 to get us started again. Welcome back from lunch. We have just a few more things to do in the open session. And the first topic up is the so-called council-initiated discussion. So I think you all know the drill here that everything else about the council agenda is set by us, by NHGRI, but we know in addition to being our advisors that you're also representing the community. So if you have issues that you would like to bring to our attention or things your colleagues are telling you back at the home institutions that you think we should be aware of, if you want to plant a seed or make a request for a future presentation at a council meeting in the future, now's the time to bring it up. So this is not new, but going back again to I think something we've said at last council to have maybe FDA come back to us, I think there's a strong interest in following up on some of the meetings that we've had. And now that they have the new person in charge there, it would be a good opportunity to have them come back to this group. So to prepare, we certainly do that reach out, but to prepare them, what are the specific issue or issues that you'd like to address? I think some of my colleagues here would probably have more insights into some of the regulatory hurdles that are being faced and certainly will be barriers to implementation of genomic medicine if they aren't addressed. Well, there's an entire issue of laboratory develop test, but I think it's very much in flux right now. There's some things in committee and Congress about whether FDA should or shouldn't do it and so it, and I guess there's sort of a self-imposed deadline of May, if things don't happen by the end of May, they're not going to happen at all because of the election cycle. So I'm not sure what the FDA could say much at this point, maybe later. I wonder if we do bring the FDA back out, if we ask them to tie together the some thoughts on precision medicine and how their views may or may not change with the evolution of precision medicine and the initiative here. Does any Laura or Christina do, anybody want to say anything about our ongoing discussions, interactions with FDA and especially we have a workshop coming up related to IDEs as I talked about in my director's report. Yeah, that's on. Yeah, so we meet the policy and program in Alice's branch in the Division of Policy Communications and Education. We have a regularly scheduled monthly meeting with most of the people who are actually on the precision medicine team and we try to work through to address the issues that are impacting the institute as well as trying to get a broader sense of where we can help them move forward their thinking. We, on June 10th, we actually have a workshop scheduled on investigational device exemptions. My standard spiel has been it's not an existential workshop, it's not as to whether or not IDEs are right or wrong but it's more of a functional workshop so we can help our grantees work through the process of whether or not your research includes a significant or a non-significant device and if it is a significant risk device and if it is a significant risk, how grantees can work through the process. We continue to collect input from the institute and grantees if anyone has questions. We like to act as a liaison to try to facilitate those relationships and as for LDTs, I know they're working on regulations and there isn't anything set in place as of the moment so I hope that was helpful. But we can certainly see how this plays out the next few months and certainly figure out if there's a right person or person group to bring over so we will have that on the list and decide the right time for it. I think Eric have the next agenda item. I'm struck over the last maybe two years of the parallel and even converging activities between NHGRI and NHLBI and I wonder if it would be good to have Gary come and talk to us. You know the word top med was used this morning several times, my guess is there's people around this table that have no idea what top med is and I think there's a lot that could be gained by more communication between the two councils. We certainly interact with them a lot especially Adam and others on the staff but we can get council, we'll have to figure out exactly when to do that but yes we will have that on the list, I think it's a great suggestion. Okay, it's a longer than usual five second rule but I just want to be sure. Certainly if you have other thoughts on the flight home you can shoot an email to me and or Eric and we'll put it in the queue as he suggests. Okay, rounding out the open session and let me draw your attention to announcements and items of interest. There are two reports that were sent to us one from the American Society of Human Genetics, the other from the National Society of Genetic Counselors. These two reports are their descriptions of the activities in which those societies have been engaged since the February council meeting so if you're tracking what goes on in those organizations I refer you to those two reports. Time for the Beloved Conflict of Interest Champ. I'm gonna go through it and this is the conflict rules that apply to 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 that are geographically separated, own organization is intended to mean the entire system except where a determination has been made that the components are separate organizations for the purposes of 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 an application from or involving your spouse, child, a recent student, recent teacher or mentor, professional collaborator with whom you have worked closely, a close personal friend or a scientist with whom you have had longstanding scientific or personal differences. The NHGRI staff will determine the appropriate action based on recency, frequency and strengths 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 discussion about any individual application, the so-called on block action, your vote will not apply to any application from an institution fulfilling any of the criteria noted above. So you'll see there's some new folders at your seats. This contains the conflict of interest and disposal of confidential materials form, which we're providing to you. Please sign them. You can just leave them here at your desk and we'll collect them during one of the breaks. We have one other task before we close the open session and that is in September, we will be introducing a new cohort of program analysts. These are people that come for about a two-year stay at NHGRI and so every year we bring in half a new group of analysts, but it's time to say goodbye to those who are moving on. This is a very talented and dedicated group of people that have worked with us for two years and they're going on to medical school, graduate school and a few cases, the next job in their career paths. So we'd like to take a moment to acknowledge them. When I call your name, would you please rise? Julie Corson, Anna Naughton, Annie Kneehouse, Alex Lee, Brenda Iglesias, Casey Martin and Kira Wong. So NHGRI Program Analyst Class of 2016. Congratulations, fare thee well and thank you for two years of service. We hope you got as much out of it as we did out of view. So you wanna gavel us to closure? And we'll reconvene with a closed session in about 10 or 15 minutes.