Transcripts For CSPAN2 Pandemic Preparedness Response 20180118

21st Century Public Health threats. The nations preparedness and response capabilities. We will hear from the assistant secretary preparedness and response at the department of human health and services. Chapter at the centers for Disease Control and prevention. And doctor Scott Gottlieb commissioner for the fda. This is the first of two hearings we plan to have on this topic. The second will be noticed for tuesday, january 23rd. Senator murray and i each have an opening statement. Then i will turn to senator alexander and casey for opening remarks they might have. After that will introduce the panel of witnesses and we will hear their testimonies and then each member will have up to five minutes for any remarks and questions. First i would like to welcome the chairman and thank him for giving me the opportunity to hold the devil today. This hearing discusses a topic that is critical to the National Security and has seen many years of bipartisan work in this committee and in this congress. Together we have developed and strengthened the grammar to ensure that we are prepared for chemical, biological, radiological and other Nuclear Threats with the potential to jeopardize the health of all americans. The pandemic and preparedness act of 2006 crater framework which is grown and changed as we have learned from each Public Health experience we have been through. We should be a part of the accomplishments under the progress made over the last decade. Our work has resulted in strong partnerships with state and local counterparts. Creating greater certainty and accountability to bring forward medical countermeasures and established a Clear Strategy with which we can combat the full range of Public Health threats we face today and thus we may encounter in the future. Despite this progress, we are not fully prepared and more work remains to accomplish our goal. The Blue Ribbon Study Panel on bio defense stated in 2015 report that i quote serious gaps in inadequacies continue to leave the nation vulnerable to threats from nature. And terrorists alike. As we move forward, and revisiting the successful and bipartisan law, i want to make it very clear to my colleagues that this is reauthorization of a National Security bill. I look forward to working with each of you on this important issue. The threats we face continue to evolve. And it is critical that we bring with this discussion, the vigilance, urgency and resolve this mission demands. We are in an unprecedented era of advancement. In november 2016 the president S Advisory Council in Science Technology warns that and i quote while the ongoing growth of biotechnology is a great moment for society also holds a series potential for destruction or destructive use by both states and technically competent individuals. And encourage the Us Government passed ways of thinking and organizing to meet biological threats needs to change to reflect and address this rapidly developing landscape. For this reason, it is critical that fostering and advancing innovation, particularly in the development of medical countermeasures, is top of mind and that we work through this reauthorization process to ensure cdc, fda, have what they need to keep pace with these rapidly changing and evolving threats. This committee has worked to push the federal government and hss in particular, to meet the challenges. An hhs fosters innovation and development of medical countermeasures and across the framework provides the greatest hope to ensure the safety of the American People. The witnesses that we have before us today, will be able to provide insight into the urgency of this mission. And a promise innovation holds it properly leveraged. Look forward to hear from each of you about the progress that we have made. And where we can continue to improve policies and programs to realize their full potential to save americans lives. I would like to turn to senator murray for any comments. Thank you very much. Thank you to all of you for joining this hearing on our nations preparedness to combat Public Health threats as we look towards now reauthorizing the pandemic and preparedness act later this year. I especially want to thank senator casey and senator burr for their bipartisan efforts on this issue. Papers show why this discussion is so important to families across the country. With headlines like, flu deaths and cases increasing in pierce county. And flu outbreak and a county kills five, 15 hospitalized. A bad flu season can be a nightmare for families and too often ends in horrible tragedy. Just as we must continue to improve the Public Health response across the board to prevent those tragedies on the local level, we have to also make sure we are vigilant against pandemics on a global scale. A pandemic can affect happily in people. More than the entire population of the United States. That is not speculation. It happened 100 years ago. The 1918 influenza epidemic was a tragedy more deadly to the human race than world war i. And today the threat of pandemic flu is joined by new threats. What have we learned in the last century . Are we better prepared for the next catastrophe . When you consider ebola and how the centers for Disease Control and prevention and summary partners supported nigeria, as they instituted evidencebased policies and track the path of that disease and contained it when the outbreak reached after words answers clearly, yesterday we consider our Strategic National stockpile which can deliver 50 tons of emergency medical supplies anywhere in the us in 12 hours, the answer is clearly, yes. Many consider the fdas approval of new medical countermeasures to combat anthrax and flu and radiation and plague, the answer is clearly yes. However our track record is far from perfect. We still can do better. We can do better than the president s way to slow response in puerto rico and the Us Virgin Islands after Hurricane Maria. The storm left Many Americans without access to clean water and electricity and healthcare for months. We can do better than the administrations response to the opioid epidemic. President trump declared that christ is a Public Health emergency 83 days ago and has taken little meaningful actions. I am glad this committee will continue the bipartisan work to address the Opioid Crisis in another hearing soon. We can also do better than our slow response and combating zika virus in 2016. The World Health Organization declared zika virus a global Health Emergency in february. Instead of a Fast Response, the response that politicized around some republicans who pushed to undermine womens healthcare and access to contraception which was a key requirement to prevent this from causing devastating birth defects. As a result it took Congress Nine months has Emergency Funding for a Public Health crisis that endangered mothers and babies and families across the world. It harmed people and families in ways they will carry for the rest of their lives. So we have to do better. We are most successful at protecting our families against pandemics threats when we respond with quick bipartisan action. We need decisions based in science. An expert medical opinion. Not ideology. Especially when it comes to womens health. We need federal, state and local agencies to hire the people and capacity and have the funding they need to protect communities. Hiring freezes and funding cuts make us less prepared, not more. We need to plan for everyone. We cannot overlook the young for the elderly. We cannot forget pregnant women or individuals with disabilities or those fighting chronic diseases like diabetes. We need innovative, medical countermeasures to protect us from todays threats like a universal flu vaccine and antibiotic to combat resistant bacteria. We must continue strong partnerships with industries that will allow us to rapidly respond to new threats. We need to stop fear and uncertainty before they create panic by giving families helpful and Accurate Information from sources that they trust. We cannot allow anyone to undermine the science of Proven Solutions like vaccines. We need to respond to Global Health crisis abroad before they travel here to home. Diseases are not stopped by borders or walls or bands. This is a place with the United States can and should leave. We should continue to see the International Partners that we are focused on these issues and will be there ally in preparing for and addressing Public Health threats. Congress has a strong bipartisan track record of addressing these challenges which strengthened the nations Public Health preparedness and created new roles and programs with authorities proposed Emergency Response. Reauthorizing the act in 2013 we built on the record. When has medical surge capacity. We modernize bio surveillance capabilities. We increased focus on atrisk individuals. I am hopeful we can continue that progress with legislation that focuses on the signs and evidencebased policies we know work. To mitigate Public Health crisis. Consider the needs of everyone and puts families in women before politics. Reports state and local Public Health officials and joes communities do not spend months waiting for emergency resources and enables us to respond to the next crisis with foresight rather than with hindsight. We do not know what the next Public Health threat will be. We do not know where, when or how. But we do know that being prepared starts now. All of you here today have a Critical Role to play in keeping our communities healthy and safe. The fda help facilitate the development and review of medical countermeasures and grants emergency use authorizations for products needed on the front lines. The assistant secretary preparedness and response guides the nations preparedness planning. Help ensure the Healthcare System is ready to face any emergency. An investor medical countermeasures, pipelines to Biomedical Advanced Research and development authority. The centers for Disease Control and prevention is on the frontline. Supporting state and local Public Health departments. Overseeing the national Strategic National stockpile. Gathering and analyzing key data and serving as a trusted source of information to the public. Im interested to hear from all of you today about your work to fulfill these Important Roles and keep our country safe. Mr. Chairman, i do want to say im frustrated that director fitzgerald is once again unable to join us today. Due to conflict of interest presented by investment the cdc director still has to recuse herself on some of the Important Health issues that we face. Including issues related to Data Collection and information sharing. Which are very relevant to the conversation we are having today. I am concerned that she still cannot give her full attention to all of the pressing Health Threats we face and hope that these conflicts of interest will be resolved soon. Thank you doctor stephen redd for joining us in her place and i look forward to hearing from you. Senator alexander. Thank you, senator. And thank you for your willingness to chair this hearing. On march 2013, president obama signed into law the bipartisan pandemic and hazard preparedness and reauthorization act. This became law in 2006 that worked with many senators on this committee. Both democratic and republican. I think im all for that. Replacing senator franken who was at the table member of the committee. Senator jones from alabama is also a new member of the committee. We welcome him. He replaced senator y. Ted who was a very valuable member of the committee, i mean whitehouse and who was taken a lesser assignment on the finance committee for some reason. But we will miss sheldon and his work on this committee. Mr. Chairman i am going to withhold my comments although what i would like to do is call on senator isakson for one minute just to make some comments and then we will go to senator casey. Thank you mr. Chairman. I wanted to reference some statements made by Ranking Member senator murray. As chairman of the Ethics Committee i have gotten her in touch with the appropriate people to deal with the issue. She is forthrightly dealing with it to the best i can determine and im working expeditiously to get it done as quickly as possible so she will not have any conflicts of testimony as well and thats her desire as well. Thank you very much senator burr. Grateful for this hearing and grateful to be working with you on this reauthorization and i commend your work on this for many years. They also want to thank the chairman, chairman alexander and Ranking Member murray for this bipartisan hearing on the nations preparedness and response capabilities in advance of the reauthorization of a pandemic all hazards and response act. I will give you one story, one brief story about how important preparation is. This is a good example of preparedness infrastructure that it supports. In this case in the aftermath of the tragedy a Train Derailment that occurred in philadelphia of may of 2015. The train was carrying 238 passengers when it derailed. Eight people lost their lives. Over 200 were injured in that derailment. Fortunately through funding from the Hospital Preparedness Program which we know by the acronym hbp Regional Health Care Coalition had long been working together for emergencies that did cause a surge in patients. When the train derailed systems for tracking bed availability in local hospitals and provided information in real time to Emergency Responders helping them to effectively triage patients sending them to the hospitals that have the capacity to accept additional patients so they could again to receive the care they needed. Because these systems were in place before the train derailed they were ready to protect and help save lives one seconds literally seconds counted. Health security threats are increasing in frequency and intensity due to a combination of factors including newly emerging Infectious Diseases, extreme weather events and our aging infrastructure so now more than ever we must continue to build our nations resiliency by investing in Countermeasure Development surveillance supporting state and local partners to reduce the impact of Health Events in the country. Id like to think todays witnesses for their service and its important to mention your service to the country as well as your commitment to protecting the americans Public Health. I look or to the hearing and grateful for the work we can do today at this hearing. Thank you mr. Chairman. Thank you and thank you for your continued help and work on this issue. Let me just remind members that this is the start of the reauthorization of popup. Having been in congress 24 years i realize when you get in involvement hhs legislation theres always the temptation to fix other things. I want to encourage you to fight the urge. Lets keep this focused on perfecting its been successful. We still have work to do but if we become distracted in create a fight over changes within fda or somewhere else because the sheer geography that pappa allows us to get into we will lose the focus of what we are doing in trying to make pappa even more effective in the future so with that id like to introduce our witnesses which will each have up to five minutes to give their testimony. Im pleased to welcome today dr. Robert kadlec. Dr. Kadlec is the assistant secretary for preparedness and response of the secretary in health and human services. If he doesnt like the title he was the one who created it. It was dr. Kadlec that created pappa to establish a clear line of support. Hes solely responsible for leading and coordinating the federal medical and Public Health preparedness and response effort across all the agencies within hhs including fda and cdc cdc. Delighted to have you back today. Next we will hear from. Terry stotts gotlieb. Dr. Kadlec exist the commission or the food and drug administration. The fda plays a Critical Role in our Emergency Preparedness and response capabilities through its review of medical countermeasures including drugs, vaccines diagnostic tests and ensuring these countermeasures are safe and effective. Further the 2013 rappers asian of pappa aim to improve regulatory certainty and predictability for medical countermeasures under review at the fda while also providing the agency with Additional Authority to support Rapid Response of emergencies. We are delighted to have you here are delighted to have you in that position at fda. Finally we will hear from doctors stephen redd the director of Public Health response and preparedness. The cdc serves a number of roles under the papa framework and has built strong relationships with state and local Public Health departments and important aspect of preparing for and responding to emergency Public Health threats. Cdc also works to make sure we have the information we need in advance of a Public Health emergency. As part of this effort cdc houses and expansive Epidemiology Laboratory capacity in its responsibility for surveillance and Public Health Data Collection activities. Again we welcome all of you. Let me just say at the beginning i believe the hurdle thats in our way is not available in our nation. They believe i believe the hurdle that is in our way his government. Clearly defining what it is that our need is and the certainty of a pathway for getting the approvals that we need we need for those to actually be deployed so i hope you keep those in mind as you go through not just your testimony and your questions but more importantly in the roles that you carry out after you leave and understand you are on the front lines at taking this happen. The floor is yours. Thank you sarah. Its exciting to be here. Good morning mr. Chairman and senator murray and distinguished members of the committee. I assumed this role five months ago we before Hurricane Harvey struck texas. Its been an interesting experience so far and i have much to share from that experience. I appreciate the opportunity to appear before you today in the second rasterization of papa. This committee championed a bipartisan effort to draft and pass its groundbreaking legislation. I want to thank you for continuing your commitment to this endeavor. Im proud to have played a part in the original legislative process during my tenure with this committee and acknowledge the vision and leadership of senator burr in the late senator ted kennedy. This morning ill share with you my perspective on the National Security of papa the mission and duties in my visions for areas of improving. The constitution states one of the governments fundamental obligation is to provide for defense and protect the American People are homeland and way of life to the strength of our nations Public Health and medical infrastructure as well as capabilities quickly mobilize the coordinate response of pandemics attacks and disasters are essential to saving lives and protecting all americans. Improving National Readiness and response capabilities for 21st century is a National Security imperative as senator burr outlined earlier and thats the crux of my effort. 21st Century Health security environment is increasingly complex and dangerous. Demands we act with urgency. Having recently left my job with the Senate Select committee on intelligence i know these threats all too well. Organizations remained determined to attack the United States. They have the means to employ chemical and biological weapons. Further we have witnessed the increased frequency of naturally occurring disasters as well as disease outbreaks and monitoring Infectious Diseases that can cause a pandemic such as the strain circulating in china. The bottom line is whatever happens your constituents, the American People expect their federal government to be ready to respond to save lives. When asked what was established by papa a decade ago the objective was to answer simple question who is in charge of all federal Public Health and medical preparedness and response . The approach adopted was based on the goldwaternichols act that created commands at the department offense. Our vision is to save lives and protect americans from these threats by recruiting the entire wave of the Public Health assets and recruits and support of the Public Health sector to support state and local activities and responses to help americans in distress. Four key priorities. First provide strong leadership locus encore edition planning and preparing for events that threaten the National Health and security. Second develop a National Disaster Health Care System. Third advocate for cdc sustainment of a robust and reliable Public Health security capability and last but certainly not least innovative countermeasures. Two areas of opportunity i will elaborate on our Operational Health Care Capacity and the medical countermeasures enterprise. The importance of the National Health care medical Search Capacity highlighted during the season after Hurricane Harvey irma and maria after federal medical Public Health Response Recovery act in the response framework. We worked closely with fema state and territorial Health Officials with hhs disaster medical assistance teams as well as a va. We learn from these disasters that we need to update its Incident Commander deployed medical capabilities as well as enhance our support for Health Care Infrastructure across the country. The Nations Health care delivery infrastructure is mostly a privatesector enterprise that must be effectively gauged in improving readiness. To address the catastrophic medical consequences of the 21st century threats we need a tiered system thats based on existing local Health Care Coalitions and Trauma Centers that integrates all medical response in capabilities including federal assets as well as Emergency Medical Services the frontline of our response capabilities. I must expand expertise and trauma behavior of health care and Chemical Biological Radiological Nuclear response and last but not least simplify the Health Care System to integrate preparedness with standards of care. I call this the salvation of the National Disaster Health Care System. The second area is her medical enterprise and im grateful dr. Rick wright a hime, when he waved to the crowd who is the director of war to the established as part of papa and part of aspr to bridge the Late Stage Development of vaccines drugs and diagnostic development and many products available or by using flexible authorities multiyear dance funding and strong Public Private partnerships and cuttingedge expertise barta has pushed many products to advance Development Stock piling fda approval. To this day 34 a been approved by fda for the surfaces of her sobbing to disasters to the credit of. Your brighton and his predecessor in the team. We have an opportunity to improve this enterprise by streamlining our decisionmaking processes finding new ways to support innovation promoting flexible Fast Response capabilities increasing collaboration with interagency partners. We also must work closely with their state and local partners as well as the private sector to enhance the capabilities quickly to distribute and dispense medical counter marchers measures. And times of great challenge with the opportunity to build on the great harvest and improve our response capabilities. Look forward to working with you and your staff and thank you again for your bipartisan support and commitment to National Security. Im happy to answer any questions you have. Thank you. Dr. Gotlieb. Senator burr Ranking Member murray met members of the committee thank you for the invitation their nation has faced many emerging Public Health challenges and unfortunately will raise additional challenges in the future. Thankfully our preparedness and ability to respond to such challenges has improved greatly since the original enactment of a pandemic all hazards preparedness act. Each emergency is unique and many infectious threats but the technology for manipulating science for diabolical purposes has become ubiquitous and widely misunderstood. 2017 was marked by the risks posed by extreme disasters which caused significant human suffering. These tragedies enhance capabilities to respond. Today im going to focus my remarks on the impact of these terms on medical products manufactured in puerto rico and the actions we are taking to mitigate existing product shortages. The impact of Hurricane Maria showed the importance of puerto rico to her medical Product Manufacturing base as well as the sometimes fragile nature of that supply chain. I want to focus on the complexities of the shortage because it has stressed our system and i know that many of you are rightly concerned by the situation. They are only a small number of primary manufactures so when one manufacture Large Production even from routine maintenance theres a stress on the entire system that won the largest manufactures of i. V. Saline is the primary sites small volume bags locate import rake. The site struggle to regain power in return to full capacity following the storm and some of the manufacturing plans for disabled. We work in partnership with the department of home and security in puerto rico authorities and bob thank you for your support as well to ensure we are able to get back on the power grid and stabilize production. We also worked with various saline manufactures to find other manufacturing as though these globally that could help supply the u. S. Until the puerto rico location was back up and running. To mitigate the shortage we work at manufactures on importation of sailing in Ireland Australia mexico canada germany and most recently brazil. When the import from International Facilities generally the manufactures adjust distribution to send some products to the u. S. But theres no actual increase in the total flow of production and products. Manufacturing facilities in puerto rico are now stable and on the grid over the power situation on the island is still fragile. We expect a return to normal production will improve the situation paid before the storm hit fda also prioritize the approval of sailing products like to manufactures. Both should start production soon and having traditional manufactures on line will increase the overall line of saline distributed to the u. S. The shortage has had a ripple effect. In order to find the saline bags in shortage providers are put in various mitigation strategies in place. One strategy has them compounding products themselves and this has caused an increased demand for i. V. Bags. Signals indicate this increased demand is putting pressure on the supply of i. V. Bags for the fda is taking steps to address the situation to determine which manufactures could increase the capacity necessary. I have reached out to some of these manufactures personally to acquire about the production and the demand price continues to increase. The scope of the flu outbreak across the country has also added to the strain on the tight supply chain. The shortage and the impact of the crisis in puerto rico underscores the need to continuously elevate our preparedness. There will be Lessons Learned from this episode and already we have made observations about our ability to maintain shortages. We have had to depend on manufactures and distributors reaching out to fda or had to seek them out proactively. Her work in the shortage situation is example of how the fda has worse reacted. At the same time we continue to work hard to improve our revelatory clarity and predictability for the development of medical countermeasures. Thats the central component of our preparedness strategy. Today we released draft guidance on the countermeasure which explains how fdas implementing a program to incentivize the development of biologic medical countermeasures. I look forward to working with congress to increase the ratings for emergencies and look forward to answering any questions that you have paid. Thank you. Doctors redd. Senator burr chairman murray and members i am the director of the office of public response for the centers of Disease Control and im pleased to be here to talk to you about the role cbc plays and Public Health preparedness response including those response abilities under the pandemic reauthorization act. Cdc is the common defense in the country against Health Threats. Our work to prepare and respond to Health Emergencies require we build on their daytoday work to particular areas. Number one our Longstanding Partnership with state and local Health Departments and number two are medical scientific and programming expertise. I will describe the three pillars of our Defense Strategy science, surveillance and service. First the cdc has a unique collection of scientific expertise that exists nowhere else in the world. We have the ability to identify agents causing them is whether the illnesses caused by an infectious microbe or chemical radiation exposure. We are ready to respond through a broad range of threats including diseases like ebola smallpox and influence. The cdc places a key role in discovering Infectious Diseases using advanced detection techniques to identify pathogens quickly and more accurately. Every year laboratories from all over the world send hundreds of thousands of specimens to cdc for testing testing. The second pillar enabling cbcs defense of the country is surveillance or Public Health surveillance is the collection of analysis and use of data to target Public Health prevention and response. Its basically making sure the best information is used to make the right decisions. Examples of this work include what we do to track implements a the National Syndrome make Surveillance System and disease detection. Influenza is probably the greatest natural Health Threat we face. Influenza viruses change continuously and require vigilance to detect these changes. Cdcs provide support to every state to several major cities and to a number of ministries of health throughout the world to conduct surveillance and laboratory work. With the National Syndrome make Surveillance Program cdc selects Health Information on causes of emergency room urgent care and hospital visits. We along with state and local Health Environments use the data in realtime and abnormal situations requiring Public Health response. Cdcs Global Disease Detection Operation Center monitors 24 7 and the potential risk to the United States from these events. In addition to science and Surveillance Services the final pillar let me focus on three particular post programs. Public Health Emergency Preparedness Programs Strategic National stockpiles and the Cities Readiness Initiative. In each of these programs the keys to success are the close collaboration between cdc and state and local Public Health departments and the connection of these programs scientific expertise. Health preparedness grants go to every state and support staff, and naval exercises to test and validate capabilities and pay for laboratory communications equipment. The Strategic National stockpile is a 7 billiondollar repository of pharmaceuticals, medical supplies and medical equipment and surveillance available for rapid delivery support responses to help in emergencies. The Cities Readiness Initiative enhances preparedness in the nation 72 largest cities were nearly 60 of the u. S. Population resides. These funds are used to develop, test and maintain plans to receive countermeasures for cdcs National Stockpile and rapidly dispense them. Id like to give this committee three primary points about the cdcs role in Public Health Emergency Preparedness and response refer cdc is against Health Threats, cdcs preparedness work is built on a daytoday foundation of our broad and deep scientific and medical and Program Expertise and three cdc has launched partnerships with state and local Health Authorities are essential. Thank you for the opportunity to testify today. Err redd thank you very much and you win the award for getting the closest to five minutes of all of our witnesses today. The chair would recognize himself the Ranking Member and then senator alexander senator casey and members in the order of todays hearing. Dr. Bought my first question is simple. Are we prepared for the Public Health threats that we face . Sir i would have to say it perfectly for some but not all. I think the reality is when this concept of papa came up in 2005 we agreed the terrorist attacks of 9 11 we were participating a pandemic and we were just experiencing katrina. Those are in the Rearview Mirror in terms of the threats that we are prepared to deal with. Quite frankly if you have to look at a nationstate threat that we are considering today or multiple nationstates that are willing to use terrible weapons against us both physical as well as cyber i think we are not prepared and quite frankly those are the things that keep me up as at night as well as the pandemic that could emerge again from asia as well as the risks that. There gotlieb identified the synthetic tools that allow people to do unimaginable things potentially. I think we have a long way to go go. We have done very well in some areas and begin a complement to the effort that was done by the federal government in support of state and local authorities and again through those three hurricanes consecutively. I think that was a great commitment to the effort by everyone that there is no time to rest on our laurels. The statute is clear on blaze bernstein teens mission to ensure sub or teen stays focused and bringing forth the countermeasures we need to protect the American People from a range of chemical biologic and radiologic threats. Y. Is an important that this nation not be diluted by matters or mandate that require barta to work on those outside of the threat specifically and how does the comment of 34 innovations relate to a focus on its mission . I think the key thing here is to remember what the mission was essentially and again barda was only part of the puzzle with a 10 the 10 year dance appropriation of the critical element of that formula of success which was the guaranteed market to manufacture to get it across the finish line but the key issue that you have raised sir is we cant boil the ocean. Quite frankly the barda model works and the resources that have been given to sub their teen are somewhat limited. We have had literally in some circumstances had to rob peter to play paul in the events that have transpired with ebola and other events. We dont have a sustained level of funding necessarily a line item for pandemic influenza that would give us great confidence that the would have to sustain uninterrupted funding streams so the answer is arguably we could do more things but the answers you can do more things with limited resources. If the focus on the National Security mission which i think is vital to the role of barda and highlight the fact that right now to use a defense analogy we are operating with a half an Aircraft Carrier of resources to basically do this mission. The National Security mission to protect nearly 20 Million People people. Thats a challenge. Your gottlieb in your experience working in countermeasures and what challenges have you seen in the medical countermeasure pipeline . I think we are doing a much better job now. I looked at this over a 15year period. I think we are doing a much better job of cleaning in with respect to trying to bring some of these technologies forward in trying to look at ways that we can develop the models on the basis of some of these products perspective guidance and talk to manufactures provide regulatory clarity. I think there are challenges around this market. Frankly having been on the other side of this in the private sector at the prospect of commercializing something for stockpiling purposes isnt enough of an incentive for the e capital cost of some of these endeavors and we are looking at you know we focused on some of the immediate dangers from the pathogen to renew and develop countermeasures and we are looking at a future thats much easier to bioengineer some of these things in ways that we cant fully anticipate. Senator murray. Thank you very much to all of you. In the wake of Hurricane Irma as hospitals were evacuating the top priority was protecting vulnerable populations including people and individuals with disabilities and children and pregnant women. In every Public Health emergency we have got to pay unique attention to people with functional needs that put them particularly at risk and that is true for preparedness planning and Emergency Response including for example making sure theres adequate emergency, adequate Countermeasure Development and dosing guidance for children in pregnant women. Papa technologist there must be specific attention paid and i want to focused on the authorization part i want to ask you to be too briefly this describe your agencys efforts and what more can we do to ensure when it comes to Public Health preparedness we are prepared for everyone and. Or dr. Redd we will start with you. Thank you for that question. Let me highlight a couple of things that we are doing at cdc. First of all our guidance to the Public Health emergency Preparedness Program requires that states have a plan for persons with functional needs so that is part of the planning process. We also work closely with the American Academy of pediatrics and the American College of obstetrics and gynecology depending on what emergency is that working with them to make sure the needs are being covered. The stockpile that we have made progress in procuring products that are needed to treat children. For example there are 100,000 treatment courses of tamivir in suspension form that are targeted for children. I think there is always more work to do. I think we need to make sure these plans are exercised and we have covered all of the bases in their notches written on paper but we actually are able to execute the plans that we have made. Dr. Gottlieb. Treatment guide lance can help guidelines with respect to pediatric dosing which we have used. We have approved 12 drugs under the animal rule. Seven have been approved with dosing requirements. This is some things we need to do better. I think one of the ways we will do that is to have Better Development of animal models that have better histories associated with the pathogens in those animal models that allow us to predict what the therapeutic impact will be on the pediatric population. This is basic research would need to do to develop those models that allow them to extrapolate the population and other populations, overall populations and dosing guidelines for those populations populations. Is there anything we can do to help improve that . To senator burrs point papa gave Agency Resources and we have developed discrete expertise in the area as a result of legislation i think thats a place where we continue to make more investment. Id like to highlight during the hurricanes we did some specific things around people with functional disabilities. I dont know of many members have heard of and power of program that allows us to identify database for medicare come people who are dependent on Durable Medical Equipment so based on requests from the state we can provide very specific information where these people live by zip code and by address. Florida was able to do ever were first 911 call so these people at risk well before evacuation orders came out to the general public to advise them that they should consider leaving before things got worse. In the cases of maria we use that data to identify on the islands of saint thomas saintecroix people who are dialysis dependent. We were able to link them up with searchandrescue teams and recover dialysis dependent people and basically evacuate. There is that part and one of the limitations crently is thats only for medicare data. Ere is state medicaid data which is limited. We can do that if we have access to that so thats one area we could benefit from working with you all to see how the states can work collaboratively to use that information prospectively. To add to the points that were made by the other gentleman clearly barda has looked at immunocompromised and products in the stock of the day that benefit of those populations. One of the areas that i highlight in my testimony is the National Disaster Health Care System. One of the specific areas we like to do is take the Lessons Learned from ebola and we created a national excellence, center of excellence at gabreski university for Infectious Disease and replicated back for other important from a related door disaster related areas like pediatrics. We think that would be a way where not only can you create necessarily a Critical Mass of expertise but also teach medicines and consultation to provide during these disasters and a shout out to the va. The va was a significant contributor to the response to barda. Hhs responded and took care of 36,000 patients. Many of those were va beneficiaries but some of those, many of those were family of va beneficiaries and a larger number were the general public. The va has capabilities that the relates to geriatric populations and thats one area became probably benefit from in terms of utilizing some of the expertise. Thank you very much. Thanks mr. Chairman. Doc or sub three and dr. Gottlieb lets talk about the flu. This is the 100th anniversary of the 1980 influenza pandemic that killed an estimated 50 Million People worldwide 600,000 in the United States. According to the center for Disease Control year in and year out between 12,000 an 56,000 americans die as a result of the seasonal flu. We heard last week in opioid hearing that opioids kill more americans than Car Accidents and those statistics that i just read would suggest in a severe year so could the flu. Dr. Collins ahead of the National Institute of health has made the prediction before a committee that we keep up our investments and biomedical research. Senator blunt senator murray and the rest of us have been doing pretty well for the last three years. We may have a universal flu vaccine as well as a vaccine for zika within the next decade and dr. Fauci at nih has said the most effective method for protecting americans against another pandemic influenza is to encourage in Development Stock piling of influenza vaccines that will protect against the virus. In tennessee the hospitals are filling up with people with the flu. Dr. Kadlec and dr. Gottlieb researchers are nih discover a Platform Technology that could speed the development of a universal flu vaccine what would barda do to support the advanced research and development of that technology and dr. Gottlieb what is the fda ready to do to encourage the use of that technology for Innovative Vaccines . I have three minutes. Mr. Chairman i will be very brief. Barda is an integrated portfolio so once barda gets through Clinical Trials and they transition to barda that part of it is done. They could produce that in eggs or tissue culture or emerging technologies. I will quickly add we have in Development Vaccines that might be universal flu vaccines and could achieve what you are outlining. We have provided advice to clinical developers and manufacturers and looking at trying to bring those technologies through. I would point to one place where the legislative suite we have adopted to address some of these biological threats is in the development and manufacturing of these new vaccines which we have made a lot of investment in as you know. That could provide the proper platform for developing these vaccines. Dr. Gottlieb we are all concerned about puerto rico and the impact they are. You told me at one point maybe one third of puerto rico has to do with medical technology. That is right. Many of those facilities that you described are destroyed. Are they rebuilding in puerto rico or other places or do you know yet is that could have a major effect on puerto ricos future. We are obviously for a host of reasons not the least of which is the puerto rican economy is based on a skilled base. The facilities we were concerned about could go into shortage and now back on the grid. The facilities didnt sustain a lot of damage. The power grid in the infrastructure between the facilities to move equipment on and off the island were fairly hard and that there are still some facilities that arent on the grid but they have such redundant generation capacity that we dont have concerned about it. The situation now looks a lot better than it did four months ago. Mr. Chairman i think my time is about a. Thank you mr. Chairman. I wanted to start with the reference i made earlier to the Train Derailment in philadelphia and the good preparation. Part of that is that it happened in an urban area where you have not just the resources but you have hospitals and other health care of the structure which is close by way of distance as well as by coordination. I represent a state that has 48 Rural Counties out of a total of 67 counties so we have a lot of small towns in rural areas where you dont have the Institutional Capacity necessarily and in the event of an emergency that could be exacerbated by distance and other challenges. When you have this type of gap or potential gap where some communities may be particularly vulnerable i will start with dr. Kadlec and then go to dr. Redd in terms of the hospital programs like hpv how did those programs intend to close the gap appeared in his among states and regions . Thank you sir for the question. The point is the way we are structuring to promote Health Care Coalition which are collections of hospitals as well as other entities like Emergency Medical Services. Thats why we would like to understand that effort. Not only would it cover specific regions that it could develop a much stronger path to do this. The idea of basically building out the National Academy of sciences basically a study on trauma systems which is worthy of reviewing because it highlights the Important Role and the foundational capability for the country not only for daytoday routine activities but extraordinary events, Train Derailment. The state of washington as an example, an essential piece of that. To leverage all of those pieces together with some of the federal assets the vi identified identified. And they provide significant healthcare to seniors and the callout also invested by the United States government and the control groups through the virginia where you can do that research and the Veterans Administration which brings me to the admiral. And having a false alarm on the missile attack that was unsettling to the people of hawaii. That is the emergency grant where you get the wrong information with pandemic at the wrong time but we concentrate on that on pandemics or on diseases . That get to the core requirements so the information you are providing is as valid as it can be. But people need to know those caveats are expressed. Getting to the basic principles of Risk Communication to tell people what we know or what we are doing. Doctor gottlieb i appreciate from senator casey with these Rare Diseases that affect children now the first drug has been approved issued by the department, and to expand the use to encourage the development it is costly to develop, how do you intend to use that with new pharmaceuticals . As you know the Program Provides an additional incentive so it is one of the tools that congress contemplated those challenges that we talked about. That this isnt a typical market with the marketbased incentives to make those Capital Investments for the products. There is work going on there is implementing a program for the prv to sell in the secondary market as a way to recoup the cost of the investment. I have done a lot of work on a disease of young people with a personal situation in my district and in the house im interested in that. There is no cure but with the Gene Therapy Development and the Delivery System between the body and the brain there is hope. Do you issue guidance letters to Research Facilities and hospitals for guidance for breakthrough drugs like that . I think one of the areas of promise is at the center of biologics with the gene based therapies with those inherited disorders that are not treatable just a short time ago. We will be putting out guidance on how sponsors could address the dream therapy to have as much long gene therapy and then look at the most common disorders then these Rare Diseases and what the pathway forward would be. I commend you on your leadership anyway we can. Thanks for your testimony and all your help. Senator smith . Thank you very much. Chair alexander and senator murray i am pleased to serve on this committee. I like to come to what they have talked is local connection and support from public organizations. Over the past year in minnesota we have dealt with three Infectious Disease outbreaks, measles, multidrugresistant tuberculosis and syphilis requiring Immediate Response as well as sustained response going forward. Long minnesota has invested heavily in Emergency Preparedness probably because of history and agriculture. But in these particular situations they were not enough so we turn to the cdc for support and there were no resources there. So we move forward with the state legislature because speed is of the essence dealing with an outbreak. So my question is and what ways does Emergency Response find strength in our efforts during an outbreak or after a disaster . Can you talk about that . That would be helpful. Resources are critical responding to an emergency we have had lengthy delays before funding became available and that hindered what we could accomplish. There has been discussion about how to do that i think those would continue but along those points would be helpful. Something we have done specifically when funds are available, we have a notice of funding opportunity to put the grantees through the Health Emergency Preparedness Program allowing them to apply for an improved but unfunded grant mechanism so we are delayed at the federal level. If i can just add there is already authorizing language of 57000. It isnt the authorization problem. But to highlight the fact it should be funded managed by the secretary based on Public Health emergency. There could be distribution of funds from that resource across hhs in a way that is rapid. There is a need for the Disaster Relief fund equivalents but obviously to notify congress in certain iterations on the basis of reporting back on some occasions that the funds are spent appropriately. So we need to make sure we have good accountability that is what i would completely agree with. So dr. Kadlec if the fund was available what would you advise without level the funding necessary to have this be workable . I have to get to that in a firm number but with evil lie or influenza those appropriations between 2. 5 and 3. 5 million. But hedge that opportunity for congress to weigh in fully. Obviously there are a lot of factors to be considered but historically to be drawn upon through the initial crisis to the point where congress can share responsibilities. Thank you very much. Senator i was stressed about what you said sticking on this committee and also how important it is to think about the process in place with the authorized legislation to make sure it works well. There is some good food for thought as we could respond as quickly as possible in the emergency. We welcome you to the committee. Senator young. Chairman the World Organization for Animal Health estimates roughly 60 of known human disease is are transmitted from animals to people from zoonotic origin every year five human diseases appear such as ebola, hiv new strains of influenza and three of which are zoonotic. In indiana we suffered considerable losses leading to the disruption of 400,000 turkeys following 2015 with the outbreak of 48 million so what can you do for the spread and transmission of diseases . I have to say quite frankly what you are outlining is important of those potential those are examples of others and we need to defer to the cdc with their rule of surveillance because they are the cutting edge recognizing rapidly. Thank you. We are working very closely with the fda on this issue and in particular influenza. We were joined at the hip with the importation of the Avian Influenza viruses. To understand we have that biology that those are rapidly detected and protect workers in the process. No doubt you do the best you can with the resources that you have. How are we doing responding to these situations . And second with those resources to optimize your efforts . I think given the strategy that is reactive, we are doing well. That predicate caught my attention given the strategy is reactive. Right. The ability to prevent importation of influenza virus transmitted by migratory fowl for example, there is a lot done but it is a challenge. But the basic identities to limit to the extent possible to a small an area as possible and prevent human infection should the virus be transmitted to be infectious to humans. So to talk about the importance and then to extend the authority to animal drugs to contemplate how we create incentives to put that breakthrough therapy designation so that is part of that as well. I look forward to working with each of you for followup questions for dealing with these matters. But doctor gottlieb you mentioned incentives in the animal context but i would like to pivot to the antibacterial resistance. Every year 2 Million People require serious acquire serious bacterial infections resistant to antibacterial drugs. But there are very few companies that are developing new antibiotics and those focused on the most serious threats are even fewer. Is additional action needed to incentivize the development of drugs to combat this global problem and if so what might they look like or met white we do as members of congress . Creating a number of new vehicles and incentives we are encouraged those pathways and i think we will have more information to contemplate additional policies i would be happy to work with you on that this is the point to think about what we could be doing but congress has taken steps recently we are very encouraged by. I have great confidence in this committees ability to work on a bipartisan way. With two observations and a concern that as you have alluded to, one of the task of Emergency Preparedness is to prepare for attack like chemical or biological even talking about hawaii this weekend but for the record, the prospect of nuclear war is discussed with frequency in this building to a degree i have ever seen the Senate Foreign Relations Committee there has been a discussion of the Korean Peninsula arm services where they volunteered in public as a member of the administration to reconstruct kansas city would be under Nuclear Attack i noticed an article the cdc wants to people prepared for nuclear war it was supposed to happen yesterday the cdc will present a workshop title that if they survive would be responsible to oversee Emergency Response and a Nuclear Attack. Although that is unlikely and there is limited time for credible protection steps despite the surroundings so join us for this session to learn the Public Health programs to prepare for nuclear detonation. And those are similar from other Emergency Response planning efforts. And the article goes on to say preparing for the on thinkable with a roadmap to radiation preparedness drives the response efforts. I understand they rescheduled that from yesterday with the roundtable on the flu instead. But this realistic discussion about the prospects with the doctor strangelove like incident where estate went out a mass email there was a Ballistic Missile incoming creating 30 minutes of panic panic finding out that north korea fired a missile in japan and then that was retracted within a few minutes. With the prospect of nuclear war. And i want to put that on the record that is a normal area for discussion is days. I find it incredibly frightening. This is a discussion of National Security right now the spending bill and january 19 and if we could find the defense accounts you are about National Security and all agencies are funded as not as part of the federal budget. So to increase the Defense Budget and to put nondefense agencies would not fund the National Security priorities. So here is my question. So with the hawaii incident so we know from history wars are started accidentally with a miscommunication overreaction. That is how most wars start. There will be a hearing in the House Armed Services committee and an investigation at the state level the part of the responsibility dr. Kadlec with the Emergency Preparedness side is communication. As a former mayor and governor that depends heavily on state and local officials. So with this climate where they can be tense, how do you look at that statement effort especially during with communication and not inAccurate Information . Taking it very seriously with Hurricane Maria to highlight the challenges to identify the command issues we have to address. Information out and information in and the issues we need to work with the cdc and state and local authorities. How do we integrate our efforts with those kinds of issues with the hurricanes or pandemics. So just to highlight one thing because we have been around the block to the u. S. Government to exercise the idea that most concerning was terrorism obviously the context is different but to your issue there is a closer mashup with our federal partners with those cross lateral information with state and local officials. That is just another example both the health and disaster people to work more seamlessly we are looking at those options right now mac i appreciate it. I hope you follow the investigation for your own purposes to have good information with that coordination i suspect there are lessons coming out of that with other circumstances as well. Mr. Chairman i want to applaud you for your leadership in this area. More than a decade ago we established a Security Program leading to the radiation portal monitor being installed at major ports so they could screen incoming and outgoing cargo, products and individuals for radiological material. With that Port Security efforts with the ability to effectively and respond to the attack using the biological or chemical agents so i would like both doctors to address the level of preparedness to respond and detect a chemical attack and specifically to know whether cities have used the federal funds to install sensors that would be able to detect these agents. Also i would like you both with our hospitals to cope with the victims of a biological attack. I remember being in israel many years ago to be so impressed with their preparation and ability to convert their hospitals to respond to that type of attack. Senator collins one of the issues is currently run by the department of Homeland Security area of protection there is a real desire over dhs of improvements to make that chemical and biological attack quite frankly those capabilities are limited quite frankly and a sincere desire on the part of hhs to do improvements to do that and how well prepared we are certainly the strategic stockpile there is work to do there with those issues but that critical area with that last mile of distribution as mentioned by senator murray we can move the stockpile resources anywhere in the country within 12 hours. But from that point forward getting it into the hands of every american who is at risk is a significant challenge collectively we need to work on. This is an important question. If we are attacked in this way the effectiveness will depend on the speed and scale of which we respond. The way that a biological attack would manifest itself would be different than a chemical attack that would require a near instantaneous local response. The cdc stockpile has employed candidates for nerve agents that are available to supplement the treatment available immediately. Also to have better capability to determine which toxin is used there is a laboratory element. On the biological side we made Great Strides with a Laboratory Response Network Every state has one laboratory to use advanced techniques to diagnose these infections. 150 laboratories to test food and water and environmental samples from animals. So that technology of genome sequencing is what we need to push out this is more information from Current Technology like a resistance to antibiotics like where did it come from kinds of questions. Thank you. I would like to add one thing. Even the bad overwhelming the hospitals. Thats why i asked the question. Thank you. Senator jones welcome i did not acknowledge you earlier but we are glad to have you here. With many different points of view this is another subject we intend to have bipartisan success. Senator warren . We are here to talk about the framework for all sorts of emergencies hazardous materials, terrorist attacks, pandemics, Natural Disasters, i returned from a trip to puerto rico. And during my trip it was clear four months after the storm the crisis is a daily reality for hundreds of thousands of people. To be in charge of preparedness and response at hhs what is the biggest thing you have learned how we need to strengthen our response capabilities . I think there are a couple of levels to go. With that healthcare structure. And with that resilience of the Public Healthcare system and importer rico in particular after that terrible devastation that literally devastated the whole island and every life was touched. But there are some incredible aerobic stories. Those with the Public Health officials who left their families and house is in disarray leaving to respond to their neighbors but what happens before the storm but then how quickly can we move in . We deploy teams to puerto rico to be available once the storm passes but even so with that level of devastation that huge piece was the lingering devastation but a damage to the port in the airfield that limited movement. So to go in aggressively before and put peoples life at risk from response people including massachusetts who responded to all three storms. They are great people representative of scituate but also a piece of those tendencies to see how we can move quicker and faster a lot of that depends on transporting to the air or responding to the island is tough. I appreciate this on glad we are thinking what we need to do but we need a better structure but we also need good data. Not just what we got white right or wrong but by how much in the difference weve made on the ground. What struck me during my trip last week was the sketchy data. I met with the federal and puerto rican officials said no more issues with Potable Water. All water is drinkable. I turned on the tap it is drinkable everywhere on the island. Sounds great but not so much. Meeting with the Massachusetts State Police officer who said they observed raw sewage in the water at the Public Health center they still dont have Potable Water for patients and they serve 100,000 people and nobody has drinkable water with the same contradictions with the statements how many people lacked power. So dr. Kadlec Public Health emergencies are challenging but how does hhs and other agencies collect data so you can employ your resources to hold yourself accountable to do what needs to be done . Learning from that experience and rectifying that the laws of communications to get information from local authorities or hospitals we literally went to the point to hughes runners from the National Guard who had satellite phones to go to hospitals or clinics but that is a major consideration that we have to address because if you have a terrible event or radiological event or nuclear you can imagine those circumstances would be more challenging. I am very concerned and im out of time but senator cassidy and i sent a letter to chairman alexander asking for a hearing on the recovering efforts Recovery Efforts puerto rico and the virgin islands. That they not be contagious but it is a humanitarian crisis we have a responsibility to exercise among other responsibilities. Thank you. Senator cassidy . Dr. Kadlec earlier responding to senator smith the Emergency Fund said with the ebola crisis with those authorizations that had to be signed off before they could travel to africa. That is crazy. I kept contrasting that authorization process without before and after katrina where they had to get the initial dollars that they recognize that isnt the best way and if it goes over that and we have another authorization. So we have put together a bill of the contracting requirements so you can deploy people during that period so with the previous 14 years to take the average of that expenditure to make those dollars available. It is still accountability to make sure the cdc doesnt go to hawaii for a conference, no offense but the point to have that built in. Now moving onto something different, i was struck speaking to people in retrospect i would be a million on the stock market but you could have predicted what would happen because brazil is flying and folks from the South Pacific to work on the lithic stadium loan Olympic Stadium that the deacon virus was breaking out where they were coming from and brazil is a petri dish and you could have predicted that. So now we can put in the travel pattern and the area of receptivity and at first blush guess where the next epidemic will be. Wouldnt that be great or is that not practical . I agree another way to look at this is the pathway that zika virus followed was similar to chicken good yeah a few years before causing a big outbreak and brazil and south america. With outbreaks in the caribbean we know travel to the u. S. It is the same place we have seen the outbreaks in the past. If we could use this predictably we could see brazilians will have this problem so lets go down there. It is hard to do that. The vector is very resilient. I just gave the example of spraying misty he does my mosquitoes but can we look at travel patterns with an outbreak to guess a spread of the outbreak . We can but the challenges what do you do with that information . To prevent the zika Virus Outbreak in Miamidade County . You are ahead of us but that is different if you can acquire the information so are we putting those systems in place . Just to take the zika virus example there are florida or the gulf coast areas that recognize recognizes. That is still afterwords after we knew there would be triple from brazil we are trying to do reactively on proactively. So to look at the South Pacific it is predictable that would break out here. That takes it to the enemy so are we doing that . Do we have a worldwide map of hotspots overlaid with the travel patterns to guess, and i understand the cdc so im asking closer to the point. The quality of information is there. I dont think we have for example the information about influenza is better than the mosquito borne diseases out there. We know what viruses are circulating in china because of influenza and the risk for a global pandemic. I have seen maps which it shows here is this or that and the hotspot of a particular virus cannot not be overlaid with travel patterns . Some discussion talks about the numbers of diseases that cause infections in humans in certain parts of the world. But your question is how do we use that information . We do have travel maps where they travel to and from and various diseases occur at variable degrees of granularity. So how you use that to take a preemptive action is the question you are getting at. I yield back. I want to ask either of you about the cost of the vaccine delivery of a. What are our thoughts on perturbation to ensure we not only have the right amount of vaccine but the vaccine delivery devices . That is one of the problems that has to be addressed and if he is welcome to at this point. Even to have better delivery or better vaccines and one dose. 600 is two per person and there are new vaccine technologies that allow you to do it. All of those issues are being evaluated and pursued yet there are significant shortfalls as a matter of concern. Until the supply standpoint of making sure we are tapping into the existing commercial market and are able to leverage that system to stockpile without market can produce. Such a wonderful model working with the industry you develop the countermeasures. In connecticut this Protein Sciences which come out with an innovative way to develop a vaccine not traditional eggbased but they Dna Technology mechanism. They raised the issue of how you make sure having spent the money to develop the vaccines there is a market so they continue to develop the process and they are available. Whats the responsibility. It is in a marketable vaccine to ensure a bridge market exists. It goes into the Publicprivate Partnership and has been the case that we need to look a looe whole variety to not only get companies and to keep them in the marketing and viable going forward. If you dont get the opportunity to use it for some other commercial purpose. These are issues that are quite frankly one of the areas that deserve a little more consideration during the reauthorization i think you raise a very valid point if we talk about a countermeasure that doesnt necessarily have a dual use the only market is going to be in preparedness and stockpiling. Depending on what youre developing the cost of m. Be too high to justify. We tried to offset some of that but i will say that the value in the marketplace have diminished so the value to add incentive has gone down over time. This is something we should all contemplate. Appreciate the discussion here this morning. You recognized in response to the question and the challenge that puerto rico faced. They are not connected to the continental United States and we dont have a lot of roads. It speaks to how you respond to an outbreak and your ability to move in quickly and limited because of access limitations and we were reminded of this with all of the airspace. They can take out a major port that serves as access or airports. We had to b have to be our own e island when it comes to response, but you try to give stockpiles of vaccines or the likes. You can get stockpiles anywhere in the United States within 12 hours, did i hear that correctly . Should i be worried in a small remote not accessible by the road shut out by whether we cant even get a state trooper in the first three days. How do we ensure we can be responsive in these areas into the other part of the question is when it comes to the infrastructure of itself, we have the first sizable cruise ship going through the arctic and all kinds of emergency preparation drills and its not because we were most fearful of an oil spill from a ship that might hit the ice but an issue on a ship where you now have 500 passengers who need a level of healthcare. Whether it is an outbreak or some kind oweresome kind of a de natural or otherwise wants assurances can you give us from those rural states coming in i will turn to doctor m. And q. , admiral. The reality cant get anywhere to be delivered to the state authorities. The ticket to th the last termil mile where people need them and that is an issue of shares concern where the work has to be done and would have challenges. We have the telecommunications and access to laboratories and the investigations that would also be limited so this is probably fought off as a broad set of capabilities that are needed to assure the protection of populations. The. Its based on the Climate Assessment predictions and the impact of alaska as the state is seeing the impact of Climate Change you might not feel it here in the east coast but its warmer back home. They were able to tree as thosee nasty mosquitoes and they cant move these levels of outbreaks. Once again thank you for your welcome to the committee. I think senator casey may have highlighted into how they were talking about the roles. We have the ability to get them thinking like that. Whats being done for this kind of emergencies with the communities that are not having the daily healthcare that the immediate healthcare needs can be given to. One of the areas i touched in my testimony is the idea of creating a Natural Disaster Healthcare System taking advantage of the trauma system we have in our country. Its to not only cover states for mississippi and alabama as part of the country where you can actually share the resources and do better coordination mutually in those kind of situations and build the kind of relationships where you know about that availability. To ensure their survival there is a lot that can be done to. In some alabama has a few major cities in mobile and clearly there are some great facilities there as well as other parts of the state. One of the things weve done in this examine there are publication issues related to oral health and in health journal. I also was going to ask a question about citizens with disabilities. We provide two states in california as a part of the norm for those that would be at riskk to the Power Outages and what we probably special assistance if they needed to be evacuated and thats one piece of the problem quite frankly we dont have the data for medicaid for the individual states to. To include a section with a vulnerable population is the response plan. When we activate our Operation Center for the Emergency Response there is a functional desk on vulnerable populations to deal with this kind o those f issues that come up. Do you have any questions or concluding remarks he would like to make . We look forward to hearing from the nongovernmental stakeholders about how we can continue to strengthen their readiness for the future Public Health emergencies and keep the American Public safe and the emergency prepared this continuous and must devolve into these new and different types of threats. I remain committed to and sure the progress we have already made and prepare fo prepared foc Health Emergencies or i should say while continuing to work to anticipate the next thread. We have a strong bipartisan history of working together on this committee to improve the communitys ability to respond to all manners of Public Health threats and i look forward to continuing that tradition in the months ahead. Thank you for your work on this as well as the Ranking Member. Thank you, senator casey. This is one of the on many areaf reauthorization of the legislation to prepare the country for the unexpected disaster that might occur. A lot of progress has been made and i want to thank senator casey for the leadership over the years in this area. As he indicated, we will be having our second hearing on this topic next tuesday, january 23, working with senator murray, senator casey, senator burr and others. We hope to be able to write legislation revisiting this act and mark it up in the committee this spring and present it to the senate for bipartisan action. So i think the witnesses for coming today. The testimony has been helpful and attendance has been good. Record will remain open for ten days and within that time if they would like to set additional information. The committee will meet again tomorrow on a different topic of 10 a. M. For a hearing entitled reauthorizing a high year education act, Financial Aid simplification and transparency. Weve been working on taking a new look at the federal governments relationship to the colleges and universities. Theres 6,000 of them. Our major role is that we appropriate about 34 billion a year in grants for students to attend colleges and there are more than 100 billion new Student Loans each year in connection with all of that money theres a lot of opportunity and need for us to look at the innovation and simplification getting through the general red tape and other activities. There will be our major focus during this year and we hope also to have that Bipartisan Legislation in the senate floor sometime this spring. Thank you for being here today. The committee will stand adjourned. [inaudible conversations] [inaudible conversations]