 Thank you very much, Operator. Good afternoon. This is Gene Carpenter. I am an agency facilitator with the U.S. Nuclear Regulatory Commission. My apologies for the delay in starting the meeting today. Also with me is Dr. Donna Beth Howe, who will be giving a presentation. This is a meeting for sodium iodine I-131 patient release information collection. What we're looking for here is to give you, the listeners, an overview of the various materials that have been put out in the Federal Register and also to answer questions on how to provide information back for the information collection portion of it and also any other questions that you might have. This is an informational meeting. It is not intended to actually be collecting comments on the material that has been presented at this stage. That information on how to provide those comments will be given out during the rest of this meeting. We have several members of the public here in the room. What we will do is, Dr. Howe will give a presentation, will pause at several points during the meeting to ask, to give the public an opportunity to ask questions. Again, this is about the information on the Federal Register notice. It's about how to supply the information. Again, if you are giving, providing comments back, we will ask that you utilize the appropriate process for doing that. For those folks that are here in the room, if there is, and this is the administrative portion of the meeting, if there is any reason that for, that far alarm or something else goes off, we'll pause the meeting, ask you to follow us out the room, and we'll continue from there at that point. Okay? At this time, I'd like to turn the meeting over to Dr. Donna Beth Howe. Thank you. That's not the first one. Next. Yeah, that's the first one. It should be there. It's not number two. There's one before that. Okay. Well, it's not really necessary. The first thing is, what is, what sodium iodide 131 treatments are we going to be covering in our information collection? And this is all about the information collection that we published in the Federal Register back in November 14th. And so, we are expecting to receive information back, back on treatments of either hypothyroid or thyroid carcinoma patients. So, it covers any sodium iodide treatment that requires, in our terms, a written directive, so it's large enough that we want to keep track of it. So, that's going to be both for hypothyroid and thyroid carcinoma. Can you switch it next slide? My apologies. We are still having some technical difficulties here. Please, salt. Well, we'll just have to proceed without the slides. The slide, if you've got the Federal Register notice, you have the information, the basic information that we're going to be talking about. And I'm just going to be hitting some of, of the highlights. The next question is, who do we want to receive information from? And we're really trying to get a, a very large number of, a very wide variety of stakeholders. And I, not that one. It's got to be that one. So, I'll show you two slides. Then my, something happened to my slides. I had them this morning. Okay. And so, who are we looking to get information from? When we're looking to get information from patients, we're looking for patient advocacy groups, we're looking for individual physicians, we're looking for medical facilities that use I-131, we're looking for the professional organizations, the agreement states, our ACM UI members, and any other interested individuals. And most of the questions that we have are about making information clear and consistent for patients. So, we really do want to hear the patient perspective from this. And what are we going to be asking for? We're going to be asking for existing information. So, if you're a licensee, we're asking you for your procedures and processes that you already have. If you're a patient, we're asking you for your experience. And so, we're asking for existing information. We're not asking anybody to generate any new data, new information, go off and do any research projects. We're really looking to see what is practical and what works for you. The information in the form of, can be provided in the form of websites and links to websites in the form of procedures and processes that you may be using that you recommend for others. And as I said earlier, it's going to be your personal experiences either in your practice or as a patient. What are we collecting? What information are we collecting? Well, if you look in the Federal Register Notice, you'll see there are four main topics. And just in summary, the first one deals with information that is responsive to patient concerns about the medical treatment involving the use of I-131. The second point is the information the physicians use to make decisions on when it's safe to release I-131 patients. And this is kind of the dialogue that we're expecting that everybody expects between the physicians or the licensee and the patient to determine, yes, the patient can be released immediately. No, they have to be held for a small period of time or they have to be held longer. And then once the patient is getting ready to be released, it's the radiation safety information that's to be used by patients once they are released to keep doses to others as low as possible. And finally, we're looking to see if there is a brochure that is available for nationwide distribution that has to do with patient release for I-131 patients. The next question is how do you submit information to NRC? As my facilitators indicated to you, we are not collecting information at this point. We're just trying to answer your questions and clarify what we wrote in the Federal Register. Information can be submitted to us electronically. And there's in the Federal Register, you'll see that the electronic information should come to us through http www regulations.gov. And then you have to search on a specific docket number. That docket number is very specific to this particular information collection. You can also, if you're not, if you have problems, you need to give them the docket number. The docket number is NRC 2015020. You can also mail the NRC. And there's a mail address. You would send it to Cindy Bladely, mail stop One White Flint 12HO8, US Nuclear Regulatory Commission, Washington DC 20555-... Well, I don't think you need the extra numbers. But so you can send information to us either electronically or by mail. If you have questions, you can send your questions on the electronic submission to Carol Gallagher. The telephone number for her is 301-415-3463. That number is also in the Federal Register. Or you can email her and her email address is carol.gallagher at nrc.gov. And that information is also in the Federal Register. Any technical clarifications or questions you should send to me. And my telephone number is 301-415-7848. Or my email address, Donabeth, D-O-N-N-A, hyphen, B-E-T-H, period, H-O-W-E, at nrc.gov. So those are the basic elements of how to submit information, what we're looking for in general terms, and the fact that we aren't looking for any new information. Now I'll move on to the first of our four components or parts of our information collection. And that is the website. The first one I told you about was where we were looking for information that the patients would want to have to know about their treatment and what's ahead for them. So for the website information, we're looking for the public and patients to identify websites that provide potential patients with information on the radioactive iodine treatment procedures so the patients will understand the medical condition, the reason for the I-131 procedure, the processes and how to reduce radiation exposure to others. Now in the Federal Register, we provided a list, and the lists are suggested topics. It's not intended to be a complete list, nor is it intended to be the best list. So if you are looking through the Federal Register, you'll see that every time we provide a list, we ask people, is this list correct? Is there something you would like to see taken off the list? Is there something you would like to see added to the list? It's clear to us when you're going to add something to the list that you think it would be beneficial. It would be helpful for us to know if you want something taken off of the list that you tell us why you think it's not important to be there. It was our first approximation to give you some suggested topics. And when you are submitting information to us, what do we want to see? Well, we want to see you identify a website, but sometimes just identifying a website is just too big. In other words, if I sent you to the NRC website, there's lots of information on it and you might not know exactly how to get to what you're looking for. So we would like to have you indicate the topic that you think the website is going to address and also provide a link to that specific information on the topic so that we can go back and look at the information and we can make it clear for people that are looking at it later. And that that completes my initial discussion on the web. Thank you, Dr. Howe. We're going to go ahead and take some questions at this time. If we have any before we do so, I'd like to focus everyone on the federal register notice Dr. Howe referenced in this that is federal register volume 80 number 220 dated Monday, November 16, 2015. It starts on page 70843. And if you take a look at the right hand column of three, you will see at the bottom of that addresses. It includes Ms. Gallagher's and also Cindy Blady from the Office of Administration, and also Dr. Howe on the following page 70844. So that if you did not get a chance to write down the information that was provided just momentarily, just a moment ago, that that information is available again on page 70843 following in the federal register. At this time, I'd like to open the floor to questions. We'll start here in the room. Once we have had a chance to go around the room, then we'll go to the operator questions in the room. No questions in the room. Operator any questions online participants on the phone. If you'd like to ask a question at this time, please press star one to record your name one moment speakers for incoming questions. Thank you. Our first question comes from Peter crane. Your line is open. Indicate that I wanted to participate in the meeting. So I have no question at this time. Thank you very much. Thank you. And by the way, if anybody on the telephone line are here in the room wishes to ask a question anonymously, you do not have to give your name in when you indicate with a star one. Next question. No questions online. I'm sure no questions in the queue. Okay. At that case, we will go to the next section on the presentation. Dr. Allen. Okay. So the the first part of it in a time sequence was essentially once the patient finds out that they are going to have a treatment and the information that they want to know. The second part of our information collection is the patient now knows they're going to have this procedure. And they're working with the licensee and the licensee, whether it's the individual physician or someone at the licensee site is talking to the patient and getting basic information that affects that they will be using to decide when to release the patient. And we've used a header. And that's the second header that you'll see in the Federal Register notice. And that's patient licensee acknowledgement form and best practices in making informed decisions on releasing patients. So we're we're looking at the best practices that are used by individual physicians and licensees that focus on enhancing the ability to make informed radiation safety decisions on when to release patients from their radiation safety control. So in this case, you may be following a national guideline, but you may have to modify it to meet the situation for your particular practice. And so we're interested in in in how you modify things to meet your practice. And what you think really works well for you as to collecting information, getting information from the patients and releasing them in a timely manner. So we are asking you to describe the policy or provide the procedure that provides confidence that the patients are released at the appropriate time. If applicable and you have a form that is signed by both the patient and the licensee that acknowledges that these topics were covered and understood, then we would like to see that form if you have one, we're not asking anybody to generate a form, we're just saying if you've got one, please share it with us. We're also going to we're also asking we've given a number of topics that we think might be topics that are discussed. Once again, we're saying, this is our suggested topics. If you've got topics you think are much more important, please tell us that if you think our topics are not important at all, then let us know and let us know why you don't think they're important. We're also asked a few timing questions. In this case, when is the best time to have this discussion between the licensee and the patient? And we're looking from the patient's perspective and we're also wanted to find out from the licensee's perspective. We've also asked that patients and other interested individuals give their perspective on the topics that they think are important for this discussion and again, the timeline. So that's the general kind of information that we're asking for. And at this point, I can open it up to questions. Very good. Thank you, Dr. Al. Again, the topics that we're discussing now are the ones on page 70845 of the federal register. It's under the first column B. Since we went to the room first time, we'll go to the phones this time. Operator, anyone on the phones? Thank you, speakers. We have three questions in queue. The next question is from Linda Croker. You may begin. Sorry, my one's a little bit maybe more related to the first section, but I didn't queue fast enough, I guess. That's perfectly fine. Go ahead. The concern would be that it's such a fluid environment, and if it gets put into, say, a rewrite of 1556 or elsewhere, how is that going to be maintained so that because, you know, websites are updated very quickly, much more quickly than things usually are updated by, say, the NRC? Our intent is not to put the website locations in a guidance document. Our intent is to develop an NRC website that has links to the information so that that could be much more fluid and up to date and could be monitored. Next question. Our next question comes from Dr. Carol Marcus. You may begin. Good afternoon. Thank you. Much of the information that is given to patients is verbal and is not one size fits all information, but information that suits the patient's perspective, the patient's education, the patient's ability to research anything or even read. And the NRC concept that all of this should be written down somewhere, I think really misses what is essential, which is a personal approach to each patient, depending on their ability to use media, ability to understand. And this really cannot be in a one size fits all document. Thank you, Dr. Marcus. I think we understand that medical practice is not a one size fits all. And we are assuming that even if there is not specific information that is repeated to every patient, but that it is more tailored to the patient, that there are certain more or less performance guidelines that that key the licensee and the patient to certain discussion items. And so when we ask for best practices and procedures, we we understand that they may not be written procedures, but the best practices might be general guidelines of what kind of things need to be discussed. And then we understand that independent decisions are made based on that dialogue back and forth. So we do not think there's going to be a one size fits all. That's one reason many of our regulations are performance based. Even though it sounds like we're looking for prescriptive information, we understand that we tend to give guidance in performance base. And so if your response would be in performance base, then that would be fine. Did I answer your question? Yes. Thank you. Thank you, speakers. Our next question comes from William Lorenzen. Your line is now open. Yes, I want to do this clarify specifically what types of therapies are you or procedures are you looking to have addressed in this request? Are be related uses of I 131 as well as clinical practice? We're looking for clinical practice with sodium iodide one I 131. We're looking for treatments for hyperthyroidism and for thyroid carcinoma treatments that require high enough amounts of iodine that a written directive has to be developed. And that may be jargon to members of the general public. But that means that the amount of activity is specifically written for a patient so that we make sure that a patient that's supposed to get a very small amount doesn't get a very large amount of sodium iodide. Does that answer your question? I just want to make sure it's clear. It does include investigational uses of I 131 covered under a written directive covered under a written directive, but it's it's not just I 131 it's sodium iodide I 131. So there are some iodine labeled materials where the iodine stays pretty well bound to the material. So it doesn't function quite the same way and it's not used for or you might even block the thyroid to have the material go somewhere else. So it's it's primarily material that's going to be going to the thyroid or thyroid like tissue. That's very helpful. Thank you. There are no other questions in the queue. Okay, thank you operator in the room. I have one question. My name is Eric Munger. Some can you make sure there's a green dot? It is a green dot. Okay, some of the administrations are performed on an outpatient basis and some patients are isolated for a period of time before released. Would there be any measures for distinguishing the advice that you'd be giving to the patients based on those two methods of release? The reason I ask is because a lot of people who are isolated will do research online and then get nervous when they see the restrictions that are recommended for those being given outpatient doses. Interesting point. We we didn't distinguish between the and this actually gets into the the next topic because this particular topic is making the decision as to whether to release someone immediately hold them for a few hours or isolate them at the medical facility. But when we get to the next one, it is the guidance that you provide the patient once they are released. And so if you've held them for a number of days and then you release them, that guidance guidance is different than if somebody treats them as an outpatient sends them home right away. And we haven't specified that you need to clarify which it is. So that was a good question. I think it's important because people that are being held will oftentimes ask about whether or not they should check themselves into hotels or avoid their family unnecessarily because they're reading recommendations that are that are normally given to outpatients. Okay. Any other questions? One more time. Any other questions operator on the line? We have a question from Peter Crane. You may begin. Yes, please. How large a dose are we talking about for some therapeutic doses can be as much as 10 millicuries? As some diagnostic dose? The activity. We did not put a threshold on the activity. A lot of, I've gotten a few comments back. One person was concerned that they thought this covered only the thyroid carcinoma patients. And they wanted to make sure that we were also addressing the hyperthyroid patients as to whether when it's safe to release them. The threshold for release is a dose to members of the public. So it is not an activity. And I've gotten other information already from from physicians which are covering both hyperthyroid and thyroid carcinoma patients. So to answer your question, there is not an activity cutoff. Well, there is kind of an activity cutoff. You have to have a written directive. So it's not the very small diagnostic tests. If you have a written directive, those are the patients we're looking for you to give us information on. For diagnostic, it kicks in at 30 microcuries. And the reason it kicks in at 30 microcuries was a very long time ago, people had problems between writing microcuries and millicuries. And so we wanted to make sure that people that were getting microcuries, got microcuries, and people getting millicuries, got millicuries. And most of the microcurie diagnostic tests are below 30 microcuries. So that was where the the line was set for the written directive. Some of the initial tests might be in the microcurie level, but then when you get to whole body scans, they would they would be in the written directive area. And, you know, the the licensee can can look at what they're giving and who they're giving it to and the expected doses to members of the public to determine whether they need to provide information, hold them or or release them immediately. Peter, what we're pretty much looking for at this point is we're looking for people's individual experience. What is it you're using if you're a medical facility or a physician to determine when to release patients? And we're also looking at the patient's individual experience as to I was one of these patients and I thought I had excellent information given to me and I want to have other people get the same information. I thought the information wasn't as good and I would have liked to have heard more about a certain area or a certain topic. So we're not looking for international standards. We are actually looking for what people are doing to determine when to release patients and how they are presenting that information to the patients. The people who work for fine institutions and I would put Dr. Markets in that category don't recognize that down at the level where a lot of patients get treatment standards are not that high and if I understand correctly what the NRC is getting at is that we want to have some kind of baseline that can then be supplemented by individual regard for the patient's situation not that this is to take the place of the individualized discussion that she thinks is so necessary. Am I correct in that? I think basically we are looking for the individual physician's experience and so if they've got a diverse population then they're going to do things a little bit differently than somebody that has a uniform population. If they've got a population that doesn't necessarily read English or speak English then they're going to do things a little bit differently and that's what we're kind of looking for. You're welcome. Any other questions online? We have another question from Linda Kroger. You may begin. I just want to get back to your mentioning of the term written directive so many times and just I think in practice that that is maybe going to be confusing because of the fact that in the summary statement at the beginning of the on page 70843 it mentions medical treatment with I-131 and then in the section we're talking about right now section B under the licensee and patient acknowledgement it's the treatment with I-131 and a written directive as you already mentioned it goes down to 30 microcuries. So there is quite a bit of I-131 use in diagnostics that requires a written directive that is not treatment and so I believe that this focus is on only the treatment the use of I-131 for treatment of patients not the use of I-131 though it might require a written directive in the diagnostic range correct? Well I think the starting point is that it requires a written directive the second point is that patients are released if they can meet criteria that for doses to members of the public that are covered under the patient release criteria in 3575 so you've got both parts going together and so that means a lot of the diagnostic is not going to rise to the point where you're going to expect to give 100 millirems to the person that is going to receive the highest dose and so you would not be providing instructions so we're looking at those patients that have to be released with instructions or have to be held before they can be released with instructions or with written either oral or written instructions. So both things come together and that eliminates many of the smaller activity procedures. Did I answer your question? Because I showed no other questions at this time. Thank you. Okay, can I go on to the next session? Yes. I'm sorry before you do I think we've resolved our technical problems I hope at this time that people who are tuned into the webcast can now see the presentation. If there is anyone who is on the webcast if they could so indicate star one I believe it is too that they are seeing slide 13 best practices I guess nobody is on the webcast. Okay we'll continue on. Next slide. The third component is guidance for released patients so in the timeframe this is the point at which you are going to be releasing your patient whether it's immediately after the treatment or after you've held them for a few hours or maybe you've held them in a hospital and the question is what guidance will you provide to them and the next question is going to be at what time is the best time to provide this this guidance. So if we look at the next slide we were asked to provide standardized guidance to reduce the variability of instructions provided to patients and eliminate some of the uncertainty in the type of information provided. That can be one of two forms it could be prescriptive which would be very specific information and as Dr. Marcus pointed out that may not be the most appropriate way of providing guidance because that would assume one size fits all. So we have another option and that is performance based guidance and if we go to the performance case based guidance then we're going to be interested in the tools the methods are means that the licensee provides the individual patients so that they can follow the guidance objectives and they can protect others. Next slide. So what are we expecting for information if you've got guidance documents that you believe provide clear instructions for released patients we're interested in seeing your guidance documents. We're interested in patient input as to what those instructions should look like to them were they easy to understand and follow and what would have made them better and when should the instructions have been provided. We once again have kind of a list in the federal register that again is a suggested list of topics and questions and we are always asking in an open-ended manner that if you think those those topics and guidance are are good that's that's fine if you think something else should be added to tell us and tell us why if you think something should be removed then tell us and tell us why because we want to make sure that our guidance however we develop it is going to hit the real important points and we may or may not have included all of them in our list in the federal register so we're interested in that input now we can go to questions okay very good for those who are following along in the federal register we are on page 70845 item c center column bottom of the page start here in the room any questions in the room no questions in the room on the telephone please excuse me speakers we had eight indicate activity on the webcast again if you'd like to ask a question please press star one and record your name okay if we have eight people go ahead with the first one our next question comes from peter crane you may begin if anybody is following on the webcast did so just to say yes it's all coming through clear but it doesn't mean i've got a question okay well thank you very much for letting us know that you're following it i take it that you can see the material on the webcast dr crane yes okay i can't see it okay excellent thank you very much did you have no other questions at this time okay thank you very much for keying back in next questioner our next question comes from mike wellings here line is open no questions the same comment dr crane thank you no questions in the q speakers so no other questions online no questions at the moment thank you very much going on to the next section our next section is probably the shortest section of all and that is next line and that is a brochure for nationwide use and the commission wanted to know if there was a brochure that explained the radiation safety and concerns for i-131 patient release and whether it was if there is one whether it could be distributed for nationwide use so we are asking people if there is such a brochure and if there is such a brochure for them to please provide us either with a copy or a link if it's located on a website and that's our fourth and so identify the brochure that you believe provides clear guidance and provides with a copy or a link to it open for questions okay no questions in the room operator i'm sharing their questions over the phone line thank you okay in the closing remarks next slide if you're watching on the webcast and if you've got your federal register submissions for this information collection are due to the nrc on february 16th 2016 you are highly recommended to get them in before february 16th if you're a little bit late we still we have discretion as to whether we take that information or not so february 16th is a date for submissions we this is the first of two public meetings the next one is a public workshop where we're expecting more conversation and dialogue between people that are coming to the workshop or people that are going to be participating at the workshop through the web and webcast and the telephone lines it's also going to be on patient release the purpose for our public meeting today is you the federal register notice has been out for about 30 days if you're thinking about it you might have some questions you want to ask us will the next public workshop which will be january 21st 2016 it will be all day from nine o'clock to four o'clock we'll have about an hour and a half for each one of our major topics it will be webcast and there will be a telephone bridge line and um there'll be about an hour and a half for each one of our major topics at that point so it'll be a much longer meeting next slide and once again i have repeated the information on how uh who to ask questions on if you've got problems with your electronic submission and sometimes people do have problems with the electronic submissions and carol gallagher is the one to contact and i've got the information on this slide it's also in the federal register notice if you want technical clarification or questions then i'm the one to contact and my information is on this slide and it's also in the federal register notice so we want to make sure that if you've got any questions that you get them in so that you will be able to submit information and a reiteration again of how do you submit information to the nrc electronically you go on to the regulations.gov website you search for our docket number which is nrc two zero one five zero zero two zero and you have a electronic mechanism where they ask you to to provide your comments sometimes that can be frustrating if you aren't comfortable with electronic submissions and you can always mail information to us to cindy bladeley office administration here at the nuclear regulatory commission that information is in the federal register and it is also on this slide are there any other questions okay no questions in the room going to the operator any questions online please we have a follow-up question from dr caro marquez you may begin thank you uh tana best at the time that 35.75 was being discussed and and uh uh being worked on um you received the brochure that the society of nuclear medicine uh makes available do you still have that i mean the five general patients specific but it certainly covers a lot of the things you're talking about and is being used i think by many at least board certified nuclear medicine physicians as uh extra written information to augment their verbal information to the patients um we have a brochure that is much older than that that was done um i believe in probably the 87 rule that was more of a pamphlet to to be passed out um and we put that i i think on our we disseminated that um there may be the society of nuclear medicine and molecular imaging provides us with a brochure that they believe is is good for everybody and and then maybe other groups or individuals that have pamphlets so so we're looking for um information from whoever has a pamphlet that they believe would be good carol okay any other questions online i'm showing no questions in the queue okay uh seeing none in the room uh barring no other ones uh on the telephone like to redirect your attention to the uh information uh that's available on your screen right now uh that is again who to contact if you have any additional questions uh carol gallagher uh and donabeth howl for technical clarifications uh at this time i can respond to that okay um there as mentioned earlier the public meeting on january 21st is going to be located it's going to be located in exactly the same room that we're in now and we're going to have a webcast and the telephone bridge lines are going to be exactly the same as the bridge lines we have now i'll be posting that meeting notice uh in the next day or two on the nrc website so that it'll be available for everyone and we'll publish the uh agenda which will look very similar to the agenda that you saw for today but with longer time periods and again the location uh for the january 21st is here at the whiteflint complex uh in rockville maryland for those of you who care to travel uh but as uh dr howl said we will have a webcast and a telephone bridge line for those who uh opt not to um so one last time one one point i'm sorry in the case of inclement weather because one can never predict what's going to happen in january in dc uh if we have snow or some other reason that we're not able to come into the office we will still hold the meeting via the telephone conference line because you need to get your information by the 16th of february and we won't have an opportunity for another meeting uh between the 21st of january and the 16th and for those of you who are not here on the east coast where we are having spring like weather um i envy you your snow but other than that yes we we always have the challenges of weather at that time of the year um one last opportunity for questions anyone on the telephone we have a question from sophie you may begin hey donna best i did so for you breaking up oh you hear me better now yes i can hear you better okay i was going to say i wanted to take the opportunity or to remind you to let people know that we'll have meeting transcripts available in the event that they weren't able to attend or they couldn't hear the full portion of the meeting okay thank you sophie yes we will okay any other questions wait do we have a second question the cue it comes from peter krane you may begin the author of that was the late dr david becker of cornell while medical center and it was very useful in its time but that was in the days of the 30 millicury rule and when the nrc published its uh 35.75 rule change in 1997 it said that you could use that uh but just adjust and the question is it adjusts the times according to the number of millicuries and so forth and the question is does that really tell licenses very much if you've got a 200 millicury dose and you've got instructions that are appropriate to a 30 millicury dose uh how do you how do you make the transition and my own view is that a new and updated brochure uh of that obsolete one is long overdue thank you peter that's also another reason why we're asking for our information collection today to find out what people are using last call for questions one moment speakers for additional questions from the phone our next question comes from bill erwin your line is open uh hi this bill erwin from md anerson cancer center um uh this is more of a common than a question the fnmmi has an updated procedure uh procedure guidelines for various types of procedures including treatment of thyroid cancer and hyperthyroidism which is dated 2012 so they have updated that that's a little more current so it may still be a useful uh document it's not so outdated and we assume that um that the society nuclear medicine and mmi will will send us a link or a copy of that uh the link if you just go to their web page and look under the practice standards that's available for public consumption there's a link right there but it's you've got to drill down just a couple levels but it is there thank you for your comment excuse me speakers we have a follow-up statement from this from dr carol marcus you may begin uh dr erwin said what i was going to say basically thank you and i'm showing no other questions in the queue no other questions no other questions sir okay very good okay uh at that time i'd like to go ahead and wrap up the meeting as was said earlier we will have a transcript of the meeting that'll be published uh here in the very near future uh there dr howell will be also providing additional information regarding the public meeting on january 21st in the meantime if you do have any questions regarding electronic submission or any tech clarifications the names on the screen carol gallagher for electronic submission and dr dotabeth howell for technical clarifications uh are available to you and with that i think we're good with that we're good and i think everyone for their participation and i wish all a happy holidays and a very happy 2016 thank you very much and the meeting is closed thank you for your participation you may disconnect at this time