 We're on to the favorite session of the Council on Initiated Discussion, and again, orientation for the new Council members. Up until this point, and we're at 422, the agenda has been controlled by NHGRI. We brought to you the things that we think are important or relevant or the business that needs to be done, but now we're turning the control of the microphones back over to you. And if there are reports that, looking ahead to future Council meetings, if there are reports that you would like to have on specific programs, if there are important issues that you've heard brewing in your institutions or at national meetings that you want to bring to our attention, if you have ideas about new initiatives that could be considered. I think we've told the story before, but the origin of the SEGs, the Centers of Excellence in Genomic Science, actually came out of a Council-initiated discussion a dozen years ago. So we're turning the microphones over to you, and we're all ears, and I deal very well with awkward silences. Any topics you want to hear about at upcoming meetings? I think at May Council we currently have slated presentation by the new Director of Nationalist and Minority Health and Health Disparities, correct? I don't think we have it locked in the date, but that was on our list of things to do. I think you locked in the date. Okay. So, Eric, in your report this morning, you gave updates, had a lot of great stuff, but we didn't get an update on the search for the NOM Director, can we get an update on that? I can only give you an update by saying that the search process is still ongoing. So, I think it's getting at a late stage, certainly, but a person has not been identified, I believe interviews are still going on. I would hope that individual would be identified by the next Council meeting, if not before, but it requires all things to work their way through, selections to be made, and appropriate due diligence done, and acceptances, and negotiations, and all the usual things. So, I mean, it's been put, you know, that and the head of the Precision Medicine Program I think are two very high priorities. I would also tell you, there are, it's a very busy search time. They're searching for a new head of the Child Health Institute, a new head of the Mental Health Institute, at least one or two other searches, I know. So, it's a busy time for NIH leadership to be conducting searches, but I know that NOM Director is further along than almost any of them. I think, certainly, once that person is identified, and the Director for the PMI is identified, it'd be great if we could hear from them. Oh, no, that's an easy one, absolutely. And in the minutes from the last meeting, we had talked about having additional presentations from FDA. Yes. Bob Kaliff. Yeah, Rob Kaliff. So, we saw that, Rudy and I were reviewing, the issue with Rob is that he's been nominated to be the Commissioner and that is trying to percolate its way through the Senate with some potential obstacles. That may be an awkward to ask him to do this at this juncture, so we haven't yet. And, you know, we'll see if he's ever confirmed. Obviously, you know, there's time running out on the Obama Administration and how many more things the Senate is going to approve in terms of nominations. But, yes, I agree that would be awesomely valuable. There's, I mean, not to tell you, you know, there's a lot of issues and a lot of interactions. We're having with the FDA and there's lots of topics we brought, people from the FDA here to a council meeting and that was very helpful. Returning to that would be terrific. I think just the timing has to be right. It has to be the right person right now. It's a little awkward. Maybe by may it would be better, but it's on the list. I agree. Hi, this is Jay. Hi, Jay. What's up? How are you doing? I've been listening. So I wanted to, it's a good time. I wanted to bring something off that I think we talked about two ago. But I think I forgot to bring it up and I think it just up in the last session, we had two councilors. One was a council of accounts which was a length of investigator initiated R01 that current act possible readdressing of that. If I remember from the discussion that we had two councils ago, there was general feeling that this was a legacy of caps that were imposed by councils during the early commitment to the project. And some past tenacity could be wrong about that. I think I followed both of that, although you're chopping a little bit on and off. I'm going to look to Jeff and Terry or anybody else to help me with this, but under the general discussion of history, of why we limit lengths of RO1s in an automated fashion the way JLG is and what was the reasons why we continue to do it, do you want me to, I mean, one of the immediate things, I mean, let me start, but I do want somebody else to come to the microphone. I mean, one of the immediate reasons that we have tended to do that was with the general attitude that genomics, unlike many other areas of science and NIH supports, is moving very quickly and there's many developments happening and that it seems that having things on relatively shorter leashes than compared to longer leashes gives us greater chance to make sure that we are capitalizing on new advances. And so the ideas in general are we have kept our grants a little shorter and certainly once the budget's got to be tight, I think that was another reason to keep things on a short leash with great uncertainty, but Jeff, do you want to expand on that or that's basically the rationale? There's not a lot to add, but that has been advised from council over a number of years. I'm not sure that we've explicitly discussed it at council for the last five years, but when we've mentioned it, we haven't heard much alternative opinion, but that doesn't mean we couldn't discuss it at council. We have to understand what the implications are, either way. We tend to give longer grants to younger investigators to give a break there, and then we tend to give a little bit shorter. And then we certainly tend to keep our major programs on something like a four-year cycle as opposed to a five-year cycle again, because the science just gets turned upside down so many times every four years. So that's the rationale, Jay. And I think we did briefly, I remember a couple of councils that we briefly touched on this as a topic area, but I guess the question is, take that, you know, what do people think? I mean, we have sort of gotten comfortable into that mode, and is there a serious opposition to it, or is there people agree with this general rationale? Well, I mean, I think it would be good to hear how, what damage it's doing. If that seems to be an indication, is that there's a problem with that. It's not a policy, it's a practice. I was just going to ask, do you know what stats are on typical media links, or the cap? You mean stats across NIH? No, an NHGRI for investigator driven. So I think it's a good idea to defer this to May, just in fairness to Jay, because Jay, we really are having a very difficult time understanding you, and maybe there's something to be said to bringing some data to the council, and it gives you guys a chance to think about this, and tell us why it's no longer appropriate to have the, I think the majority of our RO1s are three years. And so what harm that may be causing, or what could be, what would be the benefit to extending that length. But let's do this in May when Jay will be in the room. Actually, while it's true, our RO1s are generally three years. For certain programs, we make the R21s three years, which is actually longer than they usually are, because we think some of the research topics are super challenging, and it's really hard, particularly with smaller amounts of money, to make the amount of progress you're going to need in order to have the data you'll need for an RO1 application. So we've gone both ways, but again, those are smaller amounts of money. So Jay, you're mostly focusing on RO1s, right? Investigative initiated RO1s? Focusing on RO1. Okay. So I agree with Rudy. So let's do that. And we already heard a request for some data. So we will bring you a more informed set of information to have that discussion at the next council meeting. That sounds good. I think it'd be helpful for comparison to have equivalent kind of information on the non-investigator initiated awards and what their length are. Like, are the RO1s significantly shorter than everything else? Because that would seem to be like an incongruity to me. But. Okay. Are there topics either to discuss now or to put on the agenda for future meetings? Okay. Back to you, Rudy. All right. Thank you very much. Okay. A couple more things need to be done in open session. Next up is the review of the Statement of Understanding. It's just a matter of time before I refer to this as the MOU, Memorandum of Understanding. So if I say MOU, I refer to the statement and I apologize for that. The Statement of Understanding is the description of how we will conduct business between NHGRI and the council. We do this every February. We need you guys to approve the MOU. There I go already. And we do this in February because the new council members are here. So I'm not going to, it's a four-page document. I do encourage you to read through it. It's pretty plain and simple language. I'm just going to race through the basic principles right now. What's outlined in the Statement of Understanding is the responsibilities of council and a description of the actions that council can take. There's also a description of the administrative authorities that NHGRI staff has. And that means the things that we can do without council approval or bringing it to your attention. So every application that is submitted and undergoes peer review each round must undergo a second level review at the council meeting. We put many applications on the closed session agenda and we will discuss those when we get into closed session. There are many more applications that we don't put forward because we assume the review was appropriate. And we know what to do with those applications. We don't need your input and we're not required to bring them to your attention. So there is an activity that goes on called the on-block vote. That will happen at the end of the second day of council. And all the other applications that we're in for review are approved by you in the on-block vote. Now, at least the full standing members of the council have access to all of the summary statements for all of the applications. As you go through them, if you see an application that is not on the CSA that you want to have discussed, you need to bring that to our attention and we will let it do that for you. Council can take four actions. You can concur with the IRG. You can defer the application with the belief that it received an inappropriate review. You're essentially sending it back to be re-reviewed. You can vote the application as either having high-program priority or low-program priority. Or you can defer the application not because it received a poor review, but because you need more information to do your second level of review. Those are the four things that council can do. The staff has the authority to, and we do, implement something called expedited council concurrence, ECC. There are four council members that serve on the ECC subcommittee. It's Bob, Gail, Grant, and Jay Shenduri. About a month before each council meeting, they receive a list of applications for the current round. They tend to be from programs that have set aside. So SBIRs, STTRs, many of the LC applications, the investigator-initiated applications, are put on the ECC. The subcommittee reviews them and gives approval for those. Again, any council member can look at the list, ask for any of those applications to receive a full review at the meeting. Why do we do this? We do this to try to spread the work for the grants managing staff. They're going to get hit with a bolus of activity after the on-block vote tomorrow. If we can start some of the award-making process upstream, and again, from set aside, so we don't think that these are particularly contentious discussions, that's what the ECC is about. You will get a report in the electronic council book of the ECC actions for this round. So even those of you that are not on the subcommittee can see everything that's going through. Staff has authority to make supplements to existing grants. The limits of those supplements are $150,000, or 25% of the total award amounts, whichever is greater. In the case of very large grants, and we do have some, such as the sequencing centers, we're capped at a million dollars for a supplement request. So anything outside of those limits have to come to council. Again, there is a report in the electronic council book of all the supplements that have been made by the staff in the last round, so you can see what's there. And finally, in the event of the catastrophic act of nature, or... An inch of snow in the DC area, right? Like that which is... Or prediction of snow, exactly. We have the authority to stage the council meeting in an electronic format, whether that would be a telephone call or a big email exchange or Webex or something like that. So it's a four-page document. I encourage you to read it. But I do need you to approve the statement of understanding. So can I have a motion to accept the second? All in favor? Any opposed? Thank you very much. The conflict of interest statement. All right. My favorite part of the council meeting I'm going to read. I'm going to read the chant. Before I retire, I hope to have this memorized. You must leave... Now, this refers to all the applications that will be reviewed in the closed session. You must leave the meeting room when applications submitted by your own organization are being individually discussed. In the case of state higher education or other systems with multiple campuses geographically separated, quote, unquote, own organization is intended to mean the entire system except where determination has been made that the components are separate organizations for the purpose of determining conflict of interest. You should avoid situations that could give rise to charges of conflict of interest, whether real or apparent. For example, you should not participate in the deliberations and actions on any application from or involving your spouse, your child, a recent student, a recent teacher, professional collaborator with whom you've worked closely, a close personal friend or a scientist with whom you've had longstanding scientific or personal differences. The NHGRI staff will determine the appropriate action based on recency, frequency, and strength of such associations or interests, either positive or negative, and will instruct you accordingly. In council actions in which your vote on a block of applications without having any discussion on any individual one, the so-called on-block vote, your vote will not apply to any application from an institution fulfilling the criteria noted above. Please sign the conflict of interest and disposal of confidential materials forms, which are provided in the envelope at your chair, and they'll be collected at the end of the closed session. So we have one other action that is not on the agenda. I do. So the normal rotation for council members is that after serving four years, they would rotate off at the September meeting, and then the new council members come on board in the February meeting. Well, there are always exceptions to the rule. And if you need a definition of an exception to the rule, we offer Jim Evans as a shining example of that. All kinds of exceptions. If you need to have proof that he's a unique kind of person, ask him after the open session his adjourn to show you his DNA tattoo. That wasn't a joke. That is not a joke. And it is not a temporary tattoo either. On a more serious note, Jim has been an incredibly valuable advisor. He was not available last September, so we imposed on him to come back for the February meeting. You've been an incredibly valuable advisor, largely because you've been an early adopter of clinical sequencing. You've also embraced the value and the concept of embedding LC research in a clinical sequencing center. And you've been an important proponent of that. At the same time, I will tell you that many times in the middle of discussions and debates between the left side and the right side, genomic science and genomic medicine, I have heard Jim speak out and say, you can't forget about the importance of the basic science component here. That understanding function is critically important to really be able to garner all of the important clinical utility that we get out of these variants that are found associated with specific diseases. So, Jim, I've always found you to be a very balanced person. And we're really grateful for your time and effort that you've given to us. So we thank you. We will miss you and we wish you the very best. We have some lovely parting gifts. We haven't quite perfected the home version of the council game. That was a joke. I really appreciate it. I'm thinking it's probably not a bottle of scotch, even though it's the right side. No, this is the government. But that's right. It's been an absolute honor and a privilege to get to serve on council. I do have a lot of colleagues on various councils who they just take it as a matter of course with other institutes that you're a rubber stamp. And I definitely don't feel that that's the case here. So I really appreciate it. And it's just too bad that I finally feel like I'm getting the swing of it. And that's my last council. So thank you. And with that, you can gavel us to closure. I will gavel us to closure. And let's go through now what we're going to do. So you want me to do this? Sure. So we're done for the day, except for council. We're going to, this council meeting, I'm going to have two executive sessions with the council. Staff doesn't necessarily know about all the details, but I'm going to have a one right now as soon as we can clear the room in essence, and then my usual one tomorrow at lunch. So I would propose we take about a 15 minute break. It gives the AV folks a chance to clear these cameras and so they can go home, give staff a chance to clear out of the room and they can go home. But council, you can have a 15 minute breather but then come back here and we'll have our, the one couple of things we want you to talk about executive session tonight and then how are we going to handle tomorrow? Well, I need an addendum to that. We need, because of the availability of phone reviewers, we actually, we're going to tear down the cameras here, come back into closed session. We're going to do the LC Sears. Oh, I'm sorry. We're doing one thing today. We're doing one thing today because the availability of phone reviewers. Oh, so people can't. Then we'll clear the room and you can have your executive session. I forgot about that. I'm sorry. And when we get into closed session, I'll have an announcement for the staff about the catastrophic snow storm coming our way. Right. Okay, so we're going to break for 15 minutes. Got it.