 So, the President's budget for FY13 has language in it that says NIH will establish a process for additional scrutiny and review by an Institute or Center's Advisory Council of Awards for any principal investigated with existing grants of $1.5 million total cost. In addition, we would also want to ensure that the highest level of scientific quality and innovation is achieved and that we can maximize NHGRI's investment as ways to be responsive to the strategic plan. So what does this mean in terms of special counsel review? There are two sets of applications that will be considered for this review. One is the competing research project grants and those are listed. There are a lot of activity codes in the RPG line, but the ones that we use most commonly are the ROO, which is the second part of the K99. The R01s, small grants, R03s and R21s, R15s, which are the area awards. These are awards to institutions that don't have a lot of NIH funding. The program project grants and the DP1s and DP2s, which are those common fund initiatives to support innovative research. Also included are the competitive revisions, which are the competitive supplements. So what contributes to the threshold? The funds that are committed to the RPG that are awarded from all institutes, so if an application comes to NHGRI and that individual has support from the Cancer Institute or NIGMS, that will be included as part of their $1.5 million bucket. Also included will be funds that are attached to an investigator who has a P01 or a multi-component or a multi-PI application. So if there are three or four people who are part of a P01 or a multi-component or a multiple PI, those funds will be included in that as well. But what happens is that the funds are divided equally, no matter how it's cut at the lab, it's divided equally by the number of PIs just for convenience sake. So what is included in the special council review? Awarded P01s, multiple component and multiple PI grants in which all the program directors or the principal investigators meet the threshold. So that means they're going to be looking at if you have a P01 or multiple component, if all of the PIs or program directors in that grant have a total award that's exceeding $1.5 million, then they will be included, that's included. Again we talked about we will be looking at funds from NHGRI as well as any other institute that that particular applicant has funds from. And also if an institute has designated an application that's pending an award that will also be included in the $1.5 million annual cost. What will be excluded will be applications in response to requests for applications or PIs or multiple PIs or multiple components in which at least one of the principal investigators do not meet the threshold. So if you have a multiple component grant in which one of the PIs has less than $1.5 million then that throws that grant out of the pot. And also diversity and reentry supplements will not be included. The reentry grant, a supplement, that is a supplement to a parent grant in which an individual who has been out of the research workforce for several years and now they have decided to come back and get some retraining. No all right now this is all NIH wide and there is a notice that was recently published I think on Friday in the NIH guide that gives some additional information about this. But up until now this is all NIH wide. So the centers and the institutes, their councils have some flexibility in weighing what factors should be considered when we are looking at an application that hits that threshold. So now this is a mixture of NIH specific and NHGRI specific examples. So some of these include if an application is responsive to a specific institute initiative such as an RFA or whether something is specific to the strategic plan. Whether it is to continue a highly productive project. So for instance if you have had a type 2 which is a competing continuation and that applicant has been highly productive, if they hit the threshold then you need to consider whether what harm would be done if you decide not to fund it. Applications that are highly innovative and will advance the field significantly. Are applications that address a field of research requiring greater attention. By that we mean you have some types of projects that are more expensive than others. For example, other institutes have clinical research studies that are very expensive. For NHGRI we may have technology development applications that may be expensive. So that would be something to consider. If you didn't fund this, would this severely inhibit collaboration? If someone is applying new or existing concepts, methods or technologies or ways of analyzing data that result in significant advances that would be another reason to fund. To have a high indirect cost. Now we do know that institutions vary with their indirect cost and whereas that should not be an automatic reason to not consider that, it is relevant to the discussion and you can decide whether you want to include that or not because after all we are talking about 1.5 million total cost. And then sometimes applications will have a very high first year cost because they are requesting very specific unique equipment that is a one time only cost. And I put other there because there may be other issues or areas in which it would be important to sort of override the 1.5 million dollar request. Now what is important here is that this is not meant to say you cannot fund an application. It simply means that when an application hits this threshold you are required to at least examine it in a more thorough and intense way. And if you determine that this person has more than 1.5 million and this is a good investment then that is okay too. Council yes. I beg your pardon. Any other group do this scrutiny or is it just council and then a recommendation made? Just council. In fact we are going to the process we are going to use is the same one we use for special initiatives, the staff analysis so that when an application hits the threshold staff will generate a staff analysis and then you will have the option of reviewing that and either agreeing or not agreeing with staff. Those study sections and special review groups are not going to see this issue. No. That is really not relevant to them. Recommendations for funding are at this level. So in principle this could make no difference or in principle it could make a difference and it will depend on council's reading of the relevance of the work. Correct. Correct. But it is not a rubber stamp for what staff is recommending as it never is with this council and it shouldn't be. So the way this will work is that NIH now has a program that will generate a list of eligible applications going to every council. This management staff along with the program director will look at that list to make sure that everything looks appropriate. There may be some decisions they will have to make. For instance if someone has an award that ends in a month or two and they have hit that threshold well the decision may be to not include that in the 1.5 million because if that drops out and they are below the 1.5 million then a month from now that would inhibit their research. So there will be some decisions made very lightly about what should and should not be included but we won't override the basic principle. After that we will then put these applications in the electronic council book. And we will only put in applications that we are considering funding. So if we have five applications and say three of them have scores of 45 and they hit the 1.5 threshold there would be no need to discuss these because we don't plan to pay them. However many times we at the end of the year will go back and pick up applications that we hadn't thought about funding before. But if we pick up an application that hits that threshold we can't fund it until we come back and bring it to you for review. So we will treat this like we treat all applications dealing with exceptions. There will be a staff analysis. Council will have an opportunity to discuss and give their recommendations. And then after that happens we will then notify the institution and the PI if their application was in a fundable range and because of the special council review it was decided not to fund it then that information will be conveyed to the institution and the principal investigator. So I think that's all I have to convey. And if you have any questions I think between Mark and Cheryl and Monica we should be able to answer them for you as best we can. Do you have any idea what percentage of grants are going to need to be looked at this way or what number? The percentage is very, very small. Throughout NIH it was like 2,500. A GNO? It's going to be very small somewhere between 2 and 3 applications per time. We really don't have that many. Because remember we are looking at the RO1 types. Got it. I got it. And just for, yeah. All right. I'm missing the point. If somebody has a big center grant and they write an RO1. A center grant? Yeah. The center grant doesn't count. No. Oh, the center grant is excluded from the 750? Yes. All right. Yes. The other thing that reduces the numbers a lot is that everybody on a multi-component grant has to raise the alarm bell and if anybody on the grant doesn't then that grant is excluded from consideration if I understood the way you describe the rules. That's correct. The other thing is any RFA that comes to council it's not included in the review. However, if that person then say another round comes in with just a regular RO1 then that will undergo special council review. And so realistically the scenario you maybe could envision is if someone's really good at writing RO1s and then doesn't do the work then this would be a way to flag that and avoid funding. But in just about any other circumstance. Right. Because if they write a lot of RO1s and they're really good and they really do the work you're not going to get rid of them. And if it's another mechanism besides RO1 you're not likely to be getting up to a million and a half. Right. Okay. Yeah. But I think we're looking at kind of innovation and things that are really going to push the field forward. Yes. Well, maybe Mike just answered my question but as I was looking as I was listening to the several reasons which would be considered as adequate justification for going ahead and paying it. They sounded like traits that we look for in all grants, highly productive, innovative. If you have collaborators and you don't do it it'll hurt the collaboration. And I was asking, I wanted to ask what's a scenario where you would not pay? Grants have already gone through that the study sections have given them good enough scores that you know they're making the pay lines. On what basis would we turn one down? Well, I can't say exactly but I think one reason would be say we have a portfolio of grants in which similar research is being done. And this is a very good application but it doesn't move us significantly beyond what is already being funded. So I think that would be kind of a weak reason for not funding that again. I think study sections hammer that right away. Any other questions, comments? Do you, I guess for the answer to your question is that we're not really looking not to fund somebody on the basis of the rule, we just have to do it. I did get the message that it has to be done. Thank you, Bert. I do appreciate that, Marty. Well, the other part to this is that after every council round NIH will be making a report to OMD about how well we're doing in monitoring this. Okay, thank you, Betty. We will move on to our last presentation.