research to have those markers that qualify with the final guidance as they have a final rule is part of a robust response i thank you to both of you. >> solo the spirit of which you had a bipartisan effort with new ideas that not only save lives but create jobs. overall so what -- welcome dr. collins i have a great shot - - story to have the nih in my state.

really have to think how to events the mission of these agencies proselyte to thank them for hanging in there because the impediment that is created natalie to find new ideas but called back to old-fashioned ideas. teeeighteen and though you were leaving the you will continue to serve in many capacities with both the long disserving and here we are. [laughter] also of the take this opportunity for those who work at both of those agencies. so to wake up every day how i can make the world a better place so i have those

two fabulous agencies and i cannot tell you the pride and enthusiasm it has brought me so that three criteria for reform i will then get to my question in so much respect the mission of the agency and the men and women who work of the agency. it goes a long way with productivity help the congress would embrace the idea to work in the federal agencies and the second is adequate resources with a reform in a targeted way for specific problems in

specific solutions. sova to think about the three are as respect resources in the form that is targeted senator rephrase the question of sequester that goes to predictability so many of those reports were turned over to the fda so many are not justified can you talk about sustainability as well as adequacy? but what would predictability and uncertainty mean with fda?

>> edits key we hear from the industries that we regulate and for us to do our job to lay out programs they're not occurring in a one-year time frame but we need to recruit the best in the brightest scientists that we can better hire the competitive so they need to know they will be working in the environment to get the resources that they need in a continuing way. and was as noted rehab a broad band of responsibilities that matter every single day and we are set their rates and. >> so makes a harder to obtain.

>> with the predictability for what about dr. collins? >> it has been invaluable we're all grieving the fact you are planning to leave that this is a whole fleet opportunity for discussion but it is crucial about biomedical research. with visionary ideas cheerless to take on what could not be approached before but technology now makes it possible. it is very discouraging but i can show you what is troubling today is the likelihood to be supported by nih over the last 50 years that runs around 50 percent that means five

chances out of six your idea will get no answer your sciences left on the table. the weekend -- can turn the corner we can turn this around to regain the momentum we have had but it is a risk if we cannot do that. >> so with the user fees the private sector paid in. >> after arduous work to create a contemporary before the sequester so instead of

putting battles on people i think that is not the right way to govern. >> thank you senator. >> mr. chairman this is my first time publicly toward knowledge of the great contribution in tears senator mikulski and her service to the american people thank you for all she has done it has been a pleasure to serve with her. teeeighteen not to pile on debt this is a long lead up to a question and i apologize but it needs to be answered. you made reference in your statement for lack of investment in biotechnology but it does follow certainty that follows the regulatory process progress find it

troubling the fda has a much difficulty working through the reagan the jury process with the user fee bill that was a year ago but still we are waiting and reports but to issue any new regulation instead the fda seems to rely heavily a month -- most formally on guidance on warning letters to does not offer the goaler regulatory certainty and failed to ensure any policies that our enforceable last night chairman alexander in myself and other members send you a letter asking specific questions end receiving the answer 10 months later last night, 12 hours before the hearing.

with those issues from 1988. it's hell has this affected regulation m process? >> we are taking an active look this with that current thinking to a final guidance is all useful in that process and it enables us how we are thinking about the problem to get that information back to engage with the stakeholders and it is an ongoing process with the force of law but it helps to provide a specially

a mauretania make issue at hand to provide a mechanism to begin an important conversation with a broader set of stakeholders to continue through final guidance. three should not have that many. i think that going from a draft to final guidance has value as well. ever buys more certainty so i hope it is not be coming back before you but i hope soon we can demonstrate for those that may no longer really need to be updated where we can translate. thankfully we're not the only ones involved in shaping the guidance process

through other reviews before it can be published but i take your point. >> i am a victim of melanomas twice the surgeon general issued it is costing $8.1 billion per year in health has the major portion of these statements i hear very little from a fta with a sunscreen act to expedite the application for ingredients to be approved. but we're still waiting for that to happen. why are they so reluctant to follow through? period we are committed but preventing melanoma is the highest priority but prevention comes first we are committed to what we have laid out with this sunscreen innovation act

with the identified timeline to work with industry to get the data that we need with safety and effectiveness because the products are used widely, applied often and hopefully with the rights amounts and we need to understand about the chemicals and what that means for safety and efficacy with individuals using them of course, many young children who could be a greater risk with chronic use. said to have more options with sunscreen products we want to work with industry to make sure that they are safe for chronic use spinnaker later due to do whatever you can't.

>> thank you senator. calling in order of seniority is favored here at the time of the gavel. >> thank you for holding the hearing. teeeighteen i am sorry to do see you go. i would like to ask to say we cannot walk raise venture capital. and that has to do with regulatory uncertainty. but to create a pathway they can get there only water to

drugs of their 22 approved as a result of that legislation in 55 more in the pipeline as i understand it. that has succeeded beyond our wildest dreams and i want to thank you for that. and to talk about the shift of the fda as a result of that designation and how we keep that going after you the if. >> thanks for inviting me to your talk to the biotech community. those types of listening sessions and we heard loud and clear about consistency

consistency, to strengthen them. the breakthrough has been more successful than we thought so it is an example is something to extend but it does come at a cost but incredibly important lesson in that culture change is confirmed by the successful breakthrough is of value of early engagement by the fda to help shape the product development research agenda and a continuing contact. we see that in other areas as well. we can see with the informal analysis when we engage early we can help that product development process

take time and cost of the product development because we can say you don't need that steady the use this approach to get to the answers that will make a difference in the approval process. so how fda organizes itself with the broader research and industry community. >> i have heard the same thing that if they are in gauging in a much more productive way so let me ask another question over the last you read -- weeks with infectious diseases with the cdc, but it is called a

nightmare bacteria looking

across the spectrum you have a different benefit calculator with the more serious life-threatening cases if we could develop a product that is targeted to

that part of the spectrum to come into a clear focus we know we need drugs and other risks can be higher because the benefits are higher. we need to make sure that physicians understand it's that they are approved and should be labeled as such. but it will unable the products to be developed more rapidly as we continue to learn more about those products to extend the indications for use but to move much more quickly to get those products to people to create new incentives for companies to be involved as they can see a pathway that is shorter and more

streamlined. >> thank you senator. >> dr. hamburg great job. you have done remarkable progress. thank you for that. recently you put up the fda transparency initiative i have tried to understand but it does seem there is differences with a different quality of work through applications and there's some that have higher turnover than others from those that have better output. i see it as a diagnostic. but there is some issues there that is problematic.

will there be more information with oversight to lick it that on a granular level to improve the process these? speesix certainly that transparency initiative is a multifaceted undertaking to expand the understanding of what we do and how we do it and why also to hold accountable for everyone to see the progress we're making with critical issues. the fda are functioning with performance with respect to aspects of our work as the rebates to management that we have consistent high quality management with adequate resources.

>> so one division has far more? >> not always. >> i have limited time. back to my point if you could make that information more available as to look at a granular level that is our responsibility to ride that oversight is to meet user fees are often targeted through the negotiation process but as it has flexibility and predictability. >> clearly our goal is transitional. but do you track what percent of grants go to the

ph.d. is are those that go to others with a transitional research is there a difference? >> we do. our work force is made up of a variety of individuals with different backgrounds and ph.d. san mps are also significant contributors. in general they tend to be focused on clinical efforts but some are doing basic science. >> what% put it this way i come from academic some people look at a paper but not necessarily looking in translation. so when you track how much weight is given to translation or someone is successful but not someplace else how much does that weight the future grant be

awarded? to and if you have precise statistics what percent go to the ph.d. or how many are translated to transitional research and if there is a difference it does seem as if we should wait if the bias is the relations. >> i can provide the data for the record we have encouraged translation which is providing resources for the ph.d. s and andy's for the transitional science but with the small caveat we need to be careful not to discount the value of that fundamental basis. >> i totally except that the

to have that entrepreneurialism extent we can help with that. >> is a testimony you mentioned the great success we have with hiv. and alzheimer's dementia is 10 percent of the budget and this doesn't show up well by 2025 is 77% which they say is dangerous to our future and not because of the last six years of escalating the debts but with hiv/aids in dementia is a boon medicare and medicaid will go

bankrupt dealing with this. we should start -- should start shifting more aggressively to that which we are confronting. i yield back. >> mr. chairman thank you for being here today. wheat to end to have small entrepreneurial companies. i am concerned when there is the fda or other regulatory is a vintage to be product online this hips harder on smaller companies than the big ones. i notice in the accelerating madison partnership that is

the big manufacturers and obviously it is a good world because then you don't face disruptive technology so you will like it a lot of disruption. how low do you push back with the incentive of big manufacturers to make sure little manufacturers get the attention and that they need and are included to help through the process? i appreciate the court -- the question because all partners in the ecosystem made to flourish publicly and privately. santry fact to make that

data accessible to the biotech companies to recognize that they are paying for half of the cost of the research of $230 million half of it is in a traffic is companies. a should empower everyone. for this process. that is quite impressive on there part. but what is a parts dash supports bios startup for those that are highly profitable on the basis of the grant and we're increasing our support of proposals to shorten the time table because if you

are a small company trying to get started meeting that initial infusion so we're very interested in this space so one of mine closest relationships is through biotechnology listening to their concerns so to find a new cures or developments. >> my time is running down. could you comment with the control pharmaceutical the dea has one that begins at the end of the process that delays the alta mitt approval has never come to a conclusion from the fda conclusion. why we put it this

additional demand is inevitable. to make sure small providers have a shot. >> with the small business question it is said focus of concern because many of the products that we regulate our small on the medical device side, often in one product approval or a few weeks away from going under baguette that is where innovation and ochers. we tried to streamline the regulatory process to provide more assistance to help with that process to be more responsive to provide

that additional clarity another reason why this is important because there are common tools and approaches with the vial markers area so we're working on small business high priority is a complicated system it is and the bravery of a structure the process to start from scratch but based on public health and medical care but it doesn't always align. we try to work closely with them. so to make drugs available with appropriate oversight of the use of would be disingenuous to say i have

seen some of that disconnect and might be an appropriate time how best to space the different players in another area the. >>. >> first let me take you for your service but that technological breakthrough that makes a real difference for people working with diabetes with that glucose monitor helps patients control those glucose levels for costly and deadly competitions -- complications'. to be extremely supportive

because that was so surprised and a troubled said it would not reimburse or pay for insulin dependent beneficiaries to continue to have their continuous glucose monitor. so we have a situation so they get to be the age where they lose the coverage. this has led me to question consults a with a fta and nih to make the coverage decisions. do they consult with you

edward the two agencies consulted with the denial of coverage? >> i was not aware of this situation i can see why it is concerning and i think we will have more important precursors with medical devices with diabetes to make a difference. we can work more with them to look at how we do the decision making in parallel so does the data is collected than meets the needs of both agencies can be gathered and examined. but in the modern world we need to do more of that.

>> speaking to the issue of a highway priority leaving the fda that we have not adequately addressed is that we have to look at the whole ecosystem to recognize each of those proponents are actually dependent and one of the things we hear now more and more from investors it is not the fda regulatory process that worries the of the of reimbursement issues. so we're really need to take that ecosystem approach. >> hi was switched to a different issue because of the interest of time but i hope you respond in the record for my question. you put up a chart the year show the tremendous product

line dash progress with cardiovascular disease, cancer and hiv/aids. what is in an uncommon is congress made a sustained investment over the years with the nih research and has paid dividends with better treatment and falling death rates. the i am very concerned about the trajectory of alzheimer's disease which is fast becoming hour most costly diseases in this country. as a society spending $226 billion per year to care for people with alzheimer's her carry out of that one ended 53 billion comes from medicare and medicaid as dr. cassidy says the trajectory is frightening it will bankrupt

the health care system and is causing suffering for the victims and their families. i know you mentioned new treatments and i am excited bush shouldn't we do more targeted items to alzheimer's? >> i share the concern if you look at the cost of alzheimer's in in the cost of individuals afflicted not to mention the suffering that they go through we're on a trajectory anybody should be deeply concerned. we certainly are ramping of research at a pretty unprecedented rate between 2011 and the budgets present budget proposal for 2013

greater than any other area that nih supports it is not enough frankly we don't have enough to support all the other ideas but the good news is that research is in a very exciting place. we do have to reduce with therapeutics in the ability to do drug screens on cells that represent alzheimer's and the way we could not have dreamed you to believe figure out how to address those therapeutics with a lot of excitement to see that go for word pro but to be sure we're building on the capabilities of other agencies and other sources of funding. but frankly it is an example of the fact we lost 23% of

the ever purchasing power we indeed to get back on a stable trajectory to deal with other things that are looming of there as the population ages. >> mr. chairman and dr. collins thank you for being here. also dr. hamburg for your many years of service. over the past 50 years medical innovation has transformed the health of literally billions of people around the world was new treatments giving hope with hiv, leukemia, breast cancer they used to be a death sentence but that basic mechanism has two parts a foundation of taxpayer investment followed by private industry investment that turns into a viable product.

with the highest therapeutic impact through 1982 year two-thirds came directly through government supported research. it was found hour modern drugs have roots from public funding it is no accident as we have talked about for decades. as controlling the budget year by year from national institutes of health both parties work together to double the budget of the nih but that has dried up since 2003 it has studied think kept up with the pace of inflation and purchasing power is down nearly 25 percent. can you tell us how funding has hurt the american pipeline of biomedical innovation? been making for the question

this is what worries me most in keeps me up at night if you were not taking advantage of the ability of science to innovate with new ideas:can simply look at the way and a chess to deal with the ideas that come to a stem the path of them on the table that traditionally we would have funded that shows you we're slowing down the process of innovation through the clinical trials. you may be save maybe that isn't as good? we have looked at that but when you look at that top third of the applications we cannot go back to say those says gordon the 25th were not as good in the 10% so that says we are leaving great stuff that isn't supported and of course, we

are the foundation for a wonderful success story with public them private working together but we cannot keep taking it for granted if we do not support it. >> we should take our first priority to figure out how to get n.i.h. their resources it needs so the foundation for better treatment for a reliable cure but instead focusing to lower the standards for improving drugs. this is a dangerous game. dioxin made it through their rigorous approval process that was found to cause heart attack -- heart attacks killing 38,000 before being pulled from the market. teeeighteen what impact would over the safety

standards have of public health? gimmick as i said i think lowering those standards would be very dangerous detrimental to health and safety of patients but also bad for our preeminence with the pharmaceutical and biotech industries in terms of their ability to deliver product to people who need them. radio that the fda standards and requirements have helped to shape of biomedical research gets done. the notion to structure of our investments so we ask the right questions don't just published papers but actually reinsurer with leverage the opportunity of

science and technology to get important strategies. >> so high standards are important but also to shape the research that gives us the treatments that we need. i am certain there are changes we could make with the approval process to get rid of unnecessary science that supports change. but will receive the approval standards will not increase innovation. . .

>> if we are serious about better health for children congress must step up and make a commitment. >> thank you. >> thank you. i am encouraged by the partisan effort -- bipartisan effort for medical treatment. as was raised by an nih funded scientist you can

understand that i have a long-term passion for a strong investment in basic research but i remain concerned budget cuts mandated by the budget control act have put medical research at risk. we have been talking about that this morning. you have cautioned we're putting an entire generation of scientists at risk. the average age of a researcher is increasing and budget cuts are discouraging young scientists from entering the field, forcing them to continue the research. to help address this i introduced the next generation research at that would coordinate efforts and streamline efforts to improve opportunities.

it would it would improve diversity and the success of investigators applying for there 2nd grant. we have grant. we have discussed this issue a number of times and i am encouraged you share the interest and passion. can you discuss with the community any progress that has been made through the nih existing programs such as the early stage investigated program and the directors new innovative award to bolster this emerging research workforce? >> i appreciate the question because it is a fundamentally important issue if we are going to have a future where american biomedical research continues to flourish. we have we have instituted a number of programs aim to try to encourage that next generation to see a path for themselves as successful and visionary researchers.

one thing we have done that has been quite helpful is to make sure that if you are an early-stage investigator who has not come to nih before that you compete against other investigators of that sort. that has done quite a bit to equalize the success rate amongst the newbies versus those who have been in the business. that is one thing. we increase the number of awards which are bridge to independence. postdoctoral to academic position. k9 nine are zero awards which we're finding to be a successful way to make that leap from a training position to an independent faculty position and a research intensive university and are making sure we have graduate

students and postdocs exposed to multiple career paths because not all need to end up as research track faculty in an intensive university. there are jobs and industry and journalism and many other places phd levels are needed. we have started new programs and early independence award that i am excited about that allows a talented phd to skip the postdoc and go directly to an independent position. i go to the new awardees, awardees, and it is the most exciting day of the year for me because of there vision and ideas and we have this new innovator award we can apply and your idea has to be out of the box groundbreaking, a little wacky in order to even be allowed to apply for that proposal mechanism. the output has been truly impressive. all of that is great, but it does not solve the main problem we have which is this loss and purchasing power for research.

we can try to balance things and protect investigators. we investigators. we can only go so far. >> i appreciate that. resources are key to this as well as the coordination of programs we have discussed in the bill i have introduced. the flip side of that what will the impact be of the nih current program for new researchers as well as the effects of congress not renewing sequestration. >> we continue to see this downward curve which is troubling. surveys have indicated close to 20 percent of researchers supported by nih are now contemplating moving to another country or kind of career path because of the concern they have. last week i was in san diego meeting with the so-called

medical scientist training program. there there was a room for the most incredibly gifted talented future scientists you could imagine. in the past it was all about the science and how excited they were but this was a group whose brows were furrowed. really deeply anxious about whether there is a path for them. some sense of optimism. >> senator casey. >> thank you, mr. chairman. i think you and the ranking member for having this hearing. these are deadly serious issues the ones spoken about the impact of funding

definition, probably the worst example of a penny wise and pound foolish that we can imagine. sometimes it sometimes it comes down to one man, one person, one case. the end role in pennsylvania who thankfully is healthy right now who had a particular leukemia and the only way her life was saved was because of an experimental so-called t-cell therapy that was pioneered by folks researchers, i should say nih funded researchers. you have to you have to ask when it comes to these debates about funding levels which, frankly, rather bizarre when you consider the outcome positive outcomes we have have to ask what if down the road because we did make the investment because congress failed with the next whitehead be saved?

it is worth not just contemplating but using those examples as a springboard action. i just wanted to go back to something you mentioned before. it is by way of reiteration. people get the message a little better. did you say that nih has lost 23 percent of its purchasing power since 2,003? >> that is accurate. i can show you a graph that would make it more clear. if you look at the yellow line adjusted for the effect of inflation you will see the doubling that happened. you can see the steady deterioration. twenty-two, 23 percent loss. >> the other part you

highlight the percent of those contemplating leaving the us because of lack of funding or uncertainty what percentage are researchers? >> this particular survey it was 18% who said they were significantly contemplating that sort of drastic step. i appreciate you raising emily whitehead. i met her in the white house senator alexander was there as well. as was her doctor. this is the kind of amazing success story that we believe is out there and in greater numbers , but we must be sure we are investing in the steps it takes to get there. what what happened you can trace back 50 years of hard work understanding the immune system and cancer, ultimately getting to that.

>> i wanted to ask you about the pres.'s initiative, the precision medicine initiative in the context of emily and other children. tell me how that can or any other undertaking or initiative that nih will be involved in that we will focus more on the pediatric research, the pediatric research that leads to those breakthroughs. >> the precision medicine initiative aims to have an early focus on cancer and a longer-term effort to try to build this cohort across the nation to try to take advantage of a coalescence of exciting technological opportunities. one is the genomic revolution, the beat -- the ability to be able to get information about dna at a remarkably low cost. the other is is the advent of electronic health records.

another is the ability to use wearable sensors that people are excited about having access to detect aspects of human physiology, whether it's something that affects blood glucose or something that is monitoring your environment environmental exposure for your diet or your blood pressure. across gender, geography we can begin to figure what are the risk factors this is a joint effort. we are enormously excited about the way this could transform. >> one brief comment. you think about what can be done to harness the

extraordinary advances in science and the resources that nih needs to ensure important work gets done. in order to see those products, ideas become real-world products. it must be accompanied by appropriate investments that give us the opportunity to develop our area of science to forward that final bridge to real-world product. to help make sure the investment and research it in a -- nih is being done in the most efficient and streamlined way as there trying to move that product through the development pipeline into the product. product. one of the disconnects that worries me, and i have to

say it everyone thinks that if you want to deliver on the promise of science that is absolutely critical and foundational but you do not want an fda that is not fully equipped to oversee the product coming before them now well staffed to do efficient, modern regulatory reviews command you want to be able to bring the knowledge and expertise of fda and product development and earlier stages. >> i wholeheartedly agree with my colleague. >> thank you for your indulgence. thank you both for your service. work closely with you on a couple of things. thank you for your service. research see you go.

and i apologize for getting here. hearing judiciary was important. i'm proud to represent minnesota. the medical device industry and we spent time working together. when i 1st got into this job and had some -- doctor sharon came to minnesota and had some discussions with the industry roundtables with him. i noticed a different culture between the regulators and the device manufacturers, and i wondered why that would be. there was something done for the 1st time ever private public consortium on

regulatory science. i just want to ask you how you believe that is going? >> medical device innovation consortium. >> yes. it says what it is. i like names like that. just can't remember them. medical device innovation consortium. from your perspective, how has that been working? >> it is an example of the kind of thing that we can and should be doing more of. as you note bringing together private industry the private industry, academic researchers, not perfect have not-for-profit organizations, government together under one organization that is committed to advancing the regulatory science into advanced medical device development it has grown

enormously since it started. there was initially skepticism but it has grown. it has identified critical areas of research whereby advancing the research through this partnership will benefit medical device development much more broadly because it is doing things like helping to design innovative clinical trial approaches that will make the clinical trials less cumbersome and easier for products to go into clinical trials to demonstrate safety and efficacy developing computer models and those simulations where without the cost time potential, you can really examine whether the device will work and how the design should between, etc. how how you embed patient supported outcomes and their

experience of using it into the development and review process. focusing on the important issues in a way that advances science and a a way that actually creates knowledge that becomes a common good for other product development in the future. >> thank you. we are proud that private public partnership is working. i want to talk a little bit about precision medicine. sometimes when i think about precision medicine i think i i think i was born a little too early. [laughter] things have all -- 30 40 50 years from now. let's talk about dying misses, ldt's. more than 1200 genetic variations.

tested to identify risks. the mayo clinic has significant developments in evaluating sats but these folks are concerned regulation that is not thoughtful or careful enough would hamper the life-saving potential and undermine medical research designed to identify and target causes of disease. i applaud the chairman and ranking member the series of briefings. i would like to know what role nih will have with regard to regulation of oddities i think senator conroy talked about.

what is your view on how they should work together. >> this is an area we have been working together closely over the years in a particular closely working right now to try to accomplish what you said be sure the kind of laboratory developed tests are offered to patients in a way that benefits them and does not slow down innovation fda released guidance on risk-based oversight of laboratory developed test.

that has become the foundation for multiple conversation and workshops. trying to get additional input. what we can do is have already a database which samples across the entire medical literature what has been reported as far as this particular dna being contact -- connected. that is being curated in a way that people can find information, but you cannot look at that and know which of these you should rely upon in which might be a result that one person relied upon that another did not. you need a group we call claims in. it looks at the database and make decisions upon the evidence about whether a

particular dna variation has been conclusively shown to be associated with the medical risk. then at various levels of certainty, what they think about the whole set of information the fda is interested in that particular nih funded effort in order to be able to have expert advice about what you can and cannot trust. we are not the regulators. this is a great opportunity for relative roles. and it will be critical for precision medicine. a cohort of a million or more people. we want to to make sure we feed them information that is right you are always --

>> i would say the world of diagnostics is complicated but important because at the end of the day it is what guides the ability of the healthcare provider patient consumer to make sure that they are getting the best possible treatment for the conditions they have. accurate reliable diagnostic test is crucial to being able to do the fundamental research that will reveal the opportunities in treatment prevention and care. if the test is an accurate all of the research is not going to mean much. we think at the core of all of this is a responsibility to make sure diagnostic tests work, whether they are laboratory developed or much more advanced. really using genomic science and technology to give us

you us you know vastly expanded sets of information.

>> so i think by i think by your being here you help emphasize that we look forward to continuing our discussion. the hearing record we will remain open for ten days. thank you for being here and that committee stands adjourned. [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> coming up next, next, a hearing examining the 201680 budget. later, pres. later, president obama speaks to students in atlanta about student loans.

>> teewun, providing live coverage of the u.s. senate for proceedings in key public policy events, and every weekend book tv for 15 years the only television network devoted to nonfiction books and authors created by the cable tv industry brought to you as a public service. watch in hd, like on facebook, follow us on twitter. >> the senate armed services committee examines the 2016 budget for the u.s. navy.

>> good morning. i want to welcome the witnesses and thank you for being here this morning. plans and programs of the department of the navy for fiscal year 2016. i want to thank our witnesses for their distinguished service to there nation as well as the civilians serving. this is the admirals last posture hearing before the community which i am sure he is relieved to know.

his last appearance his last appearance as chief of naval operations, and i would like to thank you for your 40 years of distinguished service to our navy and wish you all of the best in the future. in the last three months some of america's most experienced statesman and strategic thinkers have offered a clear, a clear unified and alarming assessment of unified threats. a diverse and complex set of crises has not been about since the end of the global war compounded by the limitations of the budget control act and sequestration which is a self-inflicted national security crisis. all four of the service chiefs have testified.

from our strategy of rebalancing to the asia-pacific region to determining factors and many other requirements the us navy and marine corps our key pillars of our strategy. today's fleet of 275 ships 275 ships is too small to address these critical security challenges. the navy's force structure assessment requirement is 406 ships. the defense counsel calls for 323 to 346. combatant commanders say that they require 450. under sequestration the navy has said the fleet has shrunk to 260 ships. the marine corps continues

personnel reductions from 200 thousand active-duty marines in 2012 to 184,000. with the demands on sailors and marines rising these marines rising these force reductions coupled with major readiness shortfalls due to sequestration are lengthening deployments, cutting training and time at home with families, families command putting our all volunteer force under considerable strain. the pres.'s budget request attempts to buy as much readiness as a part that can execute for fiscal year 16 which is yet another reason why we cannot afford a defense budget as sequestration levels. the pres.'s budget includes significant funding requests for major navy and marine corps acquisition programs. in the current fiscal environment it is more important for this committee to conduct rigorous

oversight of these programs to ensure that the department of the navy is making the best use of limited taxpayer dollars. that is exactly what we will do. despite initial cost overruns that more than doubled the cost per ship, the navy appears to have stabilized the cost of the lcs see frames and the program still faces challenges to deliver the promised war fighting capability. all three lcs mission packages still need significant further testing and must overcome major technology integration challenges. this committee will continue to seek further information. without a clear capabilities based assessment it is unclear what requirements the upgraded lcs is designed to meet and how much more lethal and survivable a ship needs to be.

in short they must demonstrate what problem the upgraded lcs is trying to solve and cannot afford this mistake again. with the 1st three forward class carriers despite cost overruns of more than 2 billion each, this program has not exceeded the cost of the last three years. however, the 2nd, the uss john f. kennedy, was delivered in fiscal 2022 less capable and less complete due to the navy's proposed two-phase delivery approach which would leave us with an incomplete ship should world events demand an additional aircraft carrier were if the nimitz inquire -- encounters unforeseen problems. i am concerned about the plan to delay shark trials from the 1st to the 2nd forward class carriers. that delay is hard to justify for a knew ship that

is this complex. this committee this committee also has a duty to shape the future of our navy and marine corps. with research -- preservice combatant class is set to retire soon now is the time to lay the analytic groundwork to replace those ships. as the navy develops requirements of the next class of amphibious vessel we must ensure warships are capable of supporting marines in the manner they plan to fight in. we must we must also carefully examine the future aircraft carrier fleet and the carrier air wing, 12 million or more for one ship is simply too expensive. we must do more to reduce cost and increased competition within the aircraft carrier program. as challenges to american air power projection girl we must chart a path to a path to achieve the unmanned strike ability from our aircraft carriers.

we look forward to witness testimony and hope that they will cover the broad spectrum of policy procurement, readiness personnel, and resource issues that the department confronts. >> thank you very much mr. chairman. let me welcome everyone to testify the programs. the 2016 budget request. the ceremony in colorado. i want to welcome the general to his 1st posture hearing and join the chairman in commending the outstanding work as he departs at least this venue. thank you for your outstanding service to the navy and nation. i want this morning to face cues challenges as we strive to support ongoing regulations.

the the fiscal restraints of the budget control act of sequestration. for us to make painful trade-offs, and the threat of sequestration continues to loom. if congress does not act to him sequestration in sequestration i believe our long-term national security interest we will be threatened. last year the department of the nady navy was facing serious readiness problems by deferred maintenance, reduced flying hours, and cancel training and employment increased emphasis on readiness and this year's budget we will address some of the most serious problems but result in a serious shortfall in the modernization for future threats. i interested in this because of the shortfalls. all areas are overtaxed.

shortfalls and attack submarines, destroyers, strike fighters inventories. already operating for two years with fewer than the required 11 aircraft carriers. during the next decade the navy will need to buy a knew class of strategic missile submarines to replace the ohio class submarines costly adventure. interested in hearing how the navy will manage its operational tempo. i am interested in how they will manage competing issues in the budget. strength of 180,000 marines. i'm interested to learn how they will manage missing -- managed mission risk particularly with increased embassy security. security. the marine corps modernization request supports the decision made last year that made the strategy more sound. they clearly remain committed to the finalization of its assault

capabilities with a budget request that includes funds for upgrades to the current family of assault vehicles and continues a competitive search for new vehicles. the amphibious combat vehicle program would innovate a with innovative number of existing technologies. the marine corps has described this program as non-developed which raises non- developed, which raises questions about what nondevelopment means when you are developing a new system. i am interested in comment on this. it is also clear the authority is challenged on what he has called the amphibious gap. navy witnesses have testified about the number of ships required to meet amphibious shipping goals sometime lost is the fact that changes to marine corps ground or air components

ripple through the amphibious ship force requirement. the navy's planned purchase is one effort to address the enthusiast shipping shortfall. i am interested to know what else the department is doing to mitigate the gap between requirement and capability and ensure amphibious forces are capable and ready. the defense department guidance issued in january 2012 followed 2012 followed by the 2014 qtr and by the national security strategy echo a renewed orientation on the asia-pacific. the defense department has been working to realign forces in south korea and okinawa. the problem has been implementing a plan. second appointment of a us combat ship in singapore. i am interested in hearing more about these and other aspects.

again many questions, but i want to conclude by thanking all of you for your extraordinary service to the nation, navy and marine corps. thank you. >> mr. secretary. >> thank you, mr. chairman. chairman ranking member, members of this committee thank you for the opportunity to discuss the department of the navy with the chief of naval operations not of the marine corps. i have the great privilege of representing the sailors and marines who serve our nation around the world, the civilian to support them, and, and all of the families as the chairman and sen. pointed senator pointed out, this is the admirals last posture. he has been a steady hand at the helm of the navy through the past four years providing stability for stability and his judgment advice, good counsel have

been critical. it has been an honor to serve with him and he will leave a lasting legacy. today security interests face a increasing array of threats and man's well our budget situation issue so clearly pointed out grows more challenging but it is clear that the navy and marine corps team offer the best value to advance both our global security and economic interest. uniquely uniquely the navy and marine corps provide presence around the globe round-the-clock. we are the nation's 1st line of defense ready for anything that may come over the horizon. presence mean we respond faster, remain on station longer, kerry what we need with us and do whatever missions are assigned by nations leaders without needing anyone else's permission. we have always known america's success depends on an exceptional navy and marine corps.

article one of our constitution authorizes congress to raise an army we needed but direct you to provide and maintain a navy. from the 1st six frigates to our growing fleet of today from tripoli to afghanistan sailors and marines have proven the founders wisdom. american leaders across the political spectrum have understood the vital significance. we are truly america's awaiting deploy in piece as much as in war. securing sea lanes and freedom of commerce boosting our own and the world economy. ..

the most damaging and lee's reversible course of action which is why am committed to building ships to the maximum extent possible. fueling vehicles are a vital operational concern. that is why the navy has a

history of innovation particularly in energy moving from sale steam oil, sale steam, oil, and pioneering nuclear power. we believe our national security interest must be enhanced by increasing energy diversity and efficiency. our ability to maintain presence in advanced global security will be augmented through partnership, cooperation partnership, cooperation which makes us more effective and that fuses tensions. again and again our naval forces have proven themselves the most immediate, the most capable, and adaptable option when a crisis develops. overall overall the president's fy 16 budget balances current readiness need to execute missions while sustaining a highly capable fleet within a tough fiscal climate. that climate demands, as you mentioned, mr. chairman the

most rigorous examination of the dollars we spend and continuing efforts to cut unnecessary cost and shift resources from tail to tooth. they always been there. the commandant, the chief of naval operations naval operations and i look forward to answering your questions and working together with this committee and with congress to maintain our great navy and marine corps. thank you. >> thank you, mr. secretary. the complete statement has been submitted by all three of you will be included in the record. >> members of the committee, i am honored to be here today. i begin by thanking the community we feel the best trained and equipped marine corps expeditionary force.

when we fight, you expect us to win. win. you expect a lot from your marines, and you should. over 31000 marines do exactly what you would expect. the role informs how we manned man train and equip the force but prioritizes the allocation of resources. over the last few years we prioritize the readiness of forward deployed forces that you can count on for immediate response which supported the recent evacuations of cities to have citizens and south sedan. currently conducting strikes in syria and iraq. protect your embassy in baghdad.

the 22500 marines in the pacific west. forward deployed marines have been well-trained, let him and equipped. reducing budgets in 2014 and 2015. we have not sufficiently invested in our home station readiness as a result approximately a result approximately half of our nondeployed units, the ones you depend on for unforeseen contingencies. in a a major conflict these are the result of a delayed response or the unnecessary loss of american lives. over time it will result in maintaining older and obsolete equipment at higher cost integrated capabilities.

funding levels are forcing us to maintain legacy abilities instead of adapting. we don't want our marines and sailors to not be in a fair fight. context for our message this morning. there is no margin. funding levels we will exacerbate the challenges we have today and we will result in a marine corps with fewer active duty battalions and squadrons. squadrons. it will result in fewer marines and sailors being deployed to crises involving diplomatic posts, american citizens, or us interests. the american people expect us to respond to today's crisis today. and only are able to do that if properly postured forward. we require a new strategy.

thank you for the opportunity to appear before you and your lead in addressing -- addressing today's fiscal challenges. alec forward to your questions. chairman ranking member, members of the committee, thank you for the opportunity to testify today. my honor to serve in represent more than 600,000 active sailors and their families, especially those deployed today. it is my pleasure to testify today. chairman, your team is united the filling a long-standing mandate to be where it matters when it matters ready to respond to crises. to that issue recent events solidify the value of forward presence. the strike group relocated from the arabian sea and less than 30 hours and began flying 20 to 30 sorties per

day. and that was the only coalition strike option to project power against isis. arriving at the black sea black sea less than a week after russia invaded crimea. among the 1st vessels to support the surge effort for the search for flight 801. mr. chairman, as i testified before, the continuing resolution on sequestration of 2013 degraded readiness and capabilities command we have not yet recovered. budget reductions generated maintenance backlogs and compel extending unit deployments. many ships have been on deployment 48 ten months or longer in that exact the cost on the resiliency of people and the service life

of ships. it has it has reduced our ability to respond to contingencies. the three carrier strike groups need to be ready to respond within 30 days to a crisis. that is our covenant. however. however, today on average we have been able to keep one carrier strike group and one amphibious group in this readiness posture. assuming the best kayseven on time, adequate, and stable budget without major contingencies we might be able to recover from the accumulated backlog by 2018 and by 2024 amphibious readiness groups. that is just a glimpse of the damaged sequestration would cause. we have been forced to slow navy modernization. the overall impact over

three years has declined our forward fighting advantages in several areas. we have been compelled to accept significant risk in the execution of two key missions that are specified in the defense strategy. i we will provide each of your hand out summarizing where the navy stands with the missions and where we stand in relation to the missions under the two budgets. the 1st mission at risk is to deter and defeat aggression which means to when a war at sea while deterring another at sea in a different theater. the 2nd mission at risk is to project power despite denials challenges. they will arrive with insufficient ordinance and

without monarch -- modern combat systems sensors, systems sensors, and we will be inadequately prepared to fight. more sailors marines, and merchant mariners killed and credibility to deter adversaries and allies in the future. given the circumstances the submission represents the absolute minimum funding level needed for strategic violence. we focus on growth -- building the appropriate capability. compelled to upgrade aircraft, ships, submarines, and take significant reduction in chairman emissions and infrastructure. today's world is more complex, uncertain, and turbulent. adversaries are

modernizing and expanding capabilities and it is vital we have an adequate, predictable come and timely budget. i thank you and this committee for what they have done and look forward to working with the congress to find solutions to ensure our navy retains the ability to organize, train, and equip sailors and their families and the defense of this nation. thank you. >> i want to thank the witnesses. very compelling remarks avril. do you share his level of concern concerning the effects of sequestration. a significant amount of time before we can even recover from the present effects of sequestration. >> i absolutely do. it has impacted the current level of readiness. unable to meet the current strategy. forward deployed.

>> i believe you are asked this is the sequestration putting lives of men and women serving in greater risk? >> chairman i we will take that. it absolutely does in this way. when marines are called we will go weight or with shortfalls and equipment and training. >> a lot of people right recently about today and today's navy. an article recently about the future navy the benchmark of 2020. we won't have all we need to defeat and deny. >> it is -- is it affecting the retention?

>> it is. the families are angry with sequestration in general and the threat again. we have pilots as a key part of our ability to project power, and elsewhere. >> and the deployments are longer, is that correct? >> the biggest significance of the time between deployments. most of our units and infantry battalions are fighting squadrons are deploying. what that means is deploying for several months and our home. that continues almost ad infinitum. >> reenlistment. >> it will be over time. we have not seen the impact. he does have an impact on two things, training across the range of military

operations and an impact on the amount of time marines are able to spend with their families. >> the situation crossed over with the aircraft carriers, i understand the follow-on 78 and 79 it will be around $12 billion each. >> i hope given new technologies in drones and the other aspects of warfare that we will be looking at alternatives as well the nimitz class the latest class of aircraft carriers. >> senator i think that as

you and i discussed everything is getting smaller and faster. the possible exception of military. >> isn't it true that the major cost overruns were due to advances or new technology in launching and electromagnetic aircraft launching systems dual radar and advanced weapons elevators. are those the greater risks? >> you are correct. you and i are in agreement.

the way it was built is not the way to build a ship. it was being designed while it was being built with too much knew technology trying to be forced in. today it is 87% lead. the testing on the electromagnetic launch and the advanced arresting gear is where it should be and moving along. the risk of cost overruns we have had stable costs for the last three years. because down every day. testing. >> amaral could you give a brief update on the progress? ..

we had our carrier test this past summer certified. we had no boulders of the avionics, the aircraft itself the c model is good. we still have a way to go for the software that said three of software. right now we are on track for an ioc of late fiscal year 18 or early 19. my concern is that this software is able to integrate all of the

weapons systems we have on the current aircraft on our air wings. this aircraft have to fit into her air wing. we can't fit the air wing around aircraft. so far so good. we have to keep close watch on it. >> thank thank you. senator reid. >> thank you and let me first say the chairman's questions regarding sequestration and your responses about the real and dramatic effects on the lives of the men and women who serve our i thank another strong indication of the need for collective and bipartisan action to sequestration so thank you general general and thank you mr. chairman. >> mr. secretary last year in the defense authorization bill we in section 1022 created the national deterrence fund which was designed to help you from a department of defense level to build a replacement to the ohio class submarine.

can i just ask both of you how you intend to use this fund and in general your plans for the replacement of the ohio a and mr. secretary if you want to begin. >> we very much appreciate the establishment of this fund. we have been talking for some time now about when we begin to build the ohio class replacement of 2021. if it is a pure navy build it will devastate some part of the navy either shipbuilding or readiness or something because the high cost of these and because we don't recapitalize them very often. if you look back in history there is precedent for either making this a national program because it is the most survivable leg of our deterrence triad or adding funds to the

ship to accommodate it. the 41 for freedom and late 50's early 60s and the ohio class in the late 70s through 92 both times navy shipbuilding increased pretty dramatically to accommodate the subgrantor to show you the effects from 76 to 80 navy shipbuilding budget doubled to accommodate the ohio class. our fleet still declined by 40% because it simply wasn't enough to do both. >> admiral greenert. >> senator first of all i think it's a great start pretty pretty think we need to pursue clarity of the intend as a congress and what i mean by that is the legal ramifications for sources of the funding we can put in there. is it just other navy shipbuilding accounts? is it just other navy navy appropriations or do we mean the whole department of defense could contribute to this fund

which in my view would be great. >> thank you very much. in my view it would be great too and that was the intent i believe. the clarification we will try to produce. general dunford in my opening remarks i talked about the fighting vehicle program and this has been an interesting path. the expedition fighting vehicle was canceled. we have had several different concepts in the suspend the careers of several commandants. now we are into this new amphibious combat the echo which is described as non-developmental. seriously your comments on what you see as a challenge, what are you trying to accomplish by this and how do you avoid the fate of the preceding vehicles which we spent money on but could never deliver? >> senator thanks. we have been working for some time as you alluded to to replace the war-year-old

amphibious assault vehicle. until years ago we were trying to reconcile a protection against today's threats the cost we can afford in the ship to shore capability. the high-speed cell to point capability. it turned out we could reconcile those three so decision was made to break the program into thirds. a third is to address the need for ground tactical vehicles for adequate protection for marines ashore so that vehicle would be moved from ship to shore in a connector. the second phase would be to get our vehicles to please have the same capabilities that is a good self-employed from an amphibious ship. from that point down the road we have a decision point to then pursue a self applying high-speed vehicle. at that time i can reconcile those three variables i talked about or continue to make improvements to the second phase which is a vehicle with ad or greater than capability to our current assault amphibious vehicle. but senator the reason why we are where we are is we simply

could reconcile those three things the cost capability and protection required against the current threat. >> so you are focusing on the vehicle that will be basically limited forwarding ability to get a short different -- distance closer and bottomland with all the protections we have seen against ieds and those things and all the lessons we have learned. as the first phase. >> that's exactly right senator. we expect our vehicles will operate 95% of the time so this first phase is optimized for ground protection mobility unsure. >> in the second phase is going to be completely different vehicle? >> no senator i was out to nevada test center three weeks ago to look at the current state of the vehicles and quite frankly i think in most cases although we have asked for a vehicle that provides adequate ground mobility and not necessarily self applying vehicle all of the individuals right now have a vehicle that i

think may get close to the second phase that we require. >> thank you very much. >> and finally mr. secretary the test evaluation has raised some concerns about the survivability of the lcs and if general greenert mustn't take the question also. if you specifically establish survivability requirements for the modified lcs and have you are those requirements much different than the initial requirements of lcs? >> the small surface task force looked at that and did upgrade the survivability by things like hardening the area around the magazine and around various combat systems. cno has pointed out very accurately in the past the best way to survive is not to get hit

and so we have updated defensive capabilities of the ship and is also very fast ship to keep that that. it's important to keep in mind that this is a small surface combatants. the new upgraded ones have been designated a frigate but they are not destroyers. they are not cruisers and they have a very different role to play. but the survivability for a small surface combatant particularly with the upgrades meets our fleet requirements and meets the requirements to reset. >> thank you gentlemen. >> thank you mr. chairman. we have good attendance up here so we are talking about a lot of systems and i will start off on one admiral greenert that i think has changed quite a bit. that's the j. setup program. i think a year ago they were

talking about adding 4400 or so and that was in the 15 budget. i don't remember, what is the current inventory if we were going to get how many more would that represent when he said 4400? >> i have to get you those numbers. >> is at like 2000 now? >> we benchmarked against the combat requirement and again i have to get you the number. >> that's fine but i guess my point is if we were talking about projecting in last years budget 44,432 more over the life of the program which would have included at that time because we have in this budget are we had in this budget 200 to be bought and then all of a sudden at least it was to me the program was terminated. her was just wondering what has happened to cause that's to be a necessary component as it was

considered to be before now? >> we have to take some chances and i'm not happy at all. we don't have enough munitions. i'm concerned about it and i think i expressed it but the point was we felt the combat expenditure we watched closely how many we is during the year. when i say combat i mean we have enough for what we believe would be the model number. and can we reconstitute the light and we thought we could. we are taking risks. >> that's a good point. you are adding risk by having to do this. you would prefer not to. >> i would prefer not to. i've risk another munitions that is just as bad. it's not a good picture sir. >> senator reid talked about general dunford about the f-35. just to elaborate a little bit more that would actually be replacing the f-18's. is that correct in the eea six b.'s?