 Hello and welcome to the applicant webinar for the regional genomic medicine consult services funding opportunities. There we go. First, I just wanted to share a quick agenda of what we'll be covering today. First, we'll do some welcome and introductions. Then I'm going to be giving you some general information about the three different funding opportunities that we're talking about today. Then we'll specifically be talking about the RFA that is the U of 1 RFA that is, I'll give an overview on it, talk about the eligibility criteria, then we'll do questions and answers. After that, we'll then talk about these small business TARs. Again, an overview, eligibility criteria and questions and answers. The reason we're doing those separately is that we do want to make sure that if you're getting an answer, you know exactly which opportunity it applies to. So, first, for a welcome and introductions, my name is Renee Ryder and I'm the program officer for these. You can see that we also have a couple of other people joining us today. Jessica Chong is a fellow who's been working with us. She'll be answering questions in the chat and the questions and answer. And then Nephi Walton is another person here at NHGRI will be working on these funding opportunities. I have gotten some questions on whether or not this webinar is being recorded. It is being recorded. We will be posting it. It will be posted on the event page, which I put the address for the event page on this slide. But you can also just Google NHGRI e-console webinar and it is the first search result that will come up. So, if you ever want to look at the facts, that's where you can find it. That's also as a link to all three of the funding opportunities. The first thing that I think is really important to know is that these are separate opportunity that you'll one RFA those sites do not need to use the solutions that are developed under the small business TARs. And small businesses can create solutions that may not be used in the UL1 RFA site. The applicants, if they want, they can develop complimentary applications so UL1 RFA site can choose to work with a small business to create complimentary sites. However, if we fund one, we may not fund the other. So please have backup plans in case one of them is not funded. The other thing that's important to know is that there is just a single receipt date and I did get a question about that date. These are not the standard receipt dates. It is special for this funding opportunity. So look at that date and the announcement. There will be no option to revise and resubmit under this funding opportunity since it is a single receipt date. The important dates for this. Letters of intent are due by April 30th. Someone did ask if they could put them in earlier. We're accepting them at any time. We just would like to receive them by April 30th if possible. Applications are due by May 30th. Scientific merit review will occur in November of 2024. Approximately give or take a little bit. And then advisory council reviews will happen in February of 2025. And then we expect award notices to go out in about March or April of 2025. As far as application tips go, we really do recommend that you go to the how to apply application guide on the NIH website that link is at the bottom of this slide. We do recommend that you schedule a meeting to discuss a potential application with me, the program officer for these funding opportunities. And when you're writing the application, make sure that you give as much detail as possible because reviewers may not have the same knowledge base as you. So just make sure that you explain things so that they can understand it. Make sure that all of the required components that are listed in the RFA are addressed in your application. Pay attention to those review criteria as you develop your application. And then finally, we do recommend that you have someone from outside of your team review your application just to make sure that they can understand it and that you've addressed all of the required elements. So now I'd like to talk specifically about the U01 RFA. This particular RFA invites applications for sites to participate in the Genomic Medicine E-Consult Research Network. Awarded sites under this RFA will conduct research on the impact of and methods for implementing regional clinician to clinician Genomic Medicine E-Consult Services. And we are requiring that they respond to questions from the whole breadth of specialties that utilize Genomic Medicine and advise on a wide range of topics. So from what test should I order to what do my test results mean to what do I do next? We have found some people who have sent in questions asking if they can limit their service to just cancer or just metabolic disease. And the answer to that is no. We do want to create services that encompass all of those specialties and more. The mechanism that this award will be given under is a cooperative agreement and each awardee will have separate projects that test diverse service models and local barriers. That we've gotten some questions of whether or not we expect the different awardees to collaborate together to create one model and that's not what we're doing. Instead, each can propose their own models to test. Where they come together and why this is a cooperative agreement is that there will be network meetings monthly for the first 6 to 12 months and then quarterly to discuss progress and to discuss barriers and to brainstorm solution. So, I do see that there is a question in the the chat that says, would pharmacogenetic testing and consultation be included? Absolutely. We would be expecting that there would be some questions about that. So that would be something that you should make sure that you have expertise to answer those questions. We also have a question on the small business. I'll answer that when we get to the small business section. As far as the budget goes for the UL 1 RFA, these are the maximum allowable direct costs. So, starting in FY 25 to 870,000, going up to 1.02 million in the final year, that does not include indirect costs. And the direct costs are exclusive of indirects on any subcontracts. As far as the eligibility criteria for applying to the UL 1 RFA, it's really unlimited that higher education institutions, nonprofits, for-profits, small governments, small businesses can apply to the UL 1 RFA if they want, what is ineligible for applying for non-domestic or non-U.S. entities? So, do we have any questions about the UL 1 RFA? Please put them in the question and answer. I have gotten before this some emails with questions, so I'll just go through those really fast. The first one is does NHGRI have its own IRB process to use by outside agencies? And the answer to that is no, we don't have an IRB for you to use. You would need to use one at your institution or a partner institution. The next question is if an organization already has its e-consult service, would their model have to change or could funds be used to assess the efficiency of the existing model? You can absolutely adapt models that you already have in process at your own organizations, but it would need to be adapted to meet all of the components of this RFA. So, it needs to not just be your organization, but it needs to be an outside or outside. It needs to be a regional model. It needs to have genomic medicine. So, as long as it hits all of the components of the RFA, that's fine. As far as using funds to assess the efficiency of the existing model, this is to find methods for making them. And part of that is assessing the model. So, absolutely, you can use funds for that. But also do look at the RFA because there are a lot of other components like making implementation tools that would also need to be addressed. Can you give an estimate of the time commitment which might be involved? I can't give an exact estimate because it's going to really depend on how you set up your service, but this is a large project and will need to have a lot of time committed to it. If you look at the RFA, we do say that at full capacity, the service needs to expect a minimum of 1,000 consults a year. That equates to approximately 20 consults a week. So, it's going to take a bit of time for answering those and to have all of the infrastructure needed to create the service. And then you also are going to need to have time allotted for actually doing research on the service and making implementation tools. The next one is could funds be utilized to support development of infrastructure such as training and purpose of equipment software for clients and to upgrade equipment by consultants if necessary. Absolutely, you can use some of the funds for development of that infrastructure. Let's see. The next question is, do you have information available on reporting requirements and metrics? That's really something that we want each of the site to propose and this is part of the e-console network. Once we have the e-console network, we will be coming together to standardize some metrics. So, we're not giving you any reporting requirements or metrics right now. We're looking for you to propose those and then we'll agree on them in that work. The next one is can more than 1 organization collaborate on a single application? Absolutely, you can have multiple collaborators. The next question is, are there any restrictions about billing for services which will be provided during the course of the research? There are no restrictions. We're not preventing you from billing for services. If anything, we're encouraging you to bill for services. We are really trying to find out what models work and what models importantly are sustainable and part of that is probably going to be billing. So, we are going to ask our, we would imagine the applicants would want to bill for their services to create that sustainable model. Okay, those are all those questions. Let's look at the chat to see if there are questions. Yeah, Renee, there's a couple of questions. I think these can both be addressed together. So, there's one question asking, who can be involved in e-consults? I assume it includes genetic counselors too, although this is not reimbursed. And then does clinician to clinician, including genetic counselors. So this funding opportunity doesn't specify who can or can't respond to the e-consult requests. We just make sure that or ask the applicants that you make sure that your plans comply with any applicable laws or regulations such as state licensure laws that can potentially impact who could or cannot respond to those e-consult requests. Thank you very much, Jessica. Okay. Are there any other questions about the U01 RFA? The question, sorry. Okay, so there's another question of what is the definition of regional? So this doesn't have to be defined by geography necessarily. Services must meet the other criteria, though, specified in the funding opportunity. So, such as serving multiple unaffiliated healthcare organizations and large enough to expect at least, I believe it's 1000 e-consult requests per year when it's at full capacity. And actually, we did get an email question about that asking if a regional service could all be within one state and it can be within one state. We do want applicants to look at the barriers to creating these services. Having a patient's population or providers in multiple states is a known barrier. It's not a barrier you have to address. It's just a barrier that you can't address. And then I think the next question also answers that. Are there any geographical requirements for what is considered regional or is this defined only as being unaffiliated healthcare organizations? Yes, it's really just looking at unaffiliated healthcare organizations. So that could be defined regionally. So you could say, you know, any healthcare provider in this area can use this service. That's one way to define it. Or you could select a selection of unaffiliated federally qualified healthcare organizations. It's really up to you how you define. And then the next question is, does cancer genomics have to have to be part of this? I would say no, it doesn't have to. Cancer does need to be part of it. You need to expect questions from the complete breadth of what we would expect. And looking at the literature, we expect most general genetics, e-consult services get a good healthy proportion of cancer genomics. So you cannot say no cancer. I don't limit it to cancer. Sorry, go ahead, Jessica. Yep. And then can we review the award amount again? Okay. And let's see. So here is the direct costs that are limited to. This is also in the RFA. So you can look at it there. These are the direct costs. Obviously, you also have your budget will include those indirect costs. Okay. So this is another billing question. There are currently CMS coding guidelines for e-consult for both what is billable and who can bill. Are we suggesting we can bill outside of these definitions? We are not. So as we said that the RFA itself is not saying what you can or can't bill. It's really saying that you need to figure out what you can and can't bill. You can figure out alternate ways to get money. It's really up to you and that's part of the research is figuring out how to do this. I hope that answered the question. Okay. The next one is, can this be for just pediatricers that considered two specific specialized that is two specific specialized for this? Let's see. Can you define e-consult as you envision, not patient interaction. Okay. So as far as the definition of an e-consult that's really just clinician to clinician communication. What you're really trying to exclude is referrals. This is not a referral service where a primary care physician sends a patient to see a geneticist and then the geneticist takes care of it. This is really about just as an example, a primary care physician asking a question, that question being answered so that the primary care physician can take care of their patient. This also reminds me we did get an email question that asked if the consultant, so once the e-consult is the consultant puts in an e-consult to the consultant. The consultant is maybe the geneticist specialist. Because if that consultant is the one who will order the genetic testing and that would not fit what we're talking about for an e-consult. An e-consult is where the original consultant is the one who takes care of the patient, not the consultant. Okay. Let's see. The next question is 1,000 consults outside of the health system or including within the health system. We did not put a limit on the number that could come from within and without that 1,000 is including both in and outside. We did not put an exact proportion of how many need to be inside or outside. Just know that when the reviewers review it, they want to make sure that a proportion is coming from the outside. Let's see. And you define un-affiliated healthcare organization. So that is just a healthcare organization that is not owned by the original organization. That's not something that we have a definition, so I can't just quickly grab it. But what we're really talking about are, you know, an academic medical center might be the one providing the e-consults and they will provide those e-consults to a private practice physician who is not part of their organization. We're really looking at trying to get information to the groups that may not have that information within their own organization. So maybe a pediatrician practice does not have a geneticist that they don't have a geneticist to ask a question to, so they can go outside of their own organization to another one to get that question answered. Can consults be limited to all clinical areas in pediatrics? So it must include adult care too. Can it include somatic cancer testing? Absolutely. If you want to answer those questions, if you expect to get those questions on somatic cancer testing, we would want you to answer those. Let's see. Do we need to name the clinicians that would be providing e-consult services or can we generally just talk about the topics that would be covered? For the application, you can be at this point a little more general and say we will have, you know, a cancer specialist, a metabolic specialist at this point, you don't need to have them name. Let's see. Any requirements reserving pediatricians? We've got that already. It seems like education should be a significant part of responding to the e-consult. Do you agree and can you describe what might be expected? There are lots of different types of education. Absolutely. Any e-consult is going to require some education. We expect that these e-consults will allow the primary care physician to take care of their own patients. So you would need to have enough information that they could do that. Part of this is a research project. So one of the questions that you could propose to answer would be how much education is needed. You know, maybe there are some types of questions that need less information than others. So that is one of the things that you can talk about in your application. As far as describing what might be expected, we're not placing any expectations because we do think that this is an area of research. Let's see. Confirming that a GC could provide the answer. So I am not going to say that GCs can provide answers. What I'm saying is that NHGRI is not restricting it. You need to look at your own state laws. If your state allows GCs to answer, that's fine. And we're not going to prevent that, but if you're in a state that would not allow GCs to answer e-consults, being part of this research project does not change your state law. So that's, for us, it's fine, but look at your own state laws. Let's see. The next one is sometimes the correct response to an e-consult will be to make a referral to a specialist. Ideally, there are a subset of questions that can be addressed by an ordering provider, but could this be one of the metrics that is evaluated? Absolutely. So there are some indications that do need a specialist. There are some genetic syndromes that you absolutely need a specialist to do an examination, in which case we would expect you to refer to that specialist. As far as that being a metric, that is a metric that I think would be a great one for you to propose. The number of e-consults that can be resolved by the ordering provider versus the number that need to be sent onto a specialist. And if you look at the literature, that's actually a very common metric that is measured in genetic e-consults. So that is perfect. Let's see. The next question is, can funds be used for marketing? Yes, we would expect you to need to do some marketing because you need to let people know about this service. So we do expect some of it to be used for marketing. The next question is requesting clarification on your prior comment. The testing should be ordered by the primary care, indeed, not the e-consultant. Yes, that is correct. You can do a referral to a specialist. And if you do a referral to a specialist, then they would possibly do the genetic testing, but that would be outside of the e-consult system. For the actual e-consult system, we're providing answers back to the ordering provider. They would be the ones doing the care, which might be them placing a test or it might be them doing a referral. But actually within the e-consult, the consultant would not be doing testing. Okay, I hope that answered that. The next question, another billing question, this grant isn't meant to be direct billed for e-consult. Is that correct? This isn't a line item in the grant's budget. I'm not too sure what you mean by direct billed. If you can put some more information, because if you mean billing the patient, that's not the intent. So just if you could tell me a little bit more, what you mean by direct bill, that would be great. The next question is what types of consults must be included, for example, diagnosis versus treatment? Yes, both of those would need to be included in this. Those would be the first types of questions. When I think about what types of questions are you going to get, those are them. A primary care physician wants to know, how do I diagnose this? They're going to ask you. And then my patient has EDS, what do I do? Those are the types of questions you should expect. Is pharmacodynamics part of the spectrum of e-consults that would be expected? So that is really, you know, I think that you will, we can expect to get questions from primary care physicians asking, you know, things like my patient has depression and this hasn't worked. What tests can I order? Those are the types of questions that we would expect. I don't think we need to have a lot of detail. I see that Terry just came on. So Terry, would you like to talk about this? Sure. So just jumping down to his next what he meant, pharmacogenetics. Oh, okay. Yeah, so that's in. Sorry. Because I was, okay. Yes, so pharmacogenetics, we would expect to be some of the questions we would expect. Do you have guidance about logistics of documentation of the e-consult from the consultant's perspective? We do not have guidance. I think that this is one of the things that you can propose an idea. We looked at a lot of the different e-consult systems that are out there and there are a lot that work through the EHRs. So they're heavily documented in the medical chart and then there are some that are telephone hotlines that are very light on documentation. So we would expect you to think about the needs of all the clinicians involved and propose a system that you think best fits those needs. And that can also be a research question. The next question is what kind of tool development do you envision to support this long term? So long term as far as tools we were discussing in the RFA that we would want you to develop implementation tools. And those are really, you know, again, it's up to your creative minds to figure out what types of tools they are needed. You know, it could just be tools could be things like a set of templated responses for very common questions. A tool could be education and educational module that you go to different community providers in your region and give them the education. So there are lots of tools that could be developed. Let's see the next question is could the program provide education tools to the PCP for their patient to use? Absolutely. And that is, you know, again, these are questions on how do we best do e-consults? And these are things that aren't answered. It might be that the best thing to do, you know, if somebody asks about their patient with BRCA, it might be best for you to refer them to the NCCN site, or maybe it's best for you to give that provider an education sheet for them. So, again, this is for you to figure out how to best serve the patient's needs and then to test the implementation of that. Let's see. How many projects will be funded? Now we're planning on funding two to three of the U01 RFAs. Let's see. Is this considered a QIQC project and therefore no need for IRB? That completely depends on how you set it up. And I would talk to your IRB at your institution to find out what they think. Let's see. The next question is, is the IT platform included in the grants budget slash cost? The big lift is getting these requests back and forth between organizations. Yes, the IT platform is included in the budgeting costs. We know that there are some institutions that already have platforms. There are also some ones that can be purchased or were used. So that is in the cost. Let's see. The next question. The academic medical center has many small primary practices and clinics. They are owned by the parent organization but operate independently. They do not have access to genetic services at their location. Would you consider these to be affiliated locations? As written, if they are owned by the parent organization, I would say they're probably not unaffiliated that they are affiliated. If you want to talk more about this, why don't you reach out to me and we can talk about your particular situation. But if they're owned by them, right now, by definition, we would say that they are affiliated. The next question is, is there any concern that PCPs are not interested in doing this? We have found that they are very busy and want someone to do this for them, e.g. a referral. That is a great metric and this is part of the whole point of the research project is we are trying to find out the best ways to implement it. But yes, there are some, and we've looked at a lot of literature on that there are some PCPs out there who want to refer and there are other PCPs out there who realize that there are not enough specialists to refer to. And they are, these are needed. So, but, you know, the key to this particular RFA is finding out the best way to do it. Let's see the next question is should non-affiliated sites be named and included as subsites as part of the proposal. So you do not need to name all unaffiliated sites. You know, particularly if you're saying it's all anyone in the state of, what is it, North Carolina is part of, can use this service then you do not need to name every single site in North Carolina that that really does let us know who it is you're talking about. But if, if you are doing a collection of federally qualified health centers, then you just need to give us enough information so that we know exactly who it is you're talking about and how large that patient population is. Let's see the next question is I apologize if this is repetitive and RFA for the U01 it's specified like the consults cannot be clinically specialty based I need not just answer genetics. However, I don't see any directions about, okay, this is the pediatric adult question again. We do need to have it also covering adult. Is the expectation that the test costs are covered under usual medical care. Yes, this would be usual medical care if there are tests because that would be done outside the E consult the E consult itself is really just that communication between the providers. Any medical care that happens after it would be that usual care. Let's see. You mentioned that telephone consults could be an option wanted to verify technically that's not an console. We, yes, we debated that most telephone lines are electronic so they're technically covered by consults because it's an electronic communication so we are including telephones. Obviously that's debatable on whose definition you're using but we are including telephone consults. Let's see is building required can we provide the service free to the patient. If that is how you want to do it you can do that. I again, one of the major things that this study is looking at is how we can create sustainable services. So as long as you're doing some research that shows how what you're doing can be sustainable. It's acceptable, but I see Terry's got something to say about that. Yeah, so, so let's be really clear here. This is not a console to a patient. This is to another provider. So you wouldn't be billing a patient. I don't know if you can bill a provider you can try. But, but it's not for the patient. I also have a couple of clarifications, Renee, when you're finished, you're doing a fabulous job. I think we've had the end of the list to definitely do some clarifications. Oh, great. No, no, this was, this was terrific. And we will price for those that are a little bit came up a, you know, more than once we'll be sure to put them in an FAQ document a frequently asked questions document so that you, you have it. Early on there was asked about the need to collaborate among the sites we're not expecting the sites to do exactly the same things but it we will, you know, have meetings periodically and we would expect you to share, you know, different techniques tools, etc. debate, you know, approaches that sort of thing so it's a loose collaboration you don't have to be in lockstep but you do need to work together. There was a question about, you know, could we bill for the service if a referring provider was willing to pay you. You know, that would be acceptable but you need to make it very clear that you wouldn't be double billing so you wouldn't be then charging for the consultant's time if you're billing for it. And that's, that's important to be clear on on the definition of unaffiliated let us give that a little bit more thought and put that into into an FAQ so that everybody sees the same thing and we're all in agreement on it. So the question about should, should we name clinicians versus you know specific clinicians versus topics that can be be covered. Remember that you have to convince reviewers that you can do this and so think about, you know, if you don't have anybody named, they may be a little bit skeptical. You don't have to name everyone but you want to convince, you know, a peer reviewer that that you have a reasonable group of people with reasonable letters of, you know, commitment who would be willing to work with you on this. Similarly for naming the sites as Renee said you don't have to name every single site, but you need to show some evidence that you do have access to those sites and that they can produce the thousand consults per year that that she talked about. So on the education of the, the referring provider, you know, as was, as was mentioned you do probably need to give a little bit of education just as when I call an infectious disease specialist they tell me no you dummy you don't want to use an amino like the side because of this that other reasons. So, you would probably stated more more courteously than that but, but yes there's some, some information, you need to explain your response. And on the, on the ordering there was a question about can you provide a referral well you wouldn't provide a referral to the patient again this is you would recommend a referral and could you know would be more helpful. Presumably if you can actually name a specialist that they could reach out to, but you would be recommending this to the provider you're not doing direct patient care. Those were all the things I picked up Renee so did I say anything wrong. No, the only other thing I wanted to add on billing. You know just that this is your time to think creatively we did see some consult services that were actually being funded through health insurance plan. So, you know, they're, I think they, you know, just don't, don't box yourself in when you think about ways to tip on these. Yeah, there was another question about can you build providers but not patients or their insurance. I think that's sort of up to the way you have interactions with providers right. Well, and, you know, just remember though that one of the, one of the requirements of this. What I would say is that you include underserved areas too. Don't. I don't think it would review well if you were saying that you have an underserved area that's included, but possibly you might propose a billing mechanism that would make the service unusable to them so just all those issues are things that you need to think about when creating your service model. Okay. I'm going to count to 10. And if we don't get any more questions and kind of go to the next set of RFAs. Okay, no more questions. So let's go to the next set of our actually started the next set of the small business. So, these are different. These invite applications from eligible small businesses. And what we're really asking these small businesses to do is to develop solutions that can be used to enable regional clinician to clinician genomic medicine. Services. So the other RFA was creating services. And this is just creating things for those services to you. Examples of potential projects are creating solutions that enable the HR data transmission. I'm not going to read through all of these, but you can also look at the RFA. So this is a funding opportunity. Those do have some examples of things that would be considered acceptable. It's not an exclusive list. They're just to get your minds thinking. These pairs, as I said, they are separate from the one RFA. So I found some email questions asking about requirements. We're not specifying requirements such as how the data is captured or transmitted. So looking at the purpose of the NIH small business program, it's really to give small businesses grants to do research and development for them to create their own small business line. So they really need to consider the broader commercial potential when developing solutions. So if you think that one option has more commercial potential, then that's the option you should do. But you shouldn't be asking what the eCounsel network is doing. You should be asking what is commercial. As far as the small business PARs, there is only one receipt date for those, as we said before. However, if a small business wants to, if you don't get funded in that one receipt date, you could always resubmit under the omnibus SBIR STTR funding opportunity. So while the UO1s, they will not have an opportunity for resubmission. You could resubmit under a different opportunity if you're a small business looking at the small business PAR. As far as the budget goes, for those who aren't very familiar with small businesses budgets, they're divided into two different phases. There's a phase one and a phase two. Both of these phases include both direct and indirect costs. So when we say that the limit is 400,000 for phase one, that is looking at the whole of phase one, not per year. And that does include both the direct and indirect costs. For this particular funding announcement, it's not the standard timelines or the standard budgets. We do have our own budget that 400,000 in phase one, 2.15 million in phase two. For this announcement, phase one can last up to two years and phase two can last up to three years. As far as eligibility criteria for these small business PARs, we accept applications from any United States small business concern. And a small business concern is a for profit. It's small business, so it has not more than 500 employees. There are some particular requirements about who owns them that if they're not directly owned or controlled by private individuals, if it's like a venture, joint venture capitalists or capital investing. You really should look at the regulations. I put that link to that on the website or on that slide. But if you have a question as to whether or not your small business is eligible, feel free to contact me and we can make sure that you get the information that you need on eligibility. So now we're going to open it up for questions about the small business PARs. I have gotten a couple of emailed ones, so I will start to go over those while people ask questions in the question answer. So the first question is, would the consultant order the genetics test? Again, this is small business, so it is a little bit different. This is really about creating solutions like software or something like that for enabling e-consults. In our definition in e-consult is not where a consultant orders the test that would be a referral. So under this opportunity, no. Where would the application revenue come from? This again, it's small business. So that is really for you to come up with a commercialization plan and you get revenue by selling your product. It is generally how that happens, so you need to figure out what your market is and who you can market it to. The next question is, would the developer market to the consultant organizations and or PCPs? And that really depends on what it is you're creating. Most of the tools that I can think of that you would want to develop, you'd probably market to the consultant organizations, but you might come up with ones that would go to the PCPs. So that's really something that you'll need to do your own market research on. And then this was how early can we send the letters of intent? We can send them today if you want. They just need to be here by that. April 30 deadline. Okay, so going to our question and answers. The consult consult often poses the dual questions of what should I do myself and worth that I refer with a system for addressing. What should I do myself that uses decision support to get clinician to provide current information, view a differential diagnosis and get human advice based on this information be discouraged. Passing along that computable information and the referral. That was a really long question. I want to make sure that I'm understanding the question. Properly. View it. So, I think what you're asking is, should we be. I guess. What I would say here is that this is, I think is a place where those clinicians are going to need to use their, their clinical, their best clinical judgment that they're definitely going to be some where they should refer. And there are going to be somewhere, you know, primary care physician should be empowered to do the do it themselves and that that's really clinical judgment so I think that this is, this is where those consultants are going to have to use their clinical judgment unless I'm misunderstanding the question. And that's a really good question. This next one is at risk of sounding dumb. What does they are stand for? So that is P stands for program is announcement. So that's program announcements. So the R is actually with special. Receipt review. So it's just, it's a particular type of funding opportunity. The other ones that are phase are. It's just handle a little differently inside of NIH. So that that's what it stands for. Let's see. The next question is, can one apply for phase one and phase two together at milestones are clear. That is what we call the fast track mechanism that you apply for both phase one and phase two. And fast track is allowable on these. So yes, you can apply for phase one and phase two. Let's see. Are there any other questions? Okay. So we had questions about the, the U of one RFA first, and even though we're on the small business PR is I'm going to open it up now if anybody has questions about either of those or general questions now would be the time to ask. Otherwise, it does not look like we're getting any other questions. So I really want to thank all of you for attending today. And again, as Terry said, we will be putting this up as after this, we will be putting up a frequently asked questions. The one major thing that we are going to be putting into that is the, the definition of affiliated. So we will be discussing that and putting that in there. So please do expect if that was one of your questions, please go to the FAQ. And if other questions come up, please feel to reach out to me and we can talk more. And if you're planning to submit something just reach out to me and we can talk a little bit about your submission. Okay. That is it for today. Thank you very much for joining us. Bye bye.