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Welcome to the PCAST members, to the OSTP staff who are here, to the members of the wider science and technology and policy community who have joined us for this session, and welcome to those who are watching the webcast. We have as usual a full schedule this morning, and in order to move smartly into it, I'm

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going to call on my co-chair, Dr. Eric Lander, to make a couple of opening remarks. Eric. Great. Let me add my welcome to John's, my thanks to everyone on the council who's continuing

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to work very diligently on a large number of remaining projects. We're going to hear about one of them today for approval. We're going to hear a report about one that was recently publicly approved and has been made available.

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We'll have some other really important updates on aspects of nanotechnology and questions related to academic research. I wanted to particularly flag an activity that PCAST has begun. The PCAST has begun to explore how best to ensure the quality of forensic science based

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on reliable principles and methods within the criminal justice system, and PCAST is particularly interested in hearing from the broad community of experts and stakeholders in this area. We've taken the step of posting six questions on our website, and over the next 30 days we're inviting feedback from experts on these questions.

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I figured since we have a public meeting, I would mention that to the many people who are watching or will be watching on the web. You can find it on the whitehouse.gov website, the PCAST page, which you can easily find by searching for.

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You'll find the six questions there, and we thank people in advance for the input that you can provide. With that, I think we'll dive right into our opening report. I'll toss it back to John.

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Good. Good. Our first scheduled discussion is on hearing and technology, public airing of the report findings and recommendations of an ongoing project on technologies to help aging Americans,

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and I'm going to call on Chris Castle and Ed Penhoek to talk about that, and Chris, I think, will lead off. Chris. Yes.

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Thank you, John. First, I just want to acknowledge that this is a report that PCAST has approved on an open telephone meeting, and so the report, as you mentioned, has been released and is available to the public, and we have received a number of responses to it and made other

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presentations about it. This being the first in-person PCAST meeting since that time, we wanted to present it more formally in this open public session for that purpose. The first thing I want to point out is that this report is the first of what will be a

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larger report on the topic more broadly of how technology can help people as they age to remain independent, remain productive, and improve their quality of life. There's a wide range of very available and promising new technologies that can help address a range of issues, and the issues that we're looking at in that report include social engagement,

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transportation, connectivity, mobility, cognitive impairment, and the ways in which various kinds of technologies can be helpful to sustaining quality of life. So stay tuned. You'll be hearing more from us on that.

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So I'm going to focus today's comments on our hearing report, which, as I said, has been approved, and I mentioned it's part of this larger focus on aging and technology. One of the reasons we accelerated this focused report on hearing is that we recognize that it is a very focused issue where there are very specific kinds of technology issues, and

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we recognized a timely opportunity to comment and make recommendations about how changes in technology and federal policy could really accelerate improvement in both access and innovation in this area. We want to make very clear that we're looking at this very focused area.

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First of all, our remit is to look at that technology. We understand that there's a broader hearing ecosystem and health system, and that these are really important issues to address. We know that the Institute of Medicine is doing a larger report that will address these

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broader issues. Our focus is ways that the technology can be enhanced and made more available. Secondly, we're not looking at hearing problems for children, adults who have very severe hearing loss, and those with the kinds of red flag conditions that show underlying medical problems.

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So in this case, we're looking at mild to moderate hearing loss, bilateral, progressive, related to aging. This is the working group, and I want to particularly acknowledge Ashley Preetith, who is the Assistant Executive Director of PCAST, who has really led the staff effort, along with Diane Pankovich

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and Jennifer Michael, and of course, as always, Marjorie Blumenthal. This is the context. Hearing loss really is a major problem, a major public health and social problem for Americans.

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Roughly 30 million, we think actually there's an underestimate of the number of people who have difficulty hearing because so few people who have hearing impairment actually seek help. Hearing loss is associated not only with inability to interact in social environments and with

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family members, but more broadly with social isolation, with depression, with inability to get around safely, falls, and even more recently, studies have shown links with worsening dementia and other kinds of medical problems that just exacerbate the inability of older people to remain independent.

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And of course, as our population lives longer, we're going to see more of this because much of it is related to aging. Something like half of people over the age of 60 have hearing loss, which really is an enormous number of people who could be helped if technology were more available, as well

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as the broader range of services, and as we live longer, this number will only increase. So in addition to the large numbers, this remarkable finding that only 15 to 30 percent of older adults with hearing loss use hearing aids. And so that's really the problem I want you to keep in mind and that we were focused on.

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So we asked ourselves, what are the barriers? Why do so few people seek help? The major barrier is far and away the major barrier, although not the only one is cost. Hearing aids cost roughly, and this is an average, so they're very wide range, but roughly

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$2,400 per hearing aid. Most people need one for each ear, so double that, and very few insurance companies cover this. Medicare does not cover it, so most people have to pay out of pocket, and so that is

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a major barrier. Unlike almost every other area of consumer electronics, innovation and progress in the field has not reduced the cost, if anything, it has increased it. So that is one of the sort of market problems that we wanted to address.

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It's also very difficult for consumers to shop for best value. We heard this from a lot of people that the whole system for how you get access into the hearing health system is very obscure and not very user friendly. Consumers are used to shopping around, going online, finding out what's available.

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With hearing, it's much less clear what your first step is, and the current processes that are largely how it's handled are bundled so that the hearing health professionals are tied into specific companies, so people don't have the ability to really shop around and find the best value and try out all of the different options that are available on the

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market. In addition to this, each state has different regulations about this, so it becomes much more complicated and leads to even greater limitations on distribution and restrictions for online access.

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So added to this, or perhaps made worse by it, is the social stigma of hearing loss, unlike eyeglasses which are considered even fashionable these days, but certainly widely socially acceptable. Many people are embarrassed to have hearing aids, so they put it off going to get help,

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and as you wait longer, it actually becomes harder to get back to normal hearing, and so that makes it even more important to kind of try to address the fact that this is half of the people as we get older in the population who are going to need this help in order to remain engaged.

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And then finally, in part I think because of the lack of insurance coverage, hearing is not considered as part of the normal medical evaluation. When you go to your doctor for your checkup, most physicians are not real knowledgeable about it, and it's not even considered a chronic illness by the CDC or disability in

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the surveys that are done about disabilities. So the whole mindset in our society about hearing impairment we think leads to a kind of lack of awareness and lack of emphasis that really needs to be changed. So our scope is to look at technology solutions for this major public health realm.

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Not every aspect of the problem, but where are the technology parts that really could help to address some of these issues? And specifically, since we are advisors to the president and to the administration, what are the actions that could be taken administratively that could accelerate improvement in access,

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innovation and outcomes? So specifically not looking for legislative solutions, but really looking for executive or government actions that could be taken. So our conclusion is that this is a problem that's ripe for change.

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This is something where we think a few key federal actions right now could actually give momentum to changes that are needed in the environment. It's a place where new technology is advancing rapidly, and I want to just remind everyone that our focus here is on this very specific but large population of people with mild to

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moderate age-related bilateral hearing loss and only in adults. We also concluded, as I said at the beginning, that if this goes untreated, if this problem goes unaddressed, that it really is a great risk to the well-being of a large number of older people in our society.

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And while there is a risk of medical conditions that might be missed by allowing more consumer access, and we're going to say more about this, most of those conditions are relatively rare and the much greater risk of this huge number of people not getting help for their hearing problems is a much greater risk.

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So FDA and other federal agencies and every public health official knows the principle of having to weigh the risks and benefits of different federal actions and regulatory approaches, and we concluded that the risk of keeping the system the way it currently is is just too great.

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And we also think because of the innovation that is occurring in the technology space that now really is a perfect opportunity to increase access to better and cheaper technology for mild to moderate hearing loss. And we used an analogy with reading glasses, and I'll say more about that, as a way of

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bringing more people into the hearing health system, regulatory changes that were made about 20 years ago and how ophthalmologists and opticians do prescriptions for glasses, how people can get over-the-counter reading glasses really inspired us to think about how could this apply to hearing aids.

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I want to emphasize, particularly because of some of the input that we've gotten, that we do understand it's not the same and that hearing is hearing, the technology that addresses hearing loss is not identical with the kind of refractive prescription that you get for glasses or even the simple magnification that reading glasses allow, but we do think

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there are meaningful parallels, and so we believe that hearing technology could be made available in some of the same ways. So our goals for the recommendations are to reduce cost to consumers, increase the number of people who use this technology, and to stimulate innovation and technology development.

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We had four major recommendations, and these are small print apologies for this, but I wanted to display the actual language of the recommendation, and of course the reports are available so you can go to the full report and read the background. The first recommendation is that the FDA should designate as a distinct category basic hearing

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aids, non-surgical air conduction hearing aids intended to address the kind of bilateral and gradual onset, mild to moderate, age-relating hearing loss, and should adopt distinct rules for such devices, that these basic hearing aids should be available for over-the-counter sale without a requirement for consultation with a credentialed dispenser.

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They should, FDA still would regulate these as they do with any over-the-counter products, and we believe should require a list of red flag conditions be listed there, and as you know, many retail dispensers now actually provide basic clinical services from a pharmacist or a nurse or nurse practitioner, and that those kinds of making this over-the-counter

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would not eliminate actually the opportunity for those kinds of basic medical evaluations to occur. We also recommended that FDA should exempt this class of hearing aids from the current quality systems regulation that they do for other over-the-counter products, which are not electronic and are actually very different

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in the way they are manufactured. This recommendation is that FDA should look at not at eliminating oversight for the manufacturing of electronic devices, but should work with the electronics industry to come up with regulations that are appropriate for the kind of manufacturing processes that electronic devices involve. Recommendation number two is that the FDA should

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withdraw the draft guidance of November 7th, 2013, which addresses personal sound amplification products, PSAPs. PSAPs are currently regulated only as consumer electronics, and they are amplification and sometimes even more sophisticated forms of hearing assistance that are available online and through other venues. There is a great deal of innovation going on in the

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PSAP area, but PSAPs are not allowed to call themselves hearing aids or be marketed or labeled as helpful for people who have hearing impairment. This particular guidance in 2013, which still remains a draft guidance and has not been formally approved by FDA, goes even farther, though, and says that PSAPs should not say

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that they can be helpful to people with normal hearing in difficult environments such as noisy restaurants or large lecture hall and places like that. We feel that that is actually very confusing for consumers because, in fact, these PSAPs can be very helpful in those kinds of settings so that if FDA were simply to withdraw this guidance, it would allow the

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producers of PSAPs to make accurate claims about what their products could do. Recommendation number three, and this gets to the parallel that we felt was relevant with the eyeglass rule. The Federal Trade Commission should require audiologists and hearing aid dispensers who perform standard diagnostic hearing tests and hearing aid fittings

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to provide the customer with a copy of their audiogram and the programmable audio profile for hearing aids at no extra cost and in a form that can be used by other dispensers and hearing aid vendors. We do understand that the way the current prescriptions, if you want to think about it

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that way, are configured actually doesn't allow this kind of interoperability between different kind of manufacturers, and we actually think that would be a very important part of solving this problem so that consumers truly were empowered to shop around, find the best value, and particularly if they moved from one place to another, from one state

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to another, to be able to take that prescription or profile to a new vendor or a new audiologist. We also remark, and this is variable in the United States, but there still are places where the availability of hearing tests and fittings are conditioned on a basic, if not a legal agreement, sort of understanding that the person has to purchase from that hearing

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aid professional, and that that often dramatically limits their choices to devices from only one or two companies. Recommendation four is similar to the Federal Trade Commission contact lens rule, which defines a process by which patients can authorize vendors either in state or out of state to

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obtain a copy of their hearing test results, so they don't have to carry it in their own hand or in their own electronic form, but that actually they can authorize another professional to get that information from the initial person. So we want to acknowledge that we do understand that FTC has the legal authority to be able

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to initiate new rules like this, but we also understand that it is usually the case that FTC acts in response to congressional requests, so here's a place where we would encourage Congress and constituents who agree with this to add that message to the FTC to move these ideas forward.

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So in summary, as I said, untreated hearing loss is a major health and social problem. Consumers have lots of difficulty accessing hearing technologies because of costs and because of the complexity of the system, and we actually find that unlike many problems, this is an area where just a very few federal actions could actually make great progress,

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open up the market, and allow for more innovation and lower the cost. So John, let me stop there and see if Ed has any comments. All right, well let us open it up for questions and comments from the PCAST members following our usual procedure of raising your flag if you'd like to comment, and I see Bill press

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as number one. Thanks, John. Chris, as you mentioned, we've had a lot of interesting responses from various organizations to this report because it's been out for a few weeks now, and I've noticed reading them that maybe predictably many of them align with the financial and professional

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interests of the groups that are responding, and it's, of course, much more interesting if there are responses that don't have that potential conflict that could be seen as more unbiased responses, and I wonder what your assessment is on whether we've received comments of that type.

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We have received lots of different responses, and I would, I think it's fair to say most of them quite positive, and many of them with constructive suggestions that I think are very useful. First, I have to say that I think it's normal human behavior to come from the perspective that you're in in any multi-stakeholder environment, and so I don't think it's necessarily

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a bad thing that people have a perspective that is consistent with their own economic self-interest, but I do think that's the reason why we need transparency, and that's why it's so important that when people evaluate these responses that they keep those issues in mind. So from my perspective, I think the most important voice that we keep hearing over and over again

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is the consumer and the patient, and we've heard from AARP, we've heard from the Hearing Law Association of America and others who are very knowledgeable about this issue. It isn't that they're naive about the complexities, but who have been very, very positive about these recommendations. The second point I would make is that not all of the professional

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interests are saying the same thing, and we actually have heard from the academic leaders in the field of otolaryngology and audiology who actually are basically supportive of the recommendations but are asking that there be more of a hard-wired availability for this medical evaluation for the red flag conditions, which seems to me to make a lot of sense.

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I want to take this opportunity actually to make the following observations that we have this requirement, FDA has this requirement right now for a medical evaluation before you can get a hearing aid. The vast majority of people are allowed to waive that requirement, so if you can think of maybe 20 percent of people with hearing loss are actually seeking

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hearing aids, and then of that maybe 10 percent or 20 percent are actually having the medical evaluation, we're actually missing, if there are all these medical problems, we're missing a lot of them. What we think this would do is actually bring more people into the hearing health system and allow a whole lot of ways in which we could pick up those problems more.

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So I apologize, I answered two questions instead of one, but gave me a chance to do that. Senator Wright, Craig Mundie is next. Chris, my question really builds a little bit on your last answer too, which is while the analysis that we did said that the greater good favors getting more people into the system

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and that there are these potential red flags and some of the comments reflect that, we did spend quite a bit of time thinking about how as these technologies get more sophisticated, particularly tied to things like your smart phone or home computers, that in fact we may in fact be able to learn more about people and even discover that they may have a need

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to go seek medical conditions. So even those that are sort of bypassing the system today, if they were doing this, might find that. And I thought maybe you want to comment just a little bit more about that as an opportunity that actually doesn't just leave these people out there hanging, that in fact the technology might in fact find more of them.

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Right, and we're seeing that Craig, I'm glad you raised that because we're seeing that a lot more in a whole range of other medical areas where biomonitoring and other kinds of opportunities are allowing people to pick up issues that then they can bring to a professional and seek help through a wide range of options. So I think it's quite likely perhaps even

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probable that more people who had red flag conditions would be identified if we opened up the market in this way. And I might add that a number of people are reluctant to keep wearing hearing aids because the technology that currently exists doesn't meet their needs. And we did recommend and

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do recommend that the changes that we're anticipating would actually drive innovation. But I would like to point out at this point in time that we've actually heard from many potentially new players in this field who are very sophisticated in both listening to sounds and hearing sounds that we would like to be participants, but many of them have

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expressed reluctance to enter into the space because of the barriers that exist today. So we think it's not just a possibility that more innovation would occur, but it's actually highly likely because there are a number of organizations already engaged, start-up companies, existing companies that are conducting serious research and development programs in the hearing

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space that could bring this to market. So it's not a theoretical possibility that innovation will occur. I think there is a sort of a wave of innovation that's already started that could come into the marketplace if the market were more open. Great. Seeing no more flags up and being very close

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to exactly on schedule, I thank Chris and Ed and the team for their work on this. And we will now move on to our next scheduled topic, which is nanotechnology, the anniversary of a PCAST report on that topic, and the birth of a grand challenge on that topic. And I think we have Lloyd Whitman from the OSTP staff, and on PCAST, I think Michael McQuade,

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Mark Gorenberg, and Chad Mirkin have been involved. So Michael, how is this being orchestrated? We're going to turn straight to Lloyd, or you want to make some opening remarks? No, I think Lloyd is the show. Okay. Thank you. It's great to be here. I want to start by saying it's quite an honor

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to serve at OSTP, and I'm also quite grateful to NIST for allowing me to do so. My job is made much easier by the strong support for nanotechnology and advanced materials by Tom Khalil, who I work with, and Dr. Holdren, and most importantly, the President himself. So today, I'm going to give you a little bit of an overview of what's been going on the

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last year, a brief overview of the National Nanotechnology Initiative, and then an update focusing on our efforts to facilitate commercialization and launch some grand challenges. So I'd like to start my overview of the NNI with this slide that sort of brackets 15 years of what I call Presidential Nanotechnology. So, of course, the NNI was launched in a speech

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by President Clinton at Caltech on January 21st in 2000, where he asked us to imagine materials with 10 times the strength of steel and only a fraction of the weight, shrinking all the information of the Library of Congress into a device the size of a sugar cube, detecting cancerous tumors that are only a few cells in size. He also met Gordon Moore, more commonly

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known for what we refer to as Moore's Law, and even commented that he even knew what Moore's Law was. And remarkably, 15 years to the day, and this was really just a coincidence of history, President Obama visited Boise State on exactly January 21st, 2015, and talked about many of the same things. In fact, if you look at the picture, you'll see that the

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President is holding a model of graphene, which he commented was a material that's thinner than paper and stronger than steel, sort of one of the Clinton challenges. You'll see in the background of the picture, he was learning about the use of DNA in nanotechnology and manufacturing, and actually in that discussion, commented about how that could be something

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that would extend Moore's Law. And in fact, that's also one of many materials used in nanotechnology that have demonstrated the sort of storage density that would be required to achieve the Clinton challenge of the Library of Congress in a sugar cube. Also on the table, you'll see some pictures of nanoparticles and I think quantum dots and solution, which

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have been in fact used to label and identify a tag individual cancer cells. So in many ways, we sort of met that challenge. And that sort of picture really encapsulated a lot of what's going on in nanotechnology in that it shows sort of the discussion. And Moore's Law really shows the importance of the semiconductor industry to a lot of developments in nano,

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in particular in driving the sort of ways we make and measure things on the nanoscale. And also just the sort of convergence of these areas now between information technology and nanotechnology and biotechnology in a lot of different ways. So where are we today? So the NNI involves 20 federal departments and we like to say independent agencies and commissions,

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11 of which have nanotechnology budgets. In 2015, the collective R&D budget was about one and a half billion dollars and about $22 billion has been spent since the beginning. You can learn a tremendous amount about the NNI at nano.gov, which is our resource. You'll see lots of workshop reports, documents, all kinds of things. A great place to start is

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our budget supplements. The most recent one was put out last spring up there on the slide and that serves as sort of an annual report. So it has progress and plans of the different agencies and detailed budget information. I will say a little bit about the budget. This sort of shows the budget trend since the beginning. I'll just make a couple of

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comments. It's been relatively flat at about one and a half billion dollars a year for the last four years or so. Given the budget environment we've been in, flat is actually pretty good. The other notable trend is a sort of significant shift among the agencies such that actually the largest nanotechnology R&D budget is now in HHS, mostly in NIH. That's

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actually about 31 percent now. Along with NSF and DOE, that's about 80 percent. And then with adding DOD and NIST, those five agencies is collectively about 96 percent. There's a variety of other agencies out of smaller efforts. We look at our budget, break it down, and again you can see all this in the budget supplement based on the program areas shown

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here. I will just comment. One of them is related to our signature initiatives. This is an effort started about five years ago where the government agencies decided to collectively look at are there very specific areas where if we sort of shine a spotlight on that area and focus in on them and work a little more co-ordinate, a little more carefully together,

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we can make some more rapid progress. So there's been three areas that we've been working in. Solar energy, nano-manufacturing, excuse me, five areas. Solar energy, nano-manufacturing, nano-electronics, knowledge infrastructure, which is informatics, and sensors, the most recent one. The solar energy one is one area where essentially the goals of the original

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signature initiative were largely met and institutionalized within a lot of different programs such that the agencies have decided we really don't need to put a spotlight on that area anymore to make progress. Not that there isn't still progress to be made, but that tool wasn't really needed anymore, so we're sort of winding that one down and looking

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at other topics right now for that. And so we will continue doing those signature initiatives. The other thing worth commenting about on the budget side is if you look at the signature initiatives related to environmental health and safety, and you add those in, the environmental health and safety is about 10% of the NNI budget right now, or about $150 million. So

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the economic impact of the NNI continues to grow. Lux Research, which does a periodic economic analysis of the field, the most recent one being in 2014, estimates that for example by 2018 it'll be the global revenue associated with nanotechnology products will be over $4 trillion. It's interesting, this is actually my own personal observation, though shared

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by many others, that most of the current products really involve what I consider relatively low complexity products, so essentially nanoparticles for additives and coatings and things like that. Though many of them are actually quite successful, I highlight three companies here. So one is an Arkansas company named Nanomech, and that's founded by A.J. Miles from University

00:36:34.660 - 00:36:59.140

of Arkansas from NNI-funded basic research, and they have a variety of nanoparticles, and coatings used in things like cutting tools and aerospace, and I actually think in Formula 1 race cars. Another one interesting to point out is QD Vision, so again this is a spin-out from MIT from Boindy's group that makes quantum dots that are now used in the back planes

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of displays. And then a third one I've recently become aware of is a company named Titan Spine who makes a spine implants that have nanostructured surfaces that are optimized to reduce inflammation and increase the bone growth around those. And what's interesting, again, to observe is there's probably in fact many common manufacturing processes, or at least some common manufacturing

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processes, and measurement and metrology used in these three different companies, but they're so different in terms of their sectors that it becomes a significant challenge from a policy perspective to figure out how best to sort of encourage the growth of these kinds of companies. So moving on to sort of what's next and what we've been doing on this year,

00:37:47.140 - 00:38:11.620

so last October of course this group had an assessment of the NNI, I won't go through, repeat all the recommendations, but one common thread through much of the report, and this is basically my own perspective, had to do with the sort of overall need to sort of re-energize and re-inspire the broader community, that the NNI had sort of, it was sort of there

00:38:11.620 - 00:38:29.020

in the background, and certainly the federal agencies are very engaged, but sort of the rest of the stakeholder community maybe wasn't so engaged in the broader goals of the field. We really needed to sort of re-energize and re-inspire that community beyond the government and get everyone working together towards exciting goals and get us the economic development

00:38:29.020 - 00:38:49.860

that we know is possible. So as I put on the slide here, how do we re-energize the ecosystem while promoting commercialization, get the whole community, the whole ecosystem working a little bit better together, broaden awareness, get more people participating, and that ranges from the education side to the research and development through making sure that we understand

00:38:49.900 - 00:39:10.100

the environmental health and safety risks of these materials and products, ethical, legal, and societal issues, and ultimately how do we facilitate commercialization to see the economic benefit. So some of the things that we've been doing to address this question, I'll start with some highlights from the National Nanotechnology Coordinating Office and its

00:39:10.100 - 00:39:29.260

support of the federal group that works on this, the Nanoscale Science and Engineering and Technology Subcommittee. So that's been a very active year with a series of workshops and reports on a variety of topics, including carbon nanotube materials and sensors and exposure science and environmental health and safety coordination between the U.S. and the

00:39:29.260 - 00:39:55.020

U. Just to give an example, though, we had a very few hundred people participate in a workshop with the Consumer Product Safety Commission on quantifying exposure to engineered nanomaterials for consumer products. So how do we do the exposure science to understand how we know what might come from a consumer product that has nanomaterials in it? Also,

00:39:55.020 - 00:40:17.980

highlight a business webinar series that NSOs put on. Again, this is a recognition that to address the business community, we don't want, you know, going to workshops, multi-day or even day-long workshops in some cities is quite a burden. So we shift it to a webinar model where we can be much more agile, have a shorter attention span, and highlight key kinds of things. So

00:40:17.980 - 00:40:37.100

this, for example, we had a webinar on roadblocks to success in nanotechnology commercialization. What keeps the small and medium enterprise community up at night? So again, this is a way where we can bring in some successful small and medium-sized CEOs in the nano community and sort of talk, they can talk about some of the things they've done to be as successful as they

00:40:37.100 - 00:41:05.420

are. A few other things I'll point out. We've tried to be a little more creative in our outreach. So we've had a student image and video contests. In fact, it was another contest announced yesterday with NSF and the U.S. Science and Engineering Fair for high schools to design a superhero based on nanotechnology-enabled superhero properties. And NSF has also been doing some very high production

00:41:05.420 - 00:41:32.620

value videos on nanotechnology with NBC Learns. And I think the first one is coming out soon. And that actually reaches about 8.5 million students and will also have short versions sent out to their affiliates. In the area of metrics, the patent office has done an analysis of global data to assess the impact of the anion patent output in comparison to other countries. And then

00:41:32.620 - 00:41:54.060

finally, Dr. Mike Metter, who's the NSEO director, who's actually here today, is playing a key role in the OECD Working Party on Biotechnology, Nanotechnology and Convergent Technologies, which has a test force on measurement and impact. And they're in fact trying to address the specific question of what are the right metrics to measure the impact of these areas. They're having an actual

00:41:54.060 - 00:42:19.180

meeting in about three weeks. And Mike's actually will be doing the report back out to the working groups. So we'll talk about some of the events that we've held at the White House to address the issue of what's sort of holding back these higher value high complexity products. So back in February I had a round table where we brought together some fairly senior people from sort of large

00:42:19.180 - 00:42:40.060

Tier 1 companies in the aerospace and manufacturing with some of the smaller companies that would potentially be part of their supply chain. And we sort of sat them down and sort of said, what is it that's keeping these things moving into those large products? And what are some of the tools that the federal government might use to help with that? And they had in particular

00:42:40.060 - 00:43:01.500

address the question, would a manufacturing institute be that right tool? And it was a really interesting discussion that's actually had a couple of interesting outcomes. In terms of the questions, some of the things that arise that were particularly interesting, one was something that comes up a lot, which has to do with manufacturing metrology, how you measure things

00:43:01.500 - 00:43:20.060

on the nanoscale on a timescale quick enough to be effective in a manufacturing environment. And the other actually had to do with the development of a design space. So you have a material, say like aluminum in an engineer, can very easily understand if they change the shape or the thickness or even the type of aluminum, how that might affect the property of the product and they can design

00:43:20.060 - 00:43:43.900

that in. And we just don't have that design space yet for, for example, a composite that has carbon nanotubes in it yet. So that's an area that Warren's looking at. Now, interestingly enough, one of the outcomes of that was some of the participants in this meeting actually has formed a group on their own to start talking pre-competitively about how they might collectively work better

00:43:43.900 - 00:44:04.140

and do develop that, things like that design space. Now, in the area of the manufacturing institutes, the sort of message that came across through the discussions was, comes back to that slide I had earlier. Well, though there might be a lot of processes and things in common, there are across so many different spaces that it was very hard to envision a,

00:44:04.140 - 00:44:26.140

a manufacturing institute led by a mission agency, for example, DOE, or DOE, that would really, that would really have enough mission in that one space to warrant a mission, an agency-led manufacturing institute. But that, if NIST were to get funds for a industry-led manufacturing institute, that that could be a, that might be a mechanism for the industry to collectively

00:44:26.140 - 00:44:45.580

put together a picture and pitch such an institute that would help with that. But there was some interested in sort of smaller scale efforts, things like manufacturing demonstration facilities that might help some of the smaller businesses scale up. And so we're having some discussions with some of the agencies as to how we might expand in that area.

00:44:45.580 - 00:45:14.460

Okay. We also had a, a, a White House forum on, on the challenges to commercializing technology focused on smaller businesses in the spring. That really focused on partnerships. And some of the things that came out of that was a commitment to, to get the business community better tied into things like ICOR and entrepreneurship through things like venture for America.

00:45:15.260 - 00:45:37.100

Also came out of that as a new series of student groups that now involves, I think, 19 different schools that were coupling through something called a nano-emerging technology student leaders conference. The first one will be this June to bring students together with the industrial community. So I want to sort of wrap up by starting to tell you about our grand challenges

00:45:37.740 - 00:45:56.220

effort. That's one of the key recommendations of the report from PCAST. Now, there are many uses of the word grand challenges, but in, in, in the administration here, we have a very specific one, which is an ambitious but achievable goal that harnesses science, technology, and innovation to solve important national or global problems and has the potential to capture the public's

00:45:56.220 - 00:46:18.540

imagination. And some of the ones that have been launched, again, they've all been sort of a single agency mission oriented ones such as the DOE Sunshot grand challenge or the NASA asteroid grand challenge. So we decided to try to have a nanotechnology inspired grand challenge. Now, what would that mean? So not every problem can be solved by nanotechnology, but we believe there

00:46:18.540 - 00:46:41.500

are some where nanotechnology is very likely to be the key enabler of solving that, that challenge. So we worked with the federal agencies to come up with some ideas. Ultimately, we had a request for information posted in June, offering the wider community to make suggestions and we actually put six examples in there so people would have some idea what we were looking for.

00:46:43.580 - 00:47:06.620

We did extensive outreach, in fact, especially with the help of some of the professional societies. So the ACS in particular, I had a webinar, I think they advertised the availability of my webinar in the RFI to a few hundred thousand people. And we got about over a hundred responses, some of which were very, very thoughtful. Some in particular related to electronics

00:47:07.500 - 00:47:30.140

led us to look a little more deeply. We had Tom Clue and I had extensive conversations with people inside and outside the government on one particular topic and ultimately arrived at our first grand challenge related to future computing, which we announced in fact a month ago today at the National Strategic Computing Initiative workshop. We're still in fact working on developing

00:47:30.140 - 00:47:51.260

other topics as well. So let me tell you about the one that we announced, which actually sort of sits at the nexus between the NNI and the NSCI and the brain initiative, which is to create a new type of computer that can proactively interpret and learn from data, solve unfamiliar problems using what it has learned and operate with the efficiency of the human brain. So why is this

00:47:51.260 - 00:48:10.940

a nanotechnology inspired grand challenge? So computing right now has been, for decades, has been based on one particular architecture, the von Neumann architecture, and has been implemented for a long time now in transistors. And it's fantastic at doing numerical computations and doing a lot of things. And we've made it very good at things like deep learning and image

00:48:10.940 - 00:48:35.420

recognition as well. But it falls far short of what we can do in our brain on similar problems, especially when it comes to power consumption. We have a brain that's very dynamic, fault tolerant, and three-dimensional, it runs at about 20 watts. So there are many physical challenges that I think most people believe we can, we'll never get a combination of a computer that can do what we

00:48:35.420 - 00:48:55.660

can do and do it at that power. And there are many, many applications where that capability would be very, very useful to be able to move those kind of sensing and recognition problems locally and not having them off in the cloud on a supercomputer. And that's going to require a lot of different kinds of device work, different kinds of devices and probably different architectures. And we want

00:48:55.660 - 00:49:15.660

to get those, the computer science community and the nanocommunity together to think about that. And that might all be informed by the way the brain works, but maybe not. So one of the interesting methods that people have been looking at is neuromorphic computing that might achieve this, but there are others as well in analog computing or spin-based computing or not. We don't want to

00:49:15.660 - 00:49:39.260

define the solution. So this is really about doing that. It's been great in that announcing this challenge is very, very strong support from a wide variety of stakeholders in the community. So the federal agencies, the program managers working in this area are very excited about it. We're having a meeting with that group in about two weeks. There's been support for it from the

00:49:39.260 - 00:50:03.580

computing community consortia, the Moore Foundation, IEEE, Cavley and the Semiconductor Research Corporation, many of whom are already organizing meetings. I think there are three meetings alone on this topic related to the Grand Challenge in about three weeks. So I'm just going to sort of conclude with a quick demonstration of what we're after when we'll talk. So that's a

00:50:03.580 - 00:50:28.620

picture of the Blue Gene, IBM Blue Gene Q. Sequoia supercomputer at Lawrence Livermore National Laboratory. It's now number three on the top 500 list of supercomputers. It has 1.6 million processor cores. It covers about 3,000 square feet. There's another computer standing to the left. It occupies a bit smaller volume and runs slightly lower power. Now, one can argue with a lot of computer science

00:50:28.620 - 00:50:49.660

people about what we mean by efficient image recognition, but I'll demonstrate that one of those ones at 20 watts and the other one runs at 8 megawatts. And how can we get the bridge of that gap a little bit? So I'll demonstrate this, what I call, which is a small demonstration of what's known as single trial learning followed by low power image recognition

00:50:49.660 - 00:51:14.620

using only a few watts. I'll show you the following picture and ask you how many people here know what that animal is. Well, you saw that. So here's our single trial learning. So that's actually an aardvark. You can see it's kind of an interesting looking animal with a long nose and pointy ears. It also has a long tongue. It eats ants and termites. It lives in Africa. It's actually

00:51:14.620 - 00:51:33.580

the only member of the order tubula dentata. So there's no living relatives on the planet right now about that thing. Now, I'm going to guess that you've had this single trial. You've seen that as an aardvark and you'll probably be able to recognize an aardvark if you see one again, even if it's in a different position. And that's something right now you've just done with a couple

00:51:33.580 - 00:52:09.180

of watts that we really can't do with computers. So while you look for the aardvark, I will thank you for your attention. That's great. And I saw Wanda Austin as the first flag up. Wanda, please. Thank you. That's a great, you know, teachable moment there about the difference between the capacities. Congratulations on the progress that you've made in the nanotechnology area. My question

00:52:09.180 - 00:52:32.860

is down that area of looking at, you know, how we can move the ball forward. And you've talked about manufacturing and design, you know, is there some synergies that can be gained from that? I was wondering if you've also thought about test and qualification, you know, as we adopt new technology, sometimes we run faster at adoption than we do at really understanding where the

00:52:32.860 - 00:52:56.220

limits are. What's been your experience in that area? So, yeah, so that's actually very much related to the design space question, right? Because in order to sort of have that tested evaluation, you have to be able to design products and essentially have that closed loop related to that. So what I can say is that's been identified as an area that we need as we move down

00:52:56.220 - 00:53:25.020

the sort of up or up the TRL that we need to address. It's an area, I think, that places like the Advanced Manufacturing Office at DOE works in that space and they're looking at some of these things. At some point, it becomes more of a, I think when you get to that level, it isn't so much a nano problem so much anymore because hopefully the nano parts are now incorporated. So I would say

00:53:25.020 - 00:53:44.220

that this, you know, from the nano community it's been identified as an area we need to work and I think it's also in the work, from one of the workshop reports I mentioned earlier related to the carbon materials. So I think my hope is that between some of the advanced offices and also the industry now working together, that's the kind of thing that they're looking at, right, one of those

00:53:44.220 - 00:54:08.060

areas of that. So my hope is, in fact, that the extra industry community can collectively also work. They're the ones that really need to look at that together and understand how to do it. Okay. Michael McQuade is next on my list. Just a comment. I want to take a step back. When we did the NNI report a year ago, you'll recall we described a program that after 15 years of

00:54:08.060 - 00:54:29.100

very productive research in fundamental science really had reached a point where the focus on continuing the science investigation and the development of technology needed to be coupled with a community aimed at commercialization. We had a number of recommendations related to process and procedures plus a strong endorsement for continuing the EH&S

00:54:29.660 - 00:54:52.060

investigation and mission. But our primary set of recommendations really were about how to engage the community more broadly as a community taking forward to make nanotechnology relevant at scale and the grand challenges were a part of that. So my comment is simply to commend Lloyd and the team for really running with the ball in a really aggressive fashion over the last year. The

00:54:52.060 - 00:55:16.060

response that we have had to the recommendations of the report have really been terrific. I just want to make sure everybody knows we appreciate that very much. Thank you. Thank you. Maxine Savitz is next. Lloyd, I'm really pleased about this re-energization and the grand challenge. We've having PCAS has looked at this since the beginning and particularly this PCAS three times.

00:55:17.420 - 00:55:43.500

All those reports have been involved in it since that time. But the re-energization is very exciting. My question is on the international scene because particularly as you get into more manufacturing and there's been concern when we looked at the other studies on with the Asian, particularly China and Japan. So is America still the leader in this and what is happening

00:55:44.220 - 00:56:13.980

on an international front? Yeah, well still there is significant growth. I mean, it remains a concern. I think that the focus of this administration on advanced manufacturing has helped. So we now have a whole I think nine manufacturing institutes and many of which though none of them are nano specific, actually quite a few of them probably will involve some nanotechnology and certainly

00:56:13.980 - 00:56:36.860

advanced materials. So in fact one of the things in the interest of time I didn't mention was that one of the outcomes of some of these meetings we've had is a much stronger connection between the nano subcommittee and the advanced manufacturing subcommittee. In fact, that's facilitated by the fact that the OSDP is on Megan Brewster sits about 10 feet from me and we work very closely

00:56:36.860 - 00:56:59.180

together and we've actually had the leadership of those committees talking together. So we've also been looking at talking to for example both DOD and DOE who have committed to as these manufacturing institutes sort of get in place and get set up to couple them to the nanotechnology, especially the smaller businesses who might be able to participate in projects

00:56:59.900 - 00:57:20.700

going forward because these are dynamic institutes that are not fixed by the original initiative. So we are working in that area. Good. Chad Mirkin is next on my list. Yeah, so Lloyd, fantastic job. I think you've really done a great job of energizing, re-energizing the whole initiative and I think it's really important. On the global front, I have a big

00:57:20.700 - 00:57:41.340

concern. I travel quite a bit and I see the extraordinary investment going on in other countries and I'm worried about us losing our position so I'm glad you're thinking about that and you're on top of that. On the grand challenge front though, I guess I think the grand challenge is a spectacular one. I think it brings together many different fields but if you think about it

00:57:41.340 - 00:58:03.660

going back to when Clinton announced this and when the field really started it was really driven by our understanding of electronics and the importance of miniaturization there but it's grown to include so much more and what I want to know is are we thinking about grand challenges that go beyond electronics especially in the medical front to also mirror the investment

00:58:03.660 - 00:58:28.540

now in the profile that's changed over the course of the NNI. So absolutely. So this is the first and certainly not the last. One of the things though, it's been a bit of a learning process because as all things with nanotechnology, it doesn't sit in one spot but one of the things that came out of the RFI and the discussions was what I'd like to say, what I like to describe

00:58:28.540 - 00:58:50.620

as finding the the topic that will move the needle. So just as an example, we got some comments back from the RFI. One of the examples was related to cancer diagnostics and treatment for example but it became clear from a lot of discussions that though that was a great grand challenge, it was so good that everyone would basically agree vehemently that they were already

00:58:50.620 - 00:59:14.380

focused on it and that that therefore though it might bring additional attention, it would unlikely bring a whole lot of additional resources or activity that there's just a significant amount going on. I mean NCI has a significant program in this area so not to say that it isn't critically important. So so the challenge is to find the grand challenge that both excites people but also

00:59:14.380 - 00:59:34.700

makes new things happen that aren't already happening because people aren't already excited about that area and find just that opportunity where there's enough done so so again that won't say that we wouldn't have one and in fact but I think there's some opportunities we're looking at and particularly in manufacturing and materials that might actually encompass some of those spaces

00:59:34.700 - 00:59:54.700

including like regenerative medicine as under a broader umbrella as really innovative ways to make things for example. So so the I mean this quick answer is yes we're looking at other ones and but but it has it's more than just being really important and exciting because there are a lot of times if it's really important exciting people are already doing. Mark Gore and Byrne.

00:59:55.660 - 01:00:18.540

John thank you. Lloyd I want to echo everyone else saying that I mean it's easy to write reports it's very difficult to make this actually happen and you've done really a spectacular job we're all very very grateful for that. I had two questions for you more specifically on the impact of doing this by grand challenges rather than signature initiatives. One is you know there's 27 agencies

01:00:18.540 - 01:00:42.220

that are involved but three are the bulk of the funding probably 75 80 percent of the funding that goes into nanotechnology R&D. Are you finding the grand challenges are invigorating some of the agencies that have smaller NNI budgets to be part of this and my second question as part of that is also we talked about the idea of grand challenges having measurable endpoints.

01:00:42.780 - 01:01:07.020

Have you created a set of criteria when you know that this grand challenge will be successful? So I'll take the second question first is is so not yet but but actually they're actually I'm going to change my answer a little bit because they're coupled those two questions so to me the most important aspect of the grand challenge is that it not be driven by the federal government.

01:01:07.740 - 01:01:25.580

We that's somewhat what the signature issues are that we really want to make sure that this is a problem that the external community and in this particular case you know the the people involved in the electronics industry really are behind because that's what's going to give it that's what's going to make it last and that's what's going to help the government understand where the

01:01:25.580 - 01:01:50.780

investments need to be made. So in fact that's one of the most exciting aspects of that is that we have extremely strong support from a bunch of things like like I mentioned these meetings from IEEE from the Optical Society of America's I mean the Semitech Research Corporation who are really excited and self-assembling among themselves to roadmap this. So they're actually working on

01:01:50.780 - 01:02:09.260

defining those endpoints which then I expect when we get the government people together well we would I'd much rather have the government people figure out what they need to do based on that criteria than what they already think they should be doing so that's the sort of process that we're going forward it was somewhat of a a soft launch in that we set out the objective

01:02:09.260 - 01:02:35.740

but without knowing that roadmap yet and essentially challenged the community to to tell us what that roadmap should be and they're rising to that challenge. Okay Mario Molino will be the last question. Whoops thank you. Yeah thanks a lot for the presentation. Yeah you mentioned high value high complexity products and of course you can connect that to grant challenges that have not

01:02:35.740 - 01:03:08.780

yet been achieved. My question is can you give us examples of any such products that or do they already exist any high value high complexity products that employ nanotechnology as the main constituent? Well I mean you know foundationally the computer chip industry is one that has nanoscale and things like that. You know some of the for example the cancer

01:03:08.780 - 01:03:34.620

therapeutics that are being developed are quite complex in the in terms of the types of things that they are how they are structured and how they are are created but but I don't know someone's gonna kill me now because I didn't mention their thing but but you know if you think about a complicated nano system that has lots of components in a hierarchical system beyond that they're in

01:03:34.620 - 01:03:54.700

the commercial space. Nothing I don't really think there is anything so I'm gonna look at Mike at my end it's the other director and you come to mind from you Mike. You know so we have we have a lot of interesting things that are getting close things like carbon nanotube based materials and and and cabling and things like that but they don't have multiple components in them.

01:03:55.900 - 01:04:26.220

We are only three minutes behind schedule. I thank you Lloyd for that terrific presentation and Q&A. You're doing a great job with this. We are now going to move to a discussion and vote on a PCAST letter report on private sector adaptation to climate change. The folks who will be leading that discussion in an order that is not clear to me is Maxine Savitz, Rosina Birbaum

01:04:26.220 - 01:04:55.260

and Michael McQuade. So Michael is leading off. Yes, lead from behind. Michael McQuade. Thank you very much and thank you to everybody. This is the report. Oh thank you. This is the report on our letter report on actions to catalyze and support private sector adaptation efforts. Recognize the team here so the co-chairs that John just went through so it's Rosina, Maxine and I

01:04:56.060 - 01:05:18.620

with able help from other PCAST members, Mario Molina and Dan Tragg and our PCAST co-chair has a passing familiarity with this issue and has been a part of conversations and discussions as we went along the way. As is usual at PCAST we had terrific help from the staff, Marjorie and most importantly Diana Pankovich who has an amazing capacity to keep a lot of balls juggled in the

01:05:18.620 - 01:05:48.060

air at one time so I want to thank her publicly. We also had very good support from the ENE staff here at OSTP in particular Bob Simon and Tammy Dickinson so really terrific effort. So why are we here? This is a follow-on to a PCAST report from 2013 letter report to the president on climate, climate change and the chart in front of you shows an opportunity gap. Looking at actions that can

01:05:48.140 - 01:06:12.700

be taken relative to climate change by the administration we have two categories we have mitigation and we have adaptation and I should mention in passing that adaptation for us is a simplification of resilience and adaptation so when I use the word adaptation here and during the report I think both resilience and adaptation. But two categories so how do we mitigate the

01:06:12.700 - 01:06:38.060

impacts of climate change and how do we prepare for become more resilient and adapt to potential climate change or real climate change coming. And the actions that the administration has launched over the last several years have been really, really quite enormous in three of the four areas separated by actions to benefit the public sector and actions to benefit the private sector. So

01:06:38.060 - 01:07:02.300

focus on the private sector for just a moment the Clean Power Plan which is in its birth at the moment along with building energy efficiency standards, product energy efficiency standards, the American Business Act on Climate Pledge which now has over 80 members who have joined into that pledge through the White House. A whole range of activities to support mitigation in the private

01:07:02.300 - 01:07:29.340

sector. But as we began to look at follow on from our report from 2013 it was clear that work could be done on the broad category of how to help the private sector adapt to climate change. There were some places where the climate data initiative the climate resilience toolkit have specific elements that aid the private sector but really a sort of pretty broad area of opportunity

01:07:29.340 - 01:07:53.100

and in discussions with the president he asked PCAST to consider how the administration's actions not the specific actions of the private sector but what could the administration do to aid the private sector in moving forward with adaptation activities. I will get to a set of recommendations and how we got there but I would ask you to think as I go through this about three broad categories

01:07:53.100 - 01:08:21.820

that we have arrived at. One is around communication and education. One is around use of data and by use we mean usability, visibility, access and applicability of the data and one is around demonstration of adaptation and measurement of adaptation via public private partnerships and other mechanisms. So we launched into an exploration of the issue. We conducted over 25 very deep

01:08:21.820 - 01:08:46.140

conversations with various stakeholders. We had a total of over 65 different groups and people, individuals that we talked to in the process of the last six months. We looked at reports and peer reviewed papers. We had a number of workshops in which we participated and we also held a PCAST sponsored workshop at which we had over 35 stakeholders in the private sector

01:08:46.940 - 01:09:13.260

in the government and in the community that sits in between. So the NGO community, the public private partnership sector, etc. We focused on three specific areas, not that those, the areas of agriculture, energy and water and insurance, not that those three areas are exclusive and the only place where adaptation is and should be relevant but as

01:09:13.340 - 01:09:38.700

three areas where we could focus to determine a set of recommendations that were most immediately actionable and we had, as I said, representation from both the public and private sector. A number of findings, oh sorry, this is the list of all the folks who we have interacted with over the process of the report here. So just to give you an example before I go through the

01:09:38.700 - 01:10:05.420

findings of the kind of adaptation examples that we heard about and are trying to enable. So an energy provider who I won't name in the Gulf Coast partnering with the reinsurance industry post-Katrina to do long-term and medium-term risk assessments to identify resilience actions for the commercial and residential building infrastructure and in the power generation

01:10:05.420 - 01:10:29.100

infrastructure in that region. So a set of specific activities from an energy provider in the insurance industry to look at what the next Katrina-like event would mean and how to create a set of resilience and adaptation actions to make that a less impactful event in the future. We interviewed a beverage company along the way who is already in the planning stages for where

01:10:29.100 - 01:10:54.060

its supply chain, so its water supply chain, its sugar cane supply chain, will migrate over time and what it will do about that in response to a changing climate, therefore moving its supply chain resources further from where it currently obtains those resources. So those are the kind of adaptation activities that we're talking about. So our findings come into a couple of key areas.

01:10:54.780 - 01:11:20.620

One is that climate change is undervalued in the private sector and by undervalued we mean in the sense that proper and timely response to climate change will lead to or lack of proper and timely response will lead to a negative financial impact on the value of that company and its ability to pursue its business. So our findings are that while companies are aware of

01:11:20.620 - 01:11:48.300

climate change, 90% of the companies that we interviewed or had access to in various reports would suggest they understand climate change, a very small percentage actually are using it as a future long-term valuation exercise in the health of the company. The second is that companies that do focus on what we or they would call climate change really tend to focus on near-term impacts,

01:11:48.300 - 01:12:12.540

so severe weather events, things like flooding and drought, rather than long-term implications like sea level rise or long-term climate that's going to move feedstocks around, notwithstanding my beverage company example. And few major companies have really incorporated climate data and modeling into their long-term decision-making. Now part of this is the nature of the horizon on

01:12:12.540 - 01:12:33.020

which companies deliver to shareholders and part of this is the way long-term risk can or cannot be codified, but it's clear that when companies do generally talk about responding to climate change they're really operating on a much shorter time frame than some of the adaptation activities that could be relevant to the future value of those companies. It is also clear that

01:12:33.020 - 01:12:57.420

better communication is needed for the private sector to understand the long-term risks and the steps that can be taken to minimize the value to the company and also the economic, social, and ecological costs of climate change. Companies rarely report measurements for the measuring the success of climate adaptation initiatives. Partially that's because there's not a lot of

01:12:57.420 - 01:13:19.900

it going on. Partially that's because it is hard. It is hard to measure. There are not common standards or best practices for dealing with and measuring the impact of adaptation activities. And you'll see in our recommendation that this is a this is a task that we all need to get after to help here. The relevant tools and information from the federal government are large. There is a

01:13:19.900 - 01:13:40.140

lot of information that's available. Much of it I talked about as it's relevance to the public sector does have relevance to the private sector, but it is difficult to locate in the opinion of the people that we talk to and it is not easy to use. And in many cases it is not precisely tailored enough to the specific user needs. So we'll talk more about this in the recommendations,

01:13:40.780 - 01:14:06.460

but this is a broad theme. So there's an overwhelming call for easy to use single entry point access to actionable information and we'll talk about that in the findings. So our recommendations then fall into three key areas as I said before. Communication, usability of the data and access to the data and demonstration. So here are the six recommendations that are in the report

01:14:06.460 - 01:14:31.420

and I'll enunciate them and then go through each one in just a moment. So one is around education and communication. The second is around enhancing adaptation science research and technology and demonstration of adaptation activities. The third is to close the information gap to available stakeholders. The fourth is to unlock additional investment capital relevant

01:14:31.420 - 01:14:58.540

to both the private sector and the public sector. The fifth is to use public-private partnerships, either existing or new public-private partnerships to motivate adaptation activities. And the sixth is to use specifically an existing city-based project that's underway to launch a pilot program. And as usual when I go through these, as is usual PCAST practice,

01:14:58.540 - 01:15:20.060

we've tried to ensure that there's actually an owner for each of these recommendations that we make so that we can track progress going forward. So recommendation number one around education and communication. So the Council on Climate Preparedness and Resilience, which is co-chaired by OSTP, OMB, the National Security Council, the NSE and CEQ,

01:15:21.020 - 01:15:44.380

should develop and implement a broad and robust strategy for private sector education and communication. Specifically, the four areas that we talk about in the report are to ensure that, explain that the critical need for adaptation planning and actions by companies and organizations and the value of that, bring attention to the fact that the nature of such efforts

01:15:44.380 - 01:16:06.460

will often extend beyond short-term planning horizons and communicate in a language that both the private sector and the public sector can understand, the difference between how a city makes a long-term bonded investment and a company makes decisions relative to its shareholders and meeting quarterly results. So there's a communication effort there. How to integrate

01:16:06.460 - 01:16:26.860

private sector efforts with adaptation work currently going on in the public sector. And also, as we talked a little bit yesterday, to ensure that people understand the role, the critical nature that insurance and insurance regulation plays in adaptation activities, both in motivating adaptation activities and then dealing with

01:16:26.860 - 01:16:47.580

how those activities either work or do not work. And as we said in this recommendation, the Council should specifically ensure that this is not a government effort, but a government effort that involves the private sector as the integral part of that activity. Our second recommendation is around adaptation science research and technology research.

01:16:47.580 - 01:17:13.660

So this is not the data, this is the research that helps drive the recommendations for what the private sector can and should do. So the USGCRP, the Global Change Research Plan, which is the research arm of 13 federal agencies who participate in climate change adaptation and research, has a global change research plan. It's in the second iteration now and is in the

01:17:13.660 - 01:17:42.060

process of being updated, the sort of 2012 to 2021 version is in the process of being updated right now. And our recommendation is to ensure that that update include the development specifically of a research strategy around adaptation, how scientific modeling should be used to estimate adaptation, to identify adaptation activities and estimate the impact, and also to

01:17:42.060 - 01:18:04.220

identify how we should measure, project the measurements and identify the measurements and report the measurements on adaptation activities going forward. And again, as we said in the previous recommendation, the Council on Climate Preparedness and Resilience should create an interagency working group to develop this comprehensive plan on both technology development

01:18:04.220 - 01:18:27.020

and demonstration to go in conjunction with the research plan that we have in place. Our third recommendation is the broad area of what we call the information gap. So the subcommittee on global change research, so this is a subcommittee of NSTC's Committee on Environment, Natural Resources and Sustainability in consultation and close working with the private

01:18:27.020 - 01:18:51.180

sector and others who have a stake here, really needs to take charge of improving the availability of access to and usability of data. This is a very broad statement. It is easy for people to come to a table and say, I don't know where the data is and you need to make it easier for me to get to data. The question we're asking people to address here is much broader than that. This is a question

01:18:51.180 - 01:19:16.140

of where is the data? What kinds of data do we have? What's the right way to get access to the data? What's the right way to make the data live and updated over time? What's the right way to understand what the community wants from the data? So this is not just we need a new database to go to. This is a broad statement about an integrated methodology, architecture and availability of

01:19:16.140 - 01:19:43.900

data to assist the private sector in knowing what's out there from a data point of view, what modeling capabilities exist, and what programs exist to help the private sector as it looks at its adaptation activities. We point out that in the FY 2017 R&D Priorities Memo jointly issued by OST and OMB, this area of commitment to data availability and modeling

01:19:43.900 - 01:20:10.540

and resource availability is mentioned. So there's a precedent here for the recommendation. The fourth recommendation is about unlocking investment capital. We asked that the National Economic Council in conjunction with OSTP, OMB, and the Department of Treasury create a task for specifically to recommend public-private partnerships to create new public and private

01:20:10.540 - 01:20:35.100

investment capacity for adaptation. The compli- not the complication, the added issue here is to understand how these kinds of investments are evaluated, what metrics should be associated with the adaptation activities, the success of the adaptation activities, how one scores these kinds of investments given the long-term nature and the long-term nature and the preventive

01:20:35.100 - 01:21:01.660

nature of the investments. So there is a need for significant new investment capital to aid both the public and the private sector here. The fifth recommendation is around expanding public private partnerships. And in this recommendation, the idea here or the recommendation here is to build on at least one existing public-private partnership and potentially launch at least

01:21:01.660 - 01:21:26.780

three others that we identify as examples. The first that exists already is the DOE's Partnership for Energy Sector Climate Resilience. This is a partnership between the Department of Energy and 17 energy producers in the United States, which is currently already looking at adaptation activities in the energy sector. We recommend that this continue, obviously continue,

01:21:26.780 - 01:21:48.300

but to build on that to make sure that best practices and lessons learned from the adaptation element of that partnership are shared broadly beyond the partnership to the broader community. And also to develop incentives for adaptation activities based on the learnings of this partnership in areas that are not specifically related to adaptation, things like rate recovery

01:21:48.300 - 01:22:12.460

mechanisms, things like investment capital. How do we lever those from non-adaptation activities into a broader private sector adaptation? So that's an existing program that's underway. And then we identify three potential new public-private partnerships. One, I have actually already talked about, which is the creation of a public-private partnership that OSTP has been

01:22:12.460 - 01:22:35.340

encouraging to deal with this issue of climate information, best practice sharing data, etc., and how that's applicable for private sector adaptation. We recommend that the Interagency Council continue its dialogues with insurance and reinsurance leaders, specifically to include lenders, rating agencies, and the financial banking sector in identifying new capital and new

01:22:35.340 - 01:22:58.220

methods of evaluating the deployment of capital. And finally, we recommend that the Interagency Council convene an additional work stream as part of the state, local, and tribal leaders task force on climate change that works together with representatives from the private sector to implement its recommendations, but implement those as they may be applicable to an integrated

01:22:58.220 - 01:23:26.540

public and private sector set of activities related to climate adaptation. And then our final recommendation, sorry, is to launch a pilot program. So we have the public-private partnerships that we've announced. We'd like to see action quickly and identifiably, and so we recommend a very specific action to take an existing cities program, and the one we've chosen as an example

01:23:26.540 - 01:23:56.140

is the Strong Cities, Strong Communities Initiative. And our recommendation is that we take three of the SC2 cities. They might be Detroit, Fresno, and New Orleans. And essentially what we're asking is that we layer into that existing cities partnership specific activity to bring the private sector adaptation activities into the public partnership that's already in place. So understand the

01:23:56.220 - 01:24:20.620

information needs that the private sector would have, test adaptation efforts that align with the other recommendations in the report, identify opportunities where public and private sector adaptation can be co-executed and jointly undertaken for the benefit of both sectors at the same time, and to continue as always in these pilot programs to ensure that the data and the results of the

01:24:20.620 - 01:24:45.100

public-private partnership are made available ubiquitously, and lessons learned are translated as quickly as possible. So in summary in the report, we find, sorry, significant opportunities for the U.S. government to help catalyze private sector moves. At the end of the day, it is the private sector who will have to execute its adaptation activities, but the government can play a key

01:24:45.100 - 01:25:07.420

role in helping, as we say, catalyze that. And the recommendations outlined in the report specifically leverage public-private partnerships to bring focus and commitment to all stakeholders on what should ultimately be private sector activity in adaptation. With that, let me stop and let me turn it over to, I think, Rosina and Maxine for comments.

01:25:08.860 - 01:25:30.300

Just a few comments on the front. I want to reemphasize this with just looking at several industries and also the supply chain. And the supply chain are often smaller vendors, so they have less access to the data than some of the bigger companies who do have it and do make, develop their own models when they're building bigger and new facilities, particularly if you

01:25:30.300 - 01:26:01.020

look at the energy supply group and the utilities. The other thing is that the idea that they may be, the private sector may be aware of climate change, particularly the near term, but they don't frame it in the terms of risk, which is where they manage when they're concerned about their future and their bottom line and also the long-term risk, much more framed as a hazard

01:26:01.020 - 01:26:26.700

where it does not need to be managed. And the insurance industry, of course, is very concerned about this. In fact, one person told us that is appropriate because we also heard about the aging today, that aging and climate are their biggest sources of risk that concern them for future liabilities, so that really raised to that. And just to mention that there are two other studies

01:26:26.700 - 01:26:53.260

that were going on at the same time. In the workshops we did participate in, GAO on their own initiated a look at adaptation and the private sector and what they were doing. They issued their report yesterday, has a lot of the same findings, they make no recommendations, but really heard from the same things that we did. And the Center for Climate and Energy Solutions has been looking

01:26:53.260 - 01:27:16.380

at this and has some interesting case studies from various people, and they also have very similar things. So it's starting to get attention and we're hoping that this will even accelerate and particularly have more public-private partnerships. Turn over to Riz. Thanks. As the non-private sector co-chair, I'd be happy to answer a lot of the questions

01:27:16.380 - 01:27:38.700

about information or research, mainly. But I guess I did want to say that this is really timely, I think, for at least two decades. People have been thinking about the mitigation side or how emission reductions could be accomplished. And in fact, of course, we ran into many, many, many companies who disclose their carbon emissions, have set targets, and are moving on their way to

01:27:38.700 - 01:28:01.260

reduce emissions. But really, I would argue that adaptation in general, both in the public and private sectors, has been underattentive for almost two decades. And so we really have a lot of catch-up work to do now. And I think it's extremely clear that the pace and magnitude of climate change means that you need both as much mitigation as you can get and adaptation to cope with the

01:28:01.260 - 01:28:23.740

changes we're already seeing at the global average increase of 1.4 degrees Fahrenheit to date. And some of the very new research that's coming out, the statistics that show some of the heat events and some of the drought events that are so improbable, a five-sigma event in an unchanging climate, have really brought attention to the public and private sectors that learning how to

01:28:23.740 - 01:28:57.740

cope with this in fast is quite necessary. Well, thank you very much for that good account and for all the good work behind it. Let's open it up for questions. Mark, I think your flag is a holdover, but I've got mine up and closely followed by Bill Press. So in the course of this work, obviously, as you have related, you spoke to a lot of companies. And as Rosina has just noted,

01:28:57.740 - 01:29:25.020

a lot of companies have shown a lot of enthusiasm, a lot of initiative on the mitigation side. How would you characterize the welcome you got in raising these issues with the private sector? What is the level of enthusiasm or lack of it for working with the government on private sector adaptation and resilience? So at the risk of saying it's a biased sample, I would say the nature

01:29:25.020 - 01:29:53.660

of the people who we talk to were people who were willing to hear a strong message. I think that by and large, I would say two things. One, when providing information around how adaptation can and should be a strategy beyond mitigation, there was good appreciation for it. Obviously, lots of conversation about how that fits into a long-term investment stream,

01:29:54.940 - 01:30:16.620

what adaptation might mean, adaptation in place versus wholesale pickup and move, but also very strong communication on, as Rosina said, the small and medium enterprises on really needing help to understand what resources are available to execute. So bottom my answer to your question, I think strong. I think strong appreciation that adaptation

01:30:17.740 - 01:30:44.460

was something that should be on the radar screen, very incapacity on the ability to execute against that. And I would just amplify that, that the public party partnership that was started at DOE in April at the time that they issued their first part of the quadrennial energy review, which looked at infrastructure, and they had no problem signing up 17 utilities who represent 25% of all

01:30:44.460 - 01:31:15.100

the consumers. And some of their participants were at our workshop also, and they really are looking to the government to help share the best practices, and they themselves are building facilities that are around for 30 and 40 years, and so it's of big concern to them. And they also want this rate of recovery for adaptation that now occurs in their rate structures for efficiency

01:31:15.100 - 01:31:39.660

and renewables, and that's one of the things we're suggesting that DOE follow up on. But good support. I would just add one other, it really doesn't show up in detail in the report and really in its infancy, but I was struck by the interesting eye-opening viewpoint of companies on what adaptation will mean from future business. So there's adaptation, what should I do to protect my company?

01:31:39.660 - 01:32:00.140

But many companies are beginning to think about what will this mean for new markets being developed for me. So the movement of my customers from one location to another, the movement of infrastructure projects from one location to another. So there is an element of this, which is positive future business, because other people have to adapt to it, and I play a role in how they will adapt.

01:32:01.660 - 01:32:25.180

Bill Press is next. Thanks, John. So this is one of these, I am not an economist, but questions. I understand that many companies will have this barrier to action because of a certain short-term viewpoint against a long-term risk, or another way of saying that is they have to figure out how to

01:32:25.180 - 01:32:52.620

discount to the present value what's the time value of mining and so on. But it seems to me that the insurance, re-insurance business is in a sort of a uniquely different space because they have to think long, both on what they're insuring against and on how they invest their premium stream against that. And I wonder whether in that sector, which both you and Maxine mentioned, there is a kind

01:32:52.620 - 01:33:20.060

of thinking about how will climate change affect at the very macro level what their investment returns are in this long period in which they're, in a sense, banking or investing premiums. Because I could think that climate change could either be a depressor on investment returns or it could enhance investment returns. Is there any thinking along that line? I think of the folks we talk to,

01:33:20.060 - 01:33:41.740

and maybe it's a bit of what you're saying, and I would suggest the insurance industry is, the large insurance industry, is very sophisticated on this issue. And the comments about availability of data, use of data, use of models, the insurance companies are already very sophisticated. The challenge in all cases to determining whether this is long-term opportunity, long-term risk,

01:33:41.740 - 01:34:02.620

which way the discount calculation is going to go, really has much to do with the error bars. And the error bars, which are regionally specific as is the portfolio, makes it a complicated calculation. But I think, to the point you're trying to make, I think that this is the place where it really does come home to roost most directly because, I mean, this is what they do

01:34:02.620 - 01:34:22.540

for a living, right? And if they get it right or get it wrong, it's an existential question. Right, exactly. Well, they also are really, you know, they are concerned about the people they're ensuring that, you know, the return is going to be there. So therefore, they really, they encourage things like building codes that look at what you, how you might adapt those for

01:34:22.540 - 01:34:47.100

adaptation and not just fire and safety and, you know, do for energy, because that will help reduce the risk. So they are looking for public policies that will also help to minimize their risk. Good. Ed Penhout is next. So in recommendation two, you've articulated the subject matter that should be the subject of the

01:34:47.100 - 01:35:14.060

National Global Change Research Plan. But much of adaptation research, adaptive research, can be characterized as essentially practical in nature or applied in nature. So you don't articulate who would actually do this research in your recommendation. So can you go ahead out a little bit more with the discussion on who will do it? Yeah. So I said that I thought thinking

01:35:14.060 - 01:35:35.340

about adaptation itself was quite nascent. And when we finished the National Climate Assessment, which Congress mandates, and we just finished the third one a little more than a year ago, for the first time, we included adaptation activities of sectors and regions and cities, et cetera. And what was really clear is all sectors and regions are vulnerable to climate

01:35:35.340 - 01:35:53.100

change. But how to respond is not so clear. And as you might imagine, the devil is in the details of what else is going on. And, you know, you may have urbanization, habitat fragmentation, invasive species, and climate change. And so you want to think about things that will not make any one of those worse while you're trying to combat climate change.

01:35:53.100 - 01:36:15.900

But we also realized that there really are some very basic research questions that we need to answer. So for example, we know the world is getting hotter. We know we're having an increase in droughts and floods. And in some planting seasons already, it's too wet to plant. So maybe we need different crop varieties that might be able to tolerate more heat, more rain, more

01:36:15.900 - 01:36:42.620

drought. Not the crop varieties we've been using since 1970 that might be optimized to an unchanging climate. So that's a very basic research question. I think, you know, garden clubs of America are greatly terrified because if you look at the shift in growing zones in the next 50 years, about 120 miles will, planting zones will have shifted north. So now, what does planting native

01:36:42.620 - 01:37:05.500

mean anymore? And cities like Ann Arbor, my own city, are thinking about, well, we plant city trees that we want to be there for shade. What kind of trees can persist this rapid changing? So that's a research question. Every one of the federal agencies has put together a report that says how climate change will affect their missions and mandates, whether it's to protect human health or

01:37:07.420 - 01:37:32.060

reduce pollution or preserve species, et cetera. But if you have the climate map moving at a rate that we know to be four to 10 times the rate at which plant species have moved historically, you're really ripping apart ecosystems and parts that fly and swim and crawl and are wind dispersed moving at different rates. So what would a large land management entity like Department

01:37:32.060 - 01:37:54.460

of Interior or Forest Service, how do they make sure that they're having intact forest with species with ecosystem services? Those are researchable things. And I could go on and on. It's much easier to think about what kind of infrastructure do you need to withstand the new 100-year flood? And what is it in your region anyway? So those are a lot of the basic research questions. And we

01:37:54.460 - 01:38:20.540

would argue that the Global Change Research Program, the entity of 13 agencies that does about $2 billion worth of research each year, should be addressing some of those very basic research questions for the nation. The second part of that recommendation, too, was it's more than basic research. We've got to begin to start demonstrating and deploying activities so that we expand it.

01:38:20.540 - 01:38:46.940

Oh, I'm sorry. I'd like to talk about research. But there are experiments being tried now. And so if you talk to a group of mayors and the resilience task force that the president set up had some amazing recommendations from them, they are trying things now to deal with changing floods and droughts. And so assembling those best practices and distilling them in things that can be transferred

01:38:46.940 - 01:39:08.780

across communities or across sectors and to the private sector is something that's more than the research group. And that's why we put it in the purview of the four-part council and the science and technology council. So assemble what you have today and get it out there. But make sure you're answering the questions. You really need the answer for tomorrow.

01:39:11.660 - 01:39:35.500

I don't see any more flags up. Do the leaders of the study want to make any further comments before we call a vote? Michael or Rosina or Maxine? Actually, I want to come back to the first thing you said, Michael, which is that this builds on the report we gave to the president on climate change back in 2013. And I don't know. I think it was recommendation 60. But

01:39:36.220 - 01:40:03.180

I think very, very importantly, you know, we had asked that there be this interaction between the public and the private sector to both identify problems and identify solution sets. And so I think this way of bringing the public sector into a dialogue, the private sector into a dialogue that was very rich with the resilience task force that included mayors and tribal leaders and

01:40:03.180 - 01:40:31.820

governors is an important missing piece. And so I think we actually are coming back to a recommendation that we hadn't quite crystallized in 2013 with this report. Good. Chris Castle. Thank you, John. I just wanted to thank the working group for, I think, a really strong and important report and move approval. I'll second that. Approval has been moved and seconded. Is there

01:40:31.820 - 01:41:09.020

any further discussion before we vote? If not, all those in favor of accepting this report as usual subject to final edits, please raise your hands. All those opposed? Abstentions? The report is unanimously approved. Again, my thanks to the leaders of this extraordinary effort. And to the staff who so ably supported it. This takes us to the end of our pre-break activities.

01:41:09.020 - 01:41:47.660

So we will now go on a coffee break resuming at 11 o'clock sharp for a sure to be fascinating session on academic research, making sure the rules of the road don't stop the traffic. See you at 11. All right. We're going to resume for the second portion of this PCAST meeting. And we have a session on academic research, making sure the rules of the road don't stop the traffic, which is

01:41:49.100 - 01:42:21.980

nice statement about the issues involved in regulation in academic research. The National Academy of Sciences has a committee currently working on a topic called optimizing the nation's investment in academic research, colon, a new regulatory framework for the 21st century. It has already released at the end of September part one of its report. And everyone is eagerly

01:42:21.980 - 01:42:46.940

awaiting part two of the report, which is expected in the spring. And who knows, maybe the committee will decide to make this an ongoing serial with parts three and four, although I think not. It's actually a really very interesting and provocative report that was already released. And we are lucky enough to have with us here the chair of that committee and a member of that committee who

01:42:46.940 - 01:43:08.940

will be able to brief us on the report. And although they can't tell us what this the next chapter of the report is going to say, because the National Academy does not allow those kind of spoiler alerts and things, but we would like to engage them in a broad discussion about this topic and where they are broadly going. So we have with us Larry Faulkner, the president emeritus of

01:43:08.940 - 01:43:34.700

the University of Texas at Austin, who's been serving as the chair of this committee, and Barbara Birer, professor of medicine at the Harvard Medical School, and a colleague of mine up in Boston. And I want to thank you both for coming and talking to PCAST about this really important topic about optimizing our investment in academic research. Well thank you, Mr. Chairman. It's a

01:43:34.700 - 01:44:12.300

pleasure to be here. It's an honor to be here. And I think Barbara and I are eager to talk with you about the report, which has come about in a little bit different way, you know, as I will discuss. Let me draw your attention first to the title, which is optimizing the nation's investment in academic research. There is pretty broadly extant in the country now a concern about the

01:44:13.180 - 01:44:50.860

total amount of time that investigators in scientific and other kinds of research are directing away from the actual performance of research toward the administrative and compliance functions that are associated with research. The committee views that load as one that draws away from the nation's funding, the irreplaceable asset, which is the researcher's time and insight,

01:44:50.860 - 01:45:27.020

and puts it on a really a second level function. So at the same time regulatory activity is essential and it serves to protect absolutely essential interests of the public and indeed of the researchers themselves. So how do you balance properly and where is the optimum? That optimization is central. But also central to our consideration is the idea of efficiency

01:45:27.660 - 01:46:05.020

trying to maintain an efficient regulatory system that allows us to proceed in a responsible way into the future, but with as much researcher time dedicated to actual research as possible. The committee's roster is a strong one. I won't go down these names, I just put them there for you. And it does have representation from various aspects of research, but also from government and

01:46:05.100 - 01:46:47.820

from experience in the process of regulation. I draw your attention to this comment from Howard Shalansky over at OMB. Now he is essentially echoing the message that I just gave that there is a concern, there is a risk that the regulatory load has become so great that we're not getting as much for our research money as we should be getting because people can't spend the time

01:46:47.820 - 01:47:21.340

that they need. This is more elegantly stated, but I'll leave that to you. The committee was charged by Congress, charged, the Academy was asked to undertake the study by Congressional request, and we've been asked to examine all aspects of regulation. But let me draw your attention to that last paragraph that the committee will develop a new framework for regulation of the

01:47:21.420 - 01:47:54.940

research universities in the 21st century that addresses the needs of Congress, federal agencies, and the broader public. That has meant in the committee's mind that part of our charge is not just to look at individual regulations or how to lighten the load in this area or that, but it's to look at the process and apparatus by which regulation arises and to think about whether

01:47:55.980 - 01:48:27.260

there is a different configuration or a different approach that might be applied in the future. One of our recommendations bears on this issue and one that I'll dwell on as I talk with you here in a moment. These are elements from the statement of task. I won't go down all of this. It's the kinds of things you would expect to look at regulations with significant impact and to gather

01:48:27.260 - 01:49:02.540

information on how effective they are and what they cost and just won't go down, as I said, that. I do want to draw your attention back to seven. Seven is develop a framework and supporting principles for federal regulation of research universities in the 21st century. That's that part of the task that I was talking about just a moment ago. Now, this study was, as I said, charged

01:49:02.780 - 01:49:35.100

and organized. It was thought that it would be an 18-month study, but just a few months after we got started, Senator Alexander came to us and said, you know, we really need a list of things to work on by mid-September. He pushed hard for an early report rather than a later report because he has a belief that this fall represents an opportune moment for some progress.

01:49:37.580 - 01:50:12.860

As a consequence, the committee worked really hard and the staff, led by Ann Marie Matzo, who's right over here, worked really hard. We produced a part one of the report, not a usual procedure for an academy committee, in time for Senator Alexander's deadline in mid-September. That part one has been made available to you. It is said on the cover that it's a pre-publication copy. However,

01:50:12.860 - 01:50:52.620

it's been all the way through the academy's review process and it is formally released by the academy. It won't be rewritten in part two. The committee has not fulfilled all of its elements of its statement of task and is therefore continuing on. We are doing additional work this fall and by the end of the first quarter or so in calendar 2016. We expect to issue a second part,

01:50:53.260 - 01:51:22.220

but that second part will deal with items that we did not get to in the first part. It will not be a reiteration, an expansion, or a revision of the first part. We've said what we're going to say on those items. The second part will cover things that we haven't talked about in full detail, human subjects, export controls, and some other topics that have not been addressed.

01:51:23.260 - 01:51:55.900

Now, let me ask Barbara to go ahead and discuss the overarching findings. Do you want to control the slides? Thank you. The overarching findings are summarized in the next few slides and really do not detail the extent of work that went into those findings. That is more in your report if you wish to review it. Basically, we never took the position that effective regulation is not

01:51:55.900 - 01:52:27.020

necessary, rather that effective regulation is essential to the overall health of the research enterprise protecting both the national investment and the various parties in the partnerships. That the expansion of the federal regulatory system, however, and its growing requirements are diminishing the effectiveness of the research as Larry has described. Now, most federal regulations,

01:52:27.740 - 01:53:04.780

policy, guidances, rules, funding requirements, etc., are efforts to address accountability and performance, but those well-intentioned efforts are really undermining the research that can get done and undermining the nation's investment in research. These regulations really do not address the diversity of the research enterprise as we know it today. Further, many of these regulations

01:53:04.780 - 01:53:33.740

are inconsistent, duplicative, unclear, marginally different one agency to another without being substantively different, and therefore there's an enormous investment in compliance with these individual regulations. Universities therefore increase the requirements for each of the investigators to comply universally across these funding agencies in order to protect

01:53:34.860 - 01:54:02.540

themselves and to ensure that there is a compliant framework from which they work. It would be different if academic institutions received funding from one agency and had one agency's regulations to comply with, but that is not the way that current universities are funded, and we all deal with a multiplicity of sponsors for that research, and the lack of harmonization

01:54:02.540 - 01:54:36.380

is really crippling the research institutions. Some of the basis of this may be that universities have failed to respond appropriately to actions that have been inappropriate by the investigators, and there is an effort to really enhance the controls and the environment to discourage both the individual and institutional level behaviors that are in conflict with the norms of

01:54:36.380 - 01:55:10.380

the community. There is a section here addressing the inspectors general, since academic institutions may be audited by those inspectors generals, each from different agencies, many of which have very different approaches, which may even be incongruent with their cognizant agency. Our relationship in the research environment has been a partnership between the funding agencies

01:55:10.940 - 01:55:42.380

and the institutions. That has been in existence for seven decades or more, but there is no formal entity, no structure, no mechanism or process by which we, stakeholders from both partners and more dedicated to fostering, sustaining and strengthening the enterprise, can consider the effectiveness of existing research policies and review those policies with an aim to being efficient,

01:55:42.460 - 01:56:12.380

dynamic and effective, and that conforms to some of our recommendations to follow. We're going to present the recommendations, thank you Barbara, present the recommendations going over one, two, three quickly and dwelling on four and then coming back to consequences of one, two and three. There are actually only four recommendations that the committee has made,

01:56:13.020 - 01:56:42.540

they are however large in scope in some cases, so let me, let me just go quickly through them. Recommendation one calls for the regulatory regime comprising not just laws and formal regulations but also rules, policies, guidances and requirements. Governing federally funded academic research should be critically reexamined and recalibrated.

01:56:43.420 - 01:57:16.060

Now under this there is a large list of specifics, some of which I'll come back and dwell on as we go further. Recommendation two is a recommendation to the academic institutions themselves. It says that, that institutions must demand the highest standards and institutional and individual behavior that it can only be achieved if the universities foster a culture of integrity

01:57:16.060 - 01:57:40.940

among all the players and that they meet out appropriate sanctions in instances where behavior deviates from the ethical and professional norms of the institution and the research communities. Universities that deviate from or fail to enforce norms should be sanctioned and the committee recommends that possibly the research policy board that I'll talk about in a

01:57:40.940 - 01:58:12.300

moment could have a hand in this. And recommendation three is about the inspector's general saying that the inspector general responsibility should be rebalanced to provide appropriate consideration to uncovering waste fraud and abuse and to advising on economy efficiency and effectiveness. Both of those columns of responsibility are in the legislative charges

01:58:12.300 - 01:58:38.780

to the inspector general but in our observation only the first column really gets attention. And then I'll come back to that slide. So recommendation four is that the committee recommends the creation of a new mechanism to include an active public private forum with a designated official within government to foster a more effective conception development

01:58:38.780 - 01:59:13.740

and harmonization of research policies. This is the recommendations that is responsive to the element of our charge calling for us to look at framework. And I let me just say that I think the committee believes that what we have which is we believe and have judged to be an overburdening regulatory environment is the natural evolution of this complex picture of two dozen funding

01:59:13.740 - 01:59:48.460

agencies and other agencies having a hand plus hundreds of research entities all working in an environment with no focal center and on an operational point of view where we believe I think that if we were to make a fix a one time fix right now that it wouldn't stay fixed that evolution would continue to manifest itself and that we can see coming down the road spheres of scientific

01:59:48.460 - 02:00:24.780

progress that will give birth to new regulation. We can see that in big data we can see that in genomics we can see it in other areas. So the the burden is going to grow and it could grow paralyzingly if we don't actually look at the framework thoughtfully. So as we go forward the recommendation is this in sort of a graphic form. It's to place a body called the research

02:00:24.780 - 02:01:03.980

policy board into the picture and I'll say more about how that research policy board might be constituted but we view it as being connected to the academic research institutions and the funding agencies and the associations that exist already but also formally connected to OMB and OSTP. We've recommended that an associate director of OSTP be designated not just to

02:01:03.980 - 02:01:34.860

be the liaison with the research policy board but to oversee or to look out for the operating health of the research partnership. There is no single official in government that works every day thinking about the operating health of the research partnership yet it is a 65 billion dollar enterprise with a great many moving parts and lots of connections to multiple agencies.

02:01:35.900 - 02:02:10.300

We're recommending that that all happen. Now let me talk about the research policy board itself. The model that we have recommended follows the example of the financial accounting standards board which is a federal it's a federally related entity. It's actually a private sector entity that is formally linked to and overseen by the SEC. It's funded by mandatory assessments on public

02:02:10.380 - 02:02:39.660

companies on the things regulated by the SEC. It's been functional and effective since 1973 and is organized and financially able to undertake relevant projects on a current need or anticipated need basis. That's the model that we've looked at. Obviously there's a gulf great gulf between financial accounting standards and what we're talking about doing here but we believe that the

02:02:39.660 - 02:03:12.300

apparatus that has been chosen in that sector might be relevant for the sector we're talking about. The concept is a private sector entity that would be formally linked to and overseen by S OSTP and OMB using a governance basis to be determined. We haven't been too explicit about membership and how it would be managed and all of that. Our view has been essentially that if it

02:03:12.300 - 02:03:41.900

were to come into being it would come into being through a negotiated process involving all the players and perhaps Congress and people in the administration and and there are different models we haven't tried to cover all the details of how it would formulate members would be chosen and it would work but we're talking about this as a structure that it would be funded by mandatory

02:03:41.900 - 02:04:10.140

assessments of research institutions. It would be organized and financially able to undertake relevant projects on a current need or anticipated need basis and able to work flexibly with the associations. The mission would be to improve and maintain a regulatory environment conducive to optimal performance of their search partnership. We envision maybe nine to 12 members from

02:04:10.860 - 02:04:37.980

the academic institutions and six to eight liaisons from federal agencies all designated through formal processes that it should become the primary policy forum relating to the regulation of federal research programs in academic institutions. Now because it's a private entity not actually formally part of government though reporting to government its responsibility would

02:04:37.980 - 02:05:14.380

be to recommend regarding conception development and harmonization through good information through studies that it could conduct that it could organize with government agency participation dealing with perspective or existing regulations I could look at negative or adverse consequences it could look at the overall load we were asked in our process to quantify the load

02:05:15.260 - 02:05:44.060

and we weren't able actually to do that there's no there's no tool there's no information that an academy committee can make access to to give you an answer to that question but it's a question that probably ought to be thought about on a regular basis an organization like the rpb could have it as part of its charge it should be future oriented cognizant of needs

02:05:44.060 - 02:06:19.340

of trends affecting overall regulatory needs anticipatory based on future technological demands scientific demands and it should become a more systematic integrated meaning formally tied to government and effective operational forum on research related matters than any or all of the historic professional associations that's the layout for the rpb and for the

02:06:19.340 - 02:06:46.220

recommendation that we have made regarding the creation of an associate director of ostp to be focused on the operation of the research partnership I don't think I need to go further into detail now there are many specific recommendations I think if you have a copy of the slides you'll have a set of slides that I'll just say as an appendix that gives you the specific recommendations

02:06:46.940 - 02:07:31.340

let me go back to this slide right here and just now say this is what one to three addresses actually mostly this is one but there are several areas that we have recommended get early attention by by ostp by omb by agencies themselves first in that in that list is proposal preparation there is a vast quantity of investigator time that is now soaked up by the lack of

02:07:31.340 - 02:08:05.420

harmonization across agency lines in what's expected at proposal submission time many investigators prepare essentially the same proposal for multiple agencies it's a restructuring job we believe that lots of investigator time could be saved by by harmonizing in that area and also using more effective more effectively the provisions or the the ideas that already exist

02:08:05.420 - 02:08:35.820

in the community for just in time submissions of information that is not likely to be needed from the 80 percent or so of unsuccessful applicants we there are many pieces of the proposals that go in now that could be given just in time and we've made made a recommendation for wider use of that we have similar kinds of comments on conflict of interest I might ask

02:08:35.820 - 02:09:04.060

Barbara to comment on that I might ask Barbara to comment on human subjects and also on animal research but those are three other areas where we believe that there's a great deal of resonance across the community that early and creative attention could save quite a lot of effort Barbara you want to comment on any of those sure so on the conflict of interest policy there are

02:09:04.060 - 02:09:32.060

separate policies for many of the different funding agencies different thresholds different expectations of when to report what to report and we have recommended harmonizing the conflict of interest policy across the federal agencies so that there is one set of expectations which we hope would in fact enhance compliance if everybody knew for every proposal what they had to do and

02:09:32.060 - 02:10:02.780

what they didn't have to do for human subjects research it's one of the places since the NPRM for the common rule has come out since this part one of the report that we do intend to go back and not change our recommendations but potentially annotate the explanation behind them and then to enhance that for instance with further consideration of HIPAA issues but the four recommendations

02:10:03.420 - 02:10:35.500

for human subjects research is one to introduce a risk stratified human subjects review so that would that would reduce regulatory burden on minimal risk research while preserving review and attention to that research which is of higher risk or consequence to the participant that congress should require single site review for multi-site

02:10:35.500 - 02:11:02.060

research but only after there's appropriate infrastructure to support that single site review and communication pathways so an infrastructure both in terms of IT as well as policies and processes otherwise one risk having a patchwork of interactions that actually will make this process worse rather than better

02:11:03.420 - 02:11:32.140

that the congress should direct agencies to align and harmonize their regulations and indeed even their definitions for all human subjects research in order to know whether one is depending on the funding agency what how one defines the human subjects what the review expectation is what the exceptions are etc should be again harmonized across the agency if one looks

02:11:32.140 - 02:12:05.900

at the the human subjects protections from the point of view of the participant the protections indeed should not differ that we we recommend that congress amend the FDA's authority so as to allow the FDA to waive informed consent or modification of the requirements of informed consent something that they can only do right now in very limited instances and finally that

02:12:06.780 - 02:12:36.700

uh congress should uh instruct HHS to work with other agencies to allow that research involving biospecimens is eligible for a waiver or modification of informed consent so long as it meets the definition of minimal risk research in animal research we actually did a fairly deep dive and i'm just going to show you one graph which you don't need to read

02:12:36.700 - 02:13:07.420

you just have to appreciate that depending on the funding agency you the expectations are completely different and if you take the point of view of sitting as an animal one would not expect the protections to any animal to depend on the funding source so this is a good demonstration of how these kinds of regulations consume an enormous amount of time for both investigators

02:13:07.420 - 02:13:40.940

and their institutions um so do you want to take over for inspectors general and audit yes i i think i won't uh the what i wanted to convey here really is the the early attention that we're recommending in those four main areas proposal preparation conflict of interest human subjects research and animals the audit climate is the subject of our our third recommendation

02:13:41.660 - 02:14:12.780

uh it is a complex um but an issue um in some cases we've seen examples where there are policy disputes between auditors uh the intern excuse me the um the inspectors general for an agency and the agency itself on the policy promulgated by the agency they get fought out on university campuses this is a federal dispute it should be settled

02:14:12.780 - 02:14:46.940

in federal offices and not uh not uh using universities as battlegrounds but more generally if you look at um at the record of um of recoveries um from um auditing by inspectors general you will see that there's not that much uh that comes out of the world of research that this seems to be a place where inspectors general could make a greater contribution

02:14:47.980 - 02:15:21.820

using the efficiency and effectiveness column of their charge as opposed to the ways fraud and abuse column of their charge and we're simply recommending a rebalance in their attention to make positive contributions more likely compensation for personnel expenses is about payroll certification versus time and effort reporting in the recent uniform guidance

02:15:22.780 - 02:15:57.020

um the payroll certification method has been accepted uh it is okay according to uniform guidance but there are disputes still between audit figures and uh agencies over that we've simply asked for a higher level of affirmation that um payroll certification is indeed okay uh so that universities feel the latitude to actually adopt those procedures uh right now

02:15:57.020 - 02:16:19.980

they're afraid to adopt those procedures even though they're said to be okay um the remaining things that we have in uniform guidance are there they're significant but they're not I think necessary for be reported to you today so we won't talk about those uh barbie you have anything else you want to add I think it would be a good time for questions yes I think we are done so thank you

02:16:19.980 - 02:16:49.500

mr chairman well thank you for that really great summary of this report um it's our practice at pcast that we raise our flags when people want to ask questions and Susan Graham's flag is up so I want to thank you very much for all the effort that you've put into this report I think that anybody who's ever done funded research has their horror stories about the problems with

02:16:49.500 - 02:17:19.580

the present system which are only getting worse I'm a believer in evidence-based decision making and so let me let me say first we have a summary of your report but not the whole report and so it's very possible this is in your report but I have two questions about evidence one is research universities are increasingly accused of bloated administration

02:17:21.100 - 02:17:52.860

that we're hiring more and more administrators and the money should go for faculty and and so so forth and um it's our belief that a certain amount of that bloat comes from hiring people to do compliance um and so my first question is whether there's any studies any any quantitative evidence of that phenomenon and the increase in compliance officers and the like over time

02:17:54.540 - 02:18:31.420

and the second question is from the point of view of the regulators um are there any measures of the effectiveness of the um regulations in accomplishing the the avowed purposes of those regulations in other words do they actually do the job for which they're intended yeah so um I think that what uh both both comments um reflect uh a sense from the committee

02:18:31.420 - 02:19:01.260

that very little data is available and that would be one of the principle or a a function of the rpb um to collect that kind of data um we did hear from individuals but that's all anecdotal about that bloat and the rise um I'll say two things about that one the number of compliance officers or the number of people in compliance severely under estimates the number of administrators

02:19:01.260 - 02:19:31.180

that are there to ensure compliance at the transactional level so I I think that that would be a potentially one surrogate to look at but not really the um the impact that you're looking for um and I'll also say that we heard that in institutions because they have this patchwork of regulations with which to comply raise the level of expectation of all research

02:19:31.180 - 02:20:00.620

to the highest uh compliance threshold in order to ensure that they're compliant regardless of which funding agency they're uh asked you know a specific project is funded with um because it's almost impossible to ensure that if you do a project by project dollar by dollar again not a lot of data there and as far as we know I don't think we've heard any data about from the funding

02:20:00.620 - 02:20:25.900

agencies themselves about the efficacy of the um efforts particularly with the introduction of new regulations it's one of the one of our uh recommendations is to essentially review new regulations periodically say at five years with the expectation that that answer would come in we can look at a conflict of interest for instance and there has been a very good study now

02:20:25.900 - 02:20:56.460

from the AMC on the cost of the of the implementation of the NIH conflict of interest with very few uh important new um conflicts being exposed but enormous resources for the research institutions to comply with that regulation there's there's not any doubt that institutions are hiring um people to address the compliance uh uh matters uh and that there's

02:20:56.460 - 02:21:29.260

some increase that has to do with the um the broadening scope of federal regulation one statistic that we had um I can't quote it exactly at this point but the rate of introduction of new federal regulations has substantially increased since the early 1990s and uh there's certainly reaction to that we have had um declarations by individual institutions which

02:21:30.060 - 02:21:57.660

I have no doubt are accurate that they are by policy trying to unload or to relieve faculty members from having to deal with compliance issues that had historically been done at the investigator level uh and they're having to hire people to do that so there there certainly is some strategizing uh being done by institutions that is leading to hiring uh but Barbara's right

02:21:57.660 - 02:22:25.100

we don't have comprehensive numbers so just you know here I am Vanna White uh showing you the data this is the introduction of regulations this is only regulations not guidance not and this is uh for over time um and this is for instance one of these dots is HIPAA so this is by no means uh a overestimate of the kind of regulatory climate we're facing

02:22:25.340 - 02:22:50.460

those are quanta not not sizes of quanta Chad Mirkin you know first of all thanks to both of you for taking on this very important topic it's one that's uh really bothered me for quite some time and many of my colleagues um I'll start by I guess uh connecting to the first or the question just to ask which is if you do a cost

02:22:50.460 - 02:23:20.220

analysis right investment versus what we gained how does it bear out an enormous amount of money not just time money has gone into uh implementing all of these and it's over my career over 25 years has increased dramatically um I would guess that the amount of money saved or the problems found have been fairly minimal um so so the question is what are we getting out of this and from an

02:23:20.220 - 02:23:40.700

investment standpoint and then the second one is I I have a very different experience from what Larry you you referred to in terms of institutions hiring people I've I've found that universities have been hiring people to deal with these but to deal with them from the university's perspective to make sure that they are covered and in the process over the last 10 to 15 years they've

02:23:40.700 - 02:24:04.060

shifted a tremendous amount of responsibility to the individual PI who is not staffed well enough does not have the background to really deal with them and so you you you've got a real tension that's been created because of these and I was curious whether the committee has looked into dealing with that the committee hasn't looked into that issue um and I have no doubt that

02:24:04.060 - 02:24:36.380

that story plays out differently in different institutions um there are institutions I think that have made a conscious effort to try to unload investigators and um I've you know I've seen that and can testify that there are such places I can't say I can testify to the reverse all right but you ask another question really Chad the question was uh was uh essentially

02:24:36.380 - 02:25:02.940

what do we get for you know and kind of a if there's a dollar quantification there is no data that can tell you um what we're getting for the there and and it's not even easy to put in dollar terms what the diversion is um don't you think we should try because the cost is enormous I don't disagree and we one of the things we say is that the research policy board ought to have that as

02:25:02.940 - 02:25:35.020

one of its missions to try to quantify uh cost and benefit but in the end what we're diverting in my mind the most important thing is diverting is not financial resources we're devoting we're diverting investigator imagination and attention um of that investigator to the issues that we're we're paying for that we really want that investigator uniquely to address and we're

02:25:35.020 - 02:26:03.900

taking that that capability and putting it into a much lower order of activity let me call on Mike McQuade maybe sort of a two-part question and it relates to public research universities so the first part of the question is you refer to this policy or research policy board as a private entity are there any subtleties associated with the fact that there's a significant amount

02:26:03.900 - 02:26:26.700

of government funded research that occurs in public universities so does that create any sort of subtleties in how you look at this the second question is sort of the broader question is are there overlapping issues between regulatory framework imposed on public universities by states that are in play here at all or is this solely a federal research funded uh sort of view of the

02:26:26.700 - 02:26:58.620

landscape you might you want to take that second question i think you have more experience with that i come from texas where the state doesn't regulate much i come from massachusetts where it's not quite the same um so uh um we did not specifically address all of the state regulations in in our deliberations to date um so i i cannot say that we took that into account and how the

02:26:58.620 - 02:27:29.180

state regulations would uh interdigitate with the research policy board is something that we should take back to the committee and discuss thank you for that your first question was really about this sort of word private um i the um the model that we have recommended i mean it's not the only model for a research policy board it could be a purely governmental entity if uh congress

02:27:30.860 - 02:28:10.540

wanted to create such a thing um what is attractive about the fazby model i think is the flexibility that it has to do anticipatory project work it has the ability to um to um forecast what's likely to be important to organize teams flexibly to go do that and because it the the financial basis for it is outside the federal

02:28:10.540 - 02:28:45.180

budget it is not as constrained as the federal government is in organizing teams or even advisory bodies of any kind so what we see is the greater flexibility for an rpb that is separately funded outside the federal budget is worth that that distance but you're always trading of course i mean by creating distance you create less influence i mean in

02:28:45.180 - 02:29:12.460

some sense uh so i mean you have some trade off there and there i mean there are people who have talked about this who think we could go different ways um in the end as i said earlier my belief is that we if we as a nation go towards some structure like this what exactly it becomes will get argued out and and won't be settled at the national academy of sciences but just to address the

02:29:12.460 - 02:29:36.060

question directly there's no intent to exclude public universities from this uh effort how the assessment gets dealt with um and whether there are private funds it in the public universities which there are or another mechanism a waiver for those funds we didn't address but there's no expectation that they wouldn't be part of it no and to be clear my question was not about in the

02:29:36.060 - 02:29:59.820

same way there's no we haven't defined the membership just you know there could be industry representatives they're part of the scientific enterprise etc and we need to think about that further very good my co-chair john holger and has a quick comment as well i just want to first of all thank uh dr falkner and dr birer and their colleagues for what was obviously has been and

02:29:59.820 - 02:30:22.140

continues to be an extraordinary amount of work i'm very impressed by the detail you've gone into the way you've parsed the different parts of the problem i think there's going to be extremely useful to the administration as we continue to struggle with this issue we are aware of it i myself spent 40 years in universities and research institutions of other kinds since my phd

02:30:22.140 - 02:30:44.060

before i became a government official so i spent a lot more time on the receiving end of these regulations than i have spent on the dispensing end and i'm extremely sympathetic and i know that howard chalanski is as well i'm glad you showed the quote from howard chalanski early on to indicate that there are folks in the administration in key positions who understand what a big

02:30:44.060 - 02:31:11.500

problem this is but i think your report is going to be a tremendous help to us as we move ahead addressing it so thanks again let me add my thanks as well we're very much looking forward to seeing the second part of this report and really seeing the impact that you're really detailed and that's the best kind of recommendations or detailed recommendations we'll have so on behalf of all

02:31:11.500 - 02:31:40.620

a p-cast and on behalf of tens of thousands of people at universities across the country thanks for taking on this problem so in the remaining part of the meeting we're going to we're going to turn to our public comment section and we have four public commenters here with us uh and i'm going to turn to my uh to one of the p-cast vice-chairs maxine savitz

02:31:40.620 - 02:32:09.820

to lead the public comment section of today's meeting thank you i'm pleased uh pete went dr leander said that we have four uh people from the public today to uh related to the uh report on hearing technology and two related to nanotechnology uh the first one will be alicia spore the treasurer of the academy of doctors of audiology and um yes thank you for coming forward

02:32:09.820 - 02:32:33.900

and we have a two-minute rule that you have two minutes and at 90 seconds there's a light up there that will turn orange and you'll know you have 30 seconds to go fantastic well on behalf of the academy of doctors of audiology thank you for the opportunity to comment on november 12 we published a letter to the president providing qualified support for all four of the recommendations

02:32:33.900 - 02:32:56.380

contained in the p-cast report we emphasize that the provision of quality audiologic services is critical to achieving successful patient outcomes we want to ensure that fact is understood by this council particularly considering the broader initiatives for improving access to affordable care for older adults professional evaluation and treatment are vital in remediating a patient's

02:32:56.380 - 02:33:17.820

communication disabilities better hearing cannot be achieved through a device alone as it's only one component of successful treatment we recommend that over-the-counter hearing aids and p-saps include a strong recommendation that a consumer seek a comprehensive audiologic evaluation from an audiologist or physician we foresee confusion in the report's

02:33:17.820 - 02:33:43.100

terms of the word class and category due to FDA recommendations and definitions we recommend that the report only use the term category we also recommend that p-saps carry labeling that clearly indicate that they are not FDA registered devices we encourage the development of p-sap standards approved by ANSI for the record we are opposed to online diagnostic testing however we are

02:33:43.100 - 02:34:03.180

very supportive of online hearing screening tools from a clinical standpoint there is a clear distinction between testing and screening and those terms are not interchangeable the federal government must do more to ensure that older adults have access to audiologic care we have included several recommendations to bring medicare in line with today's best practices

02:34:03.740 - 02:34:25.420

finally we believe that awareness is the greatest barrier to diagnostic and treatment for hearing loss we ask that the CDC be directed to prioritize hearing loss as a significant public health issue and encourage efforts that promote greater attention to this issue by primary care physicians we are pleased to see governmental recognition of hearing loss and the focus on native hearing

02:34:25.420 - 02:34:49.980

impairment specifically related to hearing technology it's critically important that the same level of attention and emphasis be directed towards ensuring patient access to high-quality care we look forward to continue dialogue on these issues and we'd be pleased to assist thank you thank you our next speaker is um dr. neal dissono chief staff officer audiology american

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speech language hearing association thank you on behalf of the american speech language hearing association and it's more than 14 000 audiology members i am speaking with great concern and in opposition to the pcast recommendations that focus narrowly on the price of a hearing aid this narrow focus does not represent cost effective evidence-based practice of hearing

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health care a hearing aid alone is not enough to overcome a hearing disability treatment for hearing loss even mild to moderate hearing loss is complex particularly among seniors audiologists provide an individualized assessment of a person's hearing needs that goes well beyond the measure of pure tone sensitivity this includes consideration of listening

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in background noise specific tests of middle ear and inner ear function and the important cognitive and psychological factors that impact a person's ability to use a hearing aid the council made a common but serious error in assuming that hearing is analogous to vision a misconception that was evident in the pcast report is that amplification alone will enable a person with hearing loss to

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hear and understand fully in the same manner that glasses can restore vision even the most advanced hearing aids cannot restore hearing to 100 percent in the same way that prescriptive glasses or even some over-the-counter readers can provide 2020 vision a hearing aid makes sounds louder but not necessarily clearer and will not restore normal hearing function a hearing aid alone cannot address

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the consumer's disability it is the audiologist who has the focus on your parents or your grandparents need to hear and communicate at work and with family and friends it's the audiologist with scientific evidence-based methods of evaluation and rehabilitative treatment treatment who will ensure that the consumer and that could be you gets value and benefit from a device that is used

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to amplify sound we respected we respectfully request that this council takes a view that addresses hearing disability rather than focus simply on the cost of an amplification device the council should make recommendations that consider evidence-based hearing health care practices that will improve affordable access to these services and thank you for the opportunity to

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provide this statement thank you very much our next speaker will be on nanotechnology jim herd director green science exchange yeah i'll be skipping a few paragraphs from my written version due to time constraints nanotechnology is absolutely fundamental to a majority of all non-digital products sold in

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the united states today whether in semiconductors defense applications or consumer products as i've said for years when we entered the micron era 40 years ago naming a company micro or soft was the last thing you wanted but yet a company named microsoft became one of the most important companies in the entire world 40 years later nano is having the same fundamental impact but

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very few people in the general public are hearing about it we are in a nano-enabled world my battle cry to empower the average person is quote manage your own molecules end quote whether it's your biological molecules or the valuable physical objects you use in everyday life and yet many of our biggest us corporations have dramatically reduced talking about nanotech in their products

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over the last 10 years intel does not talk about its nanotechnology like it did in 2004 ibm talks less about it than it did 10 years ago duPont does not talk nearly as often about how powerful its consumer products are enabled by nanoscale features g used to talk about nano is one of the five areas that were critical to its r&d future cosmetics companies have taken the nano

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label off some of its cosmetics clothing sold across the united states that had nano coatings to stop spills is not labeled that way nearly as much as it used to be many of these companies have cut back due to threat of litigation from consumer groups who fear nanoscale products can affect the cells of their skin and tissue and also from epa litigation and compliance issues

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if the word nano is used to describe the benefits of their products countries like russia china and korea do not have the litigation from consumer groups and from environmental regulation that the us has now nanotech is primarily done by large us corporations as a result investors have run the other way when the word nano is included is pitched to investors make no mistake

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about it this is a serious problem and our brightest young minds are attracted to make digital apps not breakthrough materials innovations thank you very much the next speaker is carillon trump gill director for for federal relations the american chemical society's office of public affairs good morning my name is caroline troop gill and i am speaking today on behalf of the

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american chemical society it's more than 158 000 members and in particular acs president diane grove schmidt the acs would like to commend the obama administration for prioritizing investments in nanoscience and to affirm the importance of ostp's nanotechnology grand challenges as you heard earlier this morning the field of nanotechnology has seen enormous advances

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since the inception of the nni the interdisciplinary tools and technologies enabled by nanoscience have the potential to benefit society in many areas medicine energy water food materials and electronics to name a few breakthroughs in science and nanoscience have touched virtually all aspects of the chemistry enterprise the mission of the acs is improving people's lives through the transforming

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power of chemistry and nanotechnology has demonstrated how truly transformative chemistry and indeed all of science can be looking ahead the scientific community must now address the realities of moving promising research out of the lab to the market many basic nanomaterial applications are already in the marketplace as product enablers but high volume manufacturing of more advanced

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and sophisticated materials remains a challenge and as with all new advances meeting that challenge in an environmentally safe and responsible manner must be an integral part of the plan for all of these reasons acs believes the national nanotechnology initiative continues to play an invaluable role in providing support coordination and focus acs applauds the ostp nanotechnology grand

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challenges effort which will help ensure that nanotechnology's enormous potential continues to be developed for her for societal good and finally acs looks forward to continuing to partner with ostp and the national nanotechnology initiative to encourage our members in meeting these challenges thank you so thank you and i want to thank all the speakers from the public and we do

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encourage the public to come forward and give us their views at each of our meetings well thank you maxine that brings us to the end of the agenda for today's meeting i want to thank everyone from the p-cast everyone who's here in the room and everyone including our public speakers who have just spoken to us and who led the sessions before and everyone who's watching

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on the web i'm going to turn back to john holtron for any closing words well as usual i think this has been a full and very interesting meeting we have had a number of important issues before us have approved a new report and uh have i think a clear path forward on a variety of uh of critical issues for the science and technology future of the country so again i can only add my thanks

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to eric landers to all of the members of p-cast the ostp staff and the wider community who has been with us in all of this thank you very much indeed