Chronic Fatigue Syndrome Advisory Committee - Cfsac - Meeting day 2 June 14, 2012 10 - 15am to 11 - 15am

>> Dr. Nancy Lee: What -- I want to give a little preface to what we're going to do now, which is the title is funding another support again from our HHS agencies. And the thought around this actually came out of the ad hoc work group, which was while there isn't very much targeted funding for chronic fatigue syndrome and that is an unfortunate thing within the federal government, there are actually many opportunities for funding that we should all understand. I really appreciate, for example, Susan's discussion because -- already because NIH is the big gorilla when we're talking about research funding. >> Eileen Holderman: The big gorilla in the room? [laughter] >> Dr. Nancy Lee: It has much more than anybody else in -- of the HHS agencies combined. And so -- but these are opportunities that the research community, which by and large does not represent federal government. Most research, biomedical research in this country, the vast majority occurs and academic centers and research foundations. And so and those opportunities have to be taken and these are independent researchers and we at HHS cannot tell them what research they're going to do. And so we want the committee members, and our audience at large, to understand the opportunities and to develop ways to nurture, to inform, to collaborate with academic researchers around the country to encourage them to apply for these opportunities and to develop these opportunities. The vast majority, I think Susan just said a few moments ago, the vast majority of the research funds that come out of NIH that are awarded by NIH are investigator initiated. That means these are non-federal investigators who write a proposal and sent it into NIH; and it's a good proposal and it successfully competes with less good proposals on this topic or many others. And that is a very important way that this business of funding research by the federal government has been going on for decades. And so I thought it would be a good opportunity today for us all to learn about these opportunities and to think about ways that we can encourage non-federal researchers to get into the business of applying successfully for these funds. Again, the federal government cannot tell -- and we don't want to tell these academic researchers what to do, but we want to let them know that these opportunities exist. And it's not just NIH funding, so that's one of the things that we're going to talk about today. So let me just start with Beth. >> Dr. Beth Collins Sharp: Thank you. I really appreciate being able to have this discussion because we've heard over and over about how there isn't enough research and how frustrating that is. And it's frustrating from this side of the money as well. And so I welcome this discussion. I'm pausing for a moment because some of the things I was thinking about saying have already been said. So I'll probably emphasize most of the points that have already been made. The two -- I'm thinking about this as in other discussions that I've had with investigators or professional societies who come and say, who say, "Come and talk about AHRQ and what the funding opportunities are," and they always seem a little bit surprised that AHRQ potentially might be a fit for some of the people who are there. So I'll tell you some of the messages that I give out and I appreciate Dane's comments earlier because the most important message that I highlight is to call a project officer and to have, if you don't already, a concept paper put together, one to two-page concept paper. So that the first question that a project officer is going to have with someone is about whether there's a fit with the particular agency and/or within a particular RSA. And when people call me, for example, they often are thinking about one particular request for proposals and I might actually point them in another direction. And this is an important point because I may in fact refer somebody somewhere else. I may say, or any project officer may say, "Gee, sorry it's not a fit. Why don't you try somewhere else?" That's a hard message to deliver, but I think it's important so that investigators don't waste time applying for grants for which there is not a good fit. And that's another point is that these take a lot of work, a lot of work to put together a proposal. And it may take several rounds before a proposal is actually funded. So it's a lot of work and we recognize that. So what we want to do is to make sure that it's a good fit and if we have to refer you out somewhere else. The second thing we look at once we determine it's a good fit, is the team. And is the research team going to be able to do this research? Sometimes creating a good team means that you need to bring on collaborators that may not even be in chronic fatigue syndrome, for example; and perhaps it would be a strategy to become the second investigator, for example, which I know presents after 20 odd years of time and academic setting, I know what the pressures are to be the principal investigator and to get funding and that sort of thing. But in the long haul it may be that you sign onto somebody else's grant that could then pan out for you. So who, for example, would not have loved to have been in the room when the project echo or other similar projects were being developed and they were saying, "Well what disease are we going to focus this telemedicine project on?" And they decided -- somebody said hepatitis C, or what can we do about hepatitis C? And don't you wish that you were there and said, "Well what about "chronic fatigue syndrome? This might be a good model for this particular intervention." So collaboration is an important thing and I think making connections with other investigators that you might not think of otherwise, such as the example that Susan gave where the researcher from NINR, the Nursing Research Institute, is going to take a related topic and now has been introduced to this idea of chronic fatigue syndrome and, you know, now will be taking a closer look; so making friends with investigators that you might not have thought of before. And one way that you can do that then during -- to look for collaborators is to look at other research that's been funded by a particular agency. And this is important for two reasons, well several reasons, but one is that it tells you if there's fit, it gives you an idea for potential collaborators or consultants, and third if it's already been done, it's going to be a hard sell to have additional funding going for a project that looks like it's going to be a replication. We want to spread the money out as much as we can. And then the final comment, I guess I'll make, in terms of fit and mechanisms because the Agency for Healthcare and Research and quality -- because our portfolios are a little bit different and the funding stream may be different, and so you may need to think about adjusting your concept to fit. That's not adjusting your research, necessarily, or nobody would recommend that, that you adjust that, but there may be an aspect, a wrinkle to it that you had not thought of before or that the focus of a particular area may be evolving. For example, in our patient centered outcomes research of comparative effectiveness research portfolio that started out being funded by the Medicare Modernization Act, then it was funded by the Recovery Act. Let me backtrack a second, so the Medicare Modernization Act the focus was naturally on Medicare and Medicaid populations -- on the health services for those populations. Then the Recovery Act came along, gave money to fund in this program, gave -- authorized money for this program and so then comparative effectiveness was one of the provisions in that funding stream. Now there are Affordable Care Act provisions that are funding patient centered outcomes research. And so with each of these it's a little wrinkle, as the science evolves and as the topics evolve. The other thing to say about the Affordable Care Act funding is that it is a stream of money that, for funding, that the tap is just now being opened. And there will be, assuming the positives going forward, that this funding stream will continue. And that the tap will be opened. And that tap is going to a number of places and HCPR -- HCPR. I can't believe I said the old name. HRQ is one of those places. I can't think of a more -- a place where research needs to be more patient centered than in ME/CSF. So I think that this is -- that's a personal statement, by the way. Here's an opportunity with patient-centered outcomes research that this funding may be applicable to you. So if you were to call me up with a concept, then we could talk about how that might apply, but I may say to you, "You need "to go talk to NIH because that funding stream is going to NIH, too." And it's going to -- and it's also going to the PCORI, the Private Public Partnership Institute and that might be a better fit for you. So for example, with the PCOR, patient centered outcomes research dollars, we at ARC are focusing on methodology, dissemination, and training. So that's a real specific focus and there may be something in that the fits. But that's a little bit different focus than what NIH and PCOR -- PCORI, sorry PCORI will be focusing on. The one example I wanted to give you of one of the methodology projects that is being worked on right now is registry of registries. And this was just published information, a white paper on May 31. As by way of background to know the agency has done a fair amount of methodological work on registries, patient registries. And there is a registries handbook, which is wonderful resource that could provide a lot of technical support. It's in its second edition, the third edition is coming now and some of the drafts will be out for public comment. But the third edition is coming, the second edition is wonderful. So I highly recommend those of you who are interested in patient registries to take a look at that. But at the same time, AHRQ recognized that there was a need for what we're calling a registry of registries. So along this model of clinicaltrials.gov so that there is one central place of searchable database to find out about patient registries so that the power of these registries can be amplified by finding and having similar data elements and creating the methods for these -- and operational methods for these registries so that everyone can benefit from that and there can be a transparent, sort of process. I know those are random thoughts and I apologize for being all over the place, but I really appreciate the opportunity and look forward to hear what you have to say about these thoughts that are from a different sort of perspective then perhaps we've considered before. >> Dr. Nancy Lee: Thanks, Beth, that's great. I think I'll go in alphabetical order. So we'll do CDC next. I just want to say a couple of addendums to my earlier remarks. The first is that most of the money that goes out from the federal government for biomedical issues is research, but there is some that is not research. And so, and we have some of those agencies around the table, so just not all of this is research per se. And the second thing is I just want to say another thing -- the last meeting we had there was talk about the need to -- for NIH specifically to reach out to CFS researchers and court them. And I think that's a very difficult task for all of these agencies to do. We have not just -- CFS is not the only agenda item for research or other activities. And so we have these existing mechanisms for funding for many, many biomedical issues and they are there and academic, this is the lifeblood of academia anyway. They know about how you apply for these funds. But I think there's real opportunity for the energy that I see over and over again from the patient groups to collaborate, to nurture these academic researchers, and help them come up with ideas. And it happens all the time for many advocacy groups. And so we do what we can, but I think there's a real opportunity for the advocacy groups, for the patient centered -- for the patient organizations that are that have CSF as their mission to really work with academic researchers to build the capacity and the funding that they could get for CFS through these existing mechanisms. So with that I think I would like to go around; is that all right, Eileen? >> Eileen Holderman: I just had a question about the graph. >> Dr. Nancy Lee: About? >> Eileen Holderman: The [unintelligible]? >> Dr. Nancy Lee: Let's do that at the end. >> Eileen Holderman: Okay. >> Dr. Nancy Lee: When we hear from everyone, okay? >> Eileen Holderman: Okay. >> Dr. Nancy Lee: Ermias. >> Dr. Ermias Belay: Yeah, I'll try to keep it very brief. The CDC does not have investigator initiated funding opportunity the way NIH does not just for CFS, but for other diseases. It's just not our mandate. So there are no specific investigator initiated funding opportunities the way NIH makes it available because it's not our mandate. Those dollars go to NIH specifically. Having said that we have specific budgets for CFS, which range from 4- to $5 million a year and a good chunk of that funding is actually used to pay for the kind of activities that I described yesterday. Specifically, for provider education, to purchase the CME credits, to buy the contract for the CME credits, and also the standard -- standardized patient that I referred to that yesterday. We have the contract with that outside agency to develop the standardized patient for potential incorporation into medical school curriculum. So provider education in different formats, different ways are paid for through a contract mechanism that we have. The other way we -- that we use our funding for supporting activities is for example, yesterday, I mentioned the multi-side clinic studies, the seven clinic studies that we are funding. And again some of the money that we have is used to fund that project. And as -- >> Dr. Nancy Lee: And how did that money get put out? >> Dr. Ermias Belay: We usually use a cooperative agreement mechanism, which is different from grants and investigator initiated [unintelligible] one and the other approaches that NIH uses. So it's a very -- >> Dr. Nancy Lee: So it was competitive though. >> Dr. Ermias Belay: Its cooperative agreements that potentially competitive, yes, they are open to, you know, a lot of researchers to apply for. The only difference is the idea about the research and the activities and the projects that are initiated by CDC, that's the difference. Other than that, it's a competitive process. In the other activities that we fund is the pathogen discovery that I mentioned yesterday with the Institute in California. Again, that's actually a specific contract because we have a specific question that we'd like to address, scientific question, and then we target that funding to a specific laboratory and that's how we funded that activity, the pathogen discovery. >> Dr. Nancy Lee: And that was competitive? >> Dr. Ermias Belay: I have to check on that, but I think it was a contract. When it's a contract, it doesn't have to be competitive. >> Dr. Nancy Lee: But it may be. >> Dr. Ermias Belay: Dr. It could be, but it's like purchasing a service. I mean there's a lot of funding jargon, but I don't want to get into the details. That's pretty much it from CDC unless you have specific questions. >> Dr. Nancy Lee: Just emphasizing the competitive part because that's again an opportunity -- especially when things are competitive that people can come in with their application. >> Dr. Ermias Belay: Definitely. When we put the cooperative agreement, it's open for anyone to -- >> Dr. Nancy Lee: Right. >> Dr. Ermias Belay: -- to submit the applications. And that's how it was funded. >> Dr. Nancy Lee: Right. And our plan is -- and I think we have done this in the past, is when such specific CFS opportunities come out that we can then put a notice out our Website and a link. And with the listserve that we're trying to publicize, we could get that out more. >> Dr. Ermias Belay: That's usually announced on grants.gov, I believe, the government wide Website that actually lists the different cooperative agreements and opportunities that are available. >> Dr. Nancy Lee: I think I want to just break a moment because we have a new person at the table. Dr. Lisa Corbin, who has come to us from a redeye flight; right? >> Dr. Lisa Corbin: It was delayed two hours. >> Dr. Nancy Lee: Oh, such a good -- we really appreciate your -- thank you, Marty. We really appreciate your effort to get here. She is the associate professor Department of General Internal Medicine at the University of Colorado, Denver School of Medicine. And she's served as the medical director of the Center for Integrative Medicine at the hospital at University of Colorado and she is -- there's a clinic associated with this, and she has seeing a diverse set of referred patients for chronic fatigue syndrome and fibromyalgia and uses complementary and alternative medicine approaches to care for patients. She is an expert in complementary and alternative medicine and incorporates these principles with traditional medicine in her practice. She also conducts research in chronic fatigue and pain through the incorporation of integrated medicine. So thank you, Dr. Corbin. Do you have anything else to add? >> Dr. Lisa Corbin: [unintelligible] >> Dr. Nancy Lee: Okay, good. Yeah, and we always have to use this thing and we help each other by reminding. Good, thank you. And we're so glad you're here and appreciate your efforts at getting here for the second day. Let's have, since CMS follows CDC in the alphabet, let's have Alaine go. And I know, Alaine, you have a couple of slides? >> Dr. Alaine Perry: No. >> Dr. Nancy Lee: No? Okay. >> Dr. Alaine Perry: No, I don't actually, no. But the list of websites that I handed out also contains the Website for the Innovation Center, which I'm going to talk about. So you already have that. Okay, so I mentioned in my earlier presentation the CMS Innovation Center, which was one of the products of the Affordable Care Act. And so I want to talk a little bit more about what they do and how that's relevant potentially for us dealing with CFS. Basically, the Innovation Center was established by the Affordable Care Act to test innovative payment and service delivery models to reduce program expenditures in Medicare and Medicaid programs, while preserving or enhancing the quality of care for patients. And basically their goal, you know, more in plain English is to make transformations in the health care system where through improvements and innovations in the health care system, quality of care and access to care for patients can be improved at the same time that costs are lowered. So that is their goal. And their basic process is working with a very broad range of stakeholders to solicit ideas for innovative models, then select and develop those models to test them, to evaluate them. And then models that are successful they would then work to disseminate and spread more widely. And their focus of course, is on Medicare/Medicaid and the children's health insurance program, the programs that we run, but they are very interested in things that also can apply more broadly. So it's really about seeking better ways to do health care, not just -- not just, you know, Medicare and Medicaid programs. So some of the kinds of things that models that they've been developing or testing, things to do using telemedicine, using more integrated multidisciplinary approaches to care, using non-physician care to kind of extend capacity, a lot of emphasis on care coordination, on increasing emphasis on primary care, testing different payment models such as providing compensation for care management. They've funded -- a lot of the programs are general and would apply, you know, across different diseases, but they also do have some disease specific programs. There is -- they've done grants for a program on chronic pain, on stroke, on asthma, just to give a few examples. They also -- I actually just noticed one of -- they recently gave an award to a, I guess it's part of Project ECHO or it's the same organization that's doing Project Echo is now getting some funding from the innovation center, so that was interesting to see. So I had mentioned at an earlier point, I think I sent out some information to the committee about health care innovation grants. These were announced in the fall. And they did close applications for those, for the first round of those in the winter and they actually have already awarded some of them. They're going to announce more awards at a later point. They had said when they announced the first round that they may or may not announce a second round, open it up for a second round of applications. They have not made a decision yet about whether there will be a second round, so that is still pending. I will keep you informed about what happens with that, but I don't know at this point. But what I do want to talk about is another approach with the Innovation Center, which is what they refer to as their pipeline process. And basically, the way this works is it's a little different than a typical -- it's not a solicitation or sort of the typical approach that you would see. Basically, they are inviting any stakeholders to come up with ideas for models that they should test. So it's kind of getting in on the ground floor, as Beth was talking about. And this is something where, you know, it could be any individuals from CFSAC, it could be people outside of CFSAC, you know, it could be, you know, a couple of people in CFSAC bringing in some other colleagues from outside. You know any group, any kind of working group could pull together and work on coming up with a model. And I would be happy to provide technical assistance and, you know, brainstorm about ideas. Also the Innovation Center is very open to providing technical assistance. And what they would be looking for are again, their charge is to find ways through innovation, through improvement to both lower costs and improve quality at the same time. Lowering costs could be in the short term or it could be in the longer-term. One thing that they do really require is the development of a really clear business plan and a really convincing demonstration that the intervention will -- the model that is developed would put us on the path to both improving quality and reducing cost. And so, you know, that, you know, it would require a business plan with numbers and figures and a strong rationale for how that could work. They very much encourage collaboration with other HHS agencies, so, you know, I think if there were other agencies that wanted to come together, you know, that would be looked upon favorably. And so I think, you know, some of the kinds of ideas that we've been talking about along about the project -- doing something to the Project ECHO model, and, you know, other ideas. And I think, you know, the door is, you know, just kind of open to brainstorming and, you know, it would be something where we would need to sit down and, you know, have brainstorming conversations about what type of model might be helpful to people with CFS and advance health care, you know, for this population treatment and health care for this population. And also be something that could meet their criteria for showing cost savings in the short or long term. So and then what's interesting about the process then is that, you know, if we came up with an idea for a model then that they accepted, then at that point, they would then go out with a solicitation. So they would, you know, whether it could be through cooperative agreements, through grants, through contracts, but that is the point at which it would become a competitive process. And it would be open to anyone who met the criteria and wanted to apply to submit an application to test the model that had been outlined and developed. So the group that came up with the idea could apply, but they wouldn't necessarily be selected, although one would think that they would probably have a strong, you know, application. But so it becomes a competitive process at that stage. So it's something that obviously would take a lot of outside work, outside of, you know, this meeting to have discussions about people's ideas for what a model might look like and how a business case could be developed for that. But I'm definitely very willing to engage in any conversations with anyone who is interested on the committee or off the committee. So, thank you. >> Dr. Nancy Lee: Thanks very much, Alaine. If -- now we can have Terry talk from FDA. >> Dr. Theresa Michele: Okay, thank you very much. So I want to start off with just a little bit of background about FDA because we are essentially a fundamentally different agency than many of the others that you've heard of here today in that we are a regulatory agency. So we are responsible for actually regulating a large portion of the consumer products that people use every day. And this includes some things that don't necessarily apply to what we're thinking about here, the foods, the veterinary products and the tobacco products. The three groups at the agency that focus more specifically on health products would be the Center for Biologics Evaluation and Research, which essentially does vaccines and blood products; the Center for Radiologic and Devices, and they are what they say they are; and finally, the Center for Drug Evaluation and Research. And that's the one that I'm going to focus on because that's the area that I think probably applies most closely to the work of this committee. So just to correct one misconception that I've heard in some of the advocacy groups, there was a request put out yesterday to accelerate the FDA pipeline ME/CSF. And just be very clear, we don't have a pipeline. We don't have a pipeline for asthma or cancer or anything else because we don't do drug development. What we do is regulate drugs that come in that are in the process of being developed and that are out in the market. So the pharmaceutical companies have a pipeline and we try to facilitate that process and make sure that the products that get out on the market are both safe and effective. With that said, we don't really fund drug development either, that's up to the pharmaceutical companies to fund drug development or, you know, individual investigators or whoever else is really out there doing drug development. There are some opportunities though for funding and for facilitating this kind of development. Sponsors actually pay user fees whenever a product comes to FDA for approval for marketing. There are several situations under which those user fees are waived. One is the first approval of a drug by a small business and that's written right into the laws. So there are specific criteria of what qualifies as a small business, but if a company is small and they're certain numbers of employees and so forth, and they do not have a product on the market yet, they can qualify for a waiver of that user fee. With that said, there's a whole lot of money that goes into drug development before you get to that point. This is after you have your drug, you've done all your testing and you're ready to put it on the market. There are also waivers of user fees for orphan products. Now chronic fatigue syndrome, as you've all heard about, there are many people now with chronic fatigue syndrome and the actual numbers vary depending on who you talk to. But to qualify for orphan status, you have to have fewer than 200,000 individuals with the disease in the United States. So once upon a time, years ago, chronic fatigue syndrome did qualify for orphan status, but it no longer does. So if a new company comes to us and asks for orphan drug status, chronic fatigue doesn't qualify at this point in time. The other place that companies can get, not waivers of user fees, but additional marketing exclusivity which ties into a great deal of money for these companies is in pediatrics. So once you have a product that's on the market, you can ask for a pediatric written request in which case, if your product qualifies by doing the correct pediatric studies, you can get an additional six months of marketing exclusivity. So that's a way that once were down further along the road, we can look at making sure that these products that would eventually become available for chronic fatigue syndrome, could apply to a pediatric market. I'll also refer you to our website. There are links there that take you to the Small Businesses Administration. And there are specific grants and loans that are available through the Small Business Administration that could be used for drug development. So if you go to the FDA Website, which is very easy, www.fda.gov, click under cedar, click under industry, and then there's links to small businesses. And there are links there that will take you out of the FDA Website, to the Small Business Administration and there are specific grant mechanisms there that can help with drug development and product development for small companies. Thank you. >> Dr. Nancy Lee: Thank you. And just to re-emphasize the point that I keep reemphasizing, is this is another opportunity, I think, for our research community, for our advocate and patient community to partner this time with drugs and drug developers. And we even had one of the drug companies speak yesterday in our public testimony so you know who that person is. Maybe you can partner with him. So again these are opportunities, I think, for the energy that I see in these -- in the committed people around CFS to really find new partners, new collaboration, new nurturing opportunities. So with -- I'm on my soapbox. With that, Deborah Willis-Fillinger is going to talk about HRSA. >> Dr. Deborah Willis-Fillinger: Well, actually, I had said that there wouldn't be much from HRSA because we are an organization that supports direct care services, community organizations, and other non-for-profit that provide direct care and/or infrastructure support for health care services. We don't have specific funding for chronic fatigue, ME, or other specific diseases. So the best way -- and now the example that I had given back last November was the family to family network that was being funded at that time, and as you heard those awards have been announced in May. There isn't anything similar to that at this point, but we do have our Website, www.hrsa.gov and there's a link for funding opportunities. So between now and the next meeting, it'd be useful to keep an eye on that site for additional funding announcements. >> Dr. Nancy Lee: And Deborah, if you'll let us know, we can add it to our -- >> Dr. Deborah Willis-Fillinger: Absolutely. >> Dr. Nancy Lee: -- CFSAC and to send out the information on the listserve. >> Dr. Deborah Willis-Fillinger: Yes. >> Dr. Nancy Lee: That's great. The big gorilla can talk again. This is just the big gorilla on research; right? >> Dr. Susan Maier: Thank you, yes. >> Dr. Nancy Lee: Because we had - the big, big gorilla in HHS is CMS. They have the big budget, but they don't have as much research opportunities. >> Dr. Susan Maier: So I think during my presentation earlier, I highlighted what really is the thrust of NIH in terms of supporting research and that was the use of investigator initiated versus targeted research solicitations, if you will, to stimulate a field or encourage a field of research in a specific area. Those are really the things that we do and we do actively seek out potential investigators when we go to meetings in our specialized areas of expertise. Whenever an individual goes to a meeting, they are always a target for researchers to speak with and they do that. That's part of their job is to encourage people to apply for research in any and all areas that they are qualified and eligible to apply. There are -- and I did speak about some other opportunities that I thought might be potentials with regard to collaborations. And like I said earlier, there are limited funds. And they're a lot more people seeking funding. And it's not the -- when I was younger and seeking funding, it was, you know, one investigator one grant; one investigator one grant, or one investigator, if you were lucky, two grants that would be funded. That world, I think, is going away very rapidly. We are in a team environment. We are in a multidisciplinary research environment. We're in an environment where the techniques are available are expensive. Technologies are not cheap, if you want to look at -- if you wanted to do MRIs, or do advanced testing, or do genomic testing, or any [unintelligible] testing, those resources are expensive and it's no longer a period where we can simply just apply for a grant, where a researcher is going to apply for a grant and get that grant and do all of the research that this world now demands. So those are the things that NIH does is we are trying to leverage as much as we can with the money we have and trying to bring people together, bring resources together, support the infrastructure so it is available, for example like the CTSAs. That infrastructure support is available. There are two things I'd like to emphasize and they're a little bit, somewhat different. One is that when I discussed earlier and we've heard it also about registries, patient registries. What I think would be a really great idea, and this is something that everyone can advocate for. You do not need to be an advocate, but you can advocate for is the development of repositories; repositories for biological samples, repositories for data, data collection of any type. And this presents an opportunity because if you have a repository of data samples that are available for use, already collected data, what this does is once those data are harmonized and they're all collected similarly, and the data are all -- mean the same thing essentially in that database; once you have that, that presents an opportunity for secondary data analysis. So if my research question is different from the next person's research question, but we still need the same type of data, we can ask different questions. And even if we don't find an answer or if our answer is unclear, it's a source of information that would present an opportunity for hypothesis testing and for hypothesis generation. So we're not limited by what should I do and how should I collect those data, the question is different. Here are a set of data and, you know what can I ask? What type of hypothesis do I have and how can I ask that and can these data help me? That's a very inexpensive type of experiment, is secondary data analysis, very inexpensive. The data are already there, it's collected and I think that presents also a very good opportunity. There are other views -- >> Dr. Nancy Lee: Will NIH fund applications for such data registries, patient registries, is that an opportunity? >> Dr. Susan Maier: An opportunity always exists for individuals who would like to submit an application for developing a data repository, yes. And there may be some other opportunities for that vehicle that are not yet available. But one other thing I'd like to mention and this is an important point because I think this involves not just our committee sitting here, but our advocates who are in the room. NIH, as I said, supports much of the research they support is investigator initiative. Even when there's a targeted solicitation or targeted funding opportunity announcement out there, for example, on ME/CFS we have to receive applications in order to review them and potentially fund them. There are not very many applications submitted for ME/CFS. This is a problem because if we can't get the applications in and review them, and fund those that score well, then we can't fund ME/CFS research. And I know the second -- the thing that's popping into everyone's head is well, hello, why don't you just issue a request for applications? Put some money behind it, you know, put some teeth in there. What I've noticed, and this is working for a different institute at the center within NIH, but I'm sure you'll know which one it is, is that even don't you put out an RFA or request for applications and attach funds to it, there is no obligation to spend that money, if applications are not well crafted and they do not address the questions that are asked or that are suggested as areas of research within that request for application. So even if applications do come in in response to a request for applications, with this set aside amount of money, there's no guarantee that that research will move forward if the applications, again, do not score well or did not address the questions that NIH is seeking to answer. And this is something that the working group is struggling with is how do we get people to submit applications? How do you get them in? And that's why we're trying to do as much outreach by attending meetings in our areas of scientific expertise, in reaching out to people, reaching out to people who are not in the ME/CFS research area, but have unique approaches and ideas and reaching out to those who are in the field and letting those people cross communicate, letting that research suggestions and ideas cross fertilize to try and move the field forward. And that's our goal. And so those are, I guess all the opportunities I can -- well, I can think of a couple more, but that's what I would end with. >> Dr. Nancy Lee: And that's what you have. And I know that fortunately, Susan put together a PowerPoint that has lots of the details in it and that will be available on our website once we get them in the right compliance. And just to sort of -- I've heard this before in talking with Susan and with other leaders at NIH, that if they don't have a lot of applications through the R1 process, then there's concern that there's not a research community out there that can respond to a more targeted RFA. Let me just for people who -- I mean it can get a little confusing. There's investigator initiated, which is the stuff that mainly NIH funds. And they sent out a thing and say send us back some ideas. The other kind is the kind that said we have a need for a specific topic and here's some money if you can give us an application. So those are the request for proposals. And I think there is also a hesitancy if there's not a lot of investigator initiated issues on chronic fatigue syndrome, then to say well if we don't have that coming in, how do we know there's investigators out there who have the capacity to respond to a specific request for proposal? So again, here is an opportunity for the CFS community, both researchers and patients and advocates, to really build, nurture, collaborate, and work with the -- our academic environment to build those. Let's have some questions. And Eileen, go ahead. >> Eileen Holderman: When you say request for proposals, is that synonymous with an RFA? >> Dr. Susan Maier: Yes. Technically, a grant would be submitted -- a request for applications is the terminology used for grants and cooperative agreements in the NIH world. A request for proposals in the NIH world issued for contracts. >> Dr. Nancy Lee: And we can get those -- but they typically have a specific -- >> Dr. Susan Maier: Typically, request for applications will have a set-aside amount of funding that will be dedicated at the time that the solicitation goes out for that particular request. Applications will come in, they'll be reviewed, and then the grants, or the applications will then be funded in the order of their score, how well they did until the money runs out in that set-aside. If there are insufficient applications within that set-aside, the money doesn't get used for that, obviously. >> Eileen Holderman: Okay. And I had a question for Deborah? I love everything that you always talk about with HRSA, your programs. And I just wanted clarification. I know that they have a focus on AIDS, but everything else in HRSA is not disease specific? And if that's the case, and I would never begrudge any disease group for getting anything, but why AIDS and why not CFS as CFS has way more sufferers and also tend to follow into low income population, do you know? >> Dr. Deborah Willis-Fillinger: That's a historical -- Yeah, it's right. It's called -- There's a Ryan White Care Act that was passed, I guess it's been almost 20 years ago. And that was because at the time people were dropping dead and no one understood why and the numbers were increasing and it continued to increase worldwide. And there was a desire to provide decent services for that population. I think that the Ryan White reauthorization will be -- is being considered right now for future years and future funding now that there is treatment available to patients both for care and prevention. Those funds may be re-diverted into basic primary care in the future, but at present, that's -- I can't explain it in any other way. I think that the size of the epidemic, the political support and advocacy around that particular disorder, obviously the catastrophic impact of *** AIDS as well as the infective nature and spread. There are lots of other reasons why those kinds of diseases, that particular disease is a high-profile disorder and particular care was needed. Part of the challenge was not only that it is -- there is a catastrophic impact and it continues to spread, but also that there's a fair amount of education that needs to be provided to the public about prevention and an appropriate treatment in order to stem that epidemic and control it. >> Dr. Nancy Lee: Susan. >> Dr. Susan Levine: I had a couple questions, and I don't know if we're going to have a time to address both of them, but Beth, you were talking about -- if you could explain to us what a registry entails? Like is it providing the disease state of a, I guess de-identified individual and what more is involved with the registry? And I wanted to ask Alaine, please, to give an example, if she could, of the kind of coordinated care that you're looking for that would reduce -- like, I'm thinking maybe care of chronic illness like hypertension. What would be an example of applications that -- would it be like having a special -- somebody see a specialist just once a year and educating the primary care about illness? What would be an example of cost reduction that you are looking for that may have been implemented already? >> Dr. Beth Collins Sharp: So patient registry is a centralized place where individual -- data about individuals is collected in order to follow them through time and evaluate a number of treatment options, natural history -- >> Dr. Susan Levine: You'd search under like a subheading of sorts like hepatitis C, for instance? >> Dr. Beth Collins Sharp: Yes. In terms of the registry of registries? >> Dr. Susan Levine: Yeah, how would you access it and well how would you search for something -- a disease you were interested in? >> Dr. Beth Collins Sharp: Yes. You could search by disease, you could search by age range, you could search by a particular treatment to see where treatments are being used and across registries. While we're talking about registries, the strongest registries are those that have -- one opinion from health services perspective is the strongest registries are those that include biologic and clinical data. And the more patient centralized -- patient centric data that are included, the better. So that may not be just clinician reported data, but also patient reported data, as well as biologic data. Bringing it all together creates the strongest databases. Of course that makes sense, but it makes a significant difference when you include the clinical data with the biologic data. And then the next generation is that which includes patient level data, quality of life, patient reported symptoms, those sorts of things. >> Dr. Alaine Perry: I want to answer your question. Yeah, I don't -- I'm not going to be able to give you a model in any kind of specific detail. I will -- you actually can get a lot of details from the innovation center website about what they've currently funded and different models that they're testing, but an example of care coordination would be if, you know, someone has multiple chronic conditions, primary care organization, being paid perhaps an additional care management fee to really help track, you know, the different specialists that person is seeing. Maybe contact them at home, you know; maybe using telemedicine to, you know, check on whether they're adhering to the different regimes, that kind of thing. That's just one example and I think the cost savings come in. The idea is that things that aren't traditionally reimbursed, or not reimbursed enough to allow the providers to really have an incentive to do it might be reimbursed, but then there would be savings down the road because the person would stay healthier, reduce hospitalizations, et cetera. >> Dr. Nancy Lee: Thank you very much. So I think -- let's continue this discussion this afternoon, because we have -- we're eating into our public comment period. And well, actually not our public comment, we are eating into our break because we're going to start promptly with public comments at 1130. Pardon? We have a 10 minute break. Okay, thank you. And thanks to all of the ex officios. We have a lot of good information today.