobody has popped on?
8 My name is Sarah Lopas, and I am a member 9 of the NRC's Medical Radiation Safety Team, which is 10 part of the Medical Safety and Events Assessment Branch 11 and the NRC's Office of Nuclear Material Safety and 12 Safeguards.
6               THE OPERATOR:        Yes, no line queue at this 7 time.
13 I'm the Project Manager for the NRC's 14 training and experience evaluation, and I'll be 15 facilitating today's webinar and, also, giving part 16 of the NRC's presentation.
8               MS. LOPAS:        Okay.        All right. Well, I 9 really do appreciate everybody that joined us today 10 and took time out of the middle of their day to join 11 us on this webinar.       Like I said, we've got additional 12 meetings, public comment meetings again, where you can 13 get on the line and have your comments transcribed 14 December 11th, January 10th, and January 22nd.
17 I'm joined here at NRC's Headquarters by 18 my manager, Chris Einberg, who is the Chief of the 19 Medical Safety and Events Assessment Branch. Also 20 joining us remotely via phone is another member of the 21 Medical Radiation Safety Team and the technical lead 22 on the training and experience evaluation, Maryann 23 Ayoade. Maryann will be helping me with today's 24 presentation.
15                And  I     hope      everybody      has  a    great 16 Thanksgiving.
25 5
17                If you need anything, contact myself or 18 Maryann.
We have a short agenda for today's webinar. 1  In just a moment, my Branch Chief Chris will start 2 us out with a welcome and the purpose of today's meeting. 3  And then, myself and Maryann will go through about 4 15 slides that will cover background information on 5 the NRC's evaluation, and we will discuss The Federal 6 Register notice that was published on October 29th and 7 the questions that were contained in that Federal 8 Register notice. And we will cover how you can also 9 provide written comments by the January 29th comment 10 deadline, if you would like to submit written comments.
19                So, thank you all and have a great day.
11 Then, we're going to go to the phone lines.
20                (Whereupon, at 2:24 p.m., the meeting was 21 adjourned.)
12  We'll open them up one by one, and we'll take your 13 comments on the record.
22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
14 And now, I'm going to ask Chris Einberg, 15 Chief of the Medical Safety and Events Assessment Branch 16 in the NRC's Office of Nuclear Material Safety and 17 Safeguards, to give a short welcome.
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18 MR. EINBERG:  Okay. Thank you, Sarah.
19 Good afternoon, everyone. Thank you for 20 taking the time to attend today's webinar, which will 21 be the first of four comment acceptance meetings that 22 the NRC will be conducting on our training and 23 experience requirements evaluation.
24 The purpose of today's meeting is twofold:
25 6
to provide background information on the NRC staff's 1 planned evaluation of developing tailored training and 2 experience requirements for administering different 3 categories of radiopharmaceuticals for which a written 4 directive is required, in accordance with our 5 regulations in 10 CFR Part 35, which are our 6 regulations for medical use of byproduct materials in 7 Subpart E under Part 35, which covers unsealed byproduct 8 material, written directive required.
9 And most importantly, to listen to and 10 record your comments on the evaluation. The comments 11 that we receive from the medical community today, the 12 Agreement States, and the other stakeholders are 13 critical to the NRC staff's decision-making on whether 14 our existing training and experience requirements 15 should be revised. If you do not provide your comments 16 today, we encourage you to participate in one of the 17 future comment meetings in December and January or 18 submit written comments using regulations.gov by the 19 January 29th, 2019 comment due date. Later in the 20 presentation, we will cover how you can submit your 21 written comments.
22 And now, I'll hand the conversation back 23 to Sarah, who is going to provide some basic information 24 about today's webinar.
25 7
Sarah? 1 MS. LOPAS:  Thanks, Chris.
2 So, if there's anybody on the bridge line 3 that doesn't have the webinar up and running, or doesn't 4 have the slides in front of them, I just want to let 5 you know that you can go to the NRC's public meeting 6 website and you can find that by just Googling or going 7 to some other internet search.  "NRC public meeting," 8 search that term and kind of the first thing that pops 9 up is our website, our public meeting notice website.
10 There, if you click on that link you pull 11 down, you'll find the meeting notice for this meeting.
12  If you click on "more" under that meeting notice and 13 look a little bit further, there is a link to the slides. 14  It will be a PDF file of what we're using today. So, 15 that's just a quick notice for everybody on the phone, 16 on the bridge line.
17 So, today we're going to be discussing the 18 NRC's evaluation of training and experience 19 requirements for certain categories of 20 radiopharmaceuticals. We're going to often refer to 21 training and experience as "T&E" for short. And we 22 will often refer to authorized users -- that is, those 23 physicians who are authorized to administer 24 radiopharmaceuticals -- as "AUs".
25 8
Today's webinar is being transcribed by 1 a court reporter. And as Cedric, our operator, had 2 mentioned, this phone line is also being recorded.
3 So, we're having a double-fail option here.
4 So, the full transcript of this webinar 5 is going to be publicly available in a few weeks, and 6 it will be on our NRC's Agencywide Documents Access 7 and Management System, or ADAMS, as we call it. And 8 I'll also be posting a link of that transcript to the 9 NRC's Training and Experience website, as well as 10 posting it to the docket website for T&E on 11 regulations.gov.
12 All of the comments that you make today 13 will be captured on the docket. So, I'll be combing 14 through the transcript and pulling out your comments 15 for inclusion in our evaluation effort. So, if you 16 speak today, you do not need to then separately provide 17 those written comments on regulations.gov. And 18 because it will be captured in the transcript, we will 19 have it on the record. And it's important to note that 20 the full comments and written comments carry the same 21 weight. There's no preferred way to submit your 22 comments.
23 We'll be opening the phone lines for 24 comments after the NRC presentation concludes.
25 9
Everyone is in listen-only mode at the moment. But, 1 when it comes time to make a comment, you're just going 2 to press *1 on your phone pad. That's *1. And that 3 will let Cedric, who is the operator, know that you'll 4 need your line unmuted.
5 And now, I'm going to hand the presentation 6 over to my colleague, Health Physicist Maryann Ayoade, 7 so she can review the NRC's current T&E regulations 8 and talk about why the NRC is conducting this 9 evaluation.
10 Maryann? 11 MS. AYOADE:  Great. Thank you, Sarah.
12 Today, I will be presenting information 13 on an overview of the regulations on training and 14 experience requirements for radiopharmaceuticals 15 requiring a written directive; some background 16 information on the related stakeholder concerns 17 received, and the NRC's efforts on the evaluation thus 18 far. 19 The current regulations on training and 20 experience for radiopharmaceuticals requiring a 21 written directive are under 10 CFR Part 35, Subpart 22 E. And these training and experience requirements 23 provide two pathways that a physician may be authorized 24 to administer radiopharmaceuticals that require a 25 10 written directive.
1 The first pathway is that a physician can 2 be authorized to administer these radiopharmaceuticals 3 if they are certified by a medical specialty board whose 4 certification process is recognized by the NRC or an 5 Agreement State.
6 A physician can also be authorized, to 7 satisfy the training and experience requirements, by 8 an alternate pathway, which includes completion of 700 9 hours of training and experience, including a minimum 10 of 200 hours of classroom and laboratory training in 11 the relevant topic areas, as listed in the regulation, 12 and 500 hours of supervised work experience in the 13 relevant areas, as listed in the regulation.
14 And a third path is that a physician can 15 also be authorized if they have been previously 16 identified as an authorized user on an NRC or Agreement 17 State license or permit.
18 This training and experience evaluation 19 is focused on the alternate pathway, and the NRC staff 20 are looking into what tailored training and experience 21 requirements for limited administration of certain 22 categories of radiopharmaceuticals would look like.
23 And that is what we will be referring to as a limited 24 authorized user status.
25 11 Next slide.
1 In Subpart E there are four sections that 2 pertain to training and experience requirements. The 3 first is under 10 CFR 35.390, which is for training 4 for the use of already pharmaceuticals in Subpart E, 5 all of which require a written directive.
6 The second is under 10 CFR 35.392, which 7 is for training for oral administration of sodium 8 iodide, Iodide-131, requiring a written directive in 9 quantities less than or equal to 33 millicuries.
10 The third is under 10 CFR 35.394, which 11 is for training for oral administration of sodium 12 iodide, Iodide-131, requiring a written directive in 13 quantities greater than 33 millicuries.
14 And the fourth is in 10 CFR 35.396, which 15 is for training for parenteral administration of any 16 radiopharmaceutical requiring a written directive.
17 All of this sections of training and 18 experience include the pathway for experienced 19 authorized users already listed on a license. All of 20 these sections, except 10 CFR 35.396, include training 21 and experience under the board certification and 22 alternate pathways.
23 And so, I want to point out that 24 10 CFR 35.396 is for training that is exclusively under 25 12 the alternate pathways for radiation oncologists to 1 become authorized users by completing additional hours 2 of training and experience.
3 I also want to point out that the alternate 4 training pathways under 10 CFR 35.392 and .394 are for 5 the physician to successfully complete 80 hours of 6 classroom and lab training that is relevant to the type 7 of use for which they are seeking to be authorized.
8 Whereas, the alternative pathway under 10 CFR 35.390 9 is for the physicians who successfully complete 700 10 hours of training and experience, which includes 200 11 hours of classroom and lab training.
12 Next slide.
13 This slide provides some background 14 information on stakeholder concerns received related 15 to training and experience requirements. So, since 16 the revision to the training and experience 17 requirements in 2002, and again in 2005, stakeholders 18 have raised concerns about the effects of some of the 19 requirements on patient access to certain 20 radiopharmaceuticals.
21 Specifically, some stakeholders have 22 asserted that the 700-hour requirement in 10 CFR 35.390 23 is overly burdensome for physicians who are not 24 certified by a medical specialty board, and that the 25 13 extensive requirements have resulted in a shortage of 1 authorized users, which, thereby, limits patient access 2 to radiopharmaceuticals.
3 As a result, in 2015 and 2017, in separate 4 efforts, the NRC staff and the NRC's Advisory Committee 5 on the Medical Uses of Isotopes, also known as ACMUI, 6 independently reviewed the training and experience 7 requirements for the medical uses authorized under 8 Subpart E.
9 Specifically, NRC staff reviewed the 10 regulatory basis and comments received on past 11 rulemaking related to the medical use of byproduct 12 materials and did not identify any new information that 13 would call into question the basis of the existing 14 requirements.
15 As a result, the NRC staff did not propose 16 any changes to the regulations at the time. The NRC 17 staff is continuing to work with the ACMUI in its ongoing 18 training and experience evaluation effort.
19 Next slide.
20 As part of the Staff Requirements 21 Memorandum dated August 17, 2017 -- and that is publicly 22 available in ADAMS; there is a hyperlink reference here 23 -- the Commission directed the NRC staff to evaluate 24 whether it makes sense to establish tailored training 25 14 and experience requirements for different categories 1 of radiopharmaceuticals; how those categories should 2 be determined, such as by risk code, by use of 3 radionuclides, or by delivery method; what the 4 appropriate training and experience requirements would 5 be for each category, and whether those requirements 6 should be based on hours of training and experience 7 or more focused on competency.
8 Next slide.
9 In response to the Commission direction, 10 the NRC staff solicited feedback from some medical and 11 regulatory stakeholders in April and May of 2018. That 12 evaluation, including the NRC staff analysis and the 13 feedback received of the training and experience 14 requirements in Subpart E of 10 CFR Part 35, is 15 documented in SECY-18-0084.
16 And the results of that evaluation 17 concluded that it may be feasible to establish tailored 18 training and experience requirements for different 19 categories of radiopharmaceuticals, and to create a 20 means of authorizing the administration of certain 21 categories of radiopharmaceuticals, such as the limited 22 authorized user status.
23 The evaluation also concluded that there 24 are viable options for creating a competency-based 25 15 approach to demonstrate acceptable training and 1 experience for limited authorized user status.
2 However, the staff needs to conduct more extensive 3 outreach to stakeholders in the medical community, to 4 the Agreement States, and other members of the public, 5 before making a recommendation to the Commission.
6 And this brings us to our current 7 evaluation to date. I will now hand it back to Sarah, 8 who will discuss our current evaluation efforts and 9 how you can participate.
10 Next slide.
11 MS. LOPAS:  Thank you, Maryann.
12 The end product of our evaluation will be 13 a paper that we will send out to our five-member 14 Commission. That paper will either document our 15 reasoning for recommending no changes to our current 16 training and experience requirements or, if we do 17 recommend that changes to our T&E regulations are 18 warranted, we will document our reasoning in a 19 rulemaking plan paper.
20 This is a simplified diagram of the 21 information that we will consider in our development 22 of a recommendation to the Commission on whether changes 23 to our existing T&E requirements are warranted. This 24 diagram illustrates why this comment period is so 25 16 important to this effort. Because, in large part, the 1 feedback that we receive on the questions that we've 2 asked in our Federal Register notice will inform our 3 recommendation to the Commission. Other important 4 feedback will come from our coordination with our 5 co-regulators, the Agreement States, and the NRC's 6 Advisory Committee on the Medical Uses of Isotopes, 7 ACMUI. 8 In addition to the input we receive from 9 the public, medical stakeholders, the Agreement States, 10 and the ACMUI, the NRC staff will also examine the issue 11 of patient access. Our staff will attempt to determine 12 the number of current authorized users and their 13 geographic distribution across the United States.
14 Authorized user and associated geographic 15 data is not readily available. So, the NRC staff will 16 be spending the next few months determining of this 17 dataset is achievable.
18 Staff will also review training and 19 experience requirements in other countries, in an 20 effort to benchmark the U.S. against the international 21 medical regulation. And staff will also do a review 22 of medical and radiation safety events to determine 23 if any have a nexus to training and experience.
24 It's important to note that, if the staff 25 17 does end up recommending rulemaking, which we would, 1 again, document in a rulemaking plan, the Commission 2 would then proceed to vote on that rulemaking plan.
3 And that would determine whether or not the staff would 4 proceed with another Part 35 rulemaking effort.
5 If rulemaking is recommended, and 6 subsequently approved by the Commission, that would 7 start the NRC's extensive rulemaking process. And I'm 8 really highlighting this process information because 9 I think it's important that everybody understands where 10 we are in this process.
11 And where we are right now is that we're 12 in the information-gathering stage, and that 13 information we gather and the comments we receive are 14 going to help us determine whether a rulemaking to 15 address training and experience requirements is even 16 warranted.
17 I hope many of you have read it by now, 18 but the NRC published a Federal Register notice on 19 Monday, October 29 th. The Federal Register notice can 20 be accessed by that link at the top of your slide, or 21 you can also just Google search the citation for the 22 Federal Register notice, which is 83 FR 54380.
23 The Federal Register notice announced the 24 public comment period, which ends on Tuesday, January 25 18 29 th , 2019. It also announced the dates for these public 1 webinars and meetings. And in a couple of slides I'll 2 be talking about the additional meetings we're having 3 after this one.
4 But, most importantly, The Federal 5 Register notice asked a series of questions on which 6 we would like medical community stakeholder input.
7 I'm going to read straight through the questions in 8 the next four slides, and I'm just going to go straight 9 through them, just to provide an overall scope and 10 context of the information that we're looking for.
11 But, when we get to the comment period in just a couple 12 of minutes, I am going to be kind of walking us through 13 the topical areas to try to gather your comments kind 14 of in an organized manner. So, hold tight. We are 15 going to read through the comments in the next slide.
16 So, the first set of questions, Section 17 A in the FRN, extensively cover the crux of what we're 18 evaluating, whether the NRC should create tailored 19 training and experience requirements for certain 20 categories of radiopharmaceuticals.
21 So, the questions are:
22 Are the current pathways for obtaining AU 23 status reasonable and accessible?  Are they adequate 24 for protecting public health and safety?
25 19 Should the NRC develop a new tailored T&E 1 pathway? What would be the appropriate way to categorize 2 radiopharmaceuticals for tailored T&E requirements?
3 Should the fundamental T&E required of 4 physicians seeking limited AU status need to have the 5 same fundamental T&E required of physicians seeking 6 full AU status?
7 And how should the requirements for this 8 fundamental T&E be structured for a specific category 9 of radiopharmaceuticals?
10 Section B, there are questions about the 11 NRC's recognition of medical specialty boards. And 12 those procedures for recognizing our medical specialty 13 boards are on our Medical Uses Licensee Toolkit website, 14 and the link is there on the slide.
15 But what boards other than those already 16 recognized by the NRC could be considered for 17 recognition for medical uses under 10 CFR 35.300?
18 Are the current NRC medical specialty board 19 recognition criteria sufficient? If not, what 20 additional criteria should the NRC use?
21 The next topical area or set of questions 22 covers patient access.
23 So, is there a shortage of the number of 24 Aus for medical uses under 10 CFR 35.300?  If so, is 25 20 that shortage associated with the use of a specific 1 radiopharmaceutical?
2 Are there certain geographic areas with 3 an inadequate number of Aus?
4 Do current NRC regulations on AU T&E 5 requirements unnecessarily limit patient access to 6 procedures involving radiopharmaceuticals?
7 And do current NRC regulations on AU T&E 8 requirements unnecessarily limit research and 9 development in nuclear medicine?
10 And then, the last set of questions we have, 11 they are a set of questions asking for general input 12 on the NRC's regulation of training and experience as 13 a whole. 14 So, should the NRC regulate the T&E of 15 physicians for medical uses?
16 Are there requirements in the NRC's T&E 17 regulatory framework for physicians that are non-safety 18 related? 19 How can the NRC transform its regulatory 20 approach for T&E while still ensuring that adequate 21 protection is maintained for workers, the general 22 public, patients, and human research subjects?
23 So, those are the questions that we're 24 looking for your input on. I'll be going through those 25 21 questions when we get to the comment period in a second, 1 but it would be great if you could have the FRNO bin 2 and you can read through, because there's a lot of 3 sub-questions underneath those general questions that 4 I didn't want to laboriously read through.
5 So, how can you submit your comments on 6 our evaluation and respond to all those questions?
7 Well, in addition to speaking during today's meeting, 8 and in any of the three future meetings that we have 9 planned, you can submit your comments via 10 regulations.gov. And the link on this slide will take 11 you directly to the comment submissions form on the 12 T&E docket, which the docket ID is NRC-2018-0230. But 13 you can also just go to regulations.gov. Just type 14 in regulations.gov and it comes right up. And you can 15 enter that docket, NRC-2018-0230, into the search bar 16 right at the top of that page, and it will bring you 17 right to our docket page. Once you're in the comment 18 submission form, you can either type directly into the 19 form or you can upload a document like a Word or text 20 file or even a PDF.
21 Here at the NRC I have immediate access 22 to those comments that are submitted via 23 regulations.gov, but I will warn everybody that there's 24 an internal administrative process here at the NRC.
25 22 So, it takes a few weeks for those comments to become 1 publicly viewable on regulations.gov. So, don't panic 2 when you submit via regulations.gov and you go back 3 to see if you can find it if you can't find it. We 4 got it. It's just it has to go into our ADAMS system 5 first, and then, it goes back up on the regulations.gov.
6  So, just to clarify, your comments will be publicly 7 available on regulations.gov and in ADAMS.
8 If you encounter any issues at all when 9 you're submitting your comments via regulations.gov, 10 please contact me. You can email me or call me. My 11 contact information will be at the end of this 12 presentation.
13 And at the end of the public comment period, 14 we'll be compiling all the comments we received, both 15 written and oral, and we'll be publishing them in one 16 easily accessible comment report. Not only will that 17 comment report list all the comments out individually, 18 it will also summarize them. And the comment report 19 will be available on the NRC T&E website, and I'll also 20 ensure that it gets posted to regulations.gov. And 21 I know that whatever recommendation paper that we 22 develop, it will heavily reference that comment report. 23 I do want to point out that, because this 24 is in a rulemaking, and the purpose of collecting our 25 23 comments is to help us inform our decision-making, we 1 will not be responding to individual comments or even 2 groups of binned comments. So, that's an important 3 thing to note.
4 This slide just details the additional 5 public meetings that we're going to be having on T&E 6 in December and January, before the comment period 7 closes out. The meetings that are going to be held 8 on December 11th and January 10th, in addition to those 9 meetings accessible by webinar again and 10 teleconference, those will also be open to in-person 11 attendance here at the NRC Headquarters in Rockville.
12  The December 11th meeting will be held in the 13 Commission hearing room in our 1 White Flint Building, 14 and the Thursday, January 10th meeting will be held 15 on the ground floor conference room in our 3 White Flint 16 Building.
17 And all the details that you need to 18 participate in those meetings, again, are on the NRC's 19 public meetings schedule website. And if you have any 20 questions, again, you can contact me.
21 This slide shows our next steps, a basic 22 outline of our next steps, and the planned timeline 23 of our evaluation. After the comment period ends on 24 January 29th, the NRC will begin organizing and 25 24 evaluating the comments. The NRC staff will also be 1 conducting that additional research that I noted 2 earlier regarding patient access, international 3 benchmarking, and assessing medical and radiation 4 safety events.
5 The ACMUI Subcommittee on Training and 6 Experience will provide the NRC a report on their 7 findings and recommendations regarding the T&E 8 requirements in the spring of 2019, and the staff will 9 consider their input in developing their draft 10 recommendation.
11 Both the Agreement States and the ACMUI 12 will have an opportunity to provide comments on our 13 draft Commission paper, and the NRC will consider and 14 incorporate their comments into the final paper to the 15 Commission, which we have to finalize in early fall 16 2019. 17 So, for more information and links to all 18 the documents that we mentioned today, like the SECY 19 paper from this past September or the Staff Requirements 20 Memorandum that caused us to do this evaluation in the 21 first place, please visit the NRC's Training and 22 Experience Evaluation website. That's the link above.
23  It is housed under the NRC's Medical Licensee Toolkit 24 overall. But we will be actively maintaining this 25 25 website through the T&E effort. So, it's a good place 1 to go. 2 Again, you can also go to the 3 regulations.gov docket for T&E. So, I will also be 4 putting public participation information on that. And 5 what's good about regulations.gov is that it will list 6 all the comments that we receive. So, you can look 7 at other folks' comments.
8 And please reach out to me, Sarah Lopas, 9 as the Project Manager, if you have any kind of 10 process-type questions about the community effort.
11 And Maryann is your point of contact for your more 12 technical questions.
13 So, with that, I'm going to get us into 14 the comment period phase of this. I do want to note 15 that you'll press *1 on your phone to make a comment.
16  And you can go ahead and press *1 now if you know you 17 already have something to say. That's great. And 18 Cedric is just going to be going down the line and 19 unmuting lines as he receives those *1 requests.
20 And so, we have plenty of time for comments 21 today. We're scheduled to go to 3:00 p.m. Eastern, 22 but we can always go a little bit beyond that, if needed. 23 And I do want to remind you that our court 24 reporter -- her name is Allegra -- she's on the phone, 25 26 too. She's transcribing everything we say today. So, 1 when we do unmute your phone, please remember to start 2 by introducing yourself. If you have an affiliation 3 that you want to let us know about, you can certainly 4 include your affiliation.
5 There aren't too many of us on the line.
6  I know we've got about 24 people on the webinar, which 7 is great, and there might be more people on the line.
8  But I do think that we will try to go through the topical 9 areas of the questions that we ask in the FRN, but I 10 do understand that many of you might just have a 11 statement that you want to just read right through.
12 And that's okay. You don't need to try to break it 13 up. 14 So, we'll just get started. With that, 15 press *1 if you would like to make a comment.
16 I have brought up on the webinar Section 17 A of the questions, and I have, of course, three 18 questions under Section A, under tailored training and 19 experience requirements. Those are the topics asking 20 about: 21 Are the current pathways for obtaining AU 22 status reasonable and accessible?  Are they adequate 23 for protecting public health and safety?  And then, 24 obviously, a big one, should the NRC develop new 25 27 tailored T&E pathways for a physician?
1 So, *1. Get something to drink; maybe get 2 some coffee. And we can get started.
3 And, Cedric, just let me know whenever you 4 have anybody on the line to get going.
5 THE OPERATOR:  Sure. And our first 6 question or comment comes from Amin Mirhadi.
7 Your line is open.
8 DR. MIRHADI:  Thank you so much, Cedric.
9 Hi there. My name is Dr. Amin Mirhadi.
10 I'm a radiation oncologist at Cedars-Sinai Medical 11 Center in Los Angeles. I'm also the Vice Chair of the 12 American Society of Radiation Oncology's NRC 13 Subcommittee. And thank you for allowing me to provide 14 this statement on behalf of ASTRO, which is the acronym 15 for that.
16 ASTRO is the largest radiation oncology 17 society in the world with more than 10,000 members who 18 specialize in treating patients with radiation therapy. 19  As a leading organization in radiation oncology, 20 biology, and physics, the Society is dedicated to 21 improving patient care through education, clinical 22 practice, advancement of science, and advocacy.
23 ASTRO's highest priority has always been ensuring 24 patients receive the safest, most effective treatments.
25 28 ASTRO is pleased that the NRC has invited 1 stakeholders to provide input on training and 2 experience requirements for radiopharmaceuticals 3 through public meetings and written comments. We 4 strongly oppose any reduction in the T&E requirements 5 found in 10 CFR 35.390, training for use of unsealed 6 byproduct material for which a written directive is 7 required under the so-called "alternate pathway".
8 ASTRO believes that the requirements found 9 in this section are appropriate. They protect the 10 safety of patients, the public, and practitioners, and 11 should not be diminished.
12 Radiopharmaceuticals are highly effective 13 in treating cancer, with possible harmful effects to 14 both the patient and the public if not used correctly 15 under the supervision of the highly-trained physician.
16 We are pleased in this report entitled 17 "Staff Evaluation of Training and Experiment 18 Requirements for Administering Radiopharmaceuticals," 19 that the NRC staff determined that the current 20 requirement of 200 hours of classroom and laboratory 21 hours prescribed under the alternate pathway is 22 reasonable to acquire the fundamental knowledge that 23 an AU would need to administer any radiopharmaceutical.
24  However, we are concerned that paring the number of 25 29 hours of work experience required, based on categories 1 of radiopharmaceuticals, will lead to confusion and 2 complexity, both for licensees as well as for the NRC 3 and Agreement States.
4 We are also concerned that if new 5 radiopharmaceuticals are approved for use that do not 6 fit clearly into one of the categories, that the NRC 7 will have to promulgate any additional regulations to 8 include the new agents, a process that could take time 9 to finalize, delaying patient access to potentially 10 lifesaving radiopharmaceuticals.
11 The rigorous T&E requirements contribute 12 to the excellent safety record of radiopharmaceuticals.
13  We believe that it is important that the person 14 administering the radiopharmaceuticals is 15 appropriately trained in the safe handling, exposure 16 risk, and the management of side effects of radiation.
17 ASTRO looks forward to working with the 18 NRC as they continue deliberation and review on this 19 very important topic. In addition, I want to close 20 by saying that ASTRO will submit more detailed written 21 comments by the end of the comment period. And I really 22 appreciate the opportunity to speak to you guys today.
23 MS. LOPAS:  All right. Thank you, Dr.
24 Mirhadi. 25 30 All right. Cedric, do we have somebody 1 else on the line?
2 Again, folks, press *1 to make a comment, 3 *1, and you can either focus on -- you could read a 4 statement, just like Dr. Mirhadi did, or you could focus 5 on kind of this first slide that I have up that talks 6 about questions 1, 2, and 3.
7 Cedric? 8 THE OPERATOR:  I'm showing no one 9 currently in queue.
10 But, again, as another reminder, if you 11 would like to ask a question or make a comment, please 12 press *, then 1. If you would like to withdraw that 13 question or comment, you may press *2.
14 MS. LOPAS:  So, *1 to make a comment, *2 15 to change your mind. I just learned something new.
16 Okay. 17 All right. So, I can move through 18 different slides. Again, we have three more meetings 19 on this. My colleagues and I were determining what 20 was the best way to get comments from folks over the 21 phone line, and thought we would try walking through 22 some of the questions. So, we're going to just play 23 around with that. But we may change our comment format 24 in future meetings, just as an effort --
25 31 THE OPERATOR:  Sarah, we did have one that 1 came through.
2 MS. LOPAS:  All right. Let's go.
3 THE OPERATOR:  All right. Jeffry Siegel, 4 your line is open.
5 MR. SIEGEL:  And thanks very much for 6 having this meeting. I really appreciate it.
7 My name is Jeffry Siegel. I've been 8 involved in reviewing -- I shouldn't even say 9 "reviewing" -- but involved in writing and publishing 10 about NRC requirements and regulations which have been 11 very good.
12 And I figured I would want to start this 13 off with some controversy because I totally disagree 14 with the first speaker.
15 First, a brief history relevant to the T&E 16 issue I think is in order. Prior to the NRC revision 17 of Part 35 -- that is, pre-2002 -- only 80 hours of 18 T&E were required for the alternate pathway to obtain 19 AU status for therapeutic use, pursuant to 35.930 --
not 20 for the dyslexic, 930, not 390 -- and only I-131 use 21 was considered. At the same time, diagnostic use, 22 pursuant to 35.920, required 700 hours.
23 During the revision of Part 35, NRC 24 modified, based on a risk-informed performance-based 25 32 approach, these requirements. 35.930 was replaced by 1 35.390, requiring 700 hours for the alternate pathway.
2  Eighty hours replaced the 700 hours, except for oral 3 sodium I-131 use. Pursuant to 35.392 and .394, only 4 80 were, and still are, required for oral sodium 5 iodide-131 use. Therefore, requirements have already 6 been tailored for a specific use via 392 and 394. This 7 may be because the NRC was persuaded by endocrinologists 8 to maintain the 80 hours, and this was done 15 years 9 ago. But, today, any physician desiring limited 10 authorization to use sodium iodide can do so with only 11 80 hours.
12 Then, in 2006, a petition was submitted 13 to the NRC requesting the 700 hours be reduced to 80.
14  The NRC, of course, denied this petition, and it noted 15 that I-131 was considered to be less of a radiation 16 safety issue than the three agents in the petition; 17 namely, Quadramet, Bexxar, and Zevalin. And the 18 petition requested that med oncs and hematologists be 19 allowed to do this.
20 NRC further believed that tailoring T&E 21 requirements, which, of course, they had already done 22 for sodium iodide, would increase the complexity of 23 regulatory oversight with no benefit to anyone.
24 Now we skip forward to today. Using a 25 33 one-size-fits-all regulatory approach is not 1 beneficial to oral. Oral therapeutic 2 radiopharmaceuticals do not pose the same risk. So, 3 it follows that their use should not be subjected to, 4 and limited by, identical T&E requirements. This 5 contradicts the risk-informed approach NRC is using.
6 If a physician is seeking limited 7 authorization without any added flexibility for use 8 of a relatively safe agent, 700 hours is not warranted.
9  Requiring this number of hours, pursuant to 35.390, 10 for limited AU status conflates a single-use 11 requirement with the ability to administer all forms 12 of radionuclide therapy with unlimited flexibility, 13 which, by the way, of course, increases risks. Mandating 14 700 hours of training when it may not be necessary is, 15 indeed, burdensome to those physicians desiring to 16 attain AU status.
17 And as an example, Xofigo-only usage. At 18 this point, I wanted to mention it because it is an 19 FDA-approved commercially-available therapeutic, and 20 physicians who want to incorporate this single agent 21 into their practice should be encouraged to do so if 22 they have been appropriately and sufficiently trained.
23 Xofigo is an alpha-emitting therapeutic, 24 administered in only microcurie quantities, provided 25 34 as a unit dosage in a syringe, and unlike hundreds of 1 millicuries of sodium iodide, is of no external dose 2 concern. And since it is excreted mainly in the feces, 3 it is not a likely source of internal contamination.
4  Further, the dose to others is so low that patient 5 release instructions are not even required, pursuant 6 to 35.75. It must be pointed out that conventional 7 nuclear medicine equipment can be used to measure and 8 look for contamination, should it occur.
9 So, in closing, NRC has already tailored 10 T&E requirements for the specific use of oral sodium 11 iodide. So, the need for such tailoring requires no 12 further discussion, since it already has been done.
13 Therefore, a physician desiring to use Xofigo should 14 be able to attain limited AU status for Xofigo-only 15 usage if adequately trained to minimize any adverse 16 impact on public health and safety.
17 Since the T&E requirements should reflect 18 the risk involved, and in the case of Xofigo-only use 19 this risk is much less than for oral sodium iodide, 20 only 80 hours of T&E, perhaps even less, should be 21 required.
22 Thank you very much. I realized what I 23 just was controversial, and this should kick off public 24 comment. Thank you very much.
25 35 MS. LOPAS:  All right. Well, we 1 appreciate all comments, controversial or not. And 2 I do like ones that kind of get discussion going.
3 So, *1 if you want to respond to that 4 comment or if you have some additional comments here 5 on Section A.
6 Cedric, do we have anybody else in the line? 7 THE OPERATOR:  Not at this time.
8 MS. LOPAS:  Okay. All right. So, I have 9 up on the screen, in the webinar, if you're following 10 along on the webinar -- again, we've had some responses 11 back to should the T&E -- well, here's the question:
12  if we do develop tailored limited statuses, limited 13 AU statuses, should those folks go through the same 14 fundamental T&E required of physicians seeking full 15 AU status?  So, that was one question.
16 And the next slide, it kind of gets into 17 some of the nitty-gritty of what we're looking for.
18 We're looking for kind of, how should those fundamental 19 requirements be structured for these specific 20 categories of radiopharmaceuticals?  And this is where 21 we're asking for questions like, what should these 22 requirements specifically include?  Classroom and 23 laboratory training?  What topics under classroom and 24 laboratory training?  How many hours?  How many hours 25 36 of work experience?  And also, competency, how should 1 competency be evaluated?  Should it be evaluated 2 through a written or practical examination or by an 3 independent examining committee?
4 And let's see, what other questions do we 5 have here?  We have questions about preceptor 6 attestation. Should it be required for fundamental 7 T&E? 8 So, you can check out that slide if anybody 9 has any comments on question 5. And then, we also have 10 questions, which I've already received some feedback 11 in comments. Should AU competency be periodically 12 assessed?  And if so, how should it be assessed and 13 how often, and by whom?
14 So, there's a whole boatload of questions 15 to think about.
16 Cedric, just let me know if anybody pops 17 on the line.
18 *1 to make a comment; *2 if you change your 19 mind. 20 THE OPERATOR:  Okay. Will do.
21 MS. LOPAS:  All right. Thank you.
22 And we can go ahead, since it is radio 23 silence a little bit, we don't need to stick with -- if 24 you have comments outside of those areas, those topical 25 37 areas, please feel free just to press *1 and share your 1 thoughts. Like I said, we were just kind of exploring 2 how to best go through the comments on this, because 3 we do have a lot of questions in that Federal Register 4 notice. 5 So, Section B was recognition of medical 6 specialty boards by the NRC. Are there any additional 7 boards that the NRC should be considering?
8 And question area C was on patient access.
9  This is a big one. This is kind of the crux of some 10 of the arguments that we've been hearing that our 11 current regulations and requirements are so tough that 12 they're impacting patient access to these valuable 13 radiopharmaceuticals. So, if anybody has any insight 14 on patient access, we would really be appreciative to 15 hear some of that.
16 THE OPERATOR:  I do have a caller in the 17 queue. 18 MS. LOPAS:  All right.
19 THE OPERATOR:  I did not catch their name.
20  I believe it was Munir.
21 Your line is open.
22 DR. GHESANI:  Yes. Hi. This is Munir 23 Ghesani from SNMMI.
24 I just wanted to emphasize the big-picture 25 38 point is that, if you are comparing training and 1 experience proportionate to somebody's background, you 2 have to keep in mind that there are certain basic 3 fundamentals of radiation protection, radiation 4 physics, and training in radiology sciences that cannot 5 be simply counted in number of hours. It goes with 6 what you are practicing day-in and day-out for years, 7 whether you're in the training or afterwards.
8 So, a perfect example is understanding of 9 radiation physics, understanding of different types 10 of radioisotopes, and particles and non-particles of 11 many isotopes. All of that is ingrained in the training 12 of radiologists or radiation oncologists and nuclear 13 medicine physicians.
14 So, I would really caution the group by 15 just highlighting the point that, if somebody comes 16 from a field where none of this is part of their regular 17 training, and suddenly you are counting the number of 18 hours in which they can get that lab training and you 19 expect them to get a full understanding of the 20 radiation, I think it's an understatement. You have 21 to keep in mind that, for a radiology resident who spends 22 four years in learning it or a nuclear medicine 23 physician who spends three years after doing two years 24 of preliminary training, all of that training 25 39 eventually allows somebody to become competent in not 1 only administering in an uncomplicated setting, but 2 should complications arise, being capable of handling 3 every potential scenario of that complication.
4 So, while I really would like to caution 5 that this is something that really can't add the mark 6 in the number of hours of training. You have to keep 7 in consideration the background of their training as 8 well. 9 Thank you for your attention.
10 MS. LOPAS:  Okay. Thank you. We 11 appreciate that input.
12 Cedric, anybody else on the line?
13 THE OPERATOR:  Not at this time.
14 MS. LOPAS:  Okay.  *1, press *1, as a 15 reminder, to submit your comments.
16 If you are on the webinar and you don't 17 feel comfortable speaking, you don't want to 18 necessarily speak aloud, you can submit a comment using 19 your webinar software. If you want to do that under 20 the question function, I can read aloud your comment 21 for you, if you prefer that. That's always an option, 22 too. 23 So, I am pulling up on the webinar, I'm 24 going back to Section A again, because the last comment 25 40 was kind of in response to should these folks seeking 1 this limited AU status have the same fundamental 2 training as those with the full AU status. And that 3 last comment was basically saying, well, we shouldn't 4 be focusing just on hours; you have to consider a 5 physician's background. You know, do they have a 6 background in this?  And if they're really coming in 7 with no background, there's something to consider here. 8 We also have Section D, which is kind of 9 the more general questions on the NRC's T&E regulations 10 as a whole. And I will give some background into this 11 question.
12 The NRC has been looking at how we can 13 transform how we do things at the Agency, to continue 14 to evolve with the technologies around us. And, you 15 know, these questions are kind of in line with that.
16  How could the NRC transform its regulatory approach 17 for T&E?  So, we would be interested in hearing any 18 general comments about that as well.
19 So, *1 if you have any comments for us.
20 THE OPERATOR:  I'm showing no questions 21 or comments in the queue.
22 MS. LOPAS:  All right. Just a reminder 23 to press *1.
24 And I think, just to go through, we're going 25 41 to start from the top. And if we don't get any 1 comments --
2 THE OPERATOR:  Excuse me. I have one that 3 came through.
4 MS. LOPAS:  Okay. Great. Yes, good, 5 Cedric. 6 THE OPERATOR:  They did not record their 7 name, but your line is open.
8 MS. LOPAS:  Okay. And just remember to 9 start by introducing yourself, please.
10 MR. CROWLEY:  Good afternoon. This is 11 Dave Crowley from North Carolina's Radioactive 12 Materials Program.
13 As an Agreement State program, I would just 14 like to say that what we do as regulators, and along 15 the lines of the training and experience for authorized 16 users, it is we want to do our utmost to protect the 17 health and safety of both the patient care side of 18 things, but also the occupational side of the house 19 as well. 20 And this comment isn't so much to answer 21 any of your specific questions, but I do want to make 22 a request that in this process moving forward, to better 23 risk-inform how we proceed, that there be an evaluation 24 of all the medical events that have taken place. And 25 42 that would be a great tool for that, and looking at 1 some of the basis for the medical event rule itself 2 and the reporting of those events.
3 Part of it is to learn whether or if it 4 was justified, that that would give us insight as to 5 whether training and experience was adequate or not 6 for various medical uses. To my knowledge, I'm not 7 aware of an across-the-board review of all medical 8 events has taken place or not to evaluate that. But 9 I would, I guess, recommend or suggest that an 10 evaluation be done of all past medical events to see 11 if there is any correlation to the training experience, 12 either the pathways or the amount that the different 13 authorized users had that were related to those medical 14 events. 15 And that's all. Thank you.
16 MS. LOPAS:  All right. Thank you, Dave.
17 And actually, I have a question for 18 Maryann. Maryann, if you could take yourself off mute? 19  I have a question related to Dave's comment here, so 20 an NRC-imposed question. You can thank me later for 21 it. 22 But I am wondering, Maryann, does NMED have 23 that information?  Would it have the kind of 24 information for the doctor with how they're certified, 25 43 whether they were certified under -- would we know how 1 they would be certified?  Is it something we could find 2 out in NMED?
3 MS. AYOADE:  Hi, Sarah.
4 So, NMED doesn't always provide that 5 detailed of information. But what I wanted to point 6 out was that part of what we're doing is additional 7 information gathering. For this evaluation, for this 8 T&E, we're actually going to be looking at medical 9 events, just as you spoke about, to see if there's any 10 kind of correlation with what the causes are for the 11 medical event. And then, we would look at the training 12 and experience of the users, if it involved any kind 13 of user error or type medical event.
14 MS. LOPAS:  Okay. Great. Thank you, 15 Maryann. I appreciate that.
16 MR. CROWLEY:  I don't know if I'm still 17 unmuted or not.
18 MS. LOPAS:  No, you are -- yes, we can hear 19 you. 20 MR. CROWLEY:  Okay. Great.
21 Yes, as far as the NMED data, I don't 22 believe there's a field to actually report which 23 training pathway AUs came from or even we try to avoid 24 personal names or identifying information in our 25 44 reports that we provide. But that is some information 1 that the states may have. So, if you do a reference 2 through NMED, you might see that it falls back on 3 training being one of the underlying causes of the 4 event, and then, you can reach back out to those states 5 or whatever region had it take place, and maybe you'll 6 get some more info.
7 Or even putting out a request to the states 8 to provide any known trends or observations that they've 9 made on that front. But NMED, in and of itself, 10 probably won't just lay that info neatly, 11 unfortunately.
12 MS. LOPAS:  Okay. Great. Thank you, 13 Dave. I appreciate that insight. And, Maryann, thank 14 you. 15 Okay, *1 if anybody has any comments kind 16 of related to that.
17 Cedric, do we have anybody waiting in line 18 now? 19 THE OPERATOR:  Yes.
20 Ralph, your line is open.
21 MR. LIETO:  Thank you.
22 A point of clarification about NMED 23 reports. They are not available to the AU or to the 24 licensee. And I've had a lot of experience in looking 25 45 at specific NMED reports dealing with medical events, 1 and they do not indicate any training and experience 2 requirements as a part of the investigation, although 3 it's probably an interesting point to add.
4 But, even if they did collect that 5 information, an authorized user, a licensee, and RSO 6 does not have access to NMED reports. This was an issue 7 that was brought up before the ACMUI last year, I believe 8 it was, about making these available to AUs and to 9 licensees. And the NRC denied making that availability 10 to those groups. So, I think that's something, even 11 though the person before me had some good comments on, 12 right now the NRC is on record as not making that 13 information available.
14 Thank you.
15 MS. LOPAS:  Okay. Hey, Ralph, are you 16 comfortable with providing your last name, your full 17 name? 18 MR. LIETO:  Oh, I'm sorry, Ralph Lieto.
19 I'm a medical physicist.
20 MS. LOPAS:  Oh, sorry, can you do that one 21 more time?  Your phone is going in and out.
22 MR. LIETO:  Ralph Lieto.
23 MS. LOPAS:  Ralph, okay.
24 MR. LIETO:  Got it?
25 46 MS. LOPAS:  All right. Ralph Lieto. All 1 right. Thank you, Ralph. We appreciate that.
2 Okay. Cedric, do we have anybody else on 3 the line?
4 THE OPERATOR:  Not at this time.
5 MS. LOPAS:  Yes, I think we're having some 6 issues with the phone line on our end. But did you 7 say nobody is on the line right now, Cedric?
8 THE OPERATOR:  Yes, not at this time.
9 MS. LOPAS:  Okay. Okay. All right. Let 10 me check my webinar real quick.
11 I do have one, somebody who has submitted 12 a question. So, I do have a question or a comment 13 submitted that says -- and this is from Aria 14 Razmaria -- "The wording regarding patient access on 15 the slide, for example, geographic distribution 16 question, are not mentioned in this detail in the FRN.
17  Will there be an update to The Federal Register 18 notice?" 19 Okay. So, let me see what we're talking 20 about here.  "The wording regarding the patient access 21 on the slide" -- ah, okay.
22 No. That's a good question. So, let me 23 go back here and close out of here.
24 So, I think, are you talking about how we 25 47 would be looking at patient access, what the NRC will 1 be looking at in patient access?  I'm wondering if 2 that's what you're talking about, where we don't go 3 into that detail in the FRN.
4 That information was not included in the 5 FRN, kind of talking about how the NRC was going to 6 try to evaluate patient access. That was just 7 information we provided in the slide to kind of go into 8 more detail about the NRC evaluation. So, no, we will 9 not be updating the FRN.
10 But the question, we did get some feedback 11 that we were hoping -- well, not hoping -- we did get 12 some feedback that the NRC needed to be determining 13 these patient access questions, finding the answers 14 to these patient access questions. But we did want 15 to put these questions about patient access out to the 16 general public in the FRN, in case anybody did have 17 some insights on that.
18 So, I am going to read through those 19 questions -- unless, Cedric, is there anybody that's 20 waiting to speak?
21 THE OPERATOR:  No, not at this time.
22 MS. LOPAS:  Okay. So, patient access.
23 The questions in the FRN -- and this is kind of what 24 the NRC's staff is going to try to look into, but we 25 48 thought we would also ask everybody in the FRN.
1 Question 1:  is there a shortage in the 2 number of AUs for medical uses under 10 CFR 35.300?
3 If so, is the shortage associated with the use of a 4 specific radiopharmaceutical?  Explain how.
5 Question 2:  are there certain geographic 6 areas with an inadequate number of AUs?  Identify these 7 areas. 8 Question 3:  do current NRC regulations 9 on AU T&E requirements unnecessarily limit patient 10 access to procedures involving radiopharmaceuticals?
11  Explain how.
12 And then, question 4:  do current NRC 13 regulations on AU T&E requirements unnecessarily limit 14 research and development in nuclear medicine?
15 So, those are the questions that we're 16 going to look into, but if folks on the line, and anybody 17 out there that's planning to comment, either in written 18 or in future meetings, has any input, we would love 19 to hear that.
20 So, press *1.
21 And if I didn't respond to that other 22 question adequately, you can feel free to write me 23 another question on the webinar clarifying, and I can 24 do my best.
25 49 Cedric, nothing?
1 THE OPERATOR:  No questions.
2 MS. LOPAS:  All right. Okay. And so, 3 again, if you want to comment on something outside of 4 patient access, that's fine. We will open the lines 5 to any comments you have.
6 But I think I will go back and see if I 7 can jog any comments on Section A. And again, Section 8 A of the FRN, this is covering the tailored training 9 and experience requirements. And this is really, you 10 know, the crux of what we're trying to evaluate here, 11 right? 12 The general question:  are our current 13 pathways for obtaining AU status reasonable and 14 accessible?  And we have heard some varied responses 15 back on that.
16 Are the current pathways for obtaining AU 17 status adequate for protecting public health and 18 safety? 19 And should the NRC develop new tailored 20 T&E pathways for these physicians?  If so, what would 21 be the appropriate way to categorize the 22 radiopharmaceuticals for those tailored T&E 23 requirements?  If not, explain why the regulation 24 should remain unchanged.
25 50 And we gave some examples of how 1 radiopharmaceuticals could be categorized, including 2 those with similar delivery methods, such as oral or 3 parenteral; the same type of radiation characteristics 4 or emissions, such as alpha, beta, gamma, low-energy 5 photons; similar preparation methods, such as 6 patient-ready doses, or a combination of those. Maybe 7 there would be a category that would have a combination.
8 So, those are some, just to kind of jog 9 people, those are kind of some ideas that we put in 10 the FRN. 11 And *1 if you want to jump in and stop me 12 from talking. That's how you do it. Press *1.
13 And I have one more question here on the 14 webinar I'm going to open up here. Okay. That's just 15 somebody saying goodbye and thank you.
16 All right. And then, question 4 of Section 17 A:  should the fundamental T&E required of physicians 18 seeking limited AU status need to have the same 19 fundamental T&E required of physicians seeking full 20 AU status for all oral and parenteral administrations 21 under 10 CFR 35.300?
22 *1 if you have any comments on any of those 23 questions.
24 And then, question 5 is the big one that 25 51 kind of gets into the specifics of requirements of 1 fundamental T&E, and it's how that fundamental T&E 2 should be structured for specific categories of 3 radiopharmaceuticals.
4 So, if anybody has any comments on that, 5 *1. 6 THE OPERATOR:  Jeffry, your line is open.
7 MR. SIEGEL:  Hi, Jeff Siegel again. I'm 8 sorry for hogging this conversation, but --
9 MS. LOPAS:  No, we're here.
10 MR. SIEGEL:  Since you brought up again 11 full authorization versus limited authorization, 12 should it require the same T&E hours?  I would argue, 13 as I did in my opening, that that would not be 14 risk-informed.
15 MS. LOPAS:  Right.
16 MR. SIEGEL:  Right now, most people are 17 talking about their opinion. No studies have been 18 done, as somebody else was mentioning before, about 19 whether the T&E, whether it be 700 or 80, for the, I 20 would say, non-risk-informed approach to let any 21 physician use hundreds of millicuries of I-131 is 22 adequate or not. And I think the NRC needs to do a 23 little bit of homework.
24 But the question I would ask, is a physician 25 52 capable, or should they be allowed to use an 1 FDA-approved commercially-available product if they 2 think it would help their patients if they were 3 adequately trained?  So, the question is, yes or no, 4 could a physician just pick a particular agent for his 5 practice, like a urologist who is treating prostate 6 cancer who says, "Ah, this is great. I would love to 7 give it to my patients." 8 If they could with a reasonable T&E be able 9 to do that, as opposed to obtaining AU status based 10 on giving everything, which seems to me to be a non 11 sequitur, would the NRC agree or disagree that it would 12 be possible for a physician to medically use an FDA 13 commercially-available product, if they were 14 adequately trained?
15 And that's what, I think, the issue at hand. 16  What would be the adequate training for a given 17 therapeutic which is administered based on receiving, 18 say, unit dosage, and all this interest in radiation 19 physics and radiation dosimetry, and all this other 20 stuff -- it's important, but moot to the single-user 21 physician.
22 Thank you.
23 MS. LOPAS:  So, I have a follow-up question 24 for you. So, in question C, we asked, should the 25 53 radiopharmaceutical manufacturer be able to provide 1 the preceptor attestation?  So, if, for instance, like 2 you're saying, a physician did want to pick one 3 particular drug and become -- you know, if there was 4 a way, a pathway to just being able to administer that 5 drug, I would be curious to hear your ideas for how 6 we would go about that, what that pathway would look 7 like, and if it would involve the manufacturer.
8 MR. SIEGEL:  Yes, well, I know if this was 9 approved, for example, under 35.1000, as opposed to 10 in an alternate pathway that was either 395 or 398, 11 because I don't think you can do it as part of 390, 12 I know that the manufacturer is allowed to give that 13 training for these micro seals, and it was so specified, 14 and I'm not saying it should or it shouldn't be.
15 All I'm saying is, a physician should be 16 able to, if it's deemed appropriate by experts in the 17 field who say, okay, this particular agent, no way it 18 requires 50 years of training and experience. However, 19 this one, the way it's provided and the way it's 20 manufacturer supplied, because the manufacturer spent 21 a little bit of time coming up with a distribution model 22 that was safer than others -- so, I'm just saying it 23 should be looked at in a way that one could, then, 24 say -- and I agree with a lot of people who say that 25 54 only people who are board-certified or have 18 years 1 of experience should be able to give even the simplest 2 unit dosage.
3 But, remember, medical oncologists, as an 4 example, give on a daily basis very potent, harmful 5 drugs, that is, chemotherapy drugs. They're very 6 skilled at doing that. So, the only difference would 7 be in terms of what's in the syringe, and to figure 8 out what it is to do if there's a mishap.
9 I think it could easily be taken care of, 10 but that's up to you and people on the line and people 11 who are supplying comments as to what would be the 12 appropriate level of training, given an agent which 13 involves much less risk and it's easier to administer 14 than others in its class, as opposed to just saying 15 all oral, or oral/parenteral, or whatever. Just 16 something to think about.
17 MS. LOPAS:  Okay. Thank you. I 18 appreciate that.
19 Does anybody have any comments kind of in 20 response to Jeff's comments or any comments on anything 21 in general?  Press *1.
22 Cedric, anybody on the line?
23 THE OPERATOR:  Showing no questions.
24 MS. LOPAS:  Okay. All right. So, *1.
25 55 THE OPERATOR:  Ralph, your line is open.
1 MR. LIETO:  Thank you.
2 This is Ralph Lieto again.
3 And some of us here were talking about one 4 of the questions regarding the geographical issue and 5 patient access. I think the NRC has already in their 6 introductory comments recognized that there's the need 7 for this information.
8 What would be, I think, of value to this 9 discussion when they're gathering this information, 10 assuming it's probably going to be by zip code or 11 something of that nature, if they could get the 12 distribution by the authorized used category -- in 13 other words, is it 390, 392, 394, or 396 for this 14 geographical distribution?  And I think that would 15 really go a long ways. Because I think some of the 16 questions that I think -- or I should say the points 17 that Dr. Siegel has brought up regarding the physician 18 who wants the sort of limited use of a single modality 19 in a therapeutic application.
20 Thank you.
21 MS. LOPAS:  Okay. Thank you.
22 Maryann, do you have anything that you want 23 to add with regard to how we would look at gathering 24 that dataset?
25 56 MS. AYOADE:  Hi, Sarah.
1 Not really. What Ralph said is something 2 that we're considering. As we look at the authorized 3 users for 300 uses, we'll be able to look at the 4 different training categories that they're licensed 5 for. So, we could get that information as well, in 6 addition to the distribution, like he said.
7 MS. LOPAS:  Okay. Thank you, Maryann.
8 Okay.  *1 for any additional comments or 9 you can submit a question or comment for me to read 10 aloud via the webinar software. I can certainly do 11 that for you as well, if you would like to submit your 12 comments that way.
13 THE OPERATOR:  Aria Razmaria, your line 14 is open. 15 DR. RAZMARIA:  Hi. How are you?  This is 16 Aria Razmaria speaking. I'm a Senior Nuclear Medicine 17 Resident at UCLA Medical Center.
18 But I'm speaking on behalf of myself and, 19 also, on behalf of nuclear medicine, the nuclear medical 20 physician, on behalf of nuclear medicine training, both 21 in nuclear medicine programs and nuclear medicine and 22 biology programs.
23 And I appreciate the NRC's request for 24 public comment. It's an important topic, and there 25 57 are kind of soft processes that lend into this, again 1 reaching out to all different stakeholders in this 2 regard. 3 One comment that we would like to make is 4 that being able to administer radiopharmaceuticals in 5 just the matter of a single dose being applied, and 6 to be able to do that. It goes, also, along the line 7 of being able to enhance and encourage research in this 8 area. People that are dedicated to one specific field 9 push forward and contribute to developing new 10 pharmaceuticals, radiopharmaceuticals, for different 11 applications. So, in this regard, it's not just a 12 matter of application or administration, but also the 13 science and the developmental research that goes beyond 14 just having access to the application or administration 15 of these radiopharmaceuticals.
16 Meaning that, as a body that is interested 17 and dedicated to the science of nuclear medicine, there 18 is a dire need in the U.S. We see that all research, 19 almost the majority of research is coming from countries 20 outside of the U.S. in countries that have dedicated 21 programs for training. And there is a body of 22 physicians that are interested in the research and, 23 also, development of new avenues of therapy.
24 So, just having a single limited authorized 25 58 user license to be able to administer certain 1 radiopharmaceuticals would not push the field forward 2 in the U.S. and contribute to further advancement of 3 the science of nuclear medicine.
4 Thank you for this opportunity to 5 contribute to the discussion.
6 MS. LOPAS:  Yes. Dr. Razmaria, can I ask 7 a follow-up question related to what you just said?
8 DR. RAZMARIA:  Absolutely.
9 MS. LOPAS:  So, related to one of the FRN 10 questions we have, do you think that the current regs, 11 do they have no effect on research and development in 12 nuclear medicine or are they adversely affecting it 13 because they're limiting the number of people that are 14 getting involved?  Or are you saying that, if we make 15 it easier for folks to just pick one category, that 16 you think that wouldn't do anything to help research 17 and development?
18 DR. RAZMARIA:  Again, you actually are 19 facing a situation where I believe, actually, the 20 requirements that you are talking about, 700 hours, 21 if you calculate that, it would be four months of 22 training. Whereas, again, based on the American Board 23 of Nuclear Medicine and the American Board of Radiology, 24 there's a good understanding that that is not 25 59 sufficient, as programs have been developed sponsored 1 by the Board of Radiology and the Board of Nuclear 2 Medicine that perhaps included radiology and nuclear 3 medicine. So, there is understanding that that 4 requirement that you are talking about right now being 5 too much of training, which is just four months, it's 6 our understanding.
7 I mean, what you are facing in the U.S.
8 is that people don't realize that to be able to advance 9 the research and science, we have to be dedicated; we 10 have to be understanding that just being able to read 11 one dose and that's it, the science is weak on that.
12  It's to be able to understand, okay, what other traces 13 are possible, what other avenues?  So, it really can 14 be researched.
15 Personally, you know, I have spent the time 16 to understand the question. What you see in the nuclear 17 medicine, right now practiced in the U.S., the majority 18 are by radiologists, which they are very busy. They 19 have to cover multiple modalities. And to my 20 understanding, radiologists, when I talk to them, they 21 really didn't sign up to do that, but what we are facing, 22 they are hiring from places like hospitals.
23 College groups, they basically don't see 24 the need to having training in nuclear medicine, who 25 60 have done the basics for four years, nothing but just 1 being able to understand what nuclear medicine is, 2 professional imaging as well as PET imaging.
3 So, meaning, there is no time; there is 4 no encouragement to start these projects that are dear 5 to us, answering those specific questions that the field 6 needs. That actually is happening, if you see across 7 the border, in Europe, all the developments. The 8 radiotherapists there are talking about the change in 9 requirements, because of all that are developed in 10 Europe, in Australia, in countries that have a strong 11 standing in nuclear medicine, with people who have spent 12 time not only just administering one single dose for 13 people to be able to create revenues, but who are 14 instructed in consultations, answering questions that 15 are not answered in the field.
16 So, these are physicians that we are 17 mentioning right now in this discussion will have in 18 the future, how nuclear medicine that is practiced in 19 this country. And again, there's a new generation of 20 trainees that are interested in taking this task or 21 taking these questions, who are dedicated and want to 22 do that. And we need, if at all possible, to encourage 23 that, to enhance that. Because, as mentioned, despite 24 the U.S. being the country where nuclear medicine was 25 61 invented, we're lagging behind internationally, behind 1 many other countries. So, the rulemaking will have 2 a direct effect on that progress.
3 MS. LOPAS:  Okay. All right. I 4 appreciate that insight. Thank you.
5 Okay. Cedric, do you have anybody else 6 on the line?
7 *1, if anybody wants to respond in response 8 to what this Dr. Razmaria just spoke about or anything 9 else. 10 THE OPERATOR:  Showing no one in queue at 11 this time.
12 MS. LOPAS:  Okay. Okay, folks, let's see. 13  So, we heard a little bit about the effect that this 14 can have on future R&D in nuclear medicine. Maybe that 15 leads to specialty boards. We got a couple of comments 16 in saying that maybe we don't need an alternative 17 pathway, that maybe it should just be these specialty 18 boards that are the only ones that can certify.
19 If anybody has any comments on that, press 20 *1, or any comments in general about the NRC's medical 21 specialty board recognition process. We're happy to 22 hear those, too.
23 The current boards right now that are 24 recognized at the NRC are the American Board of Nuclear 25 62 Medicine, the American Board of Radiology, the American 1 Osteopathic Board of Radiology, and the Certification 2 Board of Nuclear Endocrinology. So, that's what we 3 have currently.
4 Are there other boards that we should be 5 considering?  Press
*1 if you have any thoughts on that. 6 THE OPERATOR:  I'm showing no questions 7 or comments in queue at this time.
8 MS. LOPAS:  Okay. Thank you.
9 All right. And if folks have more general, 10 again, any more general comments on the NRC's T&E 11 regulations in general, I know we are happy to hear 12 those as well.
13 But I understand this is the first meeting. 14  There are three additional public comment meetings.
15  Like I said, the one in December, on December 11th 16 and the one on January 10th, those are in-person 17 meetings. So, if anybody is in the area and wants to 18 travel, you can come on out and come attend one of those 19 meetings personally. And both of those will also be 20 accessible via webinar and teleconference again. And 21 those will all be, again, transcribed and recorded.
22 And then, on January 22nd, we're going to have one final 23 webinar, and that will be about a week before the comment 24 period ends. So, maybe comments will ramp up as we 25 63 move along.
1 I have one, let's see, I have one comment 2 here that is suggesting certification of nuclear 3 cardiology. I'm not seeing any other information 4 related to that.
5 Mr. Johnson, if you want to hop on the line, 6 feel free.  *1 to hop on the line, if you want to expand 7 on your comment on certification of nuclear cardiology.
8  That would be helpful. Otherwise, you can submit that 9 comment in writing as well. But I did receive that 10 comment via the webinar here.
11 Okay. All right.  *1.
12 MS. AYOADE:  This is Maryann.
13 I'm not sure why the commenter just put 14 down CBNC, but I'll point out that CBNC, the 15 Certification Board for Nuclear Cardiology, who was 16 the best for training and imaging and localization 17 studies, which is under 10 CFR 35.200. And that's not 18 a subpart of this section of training and experience 19 that we're looking at.
20 MS. LOPAS:  Okay. That's good 21 clarification. Thank you, Maryann. That's helpful.
22 *1 if there's any additional comments.
23 Cedric, do we have anybody on the line?
24 THE OPERATOR:  We did, but it seems like 25 64 they withdrew the question.
1 MS. LOPAS:  All right.  *1 to ask a 2 question; *2 to change your mind. So, somebody got 3 the *2. 4 I've been doing these webinars for a few 5 years now, and I never knew *2 was an option. So, that's 6 good to know.
7 Okay. All right. Well, we're going to 8 give it a couple more minutes. But, if we continue 9 to have no comments, we will probably end the webinar 10 early. 11 So, *1. 12 I'm going to talk a little bit again about 13 the comment deadline for written comments. If you want 14 to also submit written comments, you can submit written 15 comments via regulations.gov. It's very easy. And 16 the docket ID is NRC-2018-0230, and you just go to 17 regulations.gov and type that ID, that docket ID, right 18 in the search bar, and it will pop right up. And there's 19 a little button that says, "Comment Now" on the 20 right-hand side, and it's very easy.
21 But, again, if you have any issues, I'm 22 going to put my contact information up again. You can 23 certainly contact myself or Maryann. If you have any 24 issues submitting comments via regulations.gov, I can 25 65 certainly help you out with that. That's no problem.
1 And *1 for any final comments for folks.
2 (No response.)
3 All right. Cedric, I'm assuming it's 4 nobody has popped on?
5 THE OPERATOR:  Yes, no line queue at this 6 time. 7 MS. LOPAS:  Okay. All right. Well, I 8 really do appreciate everybody that joined us today 9 and took time out of the middle of their day to join 10 us on this webinar. Like I said, we've got additional 11 meetings, public comment meetings again, where you can 12 get on the line and have your comments transcribed 13 December 11th, January 10th, and January 22nd.
14 And I hope everybody has a great 15 Thanksgiving.
16 If you need anything, contact myself or 17 Maryann. 18 So, thank you all and have a great day.
19 (Whereupon, at 2:24 p.m., the meeting was 20 adjourned.)
21  22  23  24  25}}

Latest revision as of 07:51, 30 November 2019

Transcript: 11/14/18 Public Comment Meeting on the Nrc'S Evaluation of Training and Experience for Administering Certain Categories of Radiopharmaceuticals
ML18330A113
Person / Time
Issue date: 11/14/2018
From: Sarah Lopas
NRC/NMSS/DMSST/MSEB
To:
Sarah Lopas
References
NRC-2018-0230, NRC-3995
Download: ML18330A113 (66)
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Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Public Meeting to Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals Docket Number: NRC-2018-0230 Location: Teleconference Date: Wednesday, November 14, 2018 Work Order No.: NRC-3995 Pages 1-66 NEAL R. GROSS AND CO., INC.

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

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

1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

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

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WEDNESDAY, NOVEMBER 14, 2018

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The meeting was conducted via teleconference, at 1:00 p.m., Sarah Lopas, Office of Nuclear Material Safety and Safeguards, presiding.

NRC STAFF PRESENT:

SARAH LOPAS, Project Manager, Office of Nuclear Material Safety and Safeguards MARYANN AYOADE, Health Physicist, Office of Nuclear Material Safety and Safeguards CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch, Office of Nuclear Material Safety and Safeguards NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 ALSO PRESENT:

DAVID CROWLEY, Radioactive Material Branch Manager, North Carolina Department of Health and Human Services MUNIR GHESANI, MD, FACNM, FACR, Society of Nuclear Medicine and Molecular Imaging RALPH LIETO, St. Joseph Mercy Health System AMIN MIRHADI, MD, Cedars-Sinai Medical Center ARIA RAZMARIA, MD, UCLA Medical Center JEFFRY SIEGEL NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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3 CONTENTS Call to Order and Opening Remarks..................4 Welcome and Introduction...........................5 Review Agenda and Ground Rules.....................7 Presentation on the NRC's T&E Evaluation...........9 Public Comments...................................27 Closing Remarks...................................65 Adjourn...........................................66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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4 1 P R O C E E D I N G S 2 1:02 p.m.

3 MS. LOPAS: (presiding) Hi, everybody.

4 Good afternoon.

5 Welcome to the NRC's webinar to accept 6 comments on the Staff Evaluation of Training and 7 Experience Requirements for Different Categories of 8 Radiopharmaceuticals.

9 My name is Sarah Lopas, and I am a member 10 of the NRC's Medical Radiation Safety Team, which is 11 part of the Medical Safety and Events Assessment Branch 12 and the NRC's Office of Nuclear Material Safety and 13 Safeguards.

14 I'm the Project Manager for the NRC's 15 training and experience evaluation, and I'll be 16 facilitating today's webinar and, also, giving part 17 of the NRC's presentation.

18 I'm joined here at NRC's Headquarters by 19 my manager, Chris Einberg, who is the Chief of the 20 Medical Safety and Events Assessment Branch. Also 21 joining us remotely via phone is another member of the 22 Medical Radiation Safety Team and the technical lead 23 on the training and experience evaluation, Maryann 24 Ayoade. Maryann will be helping me with today's 25 presentation.

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5 1 We have a short agenda for today's webinar.

2 In just a moment, my Branch Chief Chris will start 3 us out with a welcome and the purpose of today's meeting.

4 And then, myself and Maryann will go through about 5 15 slides that will cover background information on 6 the NRC's evaluation, and we will discuss The Federal 7 Register notice that was published on October 29th and 8 the questions that were contained in that Federal 9 Register notice. And we will cover how you can also 10 provide written comments by the January 29th comment 11 deadline, if you would like to submit written comments.

12 Then, we're going to go to the phone lines.

13 We'll open them up one by one, and we'll take your 14 comments on the record.

15 And now, I'm going to ask Chris Einberg, 16 Chief of the Medical Safety and Events Assessment Branch 17 in the NRC's Office of Nuclear Material Safety and 18 Safeguards, to give a short welcome.

19 MR. EINBERG: Okay. Thank you, Sarah.

20 Good afternoon, everyone. Thank you for 21 taking the time to attend today's webinar, which will 22 be the first of four comment acceptance meetings that 23 the NRC will be conducting on our training and 24 experience requirements evaluation.

25 The purpose of today's meeting is twofold:

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6 1 to provide background information on the NRC staff's 2 planned evaluation of developing tailored training and 3 experience requirements for administering different 4 categories of radiopharmaceuticals for which a written 5 directive is required, in accordance with our 6 regulations in 10 CFR Part 35, which are our 7 regulations for medical use of byproduct materials in 8 Subpart E under Part 35, which covers unsealed byproduct 9 material, written directive required.

10 And most importantly, to listen to and 11 record your comments on the evaluation. The comments 12 that we receive from the medical community today, the 13 Agreement States, and the other stakeholders are 14 critical to the NRC staff's decision-making on whether 15 our existing training and experience requirements 16 should be revised. If you do not provide your comments 17 today, we encourage you to participate in one of the 18 future comment meetings in December and January or 19 submit written comments using regulations.gov by the 20 January 29th, 2019 comment due date. Later in the 21 presentation, we will cover how you can submit your 22 written comments.

23 And now, I'll hand the conversation back 24 to Sarah, who is going to provide some basic information 25 about today's webinar.

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7 1 Sarah?

2 MS. LOPAS: Thanks, Chris.

3 So, if there's anybody on the bridge line 4 that doesn't have the webinar up and running, or doesn't 5 have the slides in front of them, I just want to let 6 you know that you can go to the NRC's public meeting 7 website and you can find that by just Googling or going 8 to some other internet search. "NRC public meeting,"

9 search that term and kind of the first thing that pops 10 up is our website, our public meeting notice website.

11 There, if you click on that link you pull 12 down, you'll find the meeting notice for this meeting.

13 If you click on "more" under that meeting notice and 14 look a little bit further, there is a link to the slides.

15 It will be a PDF file of what we're using today. So, 16 that's just a quick notice for everybody on the phone, 17 on the bridge line.

18 So, today we're going to be discussing the 19 NRC's evaluation of training and experience 20 requirements for certain categories of 21 radiopharmaceuticals. We're going to often refer to 22 training and experience as "T&E" for short. And we 23 will often refer to authorized users -- that is, those 24 physicians who are authorized to administer 25 radiopharmaceuticals -- as "AUs".

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8 1 Today's webinar is being transcribed by 2 a court reporter. And as Cedric, our operator, had 3 mentioned, this phone line is also being recorded.

4 So, we're having a double-fail option here.

5 So, the full transcript of this webinar 6 is going to be publicly available in a few weeks, and 7 it will be on our NRC's Agencywide Documents Access 8 and Management System, or ADAMS, as we call it. And 9 I'll also be posting a link of that transcript to the 10 NRC's Training and Experience website, as well as 11 posting it to the docket website for T&E on 12 regulations.gov.

13 All of the comments that you make today 14 will be captured on the docket. So, I'll be combing 15 through the transcript and pulling out your comments 16 for inclusion in our evaluation effort. So, if you 17 speak today, you do not need to then separately provide 18 those written comments on regulations.gov. And 19 because it will be captured in the transcript, we will 20 have it on the record. And it's important to note that 21 the full comments and written comments carry the same 22 weight. There's no preferred way to submit your 23 comments.

24 We'll be opening the phone lines for 25 comments after the NRC presentation concludes.

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9 1 Everyone is in listen-only mode at the moment. But, 2 when it comes time to make a comment, you're just going 3 to press *1 on your phone pad. That's *1. And that 4 will let Cedric, who is the operator, know that you'll 5 need your line unmuted.

6 And now, I'm going to hand the presentation 7 over to my colleague, Health Physicist Maryann Ayoade, 8 so she can review the NRC's current T&E regulations 9 and talk about why the NRC is conducting this 10 evaluation.

11 Maryann?

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

13 Today, I will be presenting information 14 on an overview of the regulations on training and 15 experience requirements for radiopharmaceuticals 16 requiring a written directive; some background 17 information on the related stakeholder concerns 18 received, and the NRC's efforts on the evaluation thus 19 far.

20 The current regulations on training and 21 experience for radiopharmaceuticals requiring a 22 written directive are under 10 CFR Part 35, Subpart 23 E. And these training and experience requirements 24 provide two pathways that a physician may be authorized 25 to administer radiopharmaceuticals that require a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 written directive.

2 The first pathway is that a physician can 3 be authorized to administer these radiopharmaceuticals 4 if they are certified by a medical specialty board whose 5 certification process is recognized by the NRC or an 6 Agreement State.

7 A physician can also be authorized, to 8 satisfy the training and experience requirements, by 9 an alternate pathway, which includes completion of 700 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of training and experience, including a minimum 11 of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in 12 the relevant topic areas, as listed in the regulation, 13 and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience in the 14 relevant areas, as listed in the regulation.

15 And a third path is that a physician can 16 also be authorized if they have been previously 17 identified as an authorized user on an NRC or Agreement 18 State license or permit.

19 This training and experience evaluation 20 is focused on the alternate pathway, and the NRC staff 21 are looking into what tailored training and experience 22 requirements for limited administration of certain 23 categories of radiopharmaceuticals would look like.

24 And that is what we will be referring to as a limited 25 authorized user status.

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11 1 Next slide.

2 In Subpart E there are four sections that 3 pertain to training and experience requirements. The 4 first is under 10 CFR 35.390, which is for training 5 for the use of already pharmaceuticals in Subpart E, 6 all of which require a written directive.

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

11 The third is under 10 CFR 35.394, which 12 is for training for oral administration of sodium 13 iodide, Iodide-131, requiring a written directive in 14 quantities greater than 33 millicuries.

15 And the fourth is in 10 CFR 35.396, which 16 is for training for parenteral administration of any 17 radiopharmaceutical requiring a written directive.

18 All of this sections of training and 19 experience include the pathway for experienced 20 authorized users already listed on a license. All of 21 these sections, except 10 CFR 35.396, include training 22 and experience under the board certification and 23 alternate pathways.

24 And so, I want to point out that 25 10 CFR 35.396 is for training that is exclusively under NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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12 1 the alternate pathways for radiation oncologists to 2 become authorized users by completing additional hours 3 of training and experience.

4 I also want to point out that the alternate 5 training pathways under 10 CFR 35.392 and .394 are for 6 the physician to successfully complete 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of 7 classroom and lab training that is relevant to the type 8 of use for which they are seeking to be authorized.

9 Whereas, the alternative pathway under 10 CFR 35.390 10 is for the physicians who successfully complete 700 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br /> of training and experience, which includes 200 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> of classroom and lab training.

13 Next slide.

14 This slide provides some background 15 information on stakeholder concerns received related 16 to training and experience requirements. So, since 17 the revision to the training and experience 18 requirements in 2002, and again in 2005, stakeholders 19 have raised concerns about the effects of some of the 20 requirements on patient access to certain 21 radiopharmaceuticals.

22 Specifically, some stakeholders have 23 asserted that the 700-hour requirement in 10 CFR 35.390 24 is overly burdensome for physicians who are not 25 certified by a medical specialty board, and that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 extensive requirements have resulted in a shortage of 2 authorized users, which, thereby, limits patient access 3 to radiopharmaceuticals.

4 As a result, in 2015 and 2017, in separate 5 efforts, the NRC staff and the NRCs Advisory Committee 6 on the Medical Uses of Isotopes, also known as ACMUI, 7 independently reviewed the training and experience 8 requirements for the medical uses authorized under 9 Subpart E.

10 Specifically, NRC staff reviewed the 11 regulatory basis and comments received on past 12 rulemaking related to the medical use of byproduct 13 materials and did not identify any new information that 14 would call into question the basis of the existing 15 requirements.

16 As a result, the NRC staff did not propose 17 any changes to the regulations at the time. The NRC 18 staff is continuing to work with the ACMUI in its ongoing 19 training and experience evaluation effort.

20 Next slide.

21 As part of the Staff Requirements 22 Memorandum dated August 17, 2017 - and that is publicly 23 available in ADAMS; there is a hyperlink reference here 24 - the Commission directed the NRC staff to evaluate 25 whether it makes sense to establish tailored training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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14 1 and experience requirements for different categories 2 of radiopharmaceuticals; how those categories should 3 be determined, such as by risk code, by use of 4 radionuclides, or by delivery method; what the 5 appropriate training and experience requirements would 6 be for each category, and whether those requirements 7 should be based on hours of training and experience 8 or more focused on competency.

9 Next slide.

10 In response to the Commission direction, 11 the NRC staff solicited feedback from some medical and 12 regulatory stakeholders in April and May of 2018. That 13 evaluation, including the NRC staff analysis and the 14 feedback received of the training and experience 15 requirements in Subpart E of 10 CFR Part 35, is 16 documented in SECY-18-0084.

17 And the results of that evaluation 18 concluded that it may be feasible to establish tailored 19 training and experience requirements for different 20 categories of radiopharmaceuticals, and to create a 21 means of authorizing the administration of certain 22 categories of radiopharmaceuticals, such as the limited 23 authorized user status.

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15 1 approach to demonstrate acceptable training and 2 experience for limited authorized user status.

3 However, the staff needs to conduct more extensive 4 outreach to stakeholders in the medical community, to 5 the Agreement States, and other members of the public, 6 before making a recommendation to the Commission.

7 And this brings us to our current 8 evaluation to date. I will now hand it back to Sarah, 9 who will discuss our current evaluation efforts and 10 how you can participate.

11 Next slide.

12 MS. LOPAS: Thank you, Maryann.

13 The end product of our evaluation will be 14 a paper that we will send out to our five-member 15 Commission. That paper will either document our 16 reasoning for recommending no changes to our current 17 training and experience requirements or, if we do 18 recommend that changes to our T&E regulations are 19 warranted, we will document our reasoning in a 20 rulemaking plan paper.

21 This is a simplified diagram of the 22 information that we will consider in our development 23 of a recommendation to the Commission on whether changes 24 to our existing T&E requirements are warranted. This 25 diagram illustrates why this comment period is so NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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16 1 important to this effort. Because, in large part, the 2 feedback that we receive on the questions that weve 3 asked in our Federal Register notice will inform our 4 recommendation to the Commission. Other important 5 feedback will come from our coordination with our 6 co-regulators, the Agreement States, and the NRCs 7 Advisory Committee on the Medical Uses of Isotopes, 8 ACMUI.

9 In addition to the input we receive from 10 the public, medical stakeholders, the Agreement States, 11 and the ACMUI, the NRC staff will also examine the issue 12 of patient access. Our staff will attempt to determine 13 the number of current authorized users and their 14 geographic distribution across the United States.

15 Authorized user and associated geographic 16 data is not readily available. So, the NRC staff will 17 be spending the next few months determining of this 18 dataset is achievable.

19 Staff will also review training and 20 experience requirements in other countries, in an 21 effort to benchmark the U.S. against the international 22 medical regulation. And staff will also do a review 23 of medical and radiation safety events to determine 24 if any have a nexus to training and experience.

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17 1 does end up recommending rulemaking, which we would, 2 again, document in a rulemaking plan, the Commission 3 would then proceed to vote on that rulemaking plan.

4 And that would determine whether or not the staff would 5 proceed with another Part 35 rulemaking effort.

6 If rulemaking is recommended, and 7 subsequently approved by the Commission, that would 8 start the NRCs extensive rulemaking process. And Im 9 really highlighting this process information because 10 I think its important that everybody understands where 11 we are in this process.

12 And where we are right now is that were 13 in the information-gathering stage, and that 14 information we gather and the comments we receive are 15 going to help us determine whether a rulemaking to 16 address training and experience requirements is even 17 warranted.

18 I hope many of you have read it by now, 19 but the NRC published a Federal Register notice on 20 Monday, October 29th. The Federal Register notice can 21 be accessed by that link at the top of your slide, or 22 you can also just Google search the citation for the 23 Federal Register notice, which is 83 FR 54380.

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18 1 29th, 2019. It also announced the dates for these public 2 webinars and meetings. And in a couple of slides Ill 3 be talking about the additional meetings were having 4 after this one.

5 But, most importantly, The Federal 6 Register notice asked a series of questions on which 7 we would like medical community stakeholder input.

8 Im going to read straight through the questions in 9 the next four slides, and Im just going to go straight 10 through them, just to provide an overall scope and 11 context of the information that were looking for.

12 But, when we get to the comment period in just a couple 13 of minutes, I am going to be kind of walking us through 14 the topical areas to try to gather your comments kind 15 of in an organized manner. So, hold tight. We are 16 going to read through the comments in the next slide.

17 So, the first set of questions, Section 18 A in the FRN, extensively cover the crux of what were 19 evaluating, whether the NRC should create tailored 20 training and experience requirements for certain 21 categories of radiopharmaceuticals.

22 So, the questions are:

23 Are the current pathways for obtaining AU 24 status reasonable and accessible? Are they adequate 25 for protecting public health and safety?

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19 1 Should the NRC develop a new tailored T&E 2 pathway? What would be the appropriate way to categorize 3 radiopharmaceuticals for tailored T&E requirements?

4 Should the fundamental T&E required of 5 physicians seeking limited AU status need to have the 6 same fundamental T&E required of physicians seeking 7 full AU status?

8 And how should the requirements for this 9 fundamental T&E be structured for a specific category 10 of radiopharmaceuticals?

11 Section B, there are questions about the 12 NRCs recognition of medical specialty boards. And 13 those procedures for recognizing our medical specialty 14 boards are on our Medical Uses Licensee Toolkit website, 15 and the link is there on the slide.

16 But what boards other than those already 17 recognized by the NRC could be considered for 18 recognition for medical uses under 10 CFR 35.300?

19 Are the current NRC medical specialty board 20 recognition criteria sufficient? If not, what 21 additional criteria should the NRC use?

22 The next topical area or set of questions 23 covers patient access.

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20 1 that shortage associated with the use of a specific 2 radiopharmaceutical?

3 Are there certain geographic areas with 4 an inadequate number of Aus?

5 Do current NRC regulations on AU T&E 6 requirements unnecessarily limit patient access to 7 procedures involving radiopharmaceuticals?

8 And do current NRC regulations on AU T&E 9 requirements unnecessarily limit research and 10 development in nuclear medicine?

11 And then, the last set of questions we have, 12 they are a set of questions asking for general input 13 on the NRCs regulation of training and experience as 14 a whole.

15 So, should the NRC regulate the T&E of 16 physicians for medical uses?

17 Are there requirements in the NRCs T&E 18 regulatory framework for physicians that are non-safety 19 related?

20 How can the NRC transform its regulatory 21 approach for T&E while still ensuring that adequate 22 protection is maintained for workers, the general 23 public, patients, and human research subjects?

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21 1 questions when we get to the comment period in a second, 2 but it would be great if you could have the FRNO bin 3 and you can read through, because theres a lot of 4 sub-questions underneath those general questions that 5 I didn't want to laboriously read through.

6 So, how can you submit your comments on 7 our evaluation and respond to all those questions?

8 Well, in addition to speaking during today's meeting, 9 and in any of the three future meetings that we have 10 planned, you can submit your comments via 11 regulations.gov. And the link on this slide will take 12 you directly to the comment submissions form on the 13 T&E docket, which the docket ID is NRC-2018-0230. But 14 you can also just go to regulations.gov. Just type 15 in regulations.gov and it comes right up. And you can 16 enter that docket, NRC-2018-0230, into the search bar 17 right at the top of that page, and it will bring you 18 right to our docket page. Once you're in the comment 19 submission form, you can either type directly into the 20 form or you can upload a document like a Word or text 21 file or even a PDF.

22 Here at the NRC I have immediate access 23 to those comments that are submitted via 24 regulations.gov, but I will warn everybody that there's 25 an internal administrative process here at the NRC.

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22 1 So, it takes a few weeks for those comments to become 2 publicly viewable on regulations.gov. So, don't panic 3 when you submit via regulations.gov and you go back 4 to see if you can find it if you can't find it. We 5 got it. It's just it has to go into our ADAMS system 6 first, and then, it goes back up on the regulations.gov.

7 So, just to clarify, your comments will be publicly 8 available on regulations.gov and in ADAMS.

9 If you encounter any issues at all when 10 you're submitting your comments via regulations.gov, 11 please contact me. You can email me or call me. My 12 contact information will be at the end of this 13 presentation.

14 And at the end of the public comment period, 15 we'll be compiling all the comments we received, both 16 written and oral, and we'll be publishing them in one 17 easily accessible comment report. Not only will that 18 comment report list all the comments out individually, 19 it will also summarize them. And the comment report 20 will be available on the NRC T&E website, and I'll also 21 ensure that it gets posted to regulations.gov. And 22 I know that whatever recommendation paper that we 23 develop, it will heavily reference that comment report.

24 I do want to point out that, because this 25 is in a rulemaking, and the purpose of collecting our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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23 1 comments is to help us inform our decision-making, we 2 will not be responding to individual comments or even 3 groups of binned comments. So, that's an important 4 thing to note.

5 This slide just details the additional 6 public meetings that we're going to be having on T&E 7 in December and January, before the comment period 8 closes out. The meetings that are going to be held 9 on December 11th and January 10th, in addition to those 10 meetings accessible by webinar again and 11 teleconference, those will also be open to in-person 12 attendance here at the NRC Headquarters in Rockville.

13 The December 11th meeting will be held in the 14 Commission hearing room in our 1 White Flint Building, 15 and the Thursday, January 10th meeting will be held 16 on the ground floor conference room in our 3 White Flint 17 Building.

18 And all the details that you need to 19 participate in those meetings, again, are on the NRC's 20 public meetings schedule website. And if you have any 21 questions, again, you can contact me.

22 This slide shows our next steps, a basic 23 outline of our next steps, and the planned timeline 24 of our evaluation. After the comment period ends on 25 January 29th, the NRC will begin organizing and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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24 1 evaluating the comments. The NRC staff will also be 2 conducting that additional research that I noted 3 earlier regarding patient access, international 4 benchmarking, and assessing medical and radiation 5 safety events.

6 The ACMUI Subcommittee on Training and 7 Experience will provide the NRC a report on their 8 findings and recommendations regarding the T&E 9 requirements in the spring of 2019, and the staff will 10 consider their input in developing their draft 11 recommendation.

12 Both the Agreement States and the ACMUI 13 will have an opportunity to provide comments on our 14 draft Commission paper, and the NRC will consider and 15 incorporate their comments into the final paper to the 16 Commission, which we have to finalize in early fall 17 2019.

18 So, for more information and links to all 19 the documents that we mentioned today, like the SECY 20 paper from this past September or the Staff Requirements 21 Memorandum that caused us to do this evaluation in the 22 first place, please visit the NRC's Training and 23 Experience Evaluation website. That's the link above.

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25 1 website through the T&E effort. So, it's a good place 2 to go.

3 Again, you can also go to the 4 regulations.gov docket for T&E. So, I will also be 5 putting public participation information on that. And 6 what's good about regulations.gov is that it will list 7 all the comments that we receive. So, you can look 8 at other folks' comments.

9 And please reach out to me, Sarah Lopas, 10 as the Project Manager, if you have any kind of 11 process-type questions about the community effort.

12 And Maryann is your point of contact for your more 13 technical questions.

14 So, with that, I'm going to get us into 15 the comment period phase of this. I do want to note 16 that you'll press *1 on your phone to make a comment.

17 And you can go ahead and press *1 now if you know you 18 already have something to say. That's great. And 19 Cedric is just going to be going down the line and 20 unmuting lines as he receives those *1 requests.

21 And so, we have plenty of time for comments 22 today. We're scheduled to go to 3:00 p.m. Eastern, 23 but we can always go a little bit beyond that, if needed.

24 And I do want to remind you that our court 25 reporter -- her name is Allegra -- she's on the phone, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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26 1 too. She's transcribing everything we say today. So, 2 when we do unmute your phone, please remember to start 3 by introducing yourself. If you have an affiliation 4 that you want to let us know about, you can certainly 5 include your affiliation.

6 There aren't too many of us on the line.

7 I know we've got about 24 people on the webinar, which 8 is great, and there might be more people on the line.

9 But I do think that we will try to go through the topical 10 areas of the questions that we ask in the FRN, but I 11 do understand that many of you might just have a 12 statement that you want to just read right through.

13 And that's okay. You don't need to try to break it 14 up.

15 So, we'll just get started. With that, 16 press *1 if you would like to make a comment.

17 I have brought up on the webinar Section 18 A of the questions, and I have, of course, three 19 questions under Section A, under tailored training and 20 experience requirements. Those are the topics asking 21 about:

22 Are the current pathways for obtaining AU 23 status reasonable and accessible? Are they adequate 24 for protecting public health and safety? And then, 25 obviously, a big one, should the NRC develop new NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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27 1 tailored T&E pathways for a physician?

2 So, *1. Get something to drink; maybe get 3 some coffee. And we can get started.

4 And, Cedric, just let me know whenever you 5 have anybody on the line to get going.

6 THE OPERATOR: Sure. And our first 7 question or comment comes from Amin Mirhadi.

8 Your line is open.

9 DR. MIRHADI: Thank you so much, Cedric.

10 Hi there. My name is Dr. Amin Mirhadi.

11 I'm a radiation oncologist at Cedars-Sinai Medical 12 Center in Los Angeles. I'm also the Vice Chair of the 13 American Society of Radiation Oncology's NRC 14 Subcommittee. And thank you for allowing me to provide 15 this statement on behalf of ASTRO, which is the acronym 16 for that.

17 ASTRO is the largest radiation oncology 18 society in the world with more than 10,000 members who 19 specialize in treating patients with radiation therapy.

20 As a leading organization in radiation oncology, 21 biology, and physics, the Society is dedicated to 22 improving patient care through education, clinical 23 practice, advancement of science, and advocacy.

24 ASTRO's highest priority has always been ensuring 25 patients receive the safest, most effective treatments.

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28 1 ASTRO is pleased that the NRC has invited 2 stakeholders to provide input on training and 3 experience requirements for radiopharmaceuticals 4 through public meetings and written comments. We 5 strongly oppose any reduction in the T&E requirements 6 found in 10 CFR 35.390, training for use of unsealed 7 byproduct material for which a written directive is 8 required under the so-called "alternate pathway".

9 ASTRO believes that the requirements found 10 in this section are appropriate. They protect the 11 safety of patients, the public, and practitioners, and 12 should not be diminished.

13 Radiopharmaceuticals are highly effective 14 in treating cancer, with possible harmful effects to 15 both the patient and the public if not used correctly 16 under the supervision of the highly-trained physician.

17 We are pleased in this report entitled 18 "Staff Evaluation of Training and Experiment 19 Requirements for Administering Radiopharmaceuticals,"

20 that the NRC staff determined that the current 21 requirement of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br /> prescribed under the alternate pathway is 23 reasonable to acquire the fundamental knowledge that 24 an AU would need to administer any radiopharmaceutical.

25 However, we are concerned that paring the number of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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29 1 hours1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of work experience required, based on categories 2 of radiopharmaceuticals, will lead to confusion and 3 complexity, both for licensees as well as for the NRC 4 and Agreement States.

5 We are also concerned that if new 6 radiopharmaceuticals are approved for use that do not 7 fit clearly into one of the categories, that the NRC 8 will have to promulgate any additional regulations to 9 include the new agents, a process that could take time 10 to finalize, delaying patient access to potentially 11 lifesaving radiopharmaceuticals.

12 The rigorous T&E requirements contribute 13 to the excellent safety record of radiopharmaceuticals.

14 We believe that it is important that the person 15 administering the radiopharmaceuticals is 16 appropriately trained in the safe handling, exposure 17 risk, and the management of side effects of radiation.

18 ASTRO looks forward to working with the 19 NRC as they continue deliberation and review on this 20 very important topic. In addition, I want to close 21 by saying that ASTRO will submit more detailed written 22 comments by the end of the comment period. And I really 23 appreciate the opportunity to speak to you guys today.

24 MS. LOPAS: All right. Thank you, Dr.

25 Mirhadi.

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30 1 All right. Cedric, do we have somebody 2 else on the line?

3 Again, folks, press *1 to make a comment, 4 *1, and you can either focus on -- you could read a 5 statement, just like Dr. Mirhadi did, or you could focus 6 on kind of this first slide that I have up that talks 7 about questions 1, 2, and 3.

8 Cedric?

9 THE OPERATOR: I'm showing no one 10 currently in queue.

11 But, again, as another reminder, if you 12 would like to ask a question or make a comment, please 13 press *, then 1. If you would like to withdraw that 14 question or comment, you may press *2.

15 MS. LOPAS: So, *1 to make a comment, *2 16 to change your mind. I just learned something new.

17 Okay.

18 All right. So, I can move through 19 different slides. Again, we have three more meetings 20 on this. My colleagues and I were determining what 21 was the best way to get comments from folks over the 22 phone line, and thought we would try walking through 23 some of the questions. So, we're going to just play 24 around with that. But we may change our comment format 25 in future meetings, just as an effort --

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31 1 THE OPERATOR: Sarah, we did have one that 2 came through.

3 MS. LOPAS: All right. Let's go.

4 THE OPERATOR: All right. Jeffry Siegel, 5 your line is open.

6 MR. SIEGEL: And thanks very much for 7 having this meeting. I really appreciate it.

8 My name is Jeffry Siegel. I've been 9 involved in reviewing -- I shouldn't even say 10 "reviewing" -- but involved in writing and publishing 11 about NRC requirements and regulations which have been 12 very good.

13 And I figured I would want to start this 14 off with some controversy because I totally disagree 15 with the first speaker.

16 First, a brief history relevant to the T&E 17 issue I think is in order. Prior to the NRC revision 18 of Part 35 -- that is, pre-2002 -- only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of 19 T&E were required for the alternate pathway to obtain 20 AU status for therapeutic use, pursuant to 35.930 -- not 21 for the dyslexic, 930, not 390 -- and only I-131 use 22 was considered. At the same time, diagnostic use, 23 pursuant to 35.920, required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.

24 During the revision of Part 35, NRC 25 modified, based on a risk-informed performance-based NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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32 1 approach, these requirements. 35.930 was replaced by 2 35.390, requiring 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> for the alternate pathway.

3 Eighty hours replaced the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, except for oral 4 sodium I-131 use. Pursuant to 35.392 and .394, only 5 80 were, and still are, required for oral sodium 6 iodide-131 use. Therefore, requirements have already 7 been tailored for a specific use via 392 and 394. This 8 may be because the NRC was persuaded by endocrinologists 9 to maintain the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, and this was done 15 years 10 ago. But, today, any physician desiring limited 11 authorization to use sodium iodide can do so with only 12 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />.

13 Then, in 2006, a petition was submitted 14 to the NRC requesting the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> be reduced to 80.

15 The NRC, of course, denied this petition, and it noted 16 that I-131 was considered to be less of a radiation 17 safety issue than the three agents in the petition; 18 namely, Quadramet, Bexxar, and Zevalin. And the 19 petition requested that med oncs and hematologists be 20 allowed to do this.

21 NRC further believed that tailoring T&E 22 requirements, which, of course, they had already done 23 for sodium iodide, would increase the complexity of 24 regulatory oversight with no benefit to anyone.

25 Now we skip forward to today. Using a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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33 1 one-size-fits-all regulatory approach is not 2 beneficial to oral. Oral therapeutic 3 radiopharmaceuticals do not pose the same risk. So, 4 it follows that their use should not be subjected to, 5 and limited by, identical T&E requirements. This 6 contradicts the risk-informed approach NRC is using.

7 If a physician is seeking limited 8 authorization without any added flexibility for use 9 of a relatively safe agent, 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is not warranted.

10 Requiring this number of hours, pursuant to 35.390, 11 for limited AU status conflates a single-use 12 requirement with the ability to administer all forms 13 of radionuclide therapy with unlimited flexibility, 14 which, by the way, of course, increases risks. Mandating 15 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training when it may not be necessary is, 16 indeed, burdensome to those physicians desiring to 17 attain AU status.

18 And as an example, Xofigo-only usage. At 19 this point, I wanted to mention it because it is an 20 FDA-approved commercially-available therapeutic, and 21 physicians who want to incorporate this single agent 22 into their practice should be encouraged to do so if 23 they have been appropriately and sufficiently trained.

24 Xofigo is an alpha-emitting therapeutic, 25 administered in only microcurie quantities, provided NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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34 1 as a unit dosage in a syringe, and unlike hundreds of 2 millicuries of sodium iodide, is of no external dose 3 concern. And since it is excreted mainly in the feces, 4 it is not a likely source of internal contamination.

5 Further, the dose to others is so low that patient 6 release instructions are not even required, pursuant 7 to 35.75. It must be pointed out that conventional 8 nuclear medicine equipment can be used to measure and 9 look for contamination, should it occur.

10 So, in closing, NRC has already tailored 11 T&E requirements for the specific use of oral sodium 12 iodide. So, the need for such tailoring requires no 13 further discussion, since it already has been done.

14 Therefore, a physician desiring to use Xofigo should 15 be able to attain limited AU status for Xofigo-only 16 usage if adequately trained to minimize any adverse 17 impact on public health and safety.

18 Since the T&E requirements should reflect 19 the risk involved, and in the case of Xofigo-only use 20 this risk is much less than for oral sodium iodide, 21 only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of T&E, perhaps even less, should be 22 required.

23 Thank you very much. I realized what I 24 just was controversial, and this should kick off public 25 comment. Thank you very much.

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35 1 MS. LOPAS: All right. Well, we 2 appreciate all comments, controversial or not. And 3 I do like ones that kind of get discussion going.

4 So, *1 if you want to respond to that 5 comment or if you have some additional comments here 6 on Section A.

7 Cedric, do we have anybody else in the line?

8 THE OPERATOR: Not at this time.

9 MS. LOPAS: Okay. All right. So, I have 10 up on the screen, in the webinar, if you're following 11 along on the webinar -- again, we've had some responses 12 back to should the T&E -- well, here's the question:

13 if we do develop tailored limited statuses, limited 14 AU statuses, should those folks go through the same 15 fundamental T&E required of physicians seeking full 16 AU status? So, that was one question.

17 And the next slide, it kind of gets into 18 some of the nitty-gritty of what we're looking for.

19 We're looking for kind of, how should those fundamental 20 requirements be structured for these specific 21 categories of radiopharmaceuticals? And this is where 22 we're asking for questions like, what should these 23 requirements specifically include? Classroom and 24 laboratory training? What topics under classroom and 25 laboratory training? How many hours? How many hours NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 of work experience? And also, competency, how should 2 competency be evaluated? Should it be evaluated 3 through a written or practical examination or by an 4 independent examining committee?

5 And let's see, what other questions do we 6 have here? We have questions about preceptor 7 attestation. Should it be required for fundamental 8 T&E?

9 So, you can check out that slide if anybody 10 has any comments on question 5. And then, we also have 11 questions, which I've already received some feedback 12 in comments. Should AU competency be periodically 13 assessed? And if so, how should it be assessed and 14 how often, and by whom?

15 So, there's a whole boatload of questions 16 to think about.

17 Cedric, just let me know if anybody pops 18 on the line.

19 *1 to make a comment; *2 if you change your 20 mind.

21 THE OPERATOR: Okay. Will do.

22 MS. LOPAS: All right. Thank you.

23 And we can go ahead, since it is radio 24 silence a little bit, we don't need to stick with -- if 25 you have comments outside of those areas, those topical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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37 1 areas, please feel free just to press *1 and share your 2 thoughts. Like I said, we were just kind of exploring 3 how to best go through the comments on this, because 4 we do have a lot of questions in that Federal Register 5 notice.

6 So, Section B was recognition of medical 7 specialty boards by the NRC. Are there any additional 8 boards that the NRC should be considering?

9 And question area C was on patient access.

10 This is a big one. This is kind of the crux of some 11 of the arguments that we've been hearing that our 12 current regulations and requirements are so tough that 13 they're impacting patient access to these valuable 14 radiopharmaceuticals. So, if anybody has any insight 15 on patient access, we would really be appreciative to 16 hear some of that.

17 THE OPERATOR: I do have a caller in the 18 queue.

19 MS. LOPAS: All right.

20 THE OPERATOR: I did not catch their name.

21 I believe it was Munir.

22 Your line is open.

23 DR. GHESANI: Yes. Hi. This is Munir 24 Ghesani from SNMMI.

25 I just wanted to emphasize the big-picture NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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38 1 point is that, if you are comparing training and 2 experience proportionate to somebody's background, you 3 have to keep in mind that there are certain basic 4 fundamentals of radiation protection, radiation 5 physics, and training in radiology sciences that cannot 6 be simply counted in number of hours. It goes with 7 what you are practicing day-in and day-out for years, 8 whether you're in the training or afterwards.

9 So, a perfect example is understanding of 10 radiation physics, understanding of different types 11 of radioisotopes, and particles and non-particles of 12 many isotopes. All of that is ingrained in the training 13 of radiologists or radiation oncologists and nuclear 14 medicine physicians.

15 So, I would really caution the group by 16 just highlighting the point that, if somebody comes 17 from a field where none of this is part of their regular 18 training, and suddenly you are counting the number of 19 hours2.199074e-4 days <br />0.00528 hours <br />3.141534e-5 weeks <br />7.2295e-6 months <br /> in which they can get that lab training and you 20 expect them to get a full understanding of the 21 radiation, I think it's an understatement. You have 22 to keep in mind that, for a radiology resident who spends 23 four years in learning it or a nuclear medicine 24 physician who spends three years after doing two years 25 of preliminary training, all of that training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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39 1 eventually allows somebody to become competent in not 2 only administering in an uncomplicated setting, but 3 should complications arise, being capable of handling 4 every potential scenario of that complication.

5 So, while I really would like to caution 6 that this is something that really can't add the mark 7 in the number of hours of training. You have to keep 8 in consideration the background of their training as 9 well.

10 Thank you for your attention.

11 MS. LOPAS: Okay. Thank you. We 12 appreciate that input.

13 Cedric, anybody else on the line?

14 THE OPERATOR: Not at this time.

15 MS. LOPAS: Okay. *1, press *1, as a 16 reminder, to submit your comments.

17 If you are on the webinar and you don't 18 feel comfortable speaking, you don't want to 19 necessarily speak aloud, you can submit a comment using 20 your webinar software. If you want to do that under 21 the question function, I can read aloud your comment 22 for you, if you prefer that. That's always an option, 23 too.

24 So, I am pulling up on the webinar, I'm 25 going back to Section A again, because the last comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 was kind of in response to should these folks seeking 2 this limited AU status have the same fundamental 3 training as those with the full AU status. And that 4 last comment was basically saying, well, we shouldn't 5 be focusing just on hours; you have to consider a 6 physician's background. You know, do they have a 7 background in this? And if they're really coming in 8 with no background, there's something to consider here.

9 We also have Section D, which is kind of 10 the more general questions on the NRC's T&E regulations 11 as a whole. And I will give some background into this 12 question.

13 The NRC has been looking at how we can 14 transform how we do things at the Agency, to continue 15 to evolve with the technologies around us. And, you 16 know, these questions are kind of in line with that.

17 How could the NRC transform its regulatory approach 18 for T&E? So, we would be interested in hearing any 19 general comments about that as well.

20 So, *1 if you have any comments for us.

21 THE OPERATOR: I'm showing no questions 22 or comments in the queue.

23 MS. LOPAS: All right. Just a reminder 24 to press *1.

25 And I think, just to go through, we're going NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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41 1 to start from the top. And if we don't get any 2 comments --

3 THE OPERATOR: Excuse me. I have one that 4 came through.

5 MS. LOPAS: Okay. Great. Yes, good, 6 Cedric.

7 THE OPERATOR: They did not record their 8 name, but your line is open.

9 MS. LOPAS: Okay. And just remember to 10 start by introducing yourself, please.

11 MR. CROWLEY: Good afternoon. This is 12 Dave Crowley from North Carolina's Radioactive 13 Materials Program.

14 As an Agreement State program, I would just 15 like to say that what we do as regulators, and along 16 the lines of the training and experience for authorized 17 users, it is we want to do our utmost to protect the 18 health and safety of both the patient care side of 19 things, but also the occupational side of the house 20 as well.

21 And this comment isn't so much to answer 22 any of your specific questions, but I do want to make 23 a request that in this process moving forward, to better 24 risk-inform how we proceed, that there be an evaluation 25 of all the medical events that have taken place. And NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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42 1 that would be a great tool for that, and looking at 2 some of the basis for the medical event rule itself 3 and the reporting of those events.

4 Part of it is to learn whether or if it 5 was justified, that that would give us insight as to 6 whether training and experience was adequate or not 7 for various medical uses. To my knowledge, I'm not 8 aware of an across-the-board review of all medical 9 events has taken place or not to evaluate that. But 10 I would, I guess, recommend or suggest that an 11 evaluation be done of all past medical events to see 12 if there is any correlation to the training experience, 13 either the pathways or the amount that the different 14 authorized users had that were related to those medical 15 events.

16 And that's all. Thank you.

17 MS. LOPAS: All right. Thank you, Dave.

18 And actually, I have a question for 19 Maryann. Maryann, if you could take yourself off mute?

20 I have a question related to Dave's comment here, so 21 an NRC-imposed question. You can thank me later for 22 it.

23 But I am wondering, Maryann, does NMED have 24 that information? Would it have the kind of 25 information for the doctor with how they're certified, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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43 1 whether they were certified under -- would we know how 2 they would be certified? Is it something we could find 3 out in NMED?

4 MS. AYOADE: Hi, Sarah.

5 So, NMED doesn't always provide that 6 detailed of information. But what I wanted to point 7 out was that part of what we're doing is additional 8 information gathering. For this evaluation, for this 9 T&E, we're actually going to be looking at medical 10 events, just as you spoke about, to see if there's any 11 kind of correlation with what the causes are for the 12 medical event. And then, we would look at the training 13 and experience of the users, if it involved any kind 14 of user error or type medical event.

15 MS. LOPAS: Okay. Great. Thank you, 16 Maryann. I appreciate that.

17 MR. CROWLEY: I don't know if I'm still 18 unmuted or not.

19 MS. LOPAS: No, you are -- yes, we can hear 20 you.

21 MR. CROWLEY: Okay. Great.

22 Yes, as far as the NMED data, I don't 23 believe there's a field to actually report which 24 training pathway AUs came from or even we try to avoid 25 personal names or identifying information in our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 reports that we provide. But that is some information 2 that the states may have. So, if you do a reference 3 through NMED, you might see that it falls back on 4 training being one of the underlying causes of the 5 event, and then, you can reach back out to those states 6 or whatever region had it take place, and maybe you'll 7 get some more info.

8 Or even putting out a request to the states 9 to provide any known trends or observations that they've 10 made on that front. But NMED, in and of itself, 11 probably won't just lay that info neatly, 12 unfortunately.

13 MS. LOPAS: Okay. Great. Thank you, 14 Dave. I appreciate that insight. And, Maryann, thank 15 you.

16 Okay, *1 if anybody has any comments kind 17 of related to that.

18 Cedric, do we have anybody waiting in line 19 now?

20 THE OPERATOR: Yes.

21 Ralph, your line is open.

22 MR. LIETO: Thank you.

23 A point of clarification about NMED 24 reports. They are not available to the AU or to the 25 licensee. And I've had a lot of experience in looking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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45 1 at specific NMED reports dealing with medical events, 2 and they do not indicate any training and experience 3 requirements as a part of the investigation, although 4 it's probably an interesting point to add.

5 But, even if they did collect that 6 information, an authorized user, a licensee, and RSO 7 does not have access to NMED reports. This was an issue 8 that was brought up before the ACMUI last year, I believe 9 it was, about making these available to AUs and to 10 licensees. And the NRC denied making that availability 11 to those groups. So, I think that's something, even 12 though the person before me had some good comments on, 13 right now the NRC is on record as not making that 14 information available.

15 Thank you.

16 MS. LOPAS: Okay. Hey, Ralph, are you 17 comfortable with providing your last name, your full 18 name?

19 MR. LIETO: Oh, I'm sorry, Ralph Lieto.

20 I'm a medical physicist.

21 MS. LOPAS: Oh, sorry, can you do that one 22 more time? Your phone is going in and out.

23 MR. LIETO: Ralph Lieto.

24 MS. LOPAS: Ralph, okay.

25 MR. LIETO: Got it?

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46 1 MS. LOPAS: All right. Ralph Lieto. All 2 right. Thank you, Ralph. We appreciate that.

3 Okay. Cedric, do we have anybody else on 4 the line?

5 THE OPERATOR: Not at this time.

6 MS. LOPAS: Yes, I think we're having some 7 issues with the phone line on our end. But did you 8 say nobody is on the line right now, Cedric?

9 THE OPERATOR: Yes, not at this time.

10 MS. LOPAS: Okay. Okay. All right. Let 11 me check my webinar real quick.

12 I do have one, somebody who has submitted 13 a question. So, I do have a question or a comment 14 submitted that says -- and this is from Aria 15 Razmaria -- "The wording regarding patient access on 16 the slide, for example, geographic distribution 17 question, are not mentioned in this detail in the FRN.

18 Will there be an update to The Federal Register 19 notice?"

20 Okay. So, let me see what we're talking 21 about here. "The wording regarding the patient access 22 on the slide" -- ah, okay.

23 No. That's a good question. So, let me 24 go back here and close out of here.

25 So, I think, are you talking about how we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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47 1 would be looking at patient access, what the NRC will 2 be looking at in patient access? I'm wondering if 3 that's what you're talking about, where we don't go 4 into that detail in the FRN.

5 That information was not included in the 6 FRN, kind of talking about how the NRC was going to 7 try to evaluate patient access. That was just 8 information we provided in the slide to kind of go into 9 more detail about the NRC evaluation. So, no, we will 10 not be updating the FRN.

11 But the question, we did get some feedback 12 that we were hoping -- well, not hoping -- we did get 13 some feedback that the NRC needed to be determining 14 these patient access questions, finding the answers 15 to these patient access questions. But we did want 16 to put these questions about patient access out to the 17 general public in the FRN, in case anybody did have 18 some insights on that.

19 So, I am going to read through those 20 questions -- unless, Cedric, is there anybody that's 21 waiting to speak?

22 THE OPERATOR: No, not at this time.

23 MS. LOPAS: Okay. So, patient access.

24 The questions in the FRN -- and this is kind of what 25 the NRC's staff is going to try to look into, but we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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48 1 thought we would also ask everybody in the FRN.

2 Question 1: is there a shortage in the 3 number of AUs for medical uses under 10 CFR 35.300?

4 If so, is the shortage associated with the use of a 5 specific radiopharmaceutical? Explain how.

6 Question 2: are there certain geographic 7 areas with an inadequate number of AUs? Identify these 8 areas.

9 Question 3: do current NRC regulations 10 on AU T&E requirements unnecessarily limit patient 11 access to procedures involving radiopharmaceuticals?

12 Explain how.

13 And then, question 4: do current NRC 14 regulations on AU T&E requirements unnecessarily limit 15 research and development in nuclear medicine?

16 So, those are the questions that we're 17 going to look into, but if folks on the line, and anybody 18 out there that's planning to comment, either in written 19 or in future meetings, has any input, we would love 20 to hear that.

21 So, press *1.

22 And if I didn't respond to that other 23 question adequately, you can feel free to write me 24 another question on the webinar clarifying, and I can 25 do my best.

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49 1 Cedric, nothing?

2 THE OPERATOR: No questions.

3 MS. LOPAS: All right. Okay. And so, 4 again, if you want to comment on something outside of 5 patient access, that's fine. We will open the lines 6 to any comments you have.

7 But I think I will go back and see if I 8 can jog any comments on Section A. And again, Section 9 A of the FRN, this is covering the tailored training 10 and experience requirements. And this is really, you 11 know, the crux of what we're trying to evaluate here, 12 right?

13 The general question: are our current 14 pathways for obtaining AU status reasonable and 15 accessible? And we have heard some varied responses 16 back on that.

17 Are the current pathways for obtaining AU 18 status adequate for protecting public health and 19 safety?

20 And should the NRC develop new tailored 21 T&E pathways for these physicians? If so, what would 22 be the appropriate way to categorize the 23 radiopharmaceuticals for those tailored T&E 24 requirements? If not, explain why the regulation 25 should remain unchanged.

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50 1 And we gave some examples of how 2 radiopharmaceuticals could be categorized, including 3 those with similar delivery methods, such as oral or 4 parenteral; the same type of radiation characteristics 5 or emissions, such as alpha, beta, gamma, low-energy 6 photons; similar preparation methods, such as 7 patient-ready doses, or a combination of those. Maybe 8 there would be a category that would have a combination.

9 So, those are some, just to kind of jog 10 people, those are kind of some ideas that we put in 11 the FRN.

12 And *1 if you want to jump in and stop me 13 from talking. That's how you do it. Press *1.

14 And I have one more question here on the 15 webinar I'm going to open up here. Okay. That's just 16 somebody saying goodbye and thank you.

17 All right. And then, question 4 of Section 18 A: should the fundamental T&E required of physicians 19 seeking limited AU status need to have the same 20 fundamental T&E required of physicians seeking full 21 AU status for all oral and parenteral administrations 22 under 10 CFR 35.300?

23 *1 if you have any comments on any of those 24 questions.

25 And then, question 5 is the big one that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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51 1 kind of gets into the specifics of requirements of 2 fundamental T&E, and it's how that fundamental T&E 3 should be structured for specific categories of 4 radiopharmaceuticals.

5 So, if anybody has any comments on that, 6 *1.

7 THE OPERATOR: Jeffry, your line is open.

8 MR. SIEGEL: Hi, Jeff Siegel again. I'm 9 sorry for hogging this conversation, but --

10 MS. LOPAS: No, we're here.

11 MR. SIEGEL: Since you brought up again 12 full authorization versus limited authorization, 13 should it require the same T&E hours? I would argue, 14 as I did in my opening, that that would not be 15 risk-informed.

16 MS. LOPAS: Right.

17 MR. SIEGEL: Right now, most people are 18 talking about their opinion. No studies have been 19 done, as somebody else was mentioning before, about 20 whether the T&E, whether it be 700 or 80, for the, I 21 would say, non-risk-informed approach to let any 22 physician use hundreds of millicuries of I-131 is 23 adequate or not. And I think the NRC needs to do a 24 little bit of homework.

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52 1 capable, or should they be allowed to use an 2 FDA-approved commercially-available product if they 3 think it would help their patients if they were 4 adequately trained? So, the question is, yes or no, 5 could a physician just pick a particular agent for his 6 practice, like a urologist who is treating prostate 7 cancer who says, "Ah, this is great. I would love to 8 give it to my patients."

9 If they could with a reasonable T&E be able 10 to do that, as opposed to obtaining AU status based 11 on giving everything, which seems to me to be a non 12 sequitur, would the NRC agree or disagree that it would 13 be possible for a physician to medically use an FDA 14 commercially-available product, if they were 15 adequately trained?

16 And that's what, I think, the issue at hand.

17 What would be the adequate training for a given 18 therapeutic which is administered based on receiving, 19 say, unit dosage, and all this interest in radiation 20 physics and radiation dosimetry, and all this other 21 stuff -- it's important, but moot to the single-user 22 physician.

23 Thank you.

24 MS. LOPAS: So, I have a follow-up question 25 for you. So, in question C, we asked, should the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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53 1 radiopharmaceutical manufacturer be able to provide 2 the preceptor attestation? So, if, for instance, like 3 you're saying, a physician did want to pick one 4 particular drug and become -- you know, if there was 5 a way, a pathway to just being able to administer that 6 drug, I would be curious to hear your ideas for how 7 we would go about that, what that pathway would look 8 like, and if it would involve the manufacturer.

9 MR. SIEGEL: Yes, well, I know if this was 10 approved, for example, under 35.1000, as opposed to 11 in an alternate pathway that was either 395 or 398, 12 because I don't think you can do it as part of 390, 13 I know that the manufacturer is allowed to give that 14 training for these micro seals, and it was so specified, 15 and I'm not saying it should or it shouldn't be.

16 All I'm saying is, a physician should be 17 able to, if it's deemed appropriate by experts in the 18 field who say, okay, this particular agent, no way it 19 requires 50 years of training and experience. However, 20 this one, the way it's provided and the way it's 21 manufacturer supplied, because the manufacturer spent 22 a little bit of time coming up with a distribution model 23 that was safer than others -- so, I'm just saying it 24 should be looked at in a way that one could, then, 25 say -- and I agree with a lot of people who say that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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54 1 only people who are board-certified or have 18 years 2 of experience should be able to give even the simplest 3 unit dosage.

4 But, remember, medical oncologists, as an 5 example, give on a daily basis very potent, harmful 6 drugs, that is, chemotherapy drugs. They're very 7 skilled at doing that. So, the only difference would 8 be in terms of what's in the syringe, and to figure 9 out what it is to do if there's a mishap.

10 I think it could easily be taken care of, 11 but that's up to you and people on the line and people 12 who are supplying comments as to what would be the 13 appropriate level of training, given an agent which 14 involves much less risk and it's easier to administer 15 than others in its class, as opposed to just saying 16 all oral, or oral/parenteral, or whatever. Just 17 something to think about.

18 MS. LOPAS: Okay. Thank you. I 19 appreciate that.

20 Does anybody have any comments kind of in 21 response to Jeff's comments or any comments on anything 22 in general? Press *1.

23 Cedric, anybody on the line?

24 THE OPERATOR: Showing no questions.

25 MS. LOPAS: Okay. All right. So, *1.

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55 1 THE OPERATOR: Ralph, your line is open.

2 MR. LIETO: Thank you.

3 This is Ralph Lieto again.

4 And some of us here were talking about one 5 of the questions regarding the geographical issue and 6 patient access. I think the NRC has already in their 7 introductory comments recognized that there's the need 8 for this information.

9 What would be, I think, of value to this 10 discussion when they're gathering this information, 11 assuming it's probably going to be by zip code or 12 something of that nature, if they could get the 13 distribution by the authorized used category -- in 14 other words, is it 390, 392, 394, or 396 for this 15 geographical distribution? And I think that would 16 really go a long ways. Because I think some of the 17 questions that I think -- or I should say the points 18 that Dr. Siegel has brought up regarding the physician 19 who wants the sort of limited use of a single modality 20 in a therapeutic application.

21 Thank you.

22 MS. LOPAS: Okay. Thank you.

23 Maryann, do you have anything that you want 24 to add with regard to how we would look at gathering 25 that dataset?

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56 1 MS. AYOADE: Hi, Sarah.

2 Not really. What Ralph said is something 3 that we're considering. As we look at the authorized 4 users for 300 uses, we'll be able to look at the 5 different training categories that they're licensed 6 for. So, we could get that information as well, in 7 addition to the distribution, like he said.

8 MS. LOPAS: Okay. Thank you, Maryann.

9 Okay. *1 for any additional comments or 10 you can submit a question or comment for me to read 11 aloud via the webinar software. I can certainly do 12 that for you as well, if you would like to submit your 13 comments that way.

14 THE OPERATOR: Aria Razmaria, your line 15 is open.

16 DR. RAZMARIA: Hi. How are you? This is 17 Aria Razmaria speaking. I'm a Senior Nuclear Medicine 18 Resident at UCLA Medical Center.

19 But I'm speaking on behalf of myself and, 20 also, on behalf of nuclear medicine, the nuclear medical 21 physician, on behalf of nuclear medicine training, both 22 in nuclear medicine programs and nuclear medicine and 23 biology programs.

24 And I appreciate the NRC's request for 25 public comment. It's an important topic, and there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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57 1 are kind of soft processes that lend into this, again 2 reaching out to all different stakeholders in this 3 regard.

4 One comment that we would like to make is 5 that being able to administer radiopharmaceuticals in 6 just the matter of a single dose being applied, and 7 to be able to do that. It goes, also, along the line 8 of being able to enhance and encourage research in this 9 area. People that are dedicated to one specific field 10 push forward and contribute to developing new 11 pharmaceuticals, radiopharmaceuticals, for different 12 applications. So, in this regard, it's not just a 13 matter of application or administration, but also the 14 science and the developmental research that goes beyond 15 just having access to the application or administration 16 of these radiopharmaceuticals.

17 Meaning that, as a body that is interested 18 and dedicated to the science of nuclear medicine, there 19 is a dire need in the U.S. We see that all research, 20 almost the majority of research is coming from countries 21 outside of the U.S. in countries that have dedicated 22 programs for training. And there is a body of 23 physicians that are interested in the research and, 24 also, development of new avenues of therapy.

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58 1 user license to be able to administer certain 2 radiopharmaceuticals would not push the field forward 3 in the U.S. and contribute to further advancement of 4 the science of nuclear medicine.

5 Thank you for this opportunity to 6 contribute to the discussion.

7 MS. LOPAS: Yes. Dr. Razmaria, can I ask 8 a follow-up question related to what you just said?

9 DR. RAZMARIA: Absolutely.

10 MS. LOPAS: So, related to one of the FRN 11 questions we have, do you think that the current regs, 12 do they have no effect on research and development in 13 nuclear medicine or are they adversely affecting it 14 because they're limiting the number of people that are 15 getting involved? Or are you saying that, if we make 16 it easier for folks to just pick one category, that 17 you think that wouldn't do anything to help research 18 and development?

19 DR. RAZMARIA: Again, you actually are 20 facing a situation where I believe, actually, the 21 requirements that you are talking about, 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, 22 if you calculate that, it would be four months of 23 training. Whereas, again, based on the American Board 24 of Nuclear Medicine and the American Board of Radiology, 25 there's a good understanding that that is not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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59 1 sufficient, as programs have been developed sponsored 2 by the Board of Radiology and the Board of Nuclear 3 Medicine that perhaps included radiology and nuclear 4 medicine. So, there is understanding that that 5 requirement that you are talking about right now being 6 too much of training, which is just four months, it's 7 our understanding.

8 I mean, what you are facing in the U.S.

9 is that people don't realize that to be able to advance 10 the research and science, we have to be dedicated; we 11 have to be understanding that just being able to read 12 one dose and that's it, the science is weak on that.

13 It's to be able to understand, okay, what other traces 14 are possible, what other avenues? So, it really can 15 be researched.

16 Personally, you know, I have spent the time 17 to understand the question. What you see in the nuclear 18 medicine, right now practiced in the U.S., the majority 19 are by radiologists, which they are very busy. They 20 have to cover multiple modalities. And to my 21 understanding, radiologists, when I talk to them, they 22 really didn't sign up to do that, but what we are facing, 23 they are hiring from places like hospitals.

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60 1 have done the basics for four years, nothing but just 2 being able to understand what nuclear medicine is, 3 professional imaging as well as PET imaging.

4 So, meaning, there is no time; there is 5 no encouragement to start these projects that are dear 6 to us, answering those specific questions that the field 7 needs. That actually is happening, if you see across 8 the border, in Europe, all the developments. The 9 radiotherapists there are talking about the change in 10 requirements, because of all that are developed in 11 Europe, in Australia, in countries that have a strong 12 standing in nuclear medicine, with people who have spent 13 time not only just administering one single dose for 14 people to be able to create revenues, but who are 15 instructed in consultations, answering questions that 16 are not answered in the field.

17 So, these are physicians that we are 18 mentioning right now in this discussion will have in 19 the future, how nuclear medicine that is practiced in 20 this country. And again, there's a new generation of 21 trainees that are interested in taking this task or 22 taking these questions, who are dedicated and want to 23 do that. And we need, if at all possible, to encourage 24 that, to enhance that. Because, as mentioned, despite 25 the U.S. being the country where nuclear medicine was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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61 1 invented, we're lagging behind internationally, behind 2 many other countries. So, the rulemaking will have 3 a direct effect on that progress.

4 MS. LOPAS: Okay. All right. I 5 appreciate that insight. Thank you.

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

8 *1, if anybody wants to respond in response 9 to what this Dr. Razmaria just spoke about or anything 10 else.

11 THE OPERATOR: Showing no one in queue at 12 this time.

13 MS. LOPAS: Okay. Okay, folks, let's see.

14 So, we heard a little bit about the effect that this 15 can have on future R&D in nuclear medicine. Maybe that 16 leads to specialty boards. We got a couple of comments 17 in saying that maybe we don't need an alternative 18 pathway, that maybe it should just be these specialty 19 boards that are the only ones that can certify.

20 If anybody has any comments on that, press 21 *1, or any comments in general about the NRC's medical 22 specialty board recognition process. We're happy to 23 hear those, too.

24 The current boards right now that are 25 recognized at the NRC are the American Board of Nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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62 1 Medicine, the American Board of Radiology, the American 2 Osteopathic Board of Radiology, and the Certification 3 Board of Nuclear Endocrinology. So, that's what we 4 have currently.

5 Are there other boards that we should be 6 considering? Press *1 if you have any thoughts on that.

7 THE OPERATOR: I'm showing no questions 8 or comments in queue at this time.

9 MS. LOPAS: Okay. Thank you.

10 All right. And if folks have more general, 11 again, any more general comments on the NRC's T&E 12 regulations in general, I know we are happy to hear 13 those as well.

14 But I understand this is the first meeting.

15 There are three additional public comment meetings.

16 Like I said, the one in December, on December 11th 17 and the one on January 10th, those are in-person 18 meetings. So, if anybody is in the area and wants to 19 travel, you can come on out and come attend one of those 20 meetings personally. And both of those will also be 21 accessible via webinar and teleconference again. And 22 those will all be, again, transcribed and recorded.

23 And then, on January 22nd, we're going to have one final 24 webinar, and that will be about a week before the comment 25 period ends. So, maybe comments will ramp up as we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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63 1 move along.

2 I have one, let's see, I have one comment 3 here that is suggesting certification of nuclear 4 cardiology. I'm not seeing any other information 5 related to that.

6 Mr. Johnson, if you want to hop on the line, 7 feel free. *1 to hop on the line, if you want to expand 8 on your comment on certification of nuclear cardiology.

9 That would be helpful. Otherwise, you can submit that 10 comment in writing as well. But I did receive that 11 comment via the webinar here.

12 Okay. All right. *1.

13 MS. AYOADE: This is Maryann.

14 I'm not sure why the commenter just put 15 down CBNC, but I'll point out that CBNC, the 16 Certification Board for Nuclear Cardiology, who was 17 the best for training and imaging and localization 18 studies, which is under 10 CFR 35.200. And that's not 19 a subpart of this section of training and experience 20 that we're looking at.

21 MS. LOPAS: Okay. That's good 22 clarification. Thank you, Maryann. That's helpful.

23 *1 if there's any additional comments.

24 Cedric, do we have anybody on the line?

25 THE OPERATOR: We did, but it seems like NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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64 1 they withdrew the question.

2 MS. LOPAS: All right. *1 to ask a 3 question; *2 to change your mind. So, somebody got 4 the *2.

5 I've been doing these webinars for a few 6 years now, and I never knew *2 was an option. So, that's 7 good to know.

8 Okay. All right. Well, we're going to 9 give it a couple more minutes. But, if we continue 10 to have no comments, we will probably end the webinar 11 early.

12 So, *1.

13 I'm going to talk a little bit again about 14 the comment deadline for written comments. If you want 15 to also submit written comments, you can submit written 16 comments via regulations.gov. It's very easy. And 17 the docket ID is NRC-2018-0230, and you just go to 18 regulations.gov and type that ID, that docket ID, right 19 in the search bar, and it will pop right up. And there's 20 a little button that says, "Comment Now" on the 21 right-hand side, and it's very easy.

22 But, again, if you have any issues, I'm 23 going to put my contact information up again. You can 24 certainly contact myself or Maryann. If you have any 25 issues submitting comments via regulations.gov, I can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 certainly help you out with that. That's no problem.

2 And *1 for any final comments for folks.

3 (No response.)

4 All right. Cedric, I'm assuming it's 5 nobody has popped on?

6 THE OPERATOR: Yes, no line queue at this 7 time.

8 MS. LOPAS: Okay. All right. Well, I 9 really do appreciate everybody that joined us today 10 and took time out of the middle of their day to join 11 us on this webinar. Like I said, we've got additional 12 meetings, public comment meetings again, where you can 13 get on the line and have your comments transcribed 14 December 11th, January 10th, and January 22nd.

15 And I hope everybody has a great 16 Thanksgiving.

17 If you need anything, contact myself or 18 Maryann.

19 So, thank you all and have a great day.

20 (Whereupon, at 2:24 p.m., the meeting was 21 adjourned.)

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