Transcripts For CSPAN3 Key Capitol Hill Hearings 20151120

Certainly my state as well. This also represents a milestone as members of this Committee Work to complete a multiyear highway bill the first time in a decade. And long overdue. With Service Transportation programs set to expire on friday, it is imperative we work quickly to reach a bipartisan and by cbicamybicameral agreeme. A number of issues happened to be particularly important to my state. For example, upgrading the freight corridors and interstate system that moved goods through my state to Global Markets every day and providing Additional Resources for Public Private partnerships and border infrastructure. Delivering investment certainty so we can plan for and deliver the highquality infrastructure that our country and my constituents deserve. This bill is important. But im proud to say the leadership in texas havent waited on the federal government. In november 2014, 80 of texans approved a Ballot Initiative that provides 1. 7 billion to upgrade and maintain the Transportation Network. Under the leadership of Governor Abbott and the state legislature, our state passed an even grater increase in future Transportation Resources with 83 of texans agreeing to increase funds for our roads and bridges by as much as 2. 5 billion to 3 billion annually without iminposing no taxes o are fees or hardworking families. Why have we chosen to make transportation a priority . Well, were growing. Some estimates showing our state population doubling by the year 2050. On average, more than 600 people move to texas every day. A testament to the opportunities that exist in our thriving economy but a trend that requires improving roadway maintenance and capacity to meet the rising demand. Doing nothing is an unacceptable outcome. So i look forward to working with everyone on the Conference Committee and our house colleagues in particular to produce a mill tie year highway bill for the first time in a decade. Thank you, mr. Chairman. Thank you, senator. I know texas has great needs down there. They are moving and growing. With that, i recognize mr. Crawford for a statement. Thank you, mr. Chairman. Understanding everybody has been talking about working quickly. Because this patch expires december 4th, ill ask man news consent to submit my comments for the record and yield back. Did i miss that . It was good. Yield back. With that, senator brasso. Thank you for holding this important meeting for all conferrees. I also want to thank senator boxer and congressman difazio for their hard work to get us here today. It will be critical moving across state lines efficiently and safely. If we allow bureaucrats we will inevitably create a patchwork interstate system. I believe the Senate Position will help every state by distributing freight funding through the formula. If we want to maintain a national highway system, we must include rural states. . In wyoming, we have a short construction season. It starts in may and ends in october or earlier depending on the weather. So we need to give our highway contractors and state departments of transportation the certainly they need to plan as we continue to reconcile is the differences between the house and senate bill. You urge the Commerce Committee to act to ep sure a longterm bill. I look forward to working with everyone to get this done. Thank you, senator. Recognize the chairman of the senate financials committee senator hatch from utah. Thank you, mr. Chairman. And chairman inhofe as well and thank you give thanks to the rest of my colleagues senator, could you speak in the mic a little bit more. Ill get that. I will get a little closer. I want to thank all the rest of my colleagues on both sides of the hill, all of whom deserve credit for their hard work in getting us this far. Ever since the safety bill was enacted more than 10 years ago, most considered the prospect of a longterm infrastructure bill to be dim at best. Yet here we are on the cusp of enact being the longest highway bill since 2005. In many respects, we still have quite a way to go. While both the house and senate past good bills worthy of all the praise they received, most of us would like to see us establish a dedicated funding stream to pay for infrastructure so that were not continually trying to cobble together offsets to pay for roads and bridges. My hope is that we will still keep this longterm goal in mind. However, if this conference is successful, this legislation will be a tremendous accomplishment. I think for everybody. And it will give each of our states a degree of stability that they have not had for many years. It will be a significant win for good government. While there might be some who have issues with some of the individual offsets or the differences in funding levels between the senate and house bills i think it is really important to Work Together to accomplish what we are able to do right now, which is to pass a multiyear funding bill within the base lines established by each of the senate and house passed bills. With that Stable Foundation in place, there will be ample time to continue to work on infrastructure financing and funding issues. Only now we wont have to do that work staring into the abyss of insolvency. We must not take what we accomplished so far for granted. Both chambers are coming in to this conference with bipartisan bills that passed with overwhelming majorities. Now is the time to show that we can follow through. Let me say while it may be difficult and i believe we can pass this legislation before the current shortterm extension expires, i think it is a very achievable goal, one all of us should have in mind as we proceed. With that let me thank my colleagues once again for all of their hard work. Look forward to working with you there you this hard process. It has been a privilege to work with everybody so far. Thanks for listening. Thank you, senator hatch. Appreciate it. Appreciate your remarks on finding a longterm sustainable solution to the Highway Trust Fund. That is critical. As soon as it gets off the president s signature, we have to work in earnest to make sure we figure out stakeholders, all of us, how we get to a Funding Source that we dont have to go through these every five, sixyear finding money behind the couch and in the cushions. Thank you very much for those words. With that, i recognize ms. Johnson for an Opening Statement. Thank you very much, mr. Chairman. Let me thank all the leadership that have gotten us to this point. To address our Critical Infrastructure needs, i look forward to working with you on this Conference Community with our dleegz colleagues to complete work on a longterm deal that will provide certainty for states, local governments and transit agencies. Since 2009, congress has passed transit agencies. Since 2009, congress has passed 35 shortterm extensions reauthorizing surface transportation programs. This has not only undermined our ability to make longterm decisions but has driven up the cost of projects while delaying and halting our construction entirely. In a time when the Transportation System is challenged by aging infrastructure, declining revenues and increased usage, making longterm investments our transportation infrastructure is absolutely vital. One way we can achieve this is by providing access to reliable and robust financing tools in recognition of this fact one of my key priorities is to ensure that the tifia program has Adequate Funding to finance products of regional and nath significance. I urge my colleagues for the highest possible funding for this program so we can make sure financing is readily available for applicants. In the science and Technology Committee in the house, i recognize that longterm viability of our Transportation System also largely rests on quality research. Any legislation agreed to today should be absent of any provisions that inhibit the flow of fundsing toward new research or obstruct the department of transportations ability to promote new innovations. And finally, safety along our highways and freight corridors should be of the utmost important as we move forward. Comprehensive Transportation Network must include safety of the traveling public, and ensure that federal and state authorities remain intact so make important safety considerations. It is my hope we can continue to work in a bipartisan, bicameral manner on a bill that will provide our states, local governments and transit agencies with the certainty they need to plan longterm projects. This bill is far too important to the American People and to our economy for us not to come together and enact a longterm bill that adequately invests in our transportation infrastructure and in turn our future. Thank you. And i yield back. Thank you. Thank you, mr. Chairman. Even though moment bers members of the house and the senate offered long continue term solutions. It is irresponsible that neithe term solutions. It is irresponsible that neither the house nor the senate has worked on serious reforms. We have not adjusted the user fee for our infrastructure in 20 years. Or considered innovative revenue streams. Instead, we have spent valuable time searching for shortterm gimmicks. We should not be robbing the banks, homeowners or customs to pay for bridges and roads. This is fiscally irresponsible. At some point we have to say enough is enough. That time has come. We need a longterm robustly funded bill. Im hopeful this bill will provide communities the tools they need to invest in americas infrastructure. I was happy to work with chairman shuster and Ranking Member di fazio on preventing heavier trucks from driving on our local roads and ensuring that we fully fund the Highway Safety improvement program. This program invests in infrastructures like guard rails, rumble strips and retro reflective signs. While youll never read in the headline in your newspaper rumble strips save family of four, this program saves lives every day and for that reason alone should not face the cuts in the senate bill. Additionally, the house bill includes common sense provisions i champ whereon to make sure farm vehicles are not regulated like longhaul trucks. It makes crude oil by freight rail safer and gives First Responders more time to react in the unlikely event of a dera derailme derailment. Finally, many of the policy ideas that i introduced were incorporated. It is critical that flawed safety scores are not publicly displayed for buses and trucks. Investing in infrastructure is good for the local economy and good for america and i commend the committee. Thank you. It is now my pleasure to recognize for an Opening Statement senator durbin. Thank you, chairman shuster, chairman inhofe, Ranking Members boxer and di fazio and other members of the Conference Committee who worked hard to bring us to this day. I want to apologize for my speaking this morning. If i sound like i had a beer for breakfast its because i just came from the dentists office. In the past week we have seen a lot of progress toward passing a longterm surface transportation bill. Ive look forward to working with my republican and democratic colleagues to keep the momentum moving. This conference will be able to finish the bill and help rebuild our infrastructure and economy. I will ask that my statement be included as part of the record. Without objection. So i wont read it entirely. I want to say this was truly a bipartisan effort in the senate. Initially. There were perhaps six or seven senators supporting senator boxer in this effort. But as we work through it on a bipartisan basis at the end 27 Democratic Senators supported this effort. More than a majority. And of course a substantial majority on the republican side. What we bring to this conference is truly a bipartisan effort. Im sure congressman lipinski will recount the article to the midwest. I wont go into detail on it. It is critical to not only have highway money, transit money, and money for bus services around the chicago metropolitan area and around the state. Finally, as i look at the wall and see the paintings of some of the portraits of former chairs i realize that i knew most of them and served with many of them. And i can recall when this highway bill was one of the easiest bills to pass on capitol hill. This committee, the public works committee, was one of the largest in the house if not the largest. Members couldnt wait to get on the committee. Then in the name of reform, reeliminated earmarks. And things changed overnight. This became a debating topic. I happen to be one on the record who believes congressional input in terms on of congress in your strict and your state is valuable. I think i know about illinois for the Illinois Department of transportation. But i will save that debate for another day. Let me just say this. I believe that we have a cri8xkyleadership in this area s essential. In our state about 80 of highway construction is paid for with federal funds. For those who believe they should be strictly state and local responsibility i have three words. Dwight David Eisenhower who decided an interstate highway system was critical not only for National Defense that the growth of our National Economy and history has proven him right that i hope we can reaffirm our commitment to our Transportation System. I think the chairman for his kindness and allowing me to say a few words. See i thank you senator and i dont know if you heard there was a muffled i thank the chairman for allowing his kindness in applying a few words. He di i certainly agree with you on president eisenhower and going back to lincoln and beyond. Sit a federal responsibility to thatart of that team. Be so thank you for being here today. Being and i would like to mention tooe you being here means the senate participated 100 . R thats less than i can say for my house colleagues. We need to get through this. Thank you, senator durbin. Veryu iith that, miss edwards is recognized for an opening toda statement. Your thank you, very much mr. Rm shuster and also to senator em inhofe for today and for your commitment, obvious commitment to a longterm surface c comm transportation reauthorize. B as a member of the committee and Science Committee i look forward to working with you and the other members here to send a good bill to the president. For decades, our Transportation Network with robust investments. And research and development at its core supported a strong es american economy. Transportation innovations across all modes from highway pavement steelers to mass transit technologies to innovative Railroad Track and pipeline inspection. Utonomorch likewise, intelligent Transportation Systems research connected Vehicle Research and autonomous Vehicle Research wilt make transportation safer, faster and more environmentally friendly for the 21st century. Making our infrastructure work smarter for us is critical. As a representative of the Fourth District of maryland which borders the nations vatie capital, im personally investea in our federal efforts to nding mitigate cons guess in this fast growing region as well as acrose the nation, especially encouraging Innovative Technologies and processes start with sustainable funding for nab basic and applied research and development at the department of transportation. Und its Research Partners such as the university of maryland. Im concerned that both the house and senate bills contain t provisions that tax existing r o programs or otherwise put Research Funding at risk by moving it out of the Highway Trust Fund. I may agree that the additionale deployment activities are a arii worthy investment. But research and the research he funding in this bill is already far below needed levels. Ve if we dont protect Research Investment today we will not have the deployment ready befo technologies that we will need r 10 years from now. The bills before us do include s several important provisions i t support. Deong them, providing new and directpa federal oversight of eo lamada, transfer metro board appointments to the u. S. Department of transportation, localing planning agencies to mg mitigate storm water impacts, n increasing funding for o distributed to local governments and continued funding for Small Business Contract Opportunities for minorities and women througo the disadvantaged business program. And i do look forward to continuing our work on these ef efforts. Thank you, mr. Chairman. F thank you, ms. Edwards. And to mr. Farenthold. Opening statement. Ing in t thank you for investing and t modernizing in this countrys r. Infrastructure should be a top priority for congress. Em as a member of the house transportation and infrastructure committee, i was delighted to work on and support the passage of a maintear transportation bill, l which is critical to all those responsible for maintaining and using americas roads and ides bridges. This bill provides more flexibility and certainly for states and local governments. It accelerates project delivery and promotes innovation to makeg or transportation programs more effective. Ot in my home state of texas, we nd have seen massive growth both it population and in our economy r which presents a major and nfrat unique challenge for our state to build and maintain our current and future nd infrastructure. With Major Projects in texas under way, such as completing ri interstate 69, rebuilding the nu harbor bridge in my hometown of car pus tr corpus christi, texas. It is critical we get to work on completing this conference report. We must also continue to support in know vacation in our Transportation System. The 21st century is going to be very different. We will see alternative fuel ta vehicles, like ones using batterye power, natural gas and imbrianuels. Autonomous vehicles in the shared economy will be part of our 21st cent relative transportation. T we need to pave the way for these innovations. O o im honored and look forward to working with my colleague to tr find a great way to meet our 21st century Transportation Needs for texas and our nation. I yield back. Thank you. I recognize mr. Larson for an inening statement. Invehank you, mr. Chairman. In Washington State, ndansportation means jobs. S investing in our roads, our to r bridges, our highways and transit systems puts people to u work and keeps the economy moving. Atsboats. One of the issues is adequate d funding for ferry boats. Ferries are a life line in our t state and not a luxury. Both thousands of people in my district and throughout the state and the country use ferry boats every day to get to and gr from work. And i hope we can agree additional funding is a key parh of a final agreement for the ferry ses tell, about is the trouble that ferris system, particularly because it moves the chains of the funding formulas within the ferryboat particularly because it moves the chains of the funding formulas within the ferryboat ue ncin program. Bel another major issue i hear about is the trouble competing with bigger cities for resources. It creates an expedited process for smaller projects that want to use tithia financing. R willreforms will help bike anl pedestrian products. Sidewalks, bike lines are critical. Less than 2 of federal transportation funding goes to s the transportation alternatives program. But communities that leverage rp the small funds to get big results. Transits are another part of the product and people depend on lee buss and bus infrastructure to get to work and school each day. I support the changes made in to the house ball to require competition nationally for funding. And both bills require crude oil, traveling by rail and bridge infrastructure. It is hugely important to my district. Dis thwant to echo ms. Browns comments. Regarding port metrics. Thank you for your leadership, mr. Chairman. I d to and i look for the opportunity to weigh in on all these issues i yield back. M thank you, mr. Larsen. Coll thank you, chairman shuster and the rest of my colleagues for successfully getting this cg transportation bill to eed conference. First and foremost, we must to determine the overall funding levels. Highways, bridges, transit and rail keeps growing. Neither bill does much to address it. It provides flat funding of 325 billion over six years. And the senate bill is not much better. Low Everyone Wants longterm for liability and planning. Is that still the preferable option if we lock in six years of flat or minimum funding . Proga higher funding levels would be ove better course of action. Se policy provisions i am proud of the Freight Program created in the house bill which would ar provide guaranteed funding for largescale multimodal freight projects that our critical for our regional and national commit. Sthelpa a number of transit issues will be addressed in order for several conferrees to support se the final package. Ction i would like to note that although the amendment passed by voice vote it is not to put it o mildly without controversy. It section 534 oprovides critic0 would devastate transit serviced devastate service in new york, syracuse and aberdeen, marylando New Hampshire and allentown, pennsylvania. In almost the entire bipartisan ct thesection new jersey, connecticut, delaware, rhode island, new ying york, and maryland urge to concede to the senate and reject these cuts to 5340. G it should go without saying thae in an environment where fundingo is limited you simply cannot make drastic changes and cut f funding so deeply in communities around the country. Ot it is not fair. It is not sound economic policy. It would jeopardize the deals r passage. Vi new starts should be treated equally to other transit projects and we must carefully provisions relating to de the motor carrier safety. 9 finally, there is a bipartisan effort under way which i very ei much support to include the 9 1 health and Compensation Program in the final conference report. B Congress Must act to reauthorize the programs before the end of the year. Y legislation to permanently n reauthorize them already has 248 cosponsors in the house. The filibuster proved 65 d cosponsors in the senate. D surv attaching this reauthorization now will ensure the programs do not close their doors on on rthe responders and survivors. 5340 t so i urge their inclusion and the recession of 5340 to the i Senate Version of the bill. Yiel thank you, mr. Chairman. Anot i would like to thank chairman shuster and senators inhofe and boxer. Tape a im proud to support this legislation because it reduces the red tape and regulatory coi burdens and streamlining components in map 21. Ac it includes necessary forums to accountability csa program. Egatl we have heard from lots of constituents that this has flawed methodology. Encourevamp perform and revamping the methodology behind the scores that would step forward to make the system work and be a fair judgment to our motor can carrier operators. As chairman of the water subcommittee and environment and t i, we include an important n s change on the innovation act known as wifia. Ovide it is a loan and Loan Guarantee Pilot Program authorized in 2014 to provide additional Funding Source for drinking water, benei wastewater and water lenges infrastructure projects. Each wifia dollar loan leverages at least 10, making the loans extremely beneficial to communities that have major challenges with their Water Infrastructure projects. Ansbinat it allows communities to use the wifia loans in accommodation with tax exempt bonds enabling l more opportunities forren tpra structure. I hope that is included in the final bill. Finally, i am pleased by a simple amendment i offered on the floor. Its directing the department of thensportation, a study to the process of state procurement fob storm sewer and Materials Included in the star act. Import culverts have been made in the process in recent years with n changes in map 21. In light of the changes it is beneficial that a study that k o determines the how, the cost, environmental and engineering principles affect the states procurement process. D so i look forward in working with my colleagues to reach a final agreement to pass a first longterm highway bill in a decade. I yield back. Nk yoank you. Ms. Napolitano is recognized fo io. A statement. Thank you, chairman shuster. O im sorry we long congressman di fazio. Ifm. I wish him safe return. K ou im not sure if we have lostr him. Whether he went by his own accord or whether we cut him off. Hank im not sure. Ai we look forward to seeing him after thanksgiving anyway. Also to chairman inhofe and hav senator boxer. The work you have done collectively. H re and i associate myself with ng o regard to the sixyear bill and how committed you have been, sir, to getting this work done. P and how open you have been to us as members. I am honored to be on the committee. Ng and i have had input from stakeholders. Ser the alameda east construction authority, port hill transit, gateway, services of l. A. , l. A. Metro, and caltrans. Al c in requested the final issues, e ask unanimous consent that a list of these be placed on the record. Without objection, so t ordered. I refer to section 1419 included in the house and senate provisions for relinquishment. Tu we look at 1401 b on degradation. Uct we also look at allowing coordinated structure of 44 ook transit agencies to continue working under two tier fare th structures. We look at by patterson support and mitigation and air quality. N section 7011 is planned consulting the states. Congressman give bipartisan support. Storm and sewer materials. Section 1503, proposed to fix wifia. 1105 i, support local bridge funding. Transit safety measures. 44 1446 preemption of state and truck drivers. Section 1435, private engineering. And then oppose the senate title 16 subtitle c performance port measures. And lets not forget the territories of native americans. Mr. Chairman, a thank you and my fellow coverees and the staff specifically for their great work. I yield back. Thank you, ms. Napolitano. Thank you, mr. Chairman. Ive heard a lot of back slapping and congratulating ourselves on this bill. And i think the transportation did it happens in 2025 and 2026 to pay for roads and bridges built in 2016, 2017, and 2018. This is nothing more than a tax increase on tomorrow. Our fathers and our grand fathers paid for the roads and bridges with when they built them. Now this generation of members of congress are asking children to pay for our roads and bridges. Maybe we should pay for our own. It is time for this congress and most importantly this committee, this committee. We didnt have jurisdiction on i that. We have jurisdiction here. Time for this committee to stand up and pay the bill. E it ought to be important enough to pay for. I yield back. Im thank the gentleman. Agree with much of what the gentleman said. As soon as we get done with this, we need to get the stakeholders and work on what we can pass and the tax reform bill in the future. Cobbling these things together is not the best way to do it, obviously. So i thank the gentleman from wisconsin for keeping continuing talking about it. With that, i recognize mr. Lipinski. I want to echo what mr. Ribble had said. Ethat we need to do that for our country to do this the right way. Vo as he said, the authorization bill i think were doing a goode job on. I think the chairs and Ranking Member for their work. I am honored to be a conferree since 2005. I look forward to working to finalize the report. I want to thank the chairman to restore new starts, small starts and programs. N zeres am the changes that have delayed many transit projects. Instead, we have a deal that will help build up their ho capacity and serve as well. Im pleased that it includes cont priorities i worked on. Strengthening tank car safety rule and increased funding for state of good repair. By merkin creases, Technical Assistance eligibility, languag helping to deploy zero emissionn buses. Im also a member of the science base and Technology Committee and the house bill contains vehi language on High Research bill, the future trip act. First, it creates a Regional Transportation Center on connected infrastructure. They are a big part of the n a solution to alleviating congestion and improving safetyd this technology will be more prevalent. We should be doing more and opportunities stemming from connected and Automated Vehicle sy systems. In addition, the house pill hasy language for a study on connected vehicles, Inter Agency Working Group and transportation research, improvements in utc proposal regulations and th Pavement Technology program. Of course the bill is not perfect. Starting with the need for higher authorization levels. As a member of the Freight Panel led by vice chair jimmy duncan, i am pleased to see Freight Programs in both bills at a time. In the conference report, we need to allow for a series to account at as one freight project. And the Freight Program must be truly multimodal. As we all know Freight Movement it i th is. After all, we will be funding with a substantial percentage of general revenues, not just the Highway Trust Fund. We certainly have our work cut out for us. I look forward to rolling up mya sleeves and getting this critical bill done. Finally, before i yield back, am yes, my tie i am wearing is a l statement. Im happy that tap has been included in this bill. Without objection, so ordered. Next we two to mr. Perry for an Opening Statement. Thank you, mr. Chairman. Through the leadership of e chairman shuster and Ranking Member di fazio. However, in my opinion, we still have work to do. My hope with this conference is that is not an exercise in few n talt. A i hope all conferrees to have a say to our individual states ant district. No because many issues have yet to be resolved. Con i hop this is an open process and that legislation is not alsd concocted by a few select few individuals with bathroom deals and handshakes. Ticipatehis simply put, members want to participate. Do one thing this legislation doesd not address is the out of date thresho threshold. Go. To address this law since 1931. Crippling regulations is also something this Congress Must address. Motor coach school bus, Trucking Companies are continually threatening with an arbitrary pa increase by the federal government that have no jurisdiction whatsoever in this process. The house bill addressed this m issue and we must ensure the ws final product upholds our efforts and complies as well. We must ensure that we encourage private companies to compete for Public Transportation so we can start to shift away from a federal monopoly in the Public Transportation sector. Pa again, i thank everyone for their leadership and hope we do the right thing by the American People and have an open and transparent Conference Committee where members participate. And i yield. Thank the gentleman. Mr. Cohen is recognized. Chai id like to thank all the Ranking Members. Of as i look at mr. Di fazio on tvt i think of the picture of the ih leader of th that was always present on the wall. Ft. The few and the proud that are left here. Ive learned first i should have mr. Duncan cosponsor my attempts because he always wins earmarks did so good for so many years. As we cobble together a program. But it is not easy to cobble. And he is a good cobble. And he has done well. Li ourruie i would like to encourage the passage of this bill is important to my district and foa america. I would like to ask and emphasize that i would like the amendment that i got through th committee and into the bill to t be maintained. That will provide local transit systems flexibility to improve i Transit Services the next five years. It is estimated that 1 million troops will turn to civilian life. Many of whom will havedy abling conditions. We have an aging population that will be dependent on transit. Ve easter seals and the paralyzed veterans of america and the Transit Union of that amendment in the bill on the house side. We have a responsibility to the these folks. And i hope the Conference Committee will accept senate provisions that make transit oriented programs for tifia. It is important for msdirect transportation lanes, important for the people and good planning, also for the environment. People are more likely to use r the programs near transportatioa features. Of i look forward to working with the committee. Im proud to be a member of the th y committee. E t i yield back the three seconds that i have left. Thank you, mr. Chairman and vice chairman for organizing this meeting of Conference Committee members. Or theion i am pleased that the house and senate are coming together to deliver a longterm transportation bill to the American Public and i thank thel ra for their hard work. As we all know, aging infrastructure is in dire need acco of help. This approach of funding a infrastructure is uncertain where they will get reimbursed for projects. While i am encouraged by the length of both bills in the light of bills i am extremely concerned by the funding levels of each. We need to win out funding levels that meet the need of the highway and transit system. S dge while i am encouraged by the by length both bills and a lot of f good things in the bills, i am extremely concerned by the funding levels in each. I am also gravely concerned by a provision in the house bill to rid the most densely populated state over athat significant am of their transit funding. New jersey is the most densely populated state in the cup. Just to give you an idea, the community that i live is in one square mile. Of51,000 hoboken, is another square mile, cit and has another 51,000 people. New jersey city is the largest most populated city in the we rl state, soon to be. The so as residents rely heavily on transit for everyday transportation, the provision t eliminate funding for the states that make up 50 of all ridership is reckless. It is an attempt to push transit funds out of where it is most ee needed. It will significantly impair tha ability of many transit agenciee to advance under Capital Program needs. In the state and and maintain a state of repair and good maintenance. The final conference report should not approve who cuts funding to these agencies. Hardrkthank the chair and the tk vice chair for their hard work. I thank the gentleman. With that, i recognize mr. For his statement. Thank you for your crafting this bill. It is exciting to have my first year in congress capped off by what i consider to be landmark n legislation suffering from almost a decade of shortterm extensions instead of longterm fix we desperately need. I have to echo the sentiments of my colleague to my left, mr. Sire. The portion of the bill changed my amendment on the floor eliminated funding for the 5340 high density states plus program. Se the seven states provide half of all the Public Transit use in this country. Half. Eyithis syste an Important Program ensures states with the most need receive the funding they need te maintain robust systems. This misguided amendment redirects to a Discretionary Program controlled by the. Department of transportation is and in doing so would wreak havoc on the most heavily used transit agencies in the country without providing any increased funding whatsoever for the uncertainty whatsoever to agencies and other states. The Transit Agency that serves my district would see a cut of more than 20 and it already face dire financial di difficulties. The same would be inflict odd s agencies throughout the northeast, including those in k. Mr. Sires district where this funding is needed most and we should act. This is how the federal systems are supposed to work. Youre going to see a net positive benefit over the course i urge the committee to get us back to the compromise that cond assure that the committee pass the bill and receive committee unanimous support. I recognize mr. Woodsall. Th to help get the rust out of the geese, you are now doing with transportation and my er encouragement is is to make thaa absolutely as long and certain as possible. Po you cant put time on the dinners missed as folks sittinga in atlanta traffic. You cant put a price tag on creating a livable, workable balkable community for a senior. This is the beginning not the end. You were trying to do in weeks what in this committee, now dayr with this committee what others have not been able to do in years and even decades. It is a tremendous source of o encouragement for me. To has continued and im grateful to be a part of it. Folks want to pay their fair share but they want a dollars worth of value out of a dollars worth of taxes. Texas is a growinging state in which i represent the 36th district. In fact texas is projected to double in population over the h next four to five decades. Un in my district and in the state of texas we have the potential for unlimited growth and expansi expansie expansi expansion. My constituents arent interested in having Congress Pick winners and losers when if comes to transportation. We need it all. We need trucking, rail, more barges, more shipping. Texas is creating more than half of the new jocks in america ovet the last decade. Reliable roads are not just fors biges businesses. Hard working families in my district and across the country need them to get to school, to work and not to just sit in traffic. I want to thank the committee s for incorporating a number of e. Amendments and requests that ive put forward. This process is not always been easy. Nor should it be. I look forward to working with all my colleagues on both sides of the aisle, both sides of theh capitol to finish our work on b this important bill which we t request all be proud of. Before heading to congress i was a general engineering contractor for over 20 years. I built numerous roads, bridgest and dams. Y thatan i know the impact, the uncertainty this can cause in this sector of the economy. I standof withfer my colleaguef to offer my support for my multiyear funding bill. After months of hearings, conversations and no negotiations, the day has come to put the bill op the president s desk. This legislation contains key provisions like the i11 corridor. This designation is part of a larger Intermountain West corridor that is important for not only nevada but for the west and the country. Dipping into unrelated are eaviy cove covers isanning not. Sustainabl industry that relies so heavily on long term planning. I have worked on specific ta provisions with the committee. I support and including the lake tahoe treatment language in the senate drive act. Tax exempt bonds with the wifia projects, bus and transit lang, rest break periods along with those i oppose which include using custom fees as a pay for and use of tread ditz that have not gone through regular order. If the process thus far is any indication, i know the bill we i willed send to the president wi have all members input an i urge Swift Movement on this longterm funding bill. Thank you, mr. Chairman. T he thank you. Thank you, mr. Chairman. I appreciate the opportunity to be here and also to be named a conferree. I want to thank conferee. I want to thank you for your efforts to make this a sixyear bill, and i want to reurge some of the things you said in regards to moving quickly. Having run a large l. Infrastructure program in the past, the importance of having funding stability and certainty is absolutely critical. Continuing to have volatility ie funding levels, continuing to have volatility in the length of funding continues to make projects affordable. Compartmentalizing projects costs taxpayers money and delays the outcome of investments. I want to thank you again for including a number of provisions we have requested, including efforts to ensure that there are Grant Programs available for largescale, ht nationally significant and projects that arepe important fm a freight perspective. In south louisiana where im from, we are one of the only places in the nationg where thef interstate drops down to one lane. I10 from california to florida drops down to one lane in baton rouge. You can pull up yourppenin googs and you will see red right now. Its ridiculous whats happening, and i certainly want to be clear that i think that ul the fact that were in that jami is a result much of both lack of state priorities and Principal Investments as well as insufficient investments in infrastructu infrastructure. Weve seen in the past where the insufficientretional funding ha profound impacts on our nationat economy such as after hurricanes when gasoline prices after we n katrina and rita spiked 75 centt a gallon nationwide. We need to ensure that the investments in these roadways are resilient and have the al proper capacity. Mr. Chairman, we needa ns apave. We need additional lanes and wee need additional funding. But i also want t to emphasize e importance in the role that ex technology can play in improving efficiency of our existing utilization of roadways. Things like google maps and ways and others can play a really Important Role in integrating with intelligent Transportation Systems and taking it many steps further to improve the efficiency of the utilization of our existing roadways. I think its important that we proceed using appropriate perl innovation and Technology Solutions to properly utilize that excess capacity that exists today. Lastly, and as congressman defazio mentioned, i want to note that i think we need how you doing i think we need additional funds for the highwa bill. We cant continue to underinvest. But this effort to do this ho e hodgepodge of. Funding fees wil cause much more in the future. With that i want to go to mr. R riker because i know he has an appointment, so mr. Riker is recognized for a statement. Thank you, mr. Chairman, andk congratulations to you and Ranking Member defazio for yourm hard work and the entire t the committees hard work on this e bill and im honored today to ax represent the ways and Means Committee as the current chair of the tax policy along with subchairman. High members of both parties agree that our nation needs a longterm highway bill that improves our roads, bridges, movement of goods, economic competitiveness and public safety. But for too long now,o we have a not met this need. Failing to pass a longterm solution not only limits our potential as a nation but resents very real consequences for our state and local economies. My home state of washington, which is one of the nations leading exporters, producers ani growers depend on a strong, efficient freight and Transportation System to move their goods. Pl if such a system is not in place, we risk moving out to our foreign competitors. As the nation experienced this past year during the west coastn port dispute, in a global economy, getting goods to market doesnt end at the last train stop. The port slowdown resulted in m lost sales, damaged customer doll relationships, and in my area, millions of dollars of high Quality Produce going to waste. Washington apple growers alone lost an estimated 1 100 millions in apples that were no longer sellable. Congre congressmen must not only work to ensure that our surface work is strong but can rely on goods all the way to thes ov farmerset and planes that transport them e to consumers overseas. W i hope this is an issue we can address during this conference with a comprehensive highway on bill states can also focus more resources on implementing responsible road safety laws, e including those related to the t safe transportation of crude oil through our communities and working with states to address a unsecured loads. Ment although there might be follo disagreements about the means we should use to reach these goals, i am hopeful that our common objectives will help us move c past these differences and put s something American People can be proud of on the president s desk. Thank you, mr. Chairman, for taking me out of order, and i yield back. Thank you, mr. Richert. And i recognize the science, space and Technology Committee,h mr. Smith. E bi thank you, mr. Chairman. Mr. Chairman, let me thank you and Ranking Member defazio for your leadership in drafting a en longterm surface transportation bill. I also thank the other members and senators for their work on wie two highway bills that areg the subject ofth this conferenc. As chairman, i feel its important we find a safe highwat system. Qua National Surface transportation will time ensure a safe qualityt life for our residents. P i believer we have what goes ino a longterm Transportation Safety bill. However, im concerned about thd house and senate bills that divert Research Dollars away ats from Research Programs in order to fundis demonstrative initiatives. Each ofon. These reduce the alry scarce dollars available for real innovation. A provision of the highway bill by the chair of our research and Technology Subcommittee requires annual detailed and robust plans at the department of transportation was not included in the house passed bill. Commit the Senate Language in the senate bill is a priority of the Science Committee. I cosponsored the context bill which was researched by a voice vote. Innovations that result from rts federal r and d efforts in esent conjunction with state and locar efforts ultimately represent af congress. I expect there to be further discussions by our respect active staffs as we continue to work tirelessly on innovations, particularly those relevant under the jurisdiction of the Science Committee. I thank congressman defazio for their work in the house, and i. Look forward to working with i am imhoff and boxer in the wi senate. I wish toth express my thanks working with senator comstocks and my concerns. I appreciate the time and i y d yield tback. I recognize mr. Mullen. As a former member of the transportation infrastructure committee, its a great honor to be back in this room again with my fellow conferees. Lation i would like to thank speaker allen for naming me a conferee for this legislation. I would also like to thank senator imhoff and others for their leadership in getting us to this point and looking at this historical legislation. Theres obviously more workre t be done. I look forward to representing the energy and Commerce Committee and oklahoma priorities in this agreement. Vehicle and road safety is vital to thehatn stability of the futm of the nations Transportation System. For the approximately 253 million cars and trucks on the road in the United States, millions of American Families s rely on their cars each day to safely transport themselves and their families. While i believe cars are safer d today than ever before, the Automobile Industry is working hard to develop next generation Safety Technology that saves more lives, more can be done by the national highway traffic the Safety Administration and the auto manufacturers to protect the driving public and make our roads safer. The national highway Traffic Safety administrations core mission is to save lives, prevent injuries and reduce road traffic crashes. Congress and the Auto Industry share in that responsibility. As theh quality of cars increas. Americans are holding onto their cars for longer periods of time. The average age of cars on the road today is about 11 and a ndx half years and expected to grow to 12 years by 2019. Its important for the law to y keep up with the greater our longevity of cars on the road, and i believe that if we can t resolve our differences, we can take a step forward in better rn protecting the lives of the driving public. Lle i look forward to working with my colleagues to reach an agreement and i yield back. I thank the gentleman and appreciate having him on the Conference Committee. I recognize ms. Comstock. Thank you, mr. Chairman, ando i thank all my colleagues in ths house and the senate for the opportunity to produce a multiyear transportation bill. My district of Northern Virginia is particularly challenged by the need to reduce traffic congestiona in and around the metropolitan Washington Area that we all obviously deal with every day. Given that i serve on both the transportation and the science and Technology Committees, i appreciate being on this t committee being able to address the redevelopment portions of this bill, and i would like to associate myself with the comments made from the chairman of the science and Technology Committee regarding the Surface Transportation Research and development act, my bill, which we were able to pass out of the Science Committee, and i also o would like tor thank the chairmn for including portions of this bill in the transportation bill. Particularly one of these provisions is aimed at mitigating traffic congestion. Like chairman smith, and i know like chairman shuster, my goal is to ensure that all the wi differentll research and Su Development portions of thisl bill will produce real results a that yield real improvements in traffic challenges that we all face throughout the country. And so with that i yield back, s mr. Chairman. T thank you, ms. Comstock, for that, and last but certainly not least, the gentleman from illinois who i know has a desire to serve on this committee. The first time i sat on this committee 14 years ago, i was al about where that camera was. R someone actually said i was almost out thehis door, so if t is your first time in the la committee room,ter. Looking at 14 years later, you, too, might be able to be up here with the gavel. With r that i recognize mr. Loue for a statement. Nk thank you, mr. Chairman, vy much and also to Ranking Membern defazio. As a new member of congress, im grateful and humbled to be here today, and would especially like to thank chairman rob bishop and speaker ryan to ask me to participate on the house heir resources committee. I also would like to commend mye colleagues on the house. Committees hard work in getting this multiyear transportation bill through each chamber. My constituents in the 18th lont districter of illinois understa how important a glongterm op transportation bill is for economic growth. Ve the opportunity to improve and in reform our highway and transit p programs while investing in our nations infrastructure is a tremendous step in the right direction for the safety and productivity of our country. Bon our vast Transportation Network is the backbone of our economy. O making it critical that we provide longterm certainty for states, localities and businesses as repairs and th upgrades to our e transportatio network are planned and executed. 42 of illinoiss major roads are in poor or mediocre conditions, costing motorists, 3. 7 billion a year in extra vehicle repairs and operational costs. As we workncilab togetherle to e differences between our two bills, it is important that we have measures to streamline our businesses as well as updates to infrastructure on both federal and tribal lands. Particularly the Environmental Review process. I look forward to working wo together to produce a final agreement that will benefit all americans. Again, mr. Chairman, thank you for the opportunity to be part of this conference. Thank you very much, mr. H t lahood, for that. With that, and other members here, i just want to say to peter, its not the same without you sittingad next to me adding commentary on this. Mi sometimes its so colorful we cant turn his mic on. But im glad to see you. You look like youre doing welle and i look forward to seeing you back here after the thanksgiving recess. Thank you for joining us here today for this important eg meeting. G as i said, the goal from tt beginning, were going to give this toake the president of the United States by december the 4th, and i look out and see a number of stakeholders there, and ive been talking about when this thing gets done, were going to sit down and everyone wi has to cometh to terms with whas the longterm solution that everybody can agree to and were not all going to get what we want, but we have to figure out something we can live with thats going to sustain this Highway Trust Fund longterm and then get to work selling to the American People and makings of members of both legislative bodies, the house and the senate and the administration is on board to try to move something forward when we get to a point, which we will, i believe, it may not be this year but the year after, for some kind of tax reform bill. T again, after december 4, ill be to make sure we e all come together and figure out how to move forward on this. We a so, again, thanks, everybody, for being here, and we got a lot of work to do. Te staff, again oh, ms. Waters just walked in. Ms. Yowaters dur, do you wish t a statement . City you beat the gavel. Sit anywhere you want. Nt [ inaudible ] yes, maam. Ms. Waters is recognized for a statement. Thank you very much, mr. Chairman. First ik commende both democrat and republicans for coming together to reauthorize the Export Import Bank and urge the committee to leave those pac provisions as is. This bill also includes a ousl package of 17 bills that have previously passed the house under suspension of the rules. While i continue to be supportive of the policy behind these measures, i welcome proposals from my Senate Colleagues on improving these provisions so that consumer and Investor Protection are d strengt strengthened. Lastly, regarding how we are paying for this bill, un i find it difficult to understand that this bill threatens the for credibility of our central bank and our economy because there go are thoseli who are unwilling t raise the gasoline tax, or unable to reduce a guaranteed Dividend Payment to our largest banks. Raising the federal reserves Rainy Day Fund to pay for fiscal spending has a horrible precedent. It makes our federal bank respond to unforeseen events, and it undermines the banks osf independence. I believe that it is equally r problematic that we would put theoof cost of building bridged roads on the backs of those looking to buy homes, levee a fee on fannie mae and freddie mac. I look forward to this committee helping to find a way to pay foi it that neither causes a tax ong our residents. I yield back. Since there is no more business, i wish everybody a happy thanksgiving, including we staff. Ill come and serve you turkey if i have to to make sure this gets done. No other business at hand, the Conference Committee stands adjourned. On the next washington journal, Frederick Kagan on the u. S. Strategy against isis. David panetta how Law Enforcement conducts surveillance in counterterror operations. And on how they deter corruption. 7 00 a. M. Eastern time with your phone calls, tweets and facebook comments. Book tv. 48 hours of nonfiction books and authors. Our featured programs this weekend include the 32nd annual book fair. Our large online coverage starts saturday at 10 00 a. M. Eastern and sunday 10 00 a. M. Eastern on Niall Fergusons book. To think you could solve a cold war with systems and analysis. He is interviewed by Carla Anne Robbins with the council on foreign relations. And sunday at 8 00, abdel ba Abdel Bari Atwan, their methods used to take over syria and iraq. Watch book tv all weekend every weekend on cspan2. Every weekend on American History tv on cspan3, 48 hours of programs and events that tell our nations story. Sunday morning at 10 00 eastern, our new series of road to the white house rewind, looks at Herbert Walker bush. The film the last two days, the 20minute color film of john f. Kennedys fateful trip to texas in november of 1963. Then at 5 00, were live with the Radio Program back story with the radio history guys. University assistant fellow brian bell low, university of richmond president emeritus discusses d. W. Griffiths film the birth of a nation and its significance. American history tv all weekend every weekend on cspan3. Next a look at u. S. Public Health Preparations for the seasonal flu and other Infectious Diseases. A house energy and subcommittee heard from several Public Health agencies. This is about 50 minutes. Good morning. We have a subcommittee hearing from oversight investigation. Earlier this year in february, this subCommittee Held a hearing on last yearss flu vaccine mismatch. This mismatch of the predominant flu virus resulted in more deaths and hospitalizations because of the vaccines lower than usual effectiveness. Today we return to that issue to discuss what our Public Health agencies have learned in the intervening months. I want to thank my friend, Ranking Member Diana Degette from colorado for her research on this issue. Weve received briefings not only on this years vaccines but also the flu. Each year millions of americans receive shots to help protect against the illness. Even in a bad flu season, the vaccine can prevent the flu, and i urge everyone to get one even though the vaccine is not perfect. Last year the United States experienced a vaccine flu mismatch. But the virus mutated before the flu season began, resulting in an effectiveness rate of only 19 of the vaccine and even lower for citizens. We have learned, however, even in a good year the effectiveness of the vaccine is lower than it should be. For the last 10 years, the vaccine effectiveness rate fell below 40 , and it is clear that the seasonal flu can cause severe impacts on the same scale as the pandemic flu. The time for an approach to dealing with the flu has long passed. The committees oversight work has made a difference. The department is treating the flu with high priority. Things are being considered in the fight of fighting the flu. T theyre working to improve surveillance, utilize technology to speed up production and make more effect tifr vive vaccines. But there is still much work to be done. We are still largely manufacturing flu vaccines and detecting flu virus changes with Technology Developed during the 1940s. At the same time, more and more influenza viruss has spread. This situation is in bad need of modernization. We need better testing to quickly learn of mutations and seasonal flu viruses. We must increase our doses instead of heavily relying on the eggbased vaccine doses. The production time for cellbased vaccines is quickly than eggbased vaccines allowing for greater flexibility in the vaccine and manufacturing process. Nih, the biological Advancement Research authority known as barta, and other agencies undertaking the flu must determine what precisely is limiting vaccine effectiveness, particularly with the hcn2 flu strains. We must better understand how to use antigens particularly in highrisk populations such as the elderly and the young. We need a better contingency plan such as whether they use antibiotic drip or egg issues. They must improve mu tratations the Southern Hemisphere so we know whether it wont be as effective as we had hoped. Health care professionals must be better educated about the use of antivirals instead of antibiotics when treating the flu. The cdc must also come up with a better plan to increase vaccination rates. Finally, his must complete updates. The updates, which are not expected until sometime next year, are long overdue. Im encouraged by the work that was done in last years flu season, but we must also ask ourselves where we are falling short and what we need to do to modernize our response to influenza. Our nation deserves a response to this problem. I think our witnesses in cdc, barta, nih and look forward to hearing their testimony today. I now recognize the Ranking Member ms. Degette of colorado. Thank you very much. I think its important what were doing on these flu issues. Often people ask me what keeps me up at night, and i always say having been in congress when we had the h1n1 flu a few years ago, the pandemic and what it can do for our constituents and the world at large, thats what keeps me up at night. Thats why i think its important we have a hearing every year. Im really happy were having it this year before the flu season has started. I think its really critical so we can examine, first of all, whats happening with the seasonal flu as best as we can predict, and secondly, what were doing to prepare ourselves for a better response to the seasonal flu and also more devastating potentials. I see we have some medical professionals in the room here, and im always happy to see it looks like your students my daughter is a medical student, so shes also very interested in these issues. Last year, i think, was a really harsh reminder that Infectious Disease is always around us. And try as we might, were not always 100 successful in treating the annual flu. Last years flu vaccine was only moderately effective. Fortunately, it was not a severe strain, but nonetheless, it results in increased hospitalizations, particularly for vulnerable populations like Senior Citizens and young children. During the course of the last season, in fact, cdc announced that the flu vaccine had only a 23 effectiveness rate, which is significantly lower than weve observed in recent years. That was largely because the virus mutated in the eight months between the vaccine strain selection and the onset of the flu season. And that resulted in a mismatch in the virus used in the vaccine production and the one that were actually circulating. Still, we need to protect ourselves, and last year even 23 was better than nothing. But dr. Frieden reminded us last year that even a vaccine with a low effectiveness rate still protects millions of people from getting sick, and we hope, and i hear that some of the early indications are that its a better match this year, but its still kind of a crapshoot every year as to whats going to happen. So thats why im always happy to have these witnesses here today, some of whom have been to this committee before, some are new, to hear about ways that we can strengthen our response for the future. I want to ask the cdc about this flu season, but i also want to hear how were going to respond in the event of a severe flu season and what were doing to continue to prepare for the inevitability of some kind of a pandemic flu. I was pleased to see that the administration put together a memorandum for the secretary of health and Human Services based in part on lessons from last years flu season. It offers several key areas where improvements could be made, including Better Technology to quickly identify and isolate flu strains and Better Process flu manufacturing. And to better tell when they can be achieved. As you pointed out, were still relying on eggbased vaccines even though we have cellular techniques that are better. And frankly, this is the eighth hearing that weve had in the last 10 years, and i remember 10 years ago asking about the development of a new and more nimble vaccine potential, and here we are again talking about this same thing. So im really looking forward to hearing from the witnesses about the goals that they share in the memorandum that was issued, and also where we are towards moving towards better technologies on vaccine production, and what were doing to improve all of the rest of our systems for more serious identification and prevention. The importance of a strong Public Health infrastructure that allows us to prepare a response simply cannot be overstated. And were in a good position, but i think our position could be improved. We need coordinated response capabilities, Effective Communication strategies and critical investments so we can strengthen our response to all types of flu threats. So let me conclude by thanking the witnesses and agencies here today. All of you, i know, are very committed to this effort, and we look forward to partnering with you in this ongoing fight. And i yield back. I dont think we have any on our side, and given were going to be voting soon, well submit those for the record. And so Ranking Member mr. Bloom, if you want to make a statement, youre recognized for five minutes. Ill try to shorten it in light of what you just said. Obviously its important to remember that for many vulnerable americans, the flu can be dangerous. Older people and children are at higher risk for flu complications, hospitalization and death. Last year we experienced a severe flu season. Across the country hospitalizations were up. Seasonal flu remains a significant Public Health burden that requires considerable attention from our Public Health officials. In addition, the lag time between the selection of the vaccine and the vaccine manufacturing process raises inherent difficulties. We can all get vaccinated under the Affordable Care act. Flu immunizations are required to be covered by your Health Insurance without any copayments or coinsurance. I went and got my shot this morning in the in firmry. It was free, and its as easy as going to the pharmacy around the corner, so there really is no good reason not to do it. Vaccine seems to be the best method for preventing flu. Even in the year when flu vaccine is less effective, the flu shot still protects the increase of severity of illness illnesses. Unfortunately, Many Americans still have not gotten their flu shots. It lags behind in adults, particularly in 18 to 64yearolds. And during the 20142015 flu season, it highlights our need to manufacture our vaccination process, as well as virus characterization in cooperation with our Global Partners. I just want to thank all the witnesses for coming today. If i could submit my full statement for the record, mr. Chairman, i would ask unanimous consent to do that. Without objection. And if any other members have an Opening Statement, with unanimous consent the members have those submitted without objection and theyll be admitted into the record. I would like to introduce the panel for todays hearing. Dr. Jan snooket. Dr. Robin robinson is director of the Biomedical Advanced Research and directive authority, otherwise known as barta. Dr. Carol harmon is the director of Infectious Diseases at the National Institute of health. And dr. Karen methune is the director of research at the Drug Administration. Ill now swear in the witnesses. Youre aware the committee is holding an investigative hearing, and when doing so has the practice of taking testimony under oath. Do any of you have objections to testifying under oath . Seeing none, the chairman then advises you under the rules of the house and rules of the committee, you are entitled to be advised by counsel . Do you awish to be advised by counsel before your testimony today . Will you please swear them in . Do you swear the testimony you give today will be the truth, the whole truth and nothing but the truth . The witnesses have all answered in the affirmative. You must hold forth section 101 of the United States code. Well listen to each of you for five minutes. Doctor, youre first. Good morning, mr. Chairman and members of the committee. Im dr. Ann shookett, Deputy Director for disease prevention. In the 2014 season, i issued that influenza can be deadly. New vaccines are made each year based on our determinations as to which viruss are likely to be the most common in the next season. It is complex and timeconsuming with a vast majority of flu vaccines still dependent on eggbased technology. While we attack seasonal influenza, we must conduct constant global surveillance and prepare for the emergence of dramatically changed or shifted influenza viruses that could trigger the next pandemic. The 201415 season was especially severe. The h 12 virus proposed challenges. Even during seasons when vaccine and circulating viruser are well matched, we seem to see more disease when they are prominent. H2 viruses have become more difficult to grow in eggs and they were difficult to characterize using the routine lab tests that still work well for other influenza viruses. The unique properties of hn2 viruses provide challenges for production. Last year we saw how dangerous the flu season can be. It was exacerbated by circulation of strains that had drifted away from the h3n2 strain used for Vaccine Development. We saw disappointing vaccine effectiveness against these viruses. We saw the highest hospitalization rates in people 65 and older that weve seen since this type of tracking began nearly a decade ago. Despite this, the vaccine actually worked well against influenza b viruses that also circulated last season. Ill briefly mention where we are now as we head into the 201516 flu season, then describe the steps weve been taking to improve our efforts in light of the problems we faced last winter. Currently influenza circulation is low and flu season hasnt yet begun. We cant predict exactly when flu activity will start accelerating or which viruses will circulate most commonly in the weeks and months ahead. Thus far we have seen more h3n2 viruses than h1 or b viruses. Current data seems to indicate that most circulating flu viruses remain similar to the viruses used for development in the 201516 vaccines. While we cant predict how effective this years flu vaccines will be, the compilation of the 201516 flu vaccine was updated from the 201415 one to better match circulating viruse serks. And global data says that they should offer protection against the majority of viruses. I could speak at length about the significant improvements weve made to our Influenza Program over the last decade. Instead ill describe what cdc learned from the past season and what weve done to improve our ability to rapidly detect, respond and prevent flu. First we continue to work toward better protection of influenza vir viruses and overcome challenges in characterizing h12 viruses. Were performing new testing paradigms where we test first on all specimans received on characterization. Were working with domestic and international Public Health partners to transfer this technology to them, reducing processing time by weeks. Were developing better assets to characterize seasonal viruses skpen hans our ability to identify urgent viruses. We have 64 Public Health labs. Weve put out the call to all our International Partners to increase efficiency to collaborating centers, and were trying to maintain the gains weve made in the last 10 years of our global surveillance. Were working to provide and better characterize vaccine production. Were increasing the number of viruses with the potential drift capability that are fully characterized as cell and eggpropagates agated viruses a were improving the process whereby vaccine components are made closer to the season and talking to the flu network about moving the flu decision timeline as a whole closer to the season. Though ive spoken about things wed like to do better, i want to remind you the vast progress weve made in detecting, preventing andresponding to influenza threats over the past decade. Flu is a big component, but were working to protect americans at home and abroad, and im happy to answer questions. Thank you. Good morning, and i want to recognize the chairman, Ranking Member degette and Ranking Members of the committee. Im dr. Robin robinson, the director of barta and assistant secretary for preparedness and response of asper. Asper is charged with response to Public Health emergencies, providing integrated Public Policy and Strategic Direction over the Response International framework. Barta receives development and procurement of vaccines, ther y therapeutics and diagnostics of manmade and naturally occurring threats of the 2009 nh1 pandemic, and the recent ebola epidemic. We have successfully managed influenza, and 18 receiving fda approval and licensesure and six in the last two years. We started pod vaccines of preparedness in h1 viruses. We have met and overcome many, but not all, the challenges for making vaccines for pandemic influenza. These include modernization of vaccines for reconnaissance and sale of vaccine. We have advancement of biology and new advancement. Nh7n 9 viruses. Domestic pandemic influenza production to meet u. S. Pandemic vaccine needs. Lastly, providing Emergency Response capabilities to preventing vaccines through our national structure. Despite these accomplishments, our Vaccine Preparedness work is not over. Community progress toward more influential flu vaccines has been noted but much more is needed. More effective influenza vaccines may be within our grasp. The discovery of targets, and prime boost strategies may afford more veritable and provide more effective influenza vaccines. We are supporting candidates who are effective against a wider range of influenza viruses and may serve pandemic needs. We are supporting new methods to help support vaccine strengths based on evolutionary biology technologies. With our hhs partners, we are bringing a number of advancements and pandemic vaccines to face vaccine mismatch issues. These actions include better virus characterization, new seasonal virus effectiveness tools, better candidate vaccine viruses, new agent preparation and more effective vaccines. The amount we have achieved successfully is critical. We have engaged our Global Parties in the industry several times this year on our improvement efforts for influence of influenza vaccines. Who, representatives from other countries and vaccine manufacturers. The evidence showed that it may improve the way we prepare strength. It provides an improved framework how the u. S. And Global Partners may manage it. The conclusion of seasonal viruses continue to evolve and change. In fact, animals and man pose significant threats to global Public Health. Last years effectiveness and this years arrival of viruses underscore an urgent and compelling need to complete the mission. To be better prepared, our nation must continue to invest in seasonal preparedness. Thank you for your generosity, and i look forward to your questions. Thank you. Thank you, dr. Holman, youre recognized for five minutes. Thank you for recognizing the nih Public Health posed by influen influenza. The purpose of niaid is to lead the fight of diseases. We have the capacity to respond rapidly for new threats of Infectious Diseases, including pandemic influenza. Given the morbidity of influenza each year, there remains a concerted u. S. International agency and International Effort to study the spread of viruses to ensure we are prepared not only for the coming flu season but also with strains for pandemic potential. As part of this response, niaids Research Program spans basically transitional and lots of research. It could provide durability protection against viruses. Our ongoing collaborations with academia, biotechnology and pharmaceutical industries and other federal partners, particularly cdc, naiads focus is on how strains, including those with pandemic potential evolve and cause illness in animals and humans. Among the ways we contribute fundamental knowledge is through our Surveillance Program which studies the glowing emergence and provides critical information to the world health organization. Naid is also using purchase to learn more how influenza changes over time and how it can be prepared to rapidly respond to these changes. For example, naid is supporting the development of antigen c cartography to understand emergence of influenza. This is to help provide information relevant to the strain of the annual influenza vaccine. In addition, naiad has enabled scientists to visualize how the human system responds to a lifetime of influenza infections. This has alto help diagnose and properly treat influenza, naiad supports diagnostic tools that looks at the makeup of viruses, and naiad is also supporting clinical assets to determine sensitivity to ace inhibitors, drugs that can limit influenza. Naiad is also responding to the emergence of antiviral resistance to strains by looking at treatment options. As we all know, annual vaccination is important to preventing influenza. Because they evolve by spreading from person to person, the strength of the vaccine must be reevaluated every year. While recent analysis suggests a current circulation matches the current strains, it underscores the importance of naiad with support of new strains and work more closely with the vaccine that could prevent longstanding protection against pandemic preparedness. Naid vaccine focuses on several concepts, but it is to identify those parts of the viruses that are similar to other strains and the potential to respond to them. In addition to the efforts of the naid institute in collaboration with barta is supporting several promising and influential candidates by industry and academic partners. Although we cannot predict when an influenza vaccine would be publicly available, the lead effort has generated encouraged projects toward this goal. Its important to note that promising candidates will need to be evaluated over several influenza seasons to determine the extent and durability of their protection. Naiad is also challenging virus production and the ability to make a Vaccine Development including modern molecular biological techniques to help predict production. Naiad will continue to focus on new tools in collaboration with academia, the Biotechnology Institute and pharmaceutical industries and other federal partners. Thank you for the opportunity to provide this overview of naiads influenza Research Program. I would be pleased to answer any questions. Thank you and youre recognized for five minutes. Please try to keep it to five minutes. Mr. Chairman, Ranking Member degette, and members of the subcommittee. Im director of the biological research, the center responsible for irregular vaccines. Thank you for the opportunity to be here today to discuss the fdas rule in the clcollabartiv effort. The vaccines must be periodically updated to be effective against circulating viruses and participate in the Upcoming Season. It includes two types of influenza a and one or two influenza b strains dependent on whether the vaccine is quadryvalent. The who convenes experts to study recent virus systems around the world and recent disease patterns. Based on this assessment, the who makes recommendations on the compilation of vaccines, usually in late february for the Upcoming Season of the lower hemisphere and in september for the Upcoming Season of the Southern Hemisphere. The recommendations must be made months in advance because of the time required for manufacturing, testing, release and distribution of a very large number of vaccine doses. Each year following the who recommendations, fda convenes its vaccines and related biological Parts Committee particularly in late february or early march. The Committee Considers the who recommendations and reviews information of viruses and disease trends. Based on the information, likeness and the u. S. Viruses that are adapted for the world worgs clab rivera efforts. They confirm antigen. Fda accrued and distributed every year across the u. S. With a sixmonth time frame. There is limited flexibility in the time length of vaccine manufacturing and availability. After it calibrates range in manufacturers and counterparts throughout the world, these ranges are used both by the fda and manufacturers to test vaccines for potency and identity as they propose release for distribution. They submit vaccine testing results to fda for lot release. As the fda releases lots, the manufacturer can make these lots commercially available throughout the u. S. Every year the fda works with manufacturers through the Development Process and we continue to assist throughout the production phase. We engage companies on technical manufacturing issues and conduct compliance with good manufacturing practice. The seasonal and pandemic influenza, expertise with influenza can be monthly with the Risk Management meeting. The policy and problematic issues regarding countermeasures. Hhs has taken security measures so that a vaccine could be made. Several actions were proposed and tested and could be under an exercise that was conducted on november 10 with hhc agencies, manufacturers and other Global Partners. Despite the difficulties inhere inherent, cdc and other holders, congress supported these efforts. Vaccines have been licensed for competent vaccines. To enhance pandemic preparedn s preparedness. Surveillance is more extensive than ever before. Providing them with more options that the vaccine yields. We continue efforts with our government has more modern efforts for vaccine potency and st sterility. Science and manufacturing efforts are working to provide vaccines that might provide longer lasting bodily protection including against resistant strains. Although these Development Efforts are still in early stages, some may have the potential to increase and broaden protection against influenza. We will work with u. S. Government partners, manufacturers and other stakeholders to continue to facilitate the development of new vaccines and identify methods that can speed the manufacturing process. I thank you and look forward to any questions you have. Since well vote, well get to as many as we can and take a break and come back. Let me recognize myself for five minutes. Dr. Schucert, are they expanded across the globe now . We do have testing for viruses in more and more places, but we actually need to do more. The h 3 virus that was predominant last year really shows us the strain has evolved away from the tools weve been using. We had to modernize our tools and move to a sequence approach which helps us overcome the old hi tests that wasnt really helping us understand the distribution of strains. So there have been important changes in the evolution of h3 and 2 that had made it difficult with the old tools to track whats going on. And theres been a large increase in human infections with the influenza a virus over the past 20 years. Is it true there are many new types of highly infectious influenza strains . Why the range of types . We have increased the sophistication of testing, so were picking up unusual types, the types that jump from animals to people. Weve seen more of those. Its difficult to say whether this is happening more or were finding it more. We really have increased the global capacity of countries all around the world to recognize influenza tests for it and provide specimans that can be further characterized. As youre talking about global aspects, is part of it there is issue of increased International Travel and trade thats also spreading faster and influencing some of this . There are so many factors that have made infectious threats greater and greater today. The closeness with which animals and people interact these days, some of the manufacturing or agricultural practices around the world, of course, travel and trade means that people are in contact with each other in different ways. So not just for influenza but for many threats, we really see infections anywhere could be here at home soon. So what youre talking about, then, youre picking up more, there is increased threat, unpredictability, but has the flu modelling really changed to more accurately reflect the best information of the flu viruses . Specifically has it been changed more accurately to prepare for an influenza vaccine . The application of modelling approaches to the genetic data has advanced substantially. We have an enormous amount of genetic sequence data now that is being used in more sophisticated ways. So we think this is a very important tool for the future to actually use molgd idelling, re to predict what could make better vaccines. Are serum banks useful in the vaccine, and if so, could serum banks be more helpful in predicting basically, the ways that were testing candidate vaccine viruses or that were testing circulating viruses include old tools and new tools. We have been using this hi heme gluten inhibition test developed in the 40s and really not working anymore for these difficult strains. Were switching to neutralization and synthetic receptor models wed like to invest in. Its not the corner stone of how we might be going about this. Does anybody else have any thoughts about this . If not ill go on to my next question. Okay. And there a way to determine if there are any regional differences on what trace of immunity are in local populations . Thats a very interesting question. Thats why i asked it. Weve expanded our Effectiveness Network to have larger communities included in larger numbers. One thing we learn would the difficult strain we had in the drift is that it was poor generally, but in one area, pennsylvania, the vaccine worked quite well and we think the strains that were circulating in pennsylvania were the old strain and not the drifted one. So, in fact, the vaccine worked better than most places in pennsylvania. We think its really important for us to have lots of viruses and to test them with the best tools so we can understand whats circulating and that we need very good vaccine effectiveness platforms in the United States and the Southern Hemisphere to understand how the vaccines are performing in actual use, not just before we start using them. My time is expired. Thank you, mr. Chairman. Im always encouraged to hear researchers and experts come in and talk about the new Development Methods were beginning to achieve for flu vaccine. But dr. Midtune, were still primarily using egg based technologies to produce the flu vaccine in this country, correct . Its correct that most influence of vaccine is produced with eggbased technology. And one of the problems with eggbased technology is that obviously, it takes time if the virus should mutate or need to be changed. Is that correct . It does take time but it also takes time if you use cell technologies. You need to be able to have a virus that will grow well in the cell base and and the other problem is that if you have a pandemic, the additional problem to the time it takes to grow the virus in the egg actually, a lot has been invested in all im asking is it takes a lot longer if you have to rapidly grow vaccine in egg to get the vaccine, no . It is possible to get a virus that will grow more quickly in the cell based system. Look, i have five minutes. Yes or no if you have to increase egg production, it take as laot of time. Never mind, youre not going to answer my question. The technologies are not being used on a routine bases for the seasonal vaccine, is that correct . Theyre lice nsed for seasonl purposes. Thats correct. But theyre not being used routinely, why is that . Theyre new to the enterprise and they are fighting it out in the markets. Thats part of the problem is its a marketbased technology and so it costs more money, right . So far, thats correct. Okay. Now, how do you see the markets moving particularly with development of pandemic type of vaccines . Would we be able to be nimble enough to use those new technologies if we had some kind of pandemic flu and had you long would it take us to ramp up . Yes, they are part of what we do for pandemics. They have been part of what weve developed and part of our capacity to make the u. S. Independent of other countries f providing those vaccines. Right now we dont have a stock pile of pandemic flu vaccine . We have stock piles for h 5 n 1 and some of those are 10 years old, correct . And were testing those recognize now to see whether or thought theyre still good but the poetancy are good. So, lets say we had a new strain of avian flu or other pandemic flu, how long would it take us to develop those vaccines then . For h1n1, it took about 2013, we broke a record by several weeks and we now have more tools that we can do it faster. So, what you think you could go down to 20 weeks . Our assprational goal is to have the vaccine in four months. So, the problem is, of course, which we all understand, is if you see a pandemic flu, four months is going to be a long time to try to develop a new vaccine. Are there ways you think with our support we could get that even shorter . Certainly if we could keep these manufacturers going, then we have a greater chance to have those available and make larger predominance of those vaccines available, both seasonal and b pandemic. Im go having to a lot more answers and id love if you could respond in writing. Thank you. Mr. Collins for noofive minu. Thank you, mr. Chairman. Maybe to follow up, on the pandemic flu, the h 5 n 1 thats been in stock pile for 10 years, since its never jumped to humans, right . There have been a number of individuals infected with h 5 n 1. Its highly lethal. It didnt jump. Its not easily transmitted mantoman. On what basis did you characterize or decide how to produce the h 5 n 1 vaccine since its never really jumped from animals to humans . Weve been working for 10 years to put together the h 5 n 1 Development Plans and with Industry Partners and we were able to successfully make the first one licensed in 2007 and more recently in 2013 and were able to show that we can produce those in very high levels and we can do it quickly. We had an experience in 2015 for h 7 n 9 where we were able to uses egg cell and recognizant technologies to make those quicker. Lets Say Something happens and it does become a pandemic, is your organization looking at post symptomatic treatments its so deadly, especially in this case healthy individuals, for any post traumatic treatments . Weve invested heavily in new drug candidates and some have been approved by the fda. And immuno therapeutic mony clonos or pally clonos . Mony clono . Why not a poly clono . Presently the mony clonos look like they have several advantages. Im not sure the advantage anything that mutates as rapidly as this virus theyre targeted to the regions of the virus that are highly conserved. Is your opinion the stock pile we have adequate if something were to happen . So, for the antiviral stock pile we have, before it is designed and equipped to handle a severe influence of pandemic. And youve done that only to make it more potent, if you will, vaccine that originally, it was going to take so much vaccine and so many eggs at the time, that we couldnt have enough makes it more potent. And it allows now for the vaccine to protect against different strains of influenza. And a question maybe for doctor, the elderly are more at risk sometimes because of their health and is that a population where we might have two versions of the seasonal vaccine and have those over whatever, 65 in poor health have that vaccine . Right now, there are more than one formulation for the eld la erly and agmented formulations are under review. So, i think we do focus on elderly who suffer the most from influenza and in a pandemic, typically, not the 2009, but typically would suffer extensively. Theres more progress we look forward to in the future. But currently theres not an agmeanted version of the seasonal . Not yet but theres one under review. We have a licensed application for seasonal vaccine 65 age of years and older that was discussed two months ago and is currently under review. It shows it compared the immune response to the agvented, versus unagvented and it didnt show that the produced a superior immune response but none ttheless were considering for licenser. Well break for 40 45 minutes. We should get all the questions in before the second series of votes. So, well be back. Thank you. Were in recess. Well reopen the hearing and recognize the gentleman from texas, mr. Green, for five minutes. I thank eye witnesses for understanding our vote schedule on the floor and hope you had some rest between the questions earlier. I represent a very urban district in houston. Its actually medically underserved. So, 20 years ago, we started doing vaccinations for children so we would raise our vaccination rate and its been really successful. We partner with our local school districts, our county health darn department, texas Childrens Hospital. And we talk about immunizations are the cheapest medical dollar we can ever spend because its most effective. In this last weekend, we actually did a flu vaccine effort, texas Childrens Hospital did childrens vaccines, walgreens did adults and senior seniors. People expect us in august to do the childrens vaccine. My concern was last year, because of the effectiveinoness the vaccine and we want more people to get the vaccine but when you hear that its 20 or so give or take efficiency, what can we do to help make sure that you have the tools to make that efficiency much better . I know flu mutates, its really a challenge. But we would hope we could do better than 20 and i know thats been other questions and id be glad to see what congress can do to help the agencies be able to do a better job. Doctor, do you want to start . I can start and pass it along. The people represented here, the institutions have been working really close together for vaccines and future vaccines but from the cdc perspective, it gives us information that can lead to better candidate vaccine viruses and we can turn over to industry to produce. So, sustaining that investment in strong surveillance around the world, including newer approaches here at home with more samples coming in of the minority strains and sequence first so we get the information right thats actionable. And that issue of will people even want to get vaccinated after that year we had . Weve been investing in research to understand their attitudes so we can sustain better and better Immunization Coverage going forward. Anybody else . Yes, sir, weve had the montra of better and better vaccines and even for egg based to make those be made faster and a better vaccine is one that were working on to actually address the problem of it being not 23 but 75 or 80 every year, year in and year out. Thats our goal. We may never be able to attain it but thats what we want to do and to be able to have funding to go forward, not just for one year but multiple years because that may take a long time to get there but it will be the ultimate answer to this. I just want to thachkia for yo thank you for your support of nih and that research is a Foundation Point to move forward on and you know, the ability for us all to get together to work on a common goal, we each have a contribution to this. So, even though the had things we do are a little bit downstream, upstream, it really does impact the opportunities for not just next season but for season afterward. We constantly want to evolve and improve whatever were doing. So, appreciation for the recognition that research has. Previously on our community and our Health Subcommittee over the years, we were actually concerned about enough flu vaccines, a few years ago there was a shortage early on but again, if were going to continue to vaccinate folks and say i dont want one because its not effective and ill get a sore arm anyway, we dont want to give people a reason because for the elderly and the disabled, the flu vaccine is so important because their immune systems are already challenged and we need to make sure its effective as it can be. And thank you to the chairman. Thank you, mr. Chairman for holding this. I have to admit im one of those people that im not sure if ive ever resoceived a flu vaccine a there are a lot of people that are very consistent on getting one and i understand the importance of getting it. Wutconcern would the stock piles. You said your effort to stock piling vaccines against a flu outbreak and we know the flu changes constantly. And so, for stock pileing it, how are we testing it . How are we knowing that what were going to send out is going to beeffective because weve had several cases where the one we sent out was thought the one we needed to target. Can you help me understand that a little bit. Thank you for the questions, its very appropriate. The one we stock pile is prepandemic vaccines for viruses that could possibly create a outbreak. And for example, the h 5 n 1 virus appeared in 1998, we thought we got rid of them and it appeared again in 2003 and were always watching those viruses and we do an assessment with our colleagues across the board and with experts across the world in which we look at that Risk Assessment to say is this virus still something to worry about. So, the stock piles we have, every day we have those stock piles, they break a record. Usually you thing you can only keep them around for 12 months, 18 months. Some of these are eight and nine years old and the potency is really high. You test every three months. All the lots that we have and were testing in the clinic to say a vaccine thats been around for eight years, when we put them in people do they get the same immune response . So, while were looking at stock piling for potential outbreaks, does that hurt us actually being able to manufacture enough of the current flu outbreak . Because we seem like we have shortages constantly . The timing which the manufacturers make the vaccines is when theyre not making seasonal vaccines, so it does not impact their capacity for seasonal vaccines. Weve been hearing from doctors back in oklahoma that theyre having a hard time getting the vaccine, especially for children right now. And so, we contacted the Oklahoma Health department and they said there was a shortage and that theyre having a hard time getting ahold of it. Are you familiar with this . You know, the flu Vaccine Distribution so far this year is quite good with 133 million influenza doses shipped around the country so far. But we know a couple of the companies have had limited or delayed production of one or two of the pediatric formulations. Its still a lot of vaccine thats out there but there may be some particular practices that dont have all the pediatric vaccine they want and we learned that some states the way they handle the vaccine thats managed by the states, that there are probably more efficient ways for them to allocate to pediatricians the communities. So, theyre working with the state Health Departments to make sure were streamlining those distributions so the docs are getting the product when they need them. How often do you look at the product and say do we need a change . I ask because my daughter last year she got two different strains of the flu. She got the shot but the first one she got and still got and the second one they said there wasnt a vaccine for it yet. One thing i can say is we do vaccine effectiveness studies every year to see how well the vaccines performing and people get vaccinated every year and we have a network thats studying how well the vaccines actually protect people. Weve increased how intensively theyre working so we can get information sooner. Last year we were able to present interim results in january, earliest ever. I appreciate your insight on that. Can i ask a follow up question. In terms of stock piles, what are the size of these . For h 5 n 1, we have 10s of millions of doses. Its just the two areas we have. For h 5 n 1, we have four different strains represented in that stock pile and for h 7 n 9 we have one strain. And you said effective for eight years so far. So far, the potency is very high for those stock piles. And youre holding on to those. We can still use them and use them with agvents to provide greater cross protection against even new h 5 n 1 viruses. Thank you, mr. Chairman and thank you for holding and highlighting this important issue. The hearing is a reminder that theyre threats and can be tleets our National Security. The same issues we saw with last years strain mismatching can happen and obviously, the pandemic we experienced in 2009 with the h1n1 kills, as ive been told, 18,000 americans and most peopleal dont realize that and if we think about that, we werent preed a prepared and e lost thousands of american liv s s. Ive been working with other colleagues to improve the biohealth enterprise. Improve the countermeasure Development Process and would strengthen our Public Health capeicts. And my questions are going to be directed primarily to you because obviously its the job of congress and i thank you all of you for your work. And in the spirit of the focus today, for pandemic influenza. But im going to ask you and maybe because im a lawyer i have very specific questions i like your answers to. And a series of simple yes or no questions id like to ask you because theyre relevant to the types of issues weve identified and just give me yes or no and we can get into further discussion a little bit later. Do you believe additional incentives are needed to get the private sector involved in this costly endeavor of developing countermeasures . Yes. Thank you. Do you believe that the priority of the review voucher related to the material threats identified by Homeland Security already would be a useful to get the sector involved in countermeasure methods . Yes. Did they give them something no other agency has currently . Yes. Was barta do you believe it would be helpful to further expedite the Counter Measures process . Yes. Thank you. And would it be helpful to have direct control over the direct p procurement contracts. It would be helpful anything we could do to expedite. Thank you. And i understand the origin from when barta was created because that was the basis and in part what part of what congresswoman and my work is designed to do and id like to ask all of you they have just released this incredible report multiple recommendations. Can you talk to us starting with you dr. Robinson, in what more we can be doing as a government to build up a Robust Development production capability . Thank you for that question. Ill answer. At this point we need to continue the mission we set out to do. And that is to go forward with the Early Development and advanced development that barta does to actually have those products available not just for man made threats and pandemic but diseases. And where we can stock pile, we need do so. And in we need to have Emergency Response capabilities and many are platform technologies to go forward. Weve made Great Strides with fd too, be able to have the regulatory capability to do that. I think we can do more and they need to be funded to provide that capability going forward. Thank you for your work. They updaetd their adult vaccine schedule to make sure older adults get a vaccine in conjunction a routine in influenza and a follow up nume cockle vaccine and primary care physicians discussed the logistics and the medicare reimbursement and since that time, they announced they would cover the second nume cockle vaccine. Can you tell us what theyve done to work with primary care physicians in addressing their confusion . The nume acockle vaccine that was recommended for everybody 65 and over, in addition to the earl y vaccine that we had recommended for everybody 65 and over. The summer of 2015, we updated those recommendations to simplify them because wed heard about the confusion that primary care physicians had and we changed them to make them simpler so you get one when you turn 65 or later and the second a year or more later. Cms does cover two doses and it doesnt matter which one comes first but we regularly recommend getting the college gt first. Its very important for seniors who can die. And its particularly important in influenza season because it frequently followed flu. So, we recommend everybody get a annual flu shot and a nume ocockle vaccine. And do they consider how to insure uptake is streamline as possible . We have practitioners and Public Health experts members of the acip and we work hard to make it easier for people to protect themselves and their families. So, we work very closely with the american aed aocademy of physicians to make it easier to protect your family. Four in 10 seniors are not vaccinated for pneumonia, and flu has not increased in seniors. How are they working with Family Physicians to improve vaccination rates for seniors and insure they get the recommended vaccines when appropriate . One of the challenges with adults is they still think vaccines are for kids, so f providers dont recognize they can be life saving for all of us. In addition to working with the clinical community, cdc works closely with the private sector and everybodys seen pharmacies and chain stores really pick up vaccines and there are now better insurance efforts that mean everybody has access to recommended vaccines with no co pay, no deductible as long as they are vaccinated and theyre public insurers that cover the vaccine. The good thing for 65 and over is that Medicare Coverage is very good for the flu and pneumococle vaccine. And while i was not in the room, and i apologize for that, i was listening to some of the testimony earlier and i have some of the same concerns in regard to egg produced vaccines. And so, just note that shes not the only voice up here concerned about that issue. I have a very brief question, a follow up question for dr. Robertson. Can you share with me the status of the hss pandemic Preparedness Plan and has it been updated since it was issued by the Bush Administration . Yes. The department is in very strident effort to update that. We expect it will be available the end of next summer. The entire department represented here and others are actively working on that and using the pandemic plan and a National Strategic plan as a base and to go forward with that and have provided a number of different efforts to funnel towards that plan. Thank you, mr. Chairman. I dont really have questions. I just want to say that i recognize weve come a long way and appreciate the efforts of the agencies and im still concerned about the market sources and im concerned the Market Forces are really keeping us stuck in some old ways of thinking and i think that probably all of us would like to work with agencies to update that so we can be in the 21st century and thats my main goal and mr. Chairman, i think this is something we should do every year this same time and i encourage all ofio ato continue your good work, bothen the seasonal flu vaccinations and readiness and also on the longer term issues around pandemic flu. Thank you, mr. Chairman. And i have follow up questions. When youre talking about seniors is the vaccine less effective for seniors and if so, why . Many vaccines are less effective in seniors than younger people. Influenza vaccine is often less effective in seniors. And its particularly worse in the skravery elderly. So, they work less well than they work in younger populations. That said, getting vaccinated is the best way to protect yourself and so we recommend everybody 65 and over be vaksnated and we recommend everybody six months and older get an annual flu vaccination. Is the flu vaccine less effective against h 3 n 2 than other strains . The review of vaccine data, some clues that on average the vaccines were using are less effective and even in years when theres a reasonably good match. But we still see efficacy and we do know that being vaccinated protects you substantially compared to not being vaccinated. Thank you. Then, let me also echo what some of the members have said here because these hearings have been going on for a decade and we want to see if your agencies are updating also their scientific approach to this. Not only trying to guess what the next nasty bug is going to be and find out if the mutates faster but we need different scientific designs on that. I hope that this is more accurate for this years vacceen, we hope people get it, eat right, rest right and exercise. Because the vaccine is les ef effective in a person that is sickly and older. And i thank you for your testimony today and i might want to add that after unianimous consent and without objection, the documents we entered into the record we ask that as you receive questions that you respond back quickly. Members have 10 days to submit those and with that, i now ajourn this hearing. And Fredric Kagan on u. S. Strategy against isis and then Damian Paletta with Data Collection and surveillance. And then it the report that ranks the states on how they determine punishment. Tomorrow on our companion network, well take you to the urban institute for the housing symposium. Live at 8 45 a. M. Eastern on cspan 2. The mother of journalist james foely who was killed by isis last year is in front of a subcommittee. She talked about how Terrorists Groups called isis finance. This is about an hour. Without objection, all members may have five days to submit statements, questions, extrainious materials for the record subject to the length, limitation and the rules. Chair recognize itself for an Opening Statement and when Ranking Member gets here, he will be allowed to make the his Opening Statement. The terrorist attacks in paris last friday remind us the damage a terrorist organization can do with even a little bit of money. Ic isis, however is the richest terrorist organization in history. Last year they made over 1 billions. Much of that was made from seizing assets. Selling oil on the black market and taxing people. And those sources are mostly internal and dont do use the International Financial system p. And others may be easier to cut off. For example, isis made nearly 50 million from kidnapping and ransom last year. Some put it as high as 20 of isiss revenue p. A. Aqim is said to rely almost exclusively on kidnapping for funds. This is the same group that kidnapped a gas plant and killed one of my constituents after taking him hostage. From 2008 to 2014, they made roughly thousands of dollars from ransom payments spayments. Our own country has a long history of countering this barbaric practice. From the very beginning, the United States has always refused to pay ransom to terrorists. In the early 1800s, even then president Thomas Jefferson refused to pay the bounty. He said that doing so would only encourage more attacks. They have learned to ask for ransoms from those who will pay and this issue can be complex. We have the mother of james foley here with us today. I want to express my condealances for the lost of your son. The committee appreciates the fact that you were willing to testify. Terrorist groups have long depended on criminal activity. Can someone shut the door. They have long depend on criminal activity for funding, including trafficking of cultural an tick wuties. These siettes are the Cultural Heritage of humanity but isis sees them as financial opportunity. According to some estimates. At one point, an tick wuties was the second largest source of funding. And theyre destroying history. There are some people who voluntarily give their money to these murders. They have maintained connection to wealthy donors for more than a decade. And many are based in gulf countries like qataar. Saudi arabia. Theyre not the only terrorist group benefitting from these deep pocket groups that benefit from terrorist groups. And they Fund Terrorists all over the world including al qaeda, and they set up charitities and funnel the money directly to the terrorists. The leaders of the gulf countries do not do enough to stop the steady stream of financing that starts in middle eastern countries. Theyre just as guilty as the terrorists. And theyre complicit in the cri crimes. These sources have given isis hundreds of millions in the last year. Cutting off even one of these sources could make a big difference. They thrive off the feeling that theyre winning. More importantly, it would mean less victims of isiss barbaric terrorists attacks. We must use all the are esourret our disposal and that is the purpose of these hearing. To listen to these experts on this issue. I will now turn to the gentleman from massachusetts for his Opening Statement. Thank you for chairman, thank you for conducting this hearing and thank you to our witnesses for being hear today. And this is generally on terrorist financing and its an appropriate opportunity to pay particular attention to isil. Fridays attack in paris and the recent bombing of the russian metro jet in egypt indicate that they may intend to increasingly attack targets outside of their bases in iraq and syria and its worth taking a moment to express on behalf of myself and the committee, our greatest sympathies of the victims of those terrible tragedies. This worrisome development demmen straights we must endeavor in all fronts to defeat isil and we need continue to assist our allies and in addition, and not unimportantly, we must work to cut off their supply of money and man power by more effectively countering terrorist recruitment, financing and travel. According to a 2015 report by the financeal action task force, they receive money from several sources, including the occupation of territory, kidn kidnapping for ransom and support from foreign fighters, fund raising through the intern internet. One significant ways is through the elicit sale of antiquities. And theyre responsible for stock piling of cultural objects for future sale on the International Market and they earn money by charging others for licenses, they call taxes to loot archeological sites. And to date, isil has reportedly earned 10 ochz millions of dollars from antquities stolen we also need to do more here at home to insure that the United States isnt important stolen ant wick wuties and ill introduce the act that would enhance training in Homeland Security that would stop stolen antiquities from being brought into the United States. And hr 2285 was recently ported out of the committee on Homeland Security and i urge my colleagues to support this bipartisan deal that is to help stop isis from financing off of stolen property. I look forward to hearing from our witnesses and learning about different forms of terrorist financing and how better to stop this elicit stream of income. Thank you, mr. Chairman. Thank the gentleman from massachusetts massachusetts. Chair will now recognize members wanting to make Opening Statements of one minute each. Mr. Cook. Thank you, mr. Chairman. This is certainly a very timely hearing. I want to thank mrs. Foley for being here. We talked about veterans day and the sacrifice that so Many Americans have given in wars and no matter how you slice it, this is a war that we are waging with this group, isil, isis, dash, whatever you want to call them. Their tacts, you know, theres no limits. And i personally think that many fe people in the middle east, throughout the world have gotten a pass on this. We know theres been support through some nations in the middle east, the gulf states, a lot of money, all these Different Things that have already been mentioned by my colleagues but without a doubt, we have to do something about this and i think as i said, after what happened, its most timely hearing. Thank you. Chairman wants to recognize gentleman from new york and the work that hes doing on the issue of kidnapping of americans for ransom. So, gentleman from new york is recognized. Thank you for holding this important and timely hearing. And stolen items represent an alarming source of terrorist financing that has largely gone unaddressed and many are conducted without the uses of the bank and in recent years kidnapping for ransom has become an increasingly lucrative enterprise. And 65 million has been paid to al qaeda and isis since 2008 for the return of hostages. Unlike the United States United Kingdom, many of our allies continue to pay ransoms, resulting in more kidnappings. We must insure our friends and allies, hold government sponsored pay outs and im pleased to be working legislation to address this issue and i look forward to todays witnesses and yield back the balance of my time. The chairman now recognizes the gentleman from South Carolina, mr. Wilson. Thank you. I would like to extend my sincerest appreciation to mrs mrs. Foley. Our hearts are truly with you and your family. The murderous attacks in paris, and berut and the bombing of the russian jet, killing 224 passengers, further highlight that our efforts to stop Terror Financing are not working. They have the necessary resources to cut off isils funding from any way we can. And theyll provide fungd in any way and are accurately be able to be identified. I look forward to the recommendations of the panel. Do any other members wish to be recognized for an Opening Statement. And all members will have five days to submit questions and without objection, all the witnesss prepared statements will be made part of the record. I ask to keep your presentation to no more than five minutes. Ill introduce the witness and give them time for their comments. A former agent to the u. S. Department of treasurieies offi and Financial Intelligence. Hes considered an expert in Money Laundering in the middle east. Dr. David wineburg is a senior fellow at the federation of foundation of democracy. And his research folks on energy security, counterterrorism alliance transparency and human rights. Mrs. Dianne foley is the mother of james foley, who was kidnapped and killed by isis last year. Shes part of a legacy for those who have no voice. Dr. Michael concurrently serves as the academic director of oriental research, Cultural Heritage initiatives which monitors on the heritage situation in syria and iraq. Hes an archeologist with programs directing syria, iraq and iran. You have five minutes. Thank you for the opportunity to testify today. It is an honor for me to be here. Mr. Chairman, i have submitted a written statement. I would like to take just a few minutes to give a brief summary. Kidnapping for ransom is a crime as old as an tickwitty and unfortunately, they have turned to kidnapping as a relatively easy source of funding. And money paid between 2004 and 12. Some believe its our most significant terrorist financing threat today. As a tragic events in paris last friday make clear, the United States and the International Community are rightfully alarmed about isis. They have kidnapped multihundreds if not thousands of victims includi s and so brutally murdered to send a message and others to extract ransom payments. In 2014, they raised 45 million from kidnapping for ransom. And because kidnapping in associated crimes such as extortion have been so succe successful, it appears the average ransom payment is increasing. Its a vicious cycle. There is no doubt ransom payments lead to future kidnappings and future kidnappings lead to additional ransom payments and eventually they build the capacity of terrorist organization which fuels additional terrorists attacks. There have been several despite restrictions, the world has not stopped payment. The complicating factor is our humani humanity. Its difficult to turn away from the anguished cries of those kidnapped and of their loved ones. Last week, a new book i wrote was released, the next Frontier International Money Laundering enforcement. Its often over looked but the misuse of trade and Financial Systems are often part of the kidnapping equation. For example, money and value transfer systems are found throughout iraq and syria, and theyre trusted brokers and have established relationships throughout the region. They operation on trust and secrecy. They generally do not conduct Electronic Fund transfers but communicate via email, fax and phone with a local associate to pay to the Counter Party to the transaction and sometimes they use cash to settle accounts and sometimes conventional Banking System but i want to emphasize and something tatsz rr continually over looked and that is historically and culturally in every areas of the world where terrorist adversaries operate, theyre used to balance the book or settle accounts. So it could be the back door into money and value transfer systems used by terrorists. Unfortunately, neather the United States or our partners are doing this. If one includes all its varied forms, underground Financial Systems, trade based Money Laundering could be the largest money launders methodology in the world and unfortunately it it is also the least understood, recognized and enforced. Yet, im optimistic. By using modern analytic tools to explore data sets, i believe that the trade transparency is theet rhett cli achieve only to factor over many times of what we have today. As an added bonus, cracking down on trade fraud could be a revenue enhancer for the governments involved. In my book and written statement i go into detail on many of these issues and provide a number of recommendations to achieve trade transparency. I appreciate the opportunity to appear before you today and i am happy to answer any questions you may have. Thank you. Thank you. Chair will recognize dr. Weinberg for your statement. Chairman poe, Ranking Member keating and distinguished members of the subcommittee, thank you on behalf of the foundation of democracy for the opportunity to be here today. Ill highlight some weak links in americas efforts to convince our allies to target financial facilitators and private donor to terrorism who often go unpunished. I will offer some policy recommendation to hopefully address the growing epidemic of kidnapping by terrorists for ransom. I will refer to others on trafficking, i will ask your approval to enter into the record a report on antiquities traffic pging. Without objection that will be made a part of the record. Thank you, dr. Weinberg. Thank you. Several of americas allies have adversarial positions. Despite promises to so, theyve failed to obstruct the flow of such funds and punish its practitioners. I note dozens of reported examples of such negligence. In many instances these governments grant legal impunity to the people that the u. S. And u. N. Have sanctioned on funding al qaeda. I also reteal detailed new indications that turkey, kuter and saudi arabia have let them to be financial hubs for hamas. To ensure that the list isnt trooeted in the region as a mere piece of paper, the u. S. Should develop a broader range of options. Congress can help sensitize members of the executive branch outside of treasury to these concerns. When the u. S. Is confident that an individual who enjoys legal impunity in one of these jurisdictions is indeed a senior financial facilitator for terrorism, the u. S. Could privately and then publicly seek that individuals extradition. If that fails, the u. S. Could consider capturing or killing them as it does towards other terrorists operatives. Congress could help hold these governments responsible as well for extending such impunity by restricting trade and dual use items and by again amending the foreign sovereign immunity act so victims of terrorists and their families can sue foreign governments in civil court for letting operatives enjoy local immunity. As for the tactic of kidnapping for ransom, we should recognize that americans are still evid t evidently being held by terrorists today. In 2012, treasury described kidnapping for ransom the most significant source of financing isis actually makes more money off of oil sales but ransoms have helped it conquer the territory in the fist place. The Obama Administration announced a new hostage program in june but there little seen this is being matched to decrease the money that terrorists take in from such tactics. Even though the the new york times, ap, reuters and the wall street journal have described allied governments in europe or the gulf as sources of such payments. Although the states deny paying ransoms, they called such payments Game Changers which can incentivize future kidnappings. The role is particularly striking. In my written testimony i compiled press reports of 15 different episodes within three years alone in which qatar has facilitated the ransom. Congress could require the administration to expose such governments in public. Perhaps even imposing targeted financial samesexes. President obama should also direct diplomats to prioritize convincing host governments in several Key Countries to stop paying sup ransoms and encourage policymakers abroad to enact such prohibitions into local law. The u. S. Could follow in britains steps blocks Insurance Companies from reimbursing the terroris terrorists. Finally, congress and the administration could consider starting a fund with seized terrorists assets to compensate kidnapping victims and their families for their suffering. The good news is that the u. S. Now has a plan to improve efforts at hostage recovery and the proof will be in how well the steps are implement pd. The bad news is that u. S. Policy is failing to deter foreign governments from paying multimillion dollar terrorists. Our government needs a new strategy to address this critical part of the problem and congress can help facilitate that debate. Thank you very much. Thank you, dr. Weinberg. Ms. Foley . [ inaudible ] im diane foley, mother of american journalist james foley who was publicly executed by isis as you know in 2014. And i certainly want the say that our thoughts and prayers are with the people of france who have suffered such tragic loss at the hands of isis. But we too, as americans, as suffered from isis. Our son james wu tortured and starved by isis for nearly two years just for being an american. Our familys ordeal was made worse by our incoherent ineffective hostage policy. Jim was welleducated, holding two masters degrees in writing and journalism but far more importantly he was a man of service, teach in our inner cities in phoenix through teach for america and later in chicago and massachusetts. He was always passionate about those without a voice. Be they hostages, conflict journalists or disadvantaged children in our inner cities. In fact, his belief in human rights led him to become a journalist so that we americans might hear the unheard stories of suffering in conflict zones. In my opinion, our current american hostage policy has not changed. Im very aware that our u. S. Public policy is no concessions to terrorists, to include no ransom or release of prisoners. However, our policy also states that the United States will use every appropriate resource to gain the safe return of our american citizens held hostage by terrorists. During jims horrific captivity in syria, our policy was interpreted to mean no concessions. No engagement with his captors. Since 9 11 our Government Officials have often mistaken no concessions for meaning no negotiations. Leading to an inconsistent and often unjust approach to the kidnapping of our citizens. The hands of our powerful fbi were tied during the 2014 syrian captivity of our son jim and three other american citizens held by isis. I am told that our strict adherence to this policy saves lives by decreasing the rate of capture of americans. But no one has been able to show me the Research Behind our hostage policy. In fact, it would seem that americans are becoming targets at an alarming rate. I respectfully demand to see the proof that our current hostage policy is truly protecting americans. It did not protect jim or stephen or kayla or peter. In the last 18 months, these four americans have been killed because our policy was strictly applied. Whereas five ore american, scat darden, theo curtis and Sergeant Bergdahl who were negotiated for by us or others have returned home safely. This inconsistent implementation of our american hostage policy is unacceptable. Additionally, i would have you gentlemen know that we were deceived as an american family. We were told repeatedly that jim was their highest priority. Your highest priority. We trusted our government to help him return home. During the brief month that jims isis captors reached out to negotiate for his release, our government refused to engage with the isis captors. Leaving us alone as parents to negotiate for our sons freedom. 18 months after jims captivity our family and the families of three other hostages were threatened by colonel Mark Mitchell, member of our National Security council with prosecution by our government, although there was never any precedent, if we attempted to raise a ransom to free our loved ones. He also very clearly told us that our government would not ask allies to help negotiatiganr the release and never conduct a military operation to rescue them. He made it very clear to our United States government planned to abandon these four americans. Thus, it became clear that jim, peter, steven and kayla were considered Collateral Damage and that we families were truly on our own. I had spent much of our familys savings, quit my job as a Nurse Practitioner to travel monthly to washington to beg for help for jim, to the united nations, countless embassies and to europe multiple times to speak to freed hostages, all to no avail. While our u. S. Senators reached out to us and were sympathetic, we never even heard from your United States congressmen. The family the foley family did try to raise a ransom for jims release in spite of threats of prosecution. But because we believed in our government to help, we started much too late and were unable to raise the money to interest isis. The reality is, is that very few families would be able to raise money actually needed to free their loved ones. Our u. S. Government also refused to engage at a high level with our allies who also had citizens held by isis. At one point there were over 20 western hostages held together, and all of them are our were, are our allies. In the spring of 2014 a freed french hostage had very specific information from isis to negotiate for our four american hostages and the three british ones. But our government refused to engage with the french or uk to save or citizens. The result is that all of the european hostages are now home. Whereas our son, the other americans and british were brutally killed. Although we had specific information regarding the exact location of their captivity begin in the fall of 2013, a military operation was not even attempted until july of 2014, after all of the europeans were safely home. We are sincerely grateful to the baif soldiers making that attempt but it was much too late. In our situation our hostage policy prohibited our government from interacting in any way with jims captors. Prohibited even for investigating who our sons captors were. Had our government been allowed to engage the captors, perhaps vital intelligence about isis might have been gleaned. Our governments abandonment of jim allowed their deaths to be used as propaganda for isis recruitment, thus strengthening and em boldening isis. It certainly helped in the recruitment of other violent people who want to destroy us. As i said before, at one point there were more than 20 western hostages held together, all of whom are citizens of our allies. All our western allies valued their citizens enough to negotiate for their freedom. Had jim been french, spanish, german, italian or danish, he would be alive today. You know, we form coalitions for war. Why did we not engage with our ally to free all of the western hostages . I believe that much stronger coalitions with our allies are essential to deal with the shrewdness and hatred of these Terrorists Groups. I fear that our posture of no engagement with jims isis captors led to our underestimation of their intelligence and their deep seeded hatred for the United States. And our citizens. What if we had been shrewd enough to engage jims captors in the fall of 2013, to learn all we could about them instead of ignoring them. Is it ever wise to ignore enemies of freedom and justice . You know jim believed in america, he believed that our government valued him as a journalist and a citizen. I am told he was hopeful until the very end of his 20 months of captivity. He and our family were truly abandoned by our government. How would you feel if one of your son or daughters had been in jims predicament and been treated similarly. Four americans were publicly beheaded. Where is our outrage as americans . As an individual american citizen no longer valuable . Why were jim and the other americans in syria considered Collateral Damage . If our United States of america truly wants to protect and prioritize the return of its citizens, if so, i ask you, esteemed members of congress, to hold this new fusion cell accountable for the return of our american citizens. And to mandate a thorough reevaluation of our current hostage policy to make sure that recent validated research is being done to ensure that our policy truly saves the lives of americans. Thank you for your attention. Appreciate it. Thank you mrs. Foley very much. Dr. Donte . Thank you chairman poe and Ranking Member keating for this opportunity to discuss the terrorist financing. Its an honor to be here among esteemed colleagues. Since the outbreak of the syrian war in 2011 and the sudden expansion of isis in 2014, weve witnessed the worst Cultural Heritage crisis since world war ii. On a daily basis, cultural sites are being destroyed before tactical strategic and etiological reasons. Property is being pillaged to finance continued con flith. As an archologist, theres not a day too goes by that dont anguish over the syrian people. My colleagues and i at the american schools of Research Work closely with syrian and iraqi Cultural Heritage experts who are daily risking their lives to save heritage from the culture cleansing. These brave heritage professionals understand the importance of preserving the past and culture diversity. The current conflict in syria and iraq is a war over ideas and cultural identity that is rapidly spreading to neighboring countries. The project i direct, the american schools of orient tall research Cultural Heritage, constantly monitoring the Cultural Heritage and produces reports and conducts outreach for the u. S. Government and the general public. Weve seen that most of the major combatants commit Cultural Property crimes but by far isis is our greatest concern. Over the last 16 months isis has developed a highly organized approach to looting, trafficking and selling antiquities for funding. They destroy Heritage Places to promote ideology and gain media exposure. Theres no doubt that terrorists derive significant revenue from looted antiquities and stolen Cultural Property. Satellite imagery and open Source Information support this conclusion. Information and antiquities recovered by u. S. Special Operations Forces in may of the this year prove isis uses the antiquities trade as an important source of revenue. To isis antiquities are a Natural Resource to be mind from the ground. This criminal activity has increased as oil has been targeted through air strikes and other measures. Antiquities trafficking is difficult to traffic and for isis it has the benefit of rewarding collaboration with employment. Antiquities trafficking doesnt make as many enemies among the local population but instead it exploits poverty and hopelessness. Also they serve as instruments for Money Laundering. We dont know the total dollar value of the antiquities trade. But isis and other Transnational Criminal Organizations certainly find it crucial to their operations. And the financial and cultural cost to the destruction is manifest now and will have a cascading effect for generations to come. The Current Crisis requires increased and improved capacities in the United States for cultural security and cultural da pla macy. We need a more proactive and nimbler approach. High level coordination would greatly enhance the work and facilitate cob training and ultimately destroying isis and other radical groups and Transnational Criminal Organizations operating in the middle east, north africa and beyond. Reducing Global Market space fn conflict antiquities should be one of our highest priorities. Legislation is pend in the house and senate that would help to achieve these goals. Ultimately the best solutions for the current Cultural Heritage crisis in syria and Northern Iraq also contribute to alleviating the humanitarian crisis, promoting conflict resolution, strengthening Counter Terrorism efforts and fostering peace building. Thank you. Thank you very much, dr. Donte. Today i recognize myself for some questions. It seems to me i may not have all of their sources of revenue, but weve heard that Terrorists Groups will do anything for money. They will steal, like the robberies of the banks in iraq. They will i call that Money Laundering. Im a former judge. I call that Money Laundering, what you were talking about. Cooking the books on trade. They make money off of antiquities. They make money off of hostages and they make money off of their wealthy donors who want to send money to their Terrorists Groups. And there are probably a whole lot more. Let me try to address a couple of issues. Mrs. Foley, you gave us some remarkable information. And if i understand the current status of american hostage law or procedure, the United States has always had a policy not to pay ransom. Now its changed that the government wont pay money for ransom but if families or individuals do, that law will not be enforced as to that payment. Is that your understanding of the current status . Families, you know, criminal activity a family has never been prosecuted for paying ransom to criminals who have a loved one. Thats what im asking. So as far as you know, no maamly has ever been required . No. I know that because we researched it because we finally realized we were on our own and we had to try to raise the ransom. But of course we wanted to protect anyone who would care to help us. So theres in precedent for that, sir. So that portion of the law, as the president has said, is not being enforced as to prosecute the families . Well it never was meant to prosecute families. It was meant to prosecute any groups that might pretend to be a charity and instead give money to finance terrorism or something. It was never meant to be was your son kidnapped for ransom or a propaganda tool or both . Thats a good question. Only god would know what might have been in their heads. He was a westernwerner. He was obviously a westerner. He had been in and out of syria for a year. More and more of the jihadists had come in in 2012. Jim had made very good relations with a lot of the family there, trying to expose the atrocities of the assad regime. So felt protected. A lot of the rebels really welcomed journalists early on so that their plight might get out to the world. He was used as a propaganda too too, wasnt he . Initially they wanted to make money off of him. The propaganda only came when our government would not engage in any way. Nobody would negotiate for him. No one cared. So they thought well hey, we can make a spectacle of this. We can really use, get a lot of pr out of killing these americans. Dr. Weinberg, let me ask you some questions about the gulf states. Im going to be real specific here. Probably going to hurt somebodys feeling. We have a military base in qatar that we use to fly aircraft in the middle east when were engaged in military activities in afghanistan or iraq, is that right . That is correct. But we know that qatar has donors there, wealthy donors who give money to Terrorists Groups. Is that correct . Its been correct in the past. Do we know who those donors are . Name rank and serial number . The United States have sanctioned what does that mean, dont do this anymore . What is a sanction against a national in qatar who gist money to Terrorists Groups . Thats exactly the problem, sir. Dont do it again. Its not nice. And the problem is the local government often doesnt do anything about it. In fact i have seen not a single indication of qatar prosecuting anybody and convicting them under terror finance laws that have been on the books. Do we pay to have our military base in qatar . No they pay for it. So you think qatar is playing both sides. I think qatar is absolutely playing both sides. They harbor people that give money to Terrorists Group but they also have a military base where the United States can go a and attack Terrorists Groups. Yes. And individuals the United States have sanctioned live just down the wroed from where the u. S. Base is and if the United States chose to do so, it would not be difficult to launch air strikes if we were convinced. You mentioned that the United States has the authority to go after these people who are contributing to Foreign Terrorists organizations. If it choose to use that capacity, its hard to to your knowledge this is my last question. To your knowledge, of those different i have two questions. How many people are we talking about that are contributing money to the Terrorists Group . You could count them on a single hand. Its not very many. Yeah. And second, have we ever extradited, prosecuted or taken out somebody who is giving money to Terrorists Groups to your knowledge . Have we ever prosecuted, extradited well the United States sought to capture has lead from qatar in the 1990s. He was linked to the did we ever get him . He, according to former u. S. Officials cited in press reports, a senior qatar royal Family Member or Government Official tipped him off and he fled the country. So my question is just answer the question. Have we ever ak captured, extradited, brought one one of these money back guys who are giving money to terrorist groups to United States to prosecute them in. We caught ksm himself who was a senior money man but bedid it in pakistan. All right. Mr. Keating from massachusetts. Thank you, mr. Chairman. I think one of the most important things any of us can do as americans is get to the root issues of whats going on even though its dangerous, even though they risk their lives doing it and get that message out to the u. S. And the world. Mrs. Foley, your son did that. And your testimony, i think he inherited a lot of his courage from his mother. But thank you for being here. I know theres things we can do in terms of antiquities, in terms of trade based Money Laundering. I know theres things we can do to sanction some countries. But its really troubling on the issue of kidnapping ransom. Could you tell me a little bit about the james w. Foley Legacy Foundation youre so involved in. One of the things they do is hostage support. Can you describe what kind of work you do there and what the foundation is doing . In truth were just beginning. Jim was very, as i said, concerned with people without a voice. One of the big issues obviously ive been concerned about are american hostages. They end up in a truly gray zone. And gray meaning that nobody knew whose job it was to try to get them out. And no one really wanted to touch the issue. Its a hot potato. So one of the first thing weve done this past year is weve raised funds for something called hostage u. S. Which will be similar to hostage uk which will support American Families in this predicament. But the james w. Foley foundation wants to go further. We want our americans home. So whereas hostage u. S. , were going to continue to support them because families need support. But i could have cared how i was treated if jim were home. And i really feel, as american, we need to be shrewder. We need to find a way to get them home. And i recognize that its complex because we certainly dont want to Fund Terrorists. But is it wise to not even engage these people . Then we dont have a clue. We dont know whats going on, we dont know what they want, we dont know who they are. And, you know, i dont think so. I just think we have to be a lot shrewder. Otherwise were going to be out of luck. So as far as the foundation, yes, were working very closely with the fusion cell and lisa mona monaco, trying to find ways to hold them accountable a lot of u. S. Assets have been given now. 50 individuals have this mission to bring americans home. None are home yet since theyve been started. Granted its new. But im concerned. I think their hands are tied in a lot of ways. The other issue is conflict journalism. These days it used to be in world war ii journalists and aid workers were off limits. They had a certain neutrality. Not so anymore. I mean journalists and aid workers are targets. And we have to be aware of that. So as a democracy ourselves, unless we come together for Global Safety for people who are giving us information who dare to go where many dont dare to go, that is a huge concern of ours. So were really were working with an International Coalition for safety and journalism. And continue to be concerned about children without access to education because jim loved children. He really felt education was the only way for societies to get out of poverty. So were looking at that. Thank you. One of the things i hope we can do is not have others experience everything that your family experienced. And as you go forward with the foundations work, if you could keep us informed about some of the areas that you think we can get involved with as you go forward, please do that. Feel free to do that. I think we can certainly do better. We better do better, sir. Its frightening if we cant do better in that regard. Thank you. I agree. Another question for dr. Donte. May 15th raid on isil leader abaaoud sigh ef, you called that a game changer. What did we learn from that that we didnt know before . We learned that antiquities were very important to the organization and they were the functional equivalent of other Natural Resources. There were emails and documents indicating that he had been in put in charge of that trade because it was important to the organization. He was found to be in possession of hundreds of antiquitieantique of them looted from the museum and hae had other high end items on the laptop, some that were known to have been sold through turkey. Ill say this. Many times in this very turbulent times, were so frustrated, we put up our hand and say, what can we do. I think you four as witnesses have given us things we can do to further fight this effort and i appreciate it. And i think these are very tangible real suggestions that can go forward on all fronts. Thank you. I yield back. Members need to know were in the midst of voting. We will continue after the votes. We have one vote, but we will not recess until we have at least one more member ask questions. And then well come back. I apologize to our panelists. But that one vote shouldnt take a long time. Mr. Wilson from South Carolina. Ms. Foley again, thank you for your courage. As a former reporter myself, so many points youve made that indeed in other conflicts, the journalists have been noncombatants. But its such a chilling reminder that were dealing with illegal enemy combatants not in uniform. This is, to me, so extraordinarily unprecedented and putting the American People at risk. At a time even today within the last 48 hours that isil daesh issued a statement that washington and rome are the next targe targets. Weve got to be vigilant. Thats why i appreciate the point that youre making too, that we all support no concession, that doesnt mean not negotiate. So youre making a difference by raising these issues. And then it is appalling to me that there was not an effort of military rescue. Was there any reason particularly when you indicate that it was an exact location of 20 together. With that information, its just appalling to me that action was not taken. And thats one question. Then the next question, why was that not done. And then, you know, with the attack in benghazi, were still discussing who did it. What . This should be determined. And then there should be efforts to find them. On both, one no action and what is the status of determining who these murderers are. Well, those are all good questions, questions that i truly dont have the answers for. All i know is that american citizens we started to have eyewitnesses as of fall, early fall 2013 of exactly where jim was. And oush government knew that there were three other americans and british with him. And were quite sure that they also realized how many other allies were also together because slowly the other their allies were negotiating all of these people out. Jim had already been held a whole year before all these other people were added. Jim was one of the first, jim and british citizen john cant cantlie and of course aus entice who was taken in august of 2012. They were the fist ones that i know of that were taken in syria. But then gradually all of these others were taken. Most of them in later in 2013. But the other European Countries got right on it and started negotiating with the captors so that their citizens came out. As far as where they were held, we had information throughout starting in the fall of 2013 and then again december 2013. They were moved, but because hostages started coming out in early 2014 we received very detailed information. As a matter of fact, it became clearer and clearer as the string of 2014 went on because these european hostages came out with very specific information. And some of them one italian citizen skam to the u. S. Twice on his own dime trying to get somebody to hear the specifics he had in terms of exact location of where they were being held. But no one wanted to hear it. And particularly federico came more than any of the others. Some of the others hesitated to do that because their governments had figured out a way to get them out. They understandably expected our government to work with theirs to collaborate, if you will, to get our citizens out. But it didnt happen. Its inconceivable with the released captors that there couldnt be an effort to determine who the perpetrators are. Dont you think in i agree with you. I want to work with our chairman to get this straight. Thank you very much. I yield. Chair will now go to mr. Higgins for his statement. Thank you. Or question, excuse me. Mrs. Foley in your testimony you indicated that you and your family were left to negotiate with your sons captors. With whom would you negotiate and what was the nature of the discussion in. The only opportunity we had, mr. Higgins, was for a month in 2013, end of november, we, out of the blue, got an email saying that they had jim and they would send us they wanted some questions who is they . Pardon . Who is they . They really didnt want us to know. They said they were syrian rebels. They didnt identify themselves any more than that. So they initiated contact with you and your family . Absolutely. But it was through a very encrypted email that our fbi had no way of tracking. So theyre very shrewd, sir, very shrewd. They knew how to reach us but we didnt know how to reach them. So you couldnt respond back i could only respond through that email. But what i meant to say is we couldnt find out who was sending it. It was obvious that they were english speaking, however, because, you know, of the commander language. Was there specifics about a ransom number or conditions . When they initially reached out to us, yes. It was ridiculous. Like they wanted 100 million euro or all muslim prisoners kind of thing. And you know, fbi, you know, of course we right away sent tight the fbi and they just said keep them talking, keep them talking. But within a few emails when they realized they were just talking to the family, they had absolutely no interest. And so they cut off discussions until the only other time, sir, was when the french came out in march of 2014, they came out with another very specific offer to negotiate for all americans and all of the british. And your primary source of contact in the United States was the fbi . We had no primary source. I did have one we had one fbi agent who debriefed me all the time. Debriefed you on what . Anything. I mean, i was talking to anybody, all of the freed hostages that i could, there were a lot of times fbi couldnt even get to them. At any point during your ordeal did you get a sense that your son was going to be freed at some point . Not at all. However, our government told me anyone i talked to at state or fbi, that jim was the highest priority. So we were deceived throughout the first 18 months. You never believed that . I believed it totally, sir. Thats why we didnt try to raise ransom or do anything privately. We totally believed it. When did you stop believing it . By the late spring of 2014 when i could primarily when Mark Mitchell threatened us three times and made it very obvious that our government was going to do nothing for those citizens. And what was the nature of mark what was his threat . Oh, that first of all, as americans if we dared to raise a ransom to get our loved ones out, we would definitely be prosecuted. And secondly, theres in way our government would ever ask another country. He was going to by the law. And i know that the law says that were not you know, we dont want qatar to do these things. But what he was saying essentially is your government will do nothing to get your people out. Nothing. And he just said anytime a very i mean, god bless that man anyway. I dont know. Its very appalling that as an american that we would do nothing for some of the best of america . Some of our journalists, some people who care about the suffering of the people in syria . It was appalling to me, sir. I have no further questions. Thank the gentleman from new york. We will be in a short recess until the members vote and quickly come back and well continue this. I want to thank the witnesses for your patience. But your information is so important that we dont want to i dont want to end this hearing at this point. Well be in recess for 15 minutes maximum. Subcommittee will reconvene. The chair recognizes the gentleman from california, mr. Sherman. Thank you. Qatar doesnt just allow its citizens to give money to Terrorists Groups. Government money is going to hamas and other terrorist groups. I think we have to get serious about this war. Ill give you some examples of where at least some of our friends are not serious. The Iraqi Government pays salaries to tomorrower Civil Servants who live in isis controlled areas. I do not remember general due gal sending gold coins to french teachers in normandy or bordeaux. The oil fields controlled by isis we dont bomb. We bombed World War Ii Oil fields. We dont bomb these. Some say its because the iraqis want to get them back entact. Some say its because the Iraqi Government is making a lot of money on this war and doesnt want to see isis lose the revenue. But you have something which by the definitions of the war we took most seriously world war ii, a strategic target. We know that isis is pumping the oil. We hit their mobile refineries but we wont hit the oil fields. Were not hitting the dams, their electric generation facilities and i cant get a straight answer out 0 our government or the Iraqi Government as to whether iraq is providing free electricity to mosul. But the lights are on. Theyre not on all of the time but theyre on for a reason. The biggest score and i realize it may be slightly out the side of the definition of the hearing although we do have the word donations in this. Isis got its hands on 500 million of iraqi currency. What other countries do, for various reasons, is they issue new currency. You do a recall of the green backs and you issue blue backs. Iraq didnt do that because thats a technique that is used to go after corrupt politicians and organized crime. And when you have a baghdad government installed by us protected by us, financed with our money that is pretty dependent upon infiltrated by, controlled by iran and organized and corrupt elements, theyre not going to recall the currency. So as to hostages, we definitely should not do nothing. The raid didnt work, but it shows the u. S. Determination. We need to sanction iran for holding five american hostages. The president made it clear that the deal in geneva related only to nuclear weapons. And if any other country were holding five of our hostages, we would, we would certainly sanction them. Dr. Weinberg, does qatar even pretend to outlaw voluntary contributions made by its citizens to hamas . Is that a violation of qatary law . It doesnt discuss this. Theyve had several laws on the books, one approved by the ie mere this week banning individual banning citizens from collecting money without authorization for donations. But this is the thats collecting from others. Is it illegal to send your money directly . Hamas Donation Fund care of gaza. The qatary government has given itself the authority to list Terrorists Group or individuals have they listed any . Not to my knowledge. The u. S. Has yet to see serious conditions so its illegal to give money to anyone on the list and the list is a blank piece of paper . The latest law theoretically means that you need to get Governmental Authority to collect donations for anybody. To collect. But i mean, its if qatarys see that theres a disaster in bangladesh and they give to the lang la desh society or unicef or Something Like that, they dont knee government permission to write a check to unicef do they in. I think the most striking evidence in this regard is that the United States sanctioned two qatary nationals in august who, as i understand it, were running the most high profile Fundraising Organization for syria relief in qatar. The u. S. Alleged that they both were high level al qaeda official operatives. It took the qatarys almost a year after the organization was, according to the washington, endorsed on social media, to shut it down. And a year after that when the u. S. Actually sanctioned them, the u. S. Indicated that the qatary had not arrested the two men. Just because you host a u. S. Military base does not mean that the United States has to preserve your regime. We have a military base in cuba. That doesnt mean we are supporters of the government in havana, our or policy changed from this way or that way. Its nice to have the base there. That doesnt mean we have to support their government. Id also point out and with mrs. Foley here, i, you know, i feel bad saying it, but i dont think we should be allowing paying money, ransom to terrorists organizations. It from an emotional standpoint you want to, from an emotional standpoint it may get your particular loved one back. But its just a while before they kill some other americans or see some other american hostages. And of course with money that gives them both an incentive and capacity. So i will yield back. Thank you for your time. Chair recognizes mr. Keating, massachusetts. Thats okay. Thank you, mr. Chairman. A question about the nonprofits again, not just qatar but particularly mr. Cassara, dr. Weinberg, what other nonprofits are there in the world . Are some people donating unwittingly, not knowing where some of the money is going . Are we able to do that . If you could just enlighten us on some of the sources of financing that the terrorists get. Sure, absolutely. This has been a long standing practice among financial operatives for al qaeda. We cant openly practice what we do so lets cloak anytime a veneer of charitable relief. Theres a particularly noteworthy case in kuwait as well. There was a fundraising outfit operated by an individual which was presenting itself in most of its presentations as relief for the syrian people. Support for legitimate resistance. But practice according to what the u. S. Government has designated, he was basically funding al qaeda in very large amounts. And since then he has been called in for questioning by the kuwait authorities are donors aware . Are some of them innocently some of them are innocently being exploited. His tribe in kuwait as well as other twieb has been exploited by people trying to play on their sympathies. The challenge is that once these sorts of frauds are exposed, the penaltities are inconsistent at best in some f these places. So the United States can work to try to build leverage to motivate the host government to act because apparently so far they dont seem to be sufficiently consistently motivated. I imagine if you go with the nonprofit name, sort of like whacamole. In that instance that individual is under sanctions but his cocaptain in one of his main fundraising networks is a senior operative in a kuwait political party. Dr. Dante, im curious. The passage way for the antiquities. What are some of the transit countries. Whats being done there. Are their parallels . How can we i think we can do things here at home to, you know, tap down on demand, talk to people in the uk, similarly that are motivated to do that in terms of final destinations. What about the transit countries and what can we do to disrupt the chain . In the cases that weve seen over the last 16 month twbs primary trafficking points for antiquities coming out of syria were lebanon and turkey. And from that point much of the material was going to bulgaria and greece and then with the objective of moving the material into the shanken zone, the free border zone. There were allegedly routes taking them to jordan, israel and the gulf as well. Since, lets say, october, some of those routes have shifted as the turks have taken military action, some of the border crossings that the Islamic State were using have fallen to Turkish Forces and we see initial indicators that some of the sunni arab and Islamic State, isis, trafficking is moving towards lebanon. Theres been a shift in the markets there presumably to take the material from lebanon to cypress greece or bulgaria. I would say in terms of shutting the trade down, what could be done to limit the number of ports in the Illicit Trade and limit the number of people that can import legal antiquities. Are they following drug or Money Laundering . In looking at the routes that the material is taking through turkey and bulgaria, i was following a lot of other contraband out to have country, stolen automobiles and capital goods and following the route that the fighters, entering the country and illegal weapons. The same border crossings. In a pdf posted online, satellite imagery in country sources indicated that that was a route that the antiquities were leaving the country from to ports in western turkey. Its in southern and western turkey where the Islamic State is aligning with or joining us with organized crime units within turkey to move that. Islamic state is new management taking advantage of the existing Traffic Networks and theyve essentially just encouraged additional far more looting and trafficking. But these routes existed in the preconflict period. Any human traffics involved in that at all . Not that im aware of. Thank you. I field back. Chair recognizes the gentleman from new york. Kidnapping for ransom has become a significant source of Terror Financing. In 2003 al qaeda will get about 200,000 per hostage. Now theyre getting 10 million. Over half of al qaedas operating revenue comes from ransom from kidnapping. But isis seems to be different. Isis seems to be involved in other activity. And a lot of their ability to raise funds is locally, terrorizing the local population, taxing people, every activity thats done there is taxed and results in a Revenue Source for isis. Any thoughts about that distinction and what is gleaned from it . Anybody on the panel. I think its certainly important to con tech chulize this like you said. And to say that, the primary sources of revenue that isis in particular have are derived from control of local territory. I think its also important for us to recognize that treasuries indicated that isis, as well as branches of al qaeda in yemen and north africa have been able to conquer territory in part because theyve used private donations as well as ransoms to fuel and to fund that territorial conquest. Particularly as the United States and our allies work to cut off their income from Oil Smuggling and from other and from their ability to even hold territory in the first place. Theyre going to fall back on these other sorts of revenue as well. So if we really want to conquer the phenomenon, we need to address this. Weve also learned that isis and al qaeda frequently will use the private donations and external funding to particularly pay for moving recruits from other countries which theyve done in the tens of thousands to battle zones. If we can cut off these two other sources of funding, we may be able to limit the abilities the ability of the organization to function even if it still has other sources of revenue. Its not only sources of funding, its laundering money. Id just like to share a quick anecdote. 2002, not too long after 9 11 i had a conversation with a pakistani gentleman who you in markets. We were talking about things we were talking about today. I was talking to them about tradebased Money Laundering, over and under valuation, the misuse of the afghan transit trade, et cetera, et cetera, and he finally turns to me. He says, mr. John, he says, dont you know that your enemies are transferring money in value right under your noses but the west doesnt see it. Your enemies are laughing at you. I think that kind of encaps lated a lot of what this issue is all about. We spend an incredible amount of time the last 14 years since 9 11 looking in many of the wrong places. Weve been concentrating on Financial Intelligence, setting up Financial Intelligence unit, filing suspicious activity reports, sanctions and designati designations. Were a nation of laws. Our adversaries, the terrorists, theyre not. Theyre laughing at us. Okay . We need to start thinking how they operate, all right . We need to understand their cultures, their methods of doing business, their values. Were making progress but its taking far too long. I think were kind of emphasizing the wrong things. Just an observation. I would concur with that in a big way. I mean, i just feel that they have the upper hand because they are shrewder. They are they have studied us. They know how to use twitter. They know how to use pr, video, et cetera, to get their message to recruit people who hate us. And we you know, we wont even talk to them. I mean, weve got to know our enemies. Weve got to use our cultural expertise to really get serious about engaging with us. And, you know, i mean, thats why, you know, i realize jim was just a Young American but he they didnt our fbi and state didnt use that situation with four americans being held there to find out who are these people that are holding on to our americans. Why are they holding them. What do they want . They didnt even try. And how are we going to understand and engage this enemy if we dont even try to know them . Thank you. Yield back. Chair recognizes itself for a few more questions in closing. In addition to the list we started out making about where terrorist organizations get their money, we have to now add wildlife poaching is another way they get their money. And as our friend from new york mentioned, Human Trafficking. They make money off of Human Trafficking as well, and charities. Let me ask you something. You mentioned specific clibt about charities in other countries. Do we have charities in the United States that are not really charities, theyre just a front for Money Laundering or donations that go to charity but ends up in the hands of these bad guys . Yeah. The most recently u. S. Law enforcement authorities, i believe, pressed charges against a network of several yemeni nationals who were using illicit methods within the United States to fund raise for al qaeda and the Arabian Peninsula including defrauding credit card company, taking out money and then closing down the accounts. Also, if you look back historically, hamas used u. S. Territory quite deafly in methods that were exposed during the Holy Land Foundation trial and many of those individuals have gone on abroad. People who are linked to the Holy Land Foundation, to continue to be parts of hamas regional financial network, i colluding one case i identified in my written testimony. And once again, the handful of individuals who do most of the contributing to foreign terrorist organizations, giving them money. We know who those people are, is that right, or not . Sometimes. We know who some of them are . Right. Part of the challenge is the donors are often harder to track down than the operators themselves. If you look at almost as a pyramid or something i understand. Like a drug traffic get the guy who is selling drugs on the corner. We dont get the guy who is bringing it into the country. Yes. The more we take out the operatives in the middle people at the bottom of the pyramid are more prone to sting operations and stuff like that. Going back to your comments, United States has a financial investigation of money going from banks to banks, trying to track it to see if its legitimate or not. But your testimony, the terrorists dont operate that way. Is that a fair statement . They operate through trade. How much illicit money have they been making with the Money Laundering through trade that you discussed . First of all, id like to explain that, as we talked about here today. Terrorists, adversaries, diversify just like any criminal organization does. Just like a good investor does, if you will. You dont put all of your eggs in one basket. They diversify. So they use a wide variety of funding methods and laundering methods. Yes, they use banks. They do. But i think theres been an over emphasis on us targeting westernstyle financial institutions. In effect, were still fighting the war on drugs where large amounts of dirty money sloshed around through western financial institutions. In fact, our antiMoney Laundering. Counter measures were put in place, you know, a generation ago when we were fighting the war on drugs. We have to be a little bit more nimble right now. Yes, i believe trade is a huge issue. The Financial Action task force calls it one of the three largest money laund ering methodologies in the world. How much money are we talking about . The magnitude of Money Laundering in general, according to this International Monetary fund is about 3 to 5 of the world gdp, or roughly speaking, very rough numbers, say 5 trillion a year, okay . Roughly, roughly the size of the u. S. Budget. Give or take a trillion or two. Give or take a trillion or two. Were talking real money here. They further think that is about equally divided between talking suspicious activity suas, suspicious unlawful activities, to charge Money Laundering. The criminal side, fraud, antiquities, smuggling, Human Trafficking, narcotics, et cetera, and tax evasion. Equally divided. 4 trillion a year. About 2 tax evasion and 2 traditional predicate offenses. How much of that involves tradebased Money Laundering . My personal opinion is, and i detail that in this book, is that is the largest Money Laundering methodology in the world. But we dont know because it has never been systematically examined bep havent done it in the United States. Our department of treasury has never taken a look at it. I mean, the Financial Action task force did a Money Laundering methodology back about 2006, and, you know, they kind of threw up their hands. But this is its not a solvable problem, but its something that we can do a great deal more to combat because the data exists. In many hidden Money Laundering systems methodologies out there today, say, for example, bull cash smuggling, its very, very difficult to follow that trail. But this type of thing has data. And with modern analytics today, we can do a much better job. All right. I want to thank all four of you for being here. Oh, you want to ask some more questions . Yeah. Mr. Sherman. Ive been inspired by you. I just want to bring to the attention of the subcommittee, its not just qatar. The fact that theres a group in britain that gives money to hamas. Now, you got to understand that in the real circles, ints kind of very liberal. Leftist circles. Its kind of acceptable to give money to hamas. Its not al qaeda. Its not not isis, but hamas, okay. And so brought to their attention that viva, and then the website of the interreligious foundations for immunity organization that said, well help you get a Tax Deduction for giving money to Viva Palestinian so they can give the mob aney to hamas. Brought this to their attention. Not only was there no criminal action taken but after five years theres just a review of the interreligious foundations. And if theres anybody this this room who wants to get a Tax Deduction and give money they can be certain to go to hamas, the website is available to you right now. So i know were the International Affairs committee and we criticize a lot of foreign governments. Our own is in this. I will say this, the irs has published the fact that they are doing a study on this and they may eventually turn to the interreligious foundation for community organization. In spite of the fact that it has the word organization interreligious in it and deny their 501c3 status, maybe by then well see peace in the middle east and hamas wont be a problem. Second, on cultural awareness. I know mrs. Foley brought that up. Ive been on, god, ive been on a jihad to get this state department to hire just a few people who are hired because not because they can pass the Foreign Service exam, but because they are real experts in the theology and jurisdiction of islam because you do have to understand, not just your enemy but the group that were trying to win over, which is the 1. 2, 1. 3 billion muslims who isis would like to win over to their side. And theyre pretty rigid over there. You know, if you go to princeton, theyll hire you. But if your knowledge if you each one of the highest levels of knowledge in theology and jurisprudence of islam, they wont. And their arguments are basically to tell people isis is bad because they kill men women and children yazidis without being in a position to argue as to whether to deal with the argument from isis that, well, thats a good thing. Look at the look at their twisted interpretation of islamic jurisprudence and theology. So while we criticize other government, weve got a government that will still, to this day, give you a Tax Deduction for giving money that you can know goes to hamas and we do have some people in the state department that know some things about islam, whatever you can learn kind of from the outside in a couple of graduate seminars. And we have religious muslims but they may be working on trade issues. Theres no department there that says, heres how we can frame our arguments to islamic governments based on based on a real knowledge of islam. With that, i think ive gone overtime. I yield back. I havent gone. Im yielding back a minute early. Put it down. I will put it down because it is a record. But i do want to thank the members of congress. I want to thank yall for being here. I cant emphasize enough how valuable the information that youve given us is. Ranking member and i were talking during the break that we could have a hearing on each one of the issues that the four of you talked about because its its Important Information and we appreciate the fact that youve been here and have given us this information. Once again, ms. Foley, thank you so much for being here. I agree with the comment that was made, your son probably got his spunk from you, which is thats a compliment, by the way. I thank all of yall. If you have any other information you would like to share with the committee, feel free to do that. Give it to me and ill share it with the other members of the committee. The committee now is adjourned. Folk tv, 48 hours of nonfiction books and authors. Our featured programs this weekend include the 30second annual miami book fair. Our live all day coverage starts saturday and sunday at 10 00 a. M. Eastern. Saturday at 10 00 p. M. Eastern, afterwards with historian Naill Ferguson on his book kissinger qu kissinger. He was an idealist, rarity in the harvard of the 150s. I think its what made his contribution fundamentally disdinktive and made him stand out from the pack of people who thought you could solve the cold war with systems analysis. Hes interviewed by Carla Anne Robbins the council on foreign relations. And sunday night at 8 00, Abdel Bari Atwan and author of the book Islamic State, the digital caliphate. On the rise of isis, their methods used to take over much of syria and iraq and their rivalry with al qaeda. Watch book tv all weekend, every weekend, on cspan2. 48 hour of programs and events that tell our nations story. Sunday morning at 10 00 eastern, our new series road to the white house rewind looks back to the 1988 Political Campaign of george Herbert Walker bush. At 4 00 on real america, the film the last two days, 20minute color film of john f. Kennedys faithfteful trip to t. And then back story with the American History guys as the professor brian valo, university of virginia Professor Emeritus and university of richmond discussed d. W. Griffiths film the birth of the nation and its significance. American history tv, waul weekend, every weekend, on csp cspan3. President obama has nominated dr. Robert califf, cardiologist to be the next commissioner of the food and Drug Administration. The Senate Health Committee Held a confirmation hear for dr. Califf earlier this week. He was asked about high Prescription Drug prices and past work hes done for Drug Companies. Good morning, today the Health Committee will come to order. Today were reviewing the nomination of dr. Robert califf to serve as commissioner of food and drugs. Dr. Califf, welcome. Congratulations on your nomination. Welcome to you and to your Family Members, were glad they have been able to come up, some of them from columbia, South Carolina, and i enjoyed having the opportunity wass to meet with you in my office. If youre confirmed to lead the food and Drug Administration as its commissioner, youll be in charge of steering the Agency Responsible for the safety and effectiveness of our nations medical products and protecting our countrys food supply. This is a huge job. The fda affects nearly every single american almost every day and regulates about a quarter of all of our Consumer Spending in the United States, over 4 trillion annually. Its responsible for product areas as diverse as Prescription Drugs for humans and animals and medical devices, biologics, cosmetics, overthecounter medications, food and tobacco. Its a Vital Mission and we all want to make sure that the right person is leading it. The president s nominated you to do that job, and like every fulltime nominee, youve been through an exhaustive process to make sure you dont have any conflicts of interest or other problems in your background. If youll permit me, i had the privilege of coming before this committee about 24 or 25 years ago and sitting in the chair where you sat. Its not always a pleasant experience. The Democratic Senators said to me my family was sitting where yours is. Said to me, governor alexander, ive heard some very disturbing things about you, but i dont think ill bring them up this morning. And senator cassabaum leaned over and said, well, howard, i think you just did. And then he held me up for three months. I dont expect that would be happening with you because, like every fulltime nominee, youve been through an exhaustive process to make sure of the conflicts of the interest, as i said. Before the president announced your nomination, there was an extensive setting process by the white house and the fbi. You submitted paperwork to the office of government ethics. Thats been carefully reviewed, including your financial information. They found several recusals which youve committed to do so there wouldnt be any remaining conflicts of interest that would prevent you from doing your job in the opinion of the office of government ethics. The form you submitted is public. It includes every source of income over 200 and every asset worth more than 1,000 and every potential conflict that the office of government ethics determined would require a recusal. Im going through this so people will know that nominees such as yourself do this. Youve answered 37 pages of questions from our committee, including some confidential questions on financial information. Youve responded to written followup questions. Your responses included over 3,000 pages of articles and lectures that my staff reviewed and that any member of the committee may review. You were nominated on september 17. Our Committee Staff has spent two months carefully reviewing everything you submitted, and my staff tells me that they havent found anything that would call into doubt your ability to lead the fda fairly and impartially. You come here with impressive qualifications, a leading cardiologist, professor at one of the nations top medical schools. Youre an expert on Clinical Research, and youve been recognized as an author of medical publications. Youve had some experience in managing large organizations, and youve been the founding director of dukes Clinical Research institute. Im sure senator burr will go into some detail about your background when he has a chance to introduce you in a few minutes. Youve conducted a score of important Clinical Trials. Thats important to me because i think it helps to have people in government who actually know what theyre talking about because of the experience that theyve had before. So you understand how Research Gets done in the real world. Im eager to hear your priorities about how you intend to manage such a large and diverse organization. Id like to hear what youll be able to do to ensure that Affordable Drugs are available to american patients. I hope youll agree that drugs are that your job is to see that drugs are safe and effective but the fda can help market lower drug prices by approving generic drugs and other products as quickly as it possibly can so theres more choice and competition in the market. Approval times have gotten worse instead of better. Ill be asking you about that and what you intend to do about it. Second, theres never been a more exciting time to lead the agency. We know more about biology and medicine than ever before. And thats not likely to stop any time soon in the advancement of regenre tif cell therapies, 3d printing, the president s Precision Medicine initiative. Your job, if confirmed, will be to make sure that the fdas regulation is appropriate. Too much regulation could reduce investments. Too little could make it difficult for drugs to be safe and effective. Theres much work to be done. Sometimes it takes a decade to develop a drug. Sometimes it takes billions of dollars literally. In this committee were working together in a bipartisan way to help get safe, cuttingedge drugs, medical devices and treatments into american medicine cabinets and doctors offices more quickly and we hope to move that soon. Were looking forward to hearing what you believe needs to be done to build the fdas capacity and to fix the impact of its regulations so that the fda is a partner in innovation and not a barrier. I thank you, and i look forward to hearing your testimony on these important issues. Senator murray. Thank you very much, mr. Chairman. Thank you to all of our colleagues for being here today. Dr. Califf, thank you to you and your multigenerational family that is here with you today. I want to express my appreciation to all of you for accepting this nomination and continuing to offer your expertise or offer your spouse or dad in service of families and communities nationwide. As the chairman said, the fda commissioner has a Critical Role to play in supporting health and wellbeing in our country. Whether youre in a Grocery Store or the medicine cabinet or the emergency room, families depend on the fda to maintain the highest standards of product safety. As we talk about the future of the fda and the many Health Challenges our country faces, i think it is important to note that valuable efforts have been made in recent years to strengthen the fda and improve its services for patients and families. Last year, the fda approved 51 new drugs and biologics, its highest number in almost 20 years. And the agency consistently approves drugs more quickly than advanced regulatory agencies in other countries while maintaining the high standards of safety and effectiveness. The fda has also made strides towards implementing the food safety modernization act helping to bring our nations food Safety System into the 21st century. Despite these gains, the fda faces significant challenges moving forward. There are several areas in particular where i hope to see continued progress. As someone who has seen personally the challenges that patients and families face due to chronic illness, im very interested in making sure we are Encouraging Development of safe, effective treatments and cures for our most challenging unmet medical needs. Socalled super bugs are another growing threat and an issue chairman alexander and i are working on closely. As we have seen in my state and across the country where medical devices known as duotoscopes have been linked to outbreaks of antibiotic resistant infections. We have to find ways to respond more quickly and effectively when any risk arises. Especially as technology continues to evolve, we need to do more to make sure that after products reach the market, the fda has effective tools it needs to monitor their safety, taking full advantage of information technology. We need to ensure that fda continues to strengthen its generic drug and biosimilar programs. I also believe theres much more we can do to bring patients voices into the process of developing new treatments and cures and ensure their priorities are consistently reflected in the fdas work. In addition, our country faces urgent Public Health challenges that deserve our attention. To name a few, we need to move forward on making sure families have access to nutritional information and ensuring our food supply is both safe and healthy. We need to put all of the agency tools to work to stop Tobacco Companies from targeting our children. We must do more to tackle illnesses such as Heart Disease and diabetes that threaten so many people in our country. Like so many of my colleagues today, ive heard time and again that the cost of Prescription Drugs is a significant financial burden. I believe the next fda commissioner has an Important Role to play in ensuring all patients and families have access to the Prescription Drugs they need. Another critical priority is ensuring the fda always puts science over politics. As some here will remember, several of my colleagues and i fought a very long and hard to ensure that medical expertise, not ideology, govern decisionmaking on the sale of plan b over the counter. Women and families have to be able to trust the fda not to play politics with their health. As congress and the administration Work Together to address these and many other Health Challenges in which the fda plays a significant role, we need to recognize our efforts will not be successful without Additional Support for the fda. We must make sure the fda has the resources and authority it needs to hire top experts in a highly competitive field and manage its growing work load as it navigates our increasingly Global Supply chain. Many of these are issues that our committee is currently debating as we negotiate Bipartisan Legislation to advance medical innovation for patients and families. After careful consideration and review, i am confident dr. Califf would contribute leadership and expertise as we work to find new ways to advance medical innovation for patients and families and improve health and wellbeing across the country. He is a strong nominee for the fda commissioner. Dr. Califf has an impressive history of leadership and management. W8tw experience in particular at duke. He would bring to this role a record of advancing medical breakthroughs on challenging illnesses through Clinical Trials, and our review of his record demonstrates a longstanding commitment to transparency and relationships with industry and working to ensure academic integrity. Dr. Califf has made clear he will continue to uphold these values and prioritize a strong, independent fda as commissioner. Ive approached this nomination focused on the best interests of families and communities in Washington State and across the country and in making sure the fda puts them first. From drug approvals to ensuring that a childs Peanut Butter sandwich is safe to eat. As we work towards these goals, i believe dr. Califf would be a valuable partner, and i encourage my colleagues to join me in supporting his nomination, and i look forward to working with all of you to strengthen the health and wellbeing of the families and communities that we serve. Thank you, mr. Chairman. Thank you, senator murray. Dr. Califf. Mr. Chairman, thank you. And thank you to my colleagues. Dr. Califf, welcome. Thank you for sharing your family with us. Your parents are here, your bride is here, your children are here, and your granddaughter is here. Welcome, brook. Hope youre getting extra credit for being here. Dr. Robert califf is a north carolinian whose career has been distinguished by his unwavering commitment to patients. As a respected clinician, researcher, and advisor, so im particularly pleased to have the opportunity to introduce him here today. Dr. Califf has been nominated to serve as the next commissioner of the food and Drug Administration, and my colleagues and i look forward to hearing from you today. Dr. Califf is currently serving as the Deputy Commissioner of medical products and tobacco for the fda since february of this year. In this role, hes responsible for overseeing and directing the centers for drug evaluation and research, the centers for biologics evaluation and research, the centers for devices and radiological help, the centers for Tobacco Products, the office of special medical programs within the agency. Prior to his work at the fda, dr. Califf was a professor of medicine and vice chancellor for clinical and Translational Research at Duke University in durham, North Carolina. During his time at duke dr. Califf held a number of positions, including the director of translational medicine institute, the director of the Clinical Research institute. He worked to move the promising field of translational science forward as the director of Clinical Trials transformation initiative. Dr. Califf is distinguished as a researcher and an author with over 1200 peer review publications in biomedical science. Hes a graduate of Duke University school of medicine. He received his residency, training, and primary care at the university of california, san francisco, and completed a residency in cardiology at Duke University. Dr. Califfs a great father, great husband, great granddad. Hes a great doctor. I would say to my colleagues, hes a great man. And i think that stands out the most in his qualifications. How well the fda fulfills its mission touches the lives of americans each and every day, from the lifesaving treatments patients receive to the safety of the food we feed our families. The challenges facing the next commissioner are great, but also the opportunities are as well. Dr. Califf, congratulations on your nomination to serve as commissioner of the food and Drug Administration. I urge my colleagues to thoroughly get your questions answered and expeditiously move this nomination so a permanent commissioner of the fda can get to work on some very Serious Problems within our system. I thank the chair. I welcome dr. Califf. Thank you, senator burr. Senator scott has a point of clarification. Thank you, senator. Senator burr referred to dr. Califf as if he were from North Carolina. The fact of the matter is that while he could not get into the medical university of South Carolina, he had to go to duke, hes actually from South Carolina. Understanding the generational responsibilities of southerners, you realize that his parents were also from South Carolina, therefore, we know that hes a southerner but hes from South Carolina. The north, the yankees, called North Carolina. I wanted to make sure that that point was made clear that you didnt insult his parents who are in the front row from South Carolina, in the low country. Thank you very much. I welcome his parents and congratulate them on his ability to out perform the requirements of South Carolina education. Mr. Chairman . While those guys are still doing border wars, i want to also just welcome dr. Califf who, because fda is in my state, i think he would be eminently qualified and look forward to pursuing his nomination. Im glad youre the son of North Carolina who lived in North Carolina, but youre our guy, too, and i ask unanimous scent that my statement be in the record. It will be. Dr. Califf, you can see the interest the committee has in the work youre about to do. Virtually every member is here. Each will have five minutes to have a conversation with you. Ill try to give you time to answer the questions, but we want to stick pretty closely to five minutes so everyone can be involved. As i mentioned earlier, youve answered a number of questions to the Committee Staff, and if any senator has additional questions, there will be a few days after the hearing that they can ask them and we hope youll respond promptly to them. Well begin a period of a round of questions of five minutes in length. Dr. Califf, around the country and here in congress, people are talking about the high cost of pharmaceutical drugs and what can be done to make those drugs affordable. Do you excuse me. I got so excited i didnt give you a chance to make your comments. Ive been well instructed, senator, not to interrupt you. Dr. Califf, we look forward to your comments. Mr. Chairman and senator burr and senator murray, thank you for your kind comments. I want to thank you and the members of the committee for inviting me here today to discuss my nomination to be commissioner of the food and Drug Administration. Im honored to be accompanied by my family today as youve noted. Sitting hend me are my dad, a world war ii veteran. Were going to visit the monument later this afternoon. My mom, an activist teacher and a sevenyear survivor of multiple myeloma, and my wife of 42 years and high school sweetheart, lydia. My three children and my granddaughter brook are also here with us. The support of my family and their feedback have been essential to my career success and sustaining my moral compass. Im honored to have been nominated by president obama to lead the fda. Thank you for all of your willingness to share with me your perspectives on ways the agency can better serve the American People. My primary goals if confirmed would be to work with you to build on the excellent work force, relentlessly focus on the completion of priority projects and continue to develop the science base that we need to give consumers confidence that their food and medical products are safe and give patients and clinicians an accurate understanding of the benefits and risks of medical products. Amid ongoing revolutions in biological science and information technology, we must continue to strengthen the fdas vital work. Protecting americans while encouraging innovations is a promise. If confirmed it would be an honor to lead this outstanding work force in this remarkable time. Ive dedicated my career to advancing the Public Health and leader, teacher, and researcher. Like each of you, my understanding of our Health System was shaped by more than just my professional life. Our daughter was born with serious congenital Heart Disease requiring open heart surgery as an infant. I still vividly remember the inspirational work of her doctors, nurses, and Healthcare Team and the uncertainties of that experience, including the discovery that one of our daughters cardiologist had faked his medical credentials. We experienced first hand as a family how important it is to find a critical balance between innovation and safeguarding patients. When i started in cardiology, heart attack was the leading cause of death in america. Our understanding of it was limited. It was agonizing that one of six patients that i saw in our intensive care unit with a heart attack died during the first hospitalization. The intensely personal experience dealing with catastrophic illness and personally witnessing the death of many people drove us to relentlessly invent and develop effective treatments. I had the privilege to serve as a leader of Global Networks of doctors and nurses, researchers, computer scientists, and statisticians to develop drugs and life saving technologies. These efforts have cut the risk of death from heard disease by more than half and highlight for me the importance of bringing these advances to patients as fast as safely as possible. Indeed its not enough to develop new treatments. We must prove they are safe and effective and deploy them in a systemic way that reaches all americans and eventually the global population. Our initial quality registries for surgery have become Global Standards including adoption by cms quality measures and reducing medical errors. A successful fda is a critical factor for better Public Health in this changing world. The fda must be prepared to set policies that channel Innovative Technologies for safe and effective use. I also firmly believe that the best way to make this progress is for different sectors in Todays Health Care ecosystem to collaborate. Ive led efforts to help academic researchers collaborate with industry in a documented and transparent manner that retain their independence and primary role in caring for patients. More recently ive had the pleasure of jointly leading a number of projects with patients, consumers, and Community Leaders i believe to the great benefit of research and Public Health. My First Priority as commissioner would be to strengthen and better support fdas talented and dedicated work force. While fda scientists make decisions every single day about hundreds of products, as technology advances, these decisions are becoming more complex. Its essential that we keep pace. My next priority as commissioner is working with you to fulfill the ambitious agenda that we set together. The food safety modernization act, for example, will help assure americans their food is safe. The role for Tobacco Products will help us reduce tobacco related deaths and the user fee programs are entering a period of renegotiation. My third and final priority among the leading ones as commissioner would be to further develop a science base and decisionmaking, my professional love, by taking advantage of extraordinary advances in biomedicine and information sciences, we can build an infrastructure that will unlock greater amount of useful evidence about food, tobacco, and products at a lower cost. They fail to recognize national boundaries. In concert with our global colleagues we must continue to develop sophisticated systems for monitoring the safety and quality of products produced outside our borders. The fda is poised to leverage the acceleration and Biomedical Knowledge to a new era of enhanced safety and effective treatments. And if confirmed, i would be honored to lead the agency in this exciting time. Thank you for allowing me to testify before you today. Im happy to take your questions. Thank you, dr. Califf. Well now begin fiveminute round. Dr. Califf, around the country and in congress, theres lots of talk about high cost of pharmaceutical drugs. Do you believe in terms of drugs that its accurate to say that the fdas Statutory Mission is to promptly and efficiently make sure that drugs are safe and effective . As you know, senator alexander, that is our primary mission but we also can have an impact on the cost of drugs by performing that function effectively. Let me talk about that just a little bit. Do you agree that its not your job to set the price of drugs . It is not our job to set the price of drugs. Lets talk about generic treatments. If generic treatments can move more rapidly through the fda process in a safe and effective way, that would be one way to create more competition and presumably lower the cost of drugs. Despite getting about 1 billion in new funds over the last three years, generic manufacturers estimate that the fdas meeting approval time for generic drugs has gone from 30 months in 2011 to 48 months in 2014. Is that accurate based on your knowledge or can you explain how the fda with availability of 1 billion could have actually presided over a situation where the approval of generic drugs has gone from 30 months in 2011 to 48 months in 2014, especially since a more rapid approval if safe and effective might have had some effect in lowering drug prices. Senator alexander, bear with me. I appreciate the question. Bear with me for a second while i explain this. First of all, as you point out, 88 of american prescriptions now are generic. We have made tremendous progress but we can do better. You also know that were well ahead of the generic drug user fee act goals that were set, but we can still do better. Im all in favor of that. But explaining the backlog is really important. Heres a way to think about it. We started with a huge backlog, thousands of applications that were waiting until the user fees came in. The easy ones, the ones that were good, well written, went through quickly. The new ones, the ones that are pertinent to getting the first generic on the market are put in what we call a fast lane and theyre going through quickly. But we have this backlog of applications that are requiring back and forth because we want generic drugs to be just as safe and effective as the innovative drugs. When the applications are not complete or there are questions about manufacturing, those get held up. So im confident youll see over the next several years as that backlog is cleared the new applications are going through very quickly. Thank you, dr. Califf. This question will require just a short answer. Will you take a look, if youre confirmed, at the fdas policy of issuing nonbidance guidance documents instead of rule making . I talked with shawn donovan, the director of the budget and the administration of omb had strong policies between the difference of rule making which involves consultation and is legally binding and guidances which are not legally binding. Will you take a look at that . There is a bipartisan concern that agencies of the federal government, including the fda, are issuing guidances as if they were legally binding. Senator, i welcome that, too, working with you on that and taking a careful look at it. Id like for my remaining time to ask you to comment on a management issue at fda. We hear that even when products are similar, experiences of applicants varies quite a bit. Regulated parties ought to be treated with consistent and predictable ways. Why do you think that even with similar products the experience of some applicants is so different, and what could you do to make sure that regulated parties are treated in consistent and predictable ways . Senator alexander, i appreciate the question. Having spent several decades on the other side of the fence working on new therapies, i can appreciate peoples concerns, but the primary reason is really that each individual medical product is different. The Clinical Trials that need to be done, even if theyre similar, can have nuances that are critical. But still, we are committed at the fda and dr. Woodcock who you know well, working very closely with her and were going to do everything we can to produce a more even template across the fda so that the standards are the same. I wouldnt want anyone to come away thinking you can take a cookie cutter and develop a drug. Youve got to treat each one differently. Thank you, dr. Califf. Senator murray. Thank you, mr. Chairman. Dr. Califf, in contrast to some of our previous fda nominees who have come from the Public Health sector, you are a physician and a researcher with a specialty in large Clinical Trials. As a result throughout your career, you have partnered extensively with pharmaceutical industries and i wanted to ask you some questions about that. During your past Clinical Trial and consulting work youve done, how have you ensured industry views have not biased your work, and what do you plan to do to ensure you are able to lead the fda without any undo influence . Thank you, senator murray. Its important to really divide this into two parts. The Clinical Trials we do, that were done at duke during my tenure, and are still being done there. If funded by industry, we have an iron clad contract which i believe your staff has a copy of that guarantees the independent right to publish, guarantees access to the database and in the majority of cases we actually have the database. We are running the trial. And we publish the papers with input from the companies but they have absolutely no right to change what we say. We have the final right of publication. These trials are also done usually with International Steering committees representing many countries provided an independent voice thats needed. The industry funds the trial. They need to have their products evaluated, but we have an independent voice guaranteed by contract. I believe youll find that 100 of the studies that ive been involved in have been published so theyre in the Public Record for people to view. What do you see as the appropriate role of industry in working with the agency on key challenges like trials and surveillance . Its critical here to separate the role of industry for individual applications versus what we call the precompetitive space. That is, what are the right methods, how do we understand how to streamline the clinical process. How do we share information as medical products are rolled out to the public to make sure we understand the risks that may only be seen in the postmarket phase. So in the individual applications, there is no role for industry other than to present its case. It has a product that meets the criteria for safety and effectiveness, and its fdas role to independently judge that application. I think the American Public completely depends on having confidence that the fda is independent and those reviews and judgments about individual products, but in that precompetitive space weve got to Work Together. The industry funds 70 of Clinical Research, for example, globally. Nih is a minority funder, but im pleased to say that were working closely with nih right now and will bring industry into what i think would be a dramatically lower cost but more effective Clinical Research system. I very much appreciate that. I want to turn to an issue that ive raised a number of times this year. We know that patients across the country, including in my home state in seattle, got serious antibiotic resistance drugs. It seems we need to make improvements in how the fda monitors medical devices on the market to identify safety issues more quickly and prevent the tragedies that we have seen with this. What steps would you take to improve the postmarket Surveillance System for devices and better protect patients . Thank you for bringing that up. Personally, let me say as a cardiologist and someone with administrative responsibilities, the procedure youre referring to was first developed in the United Kingdom and those doctors came over to duke and we were one of the first places to do it. I understand the importance of that procedure, typically in people who are critically ill. I think we need to really work on our postmarket surveillance and devices, and i really hope that youll help us with this. The sentinel system that you all have helped with, industry has to, but really developed by the fda by dr. Janet woodcock, is a model in drugs. We have 170 million americans claims data so that when theres a problem with a drug we can look almost in real time. We need the same system on the device side. We have plans to do that, but were going to have to Work Together with you to figure out how to fund it and how to fold it in with that sentinel system. Imagine these duodenoscopes if there had been such a system, we could see it independently of industry and react to it much more rapidly. Thank you, mr. Chairman. Im concerned about that. I look forward to talking to you more about that. Thank you. Thank you, senator murray. The next four senators are burr, white house, isakson, and warren. Senator burr. Thank you, mr. Chairman. Dr. Califf. As you know the rule was after significant and in my opinion those working to develop medical Counter Measures to protect the American People in the event of a Public Health emergency, whether its natural or manmade attack on our country. If confirmed how would medical Counter Measures be prioritized within the agency and how would you ensure that the fda is advancing the development and review of these products towards the goal of a timely approval . Senator burr, thank you for that question. Im amazed at the attention and intensity you all have today given the fact that were all worried about the issue that youre bringing up. It can be either manmade or something unanticipated, like an infection. Were committed to working on this. I was pleased to get the guidance out for the rule which you had requested, but its going to take a concerted effort not just by the fda but as happened with the ebola crisis, which we just witnessed, when the federal agencies Work Together, a lot can be done to quell a crisis and deal with things. I do want to refer to the really brilliant work thats been done in the outside community, academia industry, and also within the fda. The animal rule basically says in cases where we cant do human studies, if theres an emergency, how can we extrapolate from human studies to the benefit of humans in these catastrophic situations. Were committed. Were going to be there 24 7 if needed. Thank you for getting that rule out. There had been reports that the tobacco deeming rule did not change the grandfather date for newly regulated Tobacco Products. This means that many noncombustible Tobacco Products which may have a Public Health benefit compared to the more traditional forms of tobacco would not be available to consumers for at least some period of time despite their potential benefits compared to a more traditional tobacco product. As commissioner, how would you improve the performance of the fda center for Tobacco Products with respect to the timely and predictable review of Tobacco Products . As you know, senator burr, this was a new creation just a few years ago. It started with zero employees. Its now up in the multi hundreds. There were no rules by which the tobacco applications could come in, so those have had to be developed. First of all, let me just say that you bring up a general issue of weighing the Overall Health risk of Tobacco Products where theyre graded from most serious to less serious. There is a pathway for doing that. Were committed to reviewing them in the time frames that have been agreed to. We have funding to carry out that activity. So were committed to get it done. I thank you for that commitment. I often hear from constituents in North Carolina about the importance of laboratorydeveloped tests. For researchers it means the next step in creating precise therapies. For providers, ltds help to determine accurate diagnosis and the means for more targeted treatments and therapies. As someone whos been on the front lines of research and treating patients, how would the agency collaborate with labs and other structures in this space to ensure that regulation of laboratorydeveloped tests in carried out in a workable way that moves these promising tests forward without inappropriate regulatory burdens and delays for patients and their practitioners. Im well aware of the importance of Laboratory Developed tests. Its sort of a place where home brews are made to make the test better over time so its an important activity. On the other hand, this has become a big industry with major implications for patients, especially with Precision Medicine where you have a test and it tells you if the therapy can be really good or really bad. Depending on whether its right. Were committed to work with the whole ecosystem which is quite complicated as you know, so that there is a standard for tests so we have analytical validity and clinical validity. Theres a hearing going on in the house right now about this issue. So there will be a lot more to say soon about this. Thank you. Mr. Chairman, i do have additional questions and would ask unanimous consent that those questions be allowed to be sent in writing to dr. Califf and i would conclude by saying this, not a question. The fda has over 150 outstanding guidance documents in limbo at the agency. Some of these guidances remain in draft form, and others have yet to be issued. My hope is that you will take that very seriously because without guidance, i dont know how the downstream effects are ever going to be felt of investment and development if, in fact, they dont have the guidance as to how to move forward. I thank the chair. Thank you, senator burr. Senator whitehouse. Good morning, welcome. Good morning. There are increasingly products emerging on the market that combine a pharmaceutical component, a drug, and a delivery component, a device. The fda is basically broken into one path for pharmaceuticals, the drug path, and another path for devices. Ive spoken to the people who lead both the drug side and the device side about this question of the drug device combined products. Both have said the same thing, which is that my pathway is not suitable for that. If were going to do that, we need to create a new pathway for that drug device combination. Could you let me know, a, what your thoughts are about that pathway for the drug device combination products and what you think a reasonable time frame would be for fda to have such a proposal ready for us to consider. As a cardiologist, i sort of live and breathe this kind of work because often we give life saving drugs systemically in acute situations, but it would stand to reason in many cases if you could deliver them through a catheter you could go to a much lower dose and do better. Maybe thats the best example to think about here. When you have a drug thats given in full dose systemically, you can give at lower dose, you dont want to go through the whole thing as if it were a totally new dose, but you cant assume that you know the risks and benefits of the lower dose. And so we do need and theres a strong view at the fda that we need another pathway that will give the fda the flexibility to assure the public that its safe and effect. You said that was the opinion of the fda is that your opinion as well . Yes. The time frame for designing that pathway and giving us something to look at here in congress . I feel like within the next year the fdas opinion can be adjudicated back and forth with us and were really happy to work with you. We have opinions on this now, so were happy to engage and discuss with you. Great. I think there is probably going to be legislative action thats going to be required to do this. Both of your sides of the house think it cant be done under the existing regulatory authority, that it would require congress to act. Do you agree with that . I think we need some help to get the right balance here. Great. The last thing that ill mention is that i hope that as you go forward with your responsibilities in the space of acts and Communications Technology that are adapted to measuring health effects, that youll recognize that in many respects this is a very valuable and robust industry that could well be overregulated if the fdas authority over those sorts of devices is extended too far. What do you see as the boundary between informational apps that the fda should and should not regulate . Well, i had the privilege of going back to my old home American Heart Association meeting just last week and we had a whole session on this issue and i wont show the brand but im wearing my own device here that has a number of apps on it thats like a whole different world than what existed six months ago. Theres a good statement just last year that came out from the fda, the fcc, and the office of the National Coordinator that states the full intention to regulate based on risk and exactly where to draw that boundary is a matter that we need to keep talking and thinking about. For example, clearly stated in that document, a healthrelated app where monitoring my heart rate and im healthy and i want to exercise more, thats not something that we want to be bothering with. But if this was attached to my internal defibrillator, dont worry, i dont have one, but if i did have one, that would be something we would need to regulate. Misfiring the defibrillator could kill you. We got to be able to deal with that spectrum and find that middle ground where there will be adjudication as we learn how these things work. So you would be looking along the lines of regulating technologies that could actually have a direct physical effect on the human body as opposed to just getting information that causes you to think that, oh, gosh, my hearts better than this. Im not going to run as much, and now you need to regulate that because the individual is making a different decision based on the information . Thats correct. Also i would just like to add that we are going to learn as we go through this because there may be cases where, for example, Heart Failure patients using the same app may be making more life and death decisions. What we dont want to do the time is expired. Theres so many of us, i dont want to trespass on other peoples time. Thank you, thats very courteous, senator whitehouse. Senator anderson. Following up on senator alexanders statement regarding guidance letters, the fda has two opportunities, one is issue guidance letters, the other is do rule making. While there are similarities, there are substantial differences. Under rule making you have to do a costbenefit analyses. Rule making has force effective law and guidance letters do not. Yet the fda continues to try to implement policy through guidance letters. For example, most recently, through a guidance letter youre going to talk about regulating laboratories and bringing them under the fda. Guidance letters dont have the rule making period or the Comment Period to be open. Fda continues to try and regulate parties more often through guidance letters than through rule making which shuts out the open Comment Period and has confusing affects. I have really two questions to ask. One, why is fda grown so reliant on nonbinding guidance documents for rule making, and do you think thats a problem . Senator, i appreciate your concern with this. One thing thats been really evident to me in my time at the fda so far is that everybody wants to know what the fda is thinking. I think theres a tremendous value in guidance documents to let people know what the fda is thinking and the demand for these is actually quite high. There are other situations where you need the full force of rule making. I understand there is a difference. I will have to work with you and look forward to doing it when things come up where youre concerned so we can discuss it and work through it. Specifically to that offer let me ask you the following question. Will you commit to require fda staff to go through rule making when it intends to legally bind regulated parties or change their behavior in a burdensome way . Senator, i believe the statement about guidance documents says theyre not legally binding. Theyre a statement about the fdas thinking and of course people would be wise when they see a guidance to consider that thinking. Personally in developing drugs with company ive often taken a different path. Im committed to working with you to try to deal with this tension that youre feeling. Thinking is a subjective thing. Rule making is an objective thing. You ought to have a rule making procedure rather than a guidance letter that could affect some and not others. Secondly, on sun screen, november 26th is the First Anniversary of the sun screen innovation act which this committee passed. President obama signed. Which was designed to expedite the approval of ingredients in sunscreen. As you probably know, there are sunscreens that have been available in europe for years, in some cases decades, that are still not available in the United States because the fda has refused to make decisions on some of those ingredients. Its been a year since we passed the expedited rule and still the fda has not done it. Will you commit to work with us to try to bring that forward and do the proper Due Diligence to get those products to market . I really do look forward to working with you on this. As we discussed earlier, i have a Family History of melanoma myself and a number of moles that probably should be looked at more frequently than they are. With lydia sitting behind me, she would remind me of that. Let me also say that part of what we need to work on is actually developing the evidence. Weve asked the Companies Involved for specific information which i believe they can develop, and were very open to moving as quickly as we can if we have the right evidence. I would just point to whats happened with people that have melanoma with these amazing new therapies, several of which have just come on the market. The patients with melanoma have worked closely with companies to get the Clinical Trials done to effective treatments get expedited and the ineffective ones dont get out there. I think preventing melanoma is in the same category. Weve got to do better. Its a rapidly growing cause of death, and i really do want to work with you personally on this issue. At certain stages its a death sentence for which there is no cure. I think youve known that. Ive had melanoma myself and survived two of them fortunately. Next march or april is spring break and the kids are going to hit the beaches of america and hopefully a lot of georges beaches, having a lot of fun and getting a lot of sun. My last comment and ill make it quickly because its a long question and i know my time will be up. The fda has sent mixed signals to pregnant women with regard to seafood. I know yall are in the process of using determination on seafood to make recommendations as to what was good to be eaten and not eaten. You were using results from what was called the net affects report but that seems to be abandoned now. If you would when you take over and are confirmed, will you expedite the decisionmaking process on seafood for pregnant women and the recommendations the fda makes . Yes, sir, i look forward to working on that. Thank you. Senator warren . Thank you, mr. Chairman. Dr. Califf, its no secret that during your time at Duke University you received significant Financial Support from the pharmaceutical industry both for you personally and for your research, and i know its common practice for principle investigators on Clinical Trials but it naturally raises questions about your relationship with the drug industry. One particular concern with industry funding of Academic Work is that Drug Companies may be able to exert influence over the conduct of those studies. So let me ask, for the Clinical Trials you conducted or oversaw while at duke, can you detail for us exactly what input pharmaceutical sponsors had, did and did not have, in the design of the trials, the analysis of the data, and the publication of the results. Well, im glad to do so. When industry funds a Clinical Trial, whether its devices or drugs done through our institute, the design of the trial is something thats done jointly and done very publicly because typically its done to try to get an indication from the fda. So it actually involves industry, academia, now patients involved in the design of the involved in the design of the trial and the fda. Captions Copyright National cable satellite corp. 2008 captioning performed by vitac