Response capabilities. We will hear from dr. Robert kadlick, assistant secretary for preparedness and response at the department of health and human services. Dr. Steven redd, director of the office of Public Health preparedness and response at the centers for Disease Control and prevention, and dr. Scott g gottlieb, commissioner of the food and Drug Administration. 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 im going to turn to senator alexander and senator casey for any opening remarks they might have. After that, we will introduce our panel of witnesses and hear their testimonies, and then each member will have up to five minutes for any remarks and questions. Finishes first i would like to welcome the chairman and thank him for giving me the opportunity to hold the gavel today. This hearing discusses a topic thats critical to our National Security and has seen many years of bipartisan work in this committee and in this congress. Together, we have developed and strengthened the framework to ensure we are prepared for chemical, biologic, radiolodgic and other tlinhreats. The pandemic and all hazard preparedness act created a framework which has grown and changed as weve learned from each Public Health experience we have been through. We should be proud of the accomplishments and the progress made over the last decade. Our work has resulted in strong partnerships with our states and local counterparts, created greater certainty and accountability to bring forward medical countermeasures and establish a Clear Strategy with which we can combat the full range of Public Health threats we face today, and those 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 Panel on defense stated in their 2015 report they are, i quote, serious gaps and inadequacies that continue to leave the nation vulnerable to threats from nature and terrorists alike, unquote. As we move forward, in 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 its critical that we bring with this discussion the vigilance, urgency and resolve this mission demands. We are in an unprecedented era of technological and biomedical innovation and advancement. In november 2016, the president S Advisory Council on science and technology warned that, i quote, while the ongoing growth of biotechnology is a great boon for society, it also holds serious potential for destruction destructive use by both states and technically competent individuals, unquote. I urge the u. S. Governments past ways of thinking and organizing to meet biological threats threat needs to change to reflect and address this rapidly developing landscape. For this reason, its 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 hhs in particular to meet these challenges. An hhs that fosters innovation and the development of medical countermeasures and across the framework provides the greatest hope to ensure the safety of the American People. The witnesses we have before us today will be able to provide insight into the urgency of this mission and the promise innovation holds, if properly leveraged. I look forward to hearing from each of you about the progress that weve made and where we can continue to improve policies and programs to realize their full potential to save americans lives. Now i would like to turn to senator murray for any comments she might have. 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 all hazards preparedness act later this year. I especially want to thank senator casey and senator burr for their bipartisan work and leadership on this really important issue. Local Washington State papers show why todays discussion is so important to families across this country. We have headlines like flu deaths and cases increasing in pierce county, and flu outbreak kills five, 50 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 our 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 of a global scale. A pandemic could affect half a billion people, more than the entire population of the United States, and thats not speculation. It happened a hundred years ago. The 1918 influenza epidemic was a tragedy more deadly to the human race than world war i. Today, the threat of pandemic flu is joined by new threats. So 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 so many partners supported nigeria as they instituted evidencebased policies and tracked the path of that disease, and contained it when the outbreak reached lagos, the answer is clearly yes. When you consider our Strategic National stockpile which can deliver 50 tons of emergency medical supplies anywhere in the u. S. In 12 hours, the answer is clearly yes. When you consider the fdas approval of new medical countermeasures to combat anthrax and flu and radiation mrai 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 too slow response in puerto rico and the u. S. Virgin islands after Hurricane Maria. The storm left Many Americans without access to clean water and electricity and health care for months. We can do better than the administrations response to the opioid epidemic. President trump declared the crisis a Public Health emergency 83 days ago and has taken little meaningful action since. So im glad this committee will continue its bipartisan work to address the Opioid Crisis in another hearing soon. We can also do better than our slow response in improving funding to combat zika in 2016. The World Health Organization declared zika a global Health Emergency in february. Instead of a Fast Response with needed funding, the response got politicized around some republicans who pushed to undermine Womens Health care and access to contraception which was a key requirement to prevent the virus from causing devastating birth defects. As a result, that took Congress Nine months to pass emergency funding for a Public Health crisis that endangered mothers and babies and families across the world. That delay hurt people and it harmed families in ways they are going to carry for the rest of their lives. So we have to do better. We are most successful at protecting our families against pandemic threats when we respond with quick bipartisan action. We need decisions based in science and 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 cant overlook the young or the elderly. We cant 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 antibiotics to combat resistant bacteria. And we must continue strong partnerships with industry that will allow us to rapidly respond to new threats. We need to stop fear and uncertainty before they create panic by getting families helpful and Accurate Information from sources that they trust. We cant allow anyone to undermine the science of Proven Solutions like vaccines. We need to respond to Global Health crises abroad before they travel here to home. Diseases are not stopped by borders or walls. This is a place where the United States can and should lead. We should continue to show our International Partners that we are focused on these issues and will be their ally in preparing for and addressing Public Health threats. Congress has a strong bipartisan track record of addressing these challenges through the laws which strengthed our Publics Health preparedness. Reauthorizing the act in 2013, we built on that record and enhanced medical Surge Capacity, modernized biosurveillance capabilities and increased our focus on atrisk individuals. Im hopeful we can continue that progress with legislation that focuses on the science and evidencebased policies we know work to mitigate Public Health crisis, that considers the needs of everyone and puts families and women before politics, supports state and local Public Health officials, ensures communities dont spend months waiting for needed emergency resources, and enables us to respond to the next crisis with foresight rather than learn from the next tragedy with hindsight. We dont know what the next Public Health threat will be. We dont know where or when or even how it will start. 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 food and Drug Administration helps facilitate the development and review of medical countermeasures and grants emergency use authorizations for products that are needed on the front lines. The assistant secretary of preparedness and response guides our nations preparedness planning. They help ensure our Health Care System is ready to face any emergency, and it invests in medical countermeasures, pipelines through Biomedical Advanced Research and development authority. The centers for Disease Control and prevention is on the front lines 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 i am frustrated that director fitzgerald is once again unable to join us here today due to conflicts of interest presented by investments, our 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 that were having today. Im concerned that she still cant give her full attention to all the pressing Health Threats we face and hope that these conflicts of interest will be resolved soon. Thank you, dr. Redd, for joining us in her place. I look forward to hearing from you and all of our witnesses. Thanks, senator murray. Senator alexander . Thank you, senator burr. Senator burr, thank you for your willingness to chair this hearing. On march 2013, president obama signed into law the bipartisan pandemic and all hazard preparedness reauthorization act. Senator burr was the author of that reauthorization and the original legislation which became law in 2006. He worked with many senators on this committee, both democratic and republican, and i thank them all for that. Senator murray, senator casey and others, senator isakson was another of those. Senator burr is chairing the hearing and i thank him for that. I would also like to welcome senator smith from minnesota, who is joining our committee, replacing senator franken, who was a valuable member of the committee. Senator jones from alabama is also a new member of the committee. We welcome him. He replaced senator whitehead, who was a very valuable member of the committee i mean whitehouse, who has taken a lesser assignment on the finance committee, for some reason, but we will miss sheldon and his work on this committee. Im going to, mr. Chairman, 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 well go to senator casey. Thank you, mr. Chairman. I just wanted to reference the statements made by the Ranking Member, senator murray, whom i have talked to about dr. Fitzgerald. I talked with dr. Fitzgerald yesterday. 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. Im working expeditiously to see if we can get it done as quickly as possible so she will not have any conflict to testify whatsoever. Thats her desire as well. Thank you. Senator casey . Thank you very much, senator burr, im grateful for this hearing. Grateful to be working with you again on this reauthorization and commend your work on this. For many, many years. I i also want to thank chairman alexander and Ranking Member murray for this bipartisan hearing on the nations preparedness and response capabilities in advance of the reauthorization of the pandemic all hazards and response act known as p. A. P. A. I will give you one instructive story on how important preparation is. This is a good example of preparedness infrastructure that the act supports. In this case, in the aftermath of a tragedy, a Train Derailment that occurred in philadelphia in may of 2015. The train was carrying 238 passengers when it derailed, eight people, eight people lost their lives. Over 200 were injured in that derailment. Fortunately through funding from the Hospital Preparedness Program which we know by hpp, the Pennsylvania Department of health and Regional Health care and a Regional Health Care Coalition had long been working together to prepare local Health Care Systems for emergencies that could cause a surge in patients. When the train derailed, hpp funded systems were tracking bed availability in local hospitals and providing that information in realtime to Emergency Responders, who were at the scene helping them to effectively triage patients, send them to hospitals that had the capacity to accept additional patients so they could begin to receive the care they needed. Because these systems were in place, before the train derailed, they were ready to protect both health and to save lives when seconds, literally seconds counted. Yet security, Health Security threats are increasing at frequently 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 and supporting state and local partners to reduce the impact of Health Events in the country. I would like to thank todays witnesses for their service. Its important to mention your service to the country. As well as your commitment to protecting americas Public Health. We look forward to the hearing and grateful for the work that we can do today at this hearing. Thank you, mr. Chairman. Senator casey, thank you. 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 the bill. Now, having been in congress for 24 years, i realize that when you get involved in hhs legislation and fda legislation, there is always a temptation to fix other things. I want to encourage you to fight the urge. Lets keep this focused on perfecting p. A. P. A. Its been successful. We still have work to do but if we become distracted and create a fight over changes within fda that have nothing related to this, or hhs or somewhere else, because the sheer geography that this allows us to get into, we will lose the focus of what we are doing and thats trying to make the act even more effective in the future. With that, i would like to introduce our witnesses which will each have up to five minutes to give their testimony. Im pleased to welcome today dr. Robert cadlick, assistant secretary for preparedness and response at the department of health and human services. If he doesnt like the title, he was the one that created it. It was with the doctors help we created the position to establish a clear line of authority in the event of a Public Health emergency. Hes the person at hhs solely respond for leading and coordinating the federal, medical and Public Health preparedness and response effort across all the agencies within hhs, including fda and cdc. Dr. Bob, delighted to have you back today. Next, we will hear from dr. Scott gottlieb, commissioner of 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, vaccine, diagnostic tests and by ensuring these countermeasures are safe and effective. Further, the 2013 reauthorization aimed to improve regulatory certainty and predictability for medical countermeasures under review at the fda while also providing the agency with additional authorities to support Rapid Response to Public Health emergencies. Scott, we are delighted to have you here and delighted to have you in that position at fda. Finally, we will hear from dr. Steven redd, the director of the office of Public Health preparedness and response at the centers for Disease Control and prevention, cdc serves a number of roles under the framework and has built a strong relationship with state and local Public Health departments, an 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 and during a Public Health emergency. As part of this effort, cdc houses an expansive Epidemiology Laboratory capacity and its responsibility for biosurveillance 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 innovation. I believe the hurdle thats in our way is government. Clearly defining what it is that our need is and the certainty of a pathway for getting the approvals that we need for those to actually be deployed. I hope you will keep those in mind as you go through not just your testimony, your questions, but more importantly, in the roles that you carry out after you leave, understand you are on the front lines at making this happen. Dr. Bob . Floor is yours. Thank you, sir. Sorry for the false start there. Im excited to be here. I was ready to go. Good morning, mr. Chairman, both of you sirs, and senator murray and distinguished members of the committee. I assumed this role five months ago just a week 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 as you prepare to consider the second reauthorization. This committee championed the bipartisan effort to draft and pass this groundbreaking legislation. I want to thank you for continuing, your continuing 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 and the late senator ted kennedy. This morning i will share with you my perspective on the National Security imperative of the act, the missions and duties and my visions for areas of improvement. The constitution states one of the federal governments fundamental obligations to provide for the common defense, protect the American People, our homeland and way of life. The strength of our nations Public Health and medical infrastructure as well as the capabilities to quickly mobilize and coordinate National Response to pandemics, attacks and disasters are essential to save lives and protect all americans. Therefore, improving National Readiness and response capabilities for 21st centurys threats is a National Security imperative, as senator burr outlined earlier, and is the crux of my effort. The 21st century lehealth secury environment is increasingly complex and dangerous. It demands we act with urgency. Having recently left my job with the Senate Select committee on intelligence, i know these threats all too well. Terrorist organizations remain determined to attack the United States. State actors now directly threaten our homeland with Nuclear Weapons and have the means to employ both chemical and biological weapons. Further, we have witnessed the increased frequency of naturally occurring disasters as well as disease outbreaks and are currently monitoring potentially emerging Infectious Diseases that could cause a pandemic such as the influenza strain circulating in china. The bottom line is whatever happens, your con stitch yestit expect the government to be ready to save lives. When this position was originally established a decade ago, the objective was to answer a simple question. Who is in charge of all federal Public Health and medical preparedness and response functions. The approach adopted was based on the Goldwater Nichols act that unified the combatant commands at the department of defense. The mission is to save lives and protect americans from these threats by recruiting the entire weight of the federal medical and Public Health assets and recruit support of the Public Health sector to support state and local activities and responses to help americans in distress. I have four key priorities. First, provide strong leadership. Focus on coordination, planning and preparing for events that threaten the national Health Security. Second, develop National Disaster Health Care System. Third, advocate for cdc sustainment of a robust and reliable Public Health Security Capabilities and last, but certainly not least, advance an innovative medical countermeasure enterprise. Two areas of progress and opportunity i will elaborate on, Operational Health care readiness capacity and the medical countermeasures enterprise. The importance of the National Health care readiness and medical Surge Capacity was highlighted during this hurricane season, after hurricanes harvey, irma and maria. We led federal medical and Public Health response and recovery activities under the fra framework, working closely with fema with hhs disaster medical assistance teams as well as va and dod assets. We learned from these disasters that we need to update incident command and deployable medical capabilities as well as enhance our support for the Health Care Infrastructure across the country. As with medical countermeasures, the Nations Health care delivery infrastructure is mostly a private sector enterprise that must be effectively engaged in proving readiness. To address the potential catastrophic medical consequences of the 21st century threats, we need a tiered regional system thats based on existing local health Care Coalitions and Trauma Centers that integrates all medical response capabilities, including federal assets, as well as Emergency Medical Services, the front line of our response capabilities. We must expand specialty care, expertise and trauma, Behavioral Health care and chemical, biological, radiological and Nuclear Event response. And last but not least, incentivize the Health Care System to integrate measures of preparedness into daily standards of care. I call this the foundation of a National Disaster Health Care System. The second areas are medical counter enterprise. Im grateful that dr. Rick bright behind me, why dont you wave to the crowd, who is director, has joined me today. It was established as part of the act and is a component to bridge the socalled valley of death in the Late Stage Development of vaccine, drug and diagnostic development, when many products historically languished or failed. By using flexibility, nimble authorities, multiyear advanced funding, strong Public Private partnerships and cutting edge expertise, we have successfully pushed many Innovative Products to advanced development to stockpiling fda approval. To this date, 34 products have been approved by fda for the purposes of responding to disasters to the credit of dr. Bright and his predecessor, dr. Robinson and the team. We have opportunities to further improve this enterprise by streamlining our internal decisionmaking processes, finding new ways to support innovation, promoting flexible, Fast Response capabilities, increasing our collaboration with federal interagency partners. We also must work closely with our state and local partners as well as the private sector to enhance the capability to quickly distribute and dispense medical countermeasures in an emergency. In times of great challenge, we have the opportunity to build on the great progress made and further improve our National Readiness and response capabilities. I 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. Bob. Dr. Gottlieb . Senator burr, Ranking Member murray and members of the committee, thank you for the invitation to testify today. Our nation has faced many emerging Public Health challenges and unfortunately, will face additional challenges in the future. Thankfully, our preparedness and the ability to respond to such challenges has improved greatly since the original enactment of the pandemic all hazards preparedness act. Each emergency is unique. Many are the result of emerging infectious threats, but the technology for manipulating science for diabolical purposes is becoming ubiquitous and widely understood so we face new and pervasive risks. 2017 was marked by the risks posed by several extreme natural disasters which caused significant devastation and human suffering. These tragedies tested our nations capabilities to respond. Today, im going to focus my remarks on the impact of these storms on medical products manufactured in puerto rico and the actions we are taking to mitigate existing and potential product shortages. The impact of Hurricane Maria showed the importance of puerto rico to our medical Product Manufacturing base, as well as the intricate and sometimes fragile nature of that supply chain. I want to focus on the complexities of a saline shortage because it stressed our system. I know that many of you are deeply and rightly concerned by this situation. Saline solution has been in and out of shortage for several years. There are only a small number of primary manufacturers, so when one manufacturer lowers production even for routine maintenance, there is stress on the entire system. One of the largest manufacturers of iv saline is baxter and their primary sites for small volume bags are located in puerto rico. These sites struggle to regain power and return to full capacity following the storm, and roads to some of the manufacturing plants were disabled. We worked closely with baxter in partnership with the department of Homeland Security and puerto rico authorities and bob, thank you for your support as well, to ensure that they were able to get back on the power grid on a priority basis to stabilize production. We also worked with various saline manufacturers to find other manufacturing facilities globally that could help supply the u. S. Until baxters puerto rico location was back up and running and the sthohortage was addressed. To mitigate that shortage we worked with manufacturers on the importation of saline from ireland, australia, mexico, canada, germany and most recently, brazil. When we import from international facilities, generally the manufacturers adjust their distribution to send some product to the u. S. But theres no actual increase in the total Global Production of product. Baxters manufacturing facilities in puerto rico are now stable and on the grid, although the power situation on the island is still fragile. We expect their return to normal production will improve the situation. Before this storm hits, in anticipation of the crisis, fda also prioritized the approval of saline products by two manufacture manufacturers. Both should start production soon. Having these two additional manufacturers online will help increase the overall supply of saline produced and distributed in the u. S. But this shortage has also had ripple effects. In order to find work grounds for the filled saline bags that were in shortage, providers put various mitigation strategies in place. One strategy has hospitals co compounding product sthechthems. There have been signals indicating this increased demand is putting pressure on the supply of empty iv bags. Fda is taking steps to address this situation and determine which manufacturers could potentially increase capacity if necessary. I have reached out to some of these medical Device Manufacturers personally to inquire about their capacity to increase production, if demand for iv containers continues to increase. The scope of the flu outbreak across the country has also added to the strain on this supply chain. This shortage and the impact of the crisis in puerto rico underscores the need to continuously elevate our preparedness. There are going to be Lessons Learned from this episode. Already we have made key observations about our ability to detect device shortages, since we lack authorities to require notification of device shortages, we have had to depend on manufacturers and distributors reaching out to fda or had to seek them out. Our work in the shortage situation is an example of how the fda has reacted in response to emergency situations. At the same time, we continue to work hard to improve our regulatory clarity and predictability for the development of medical countermeasures. Thats an essential component of our National Preparedness strategy. Today, we release draft guidance on material threat medical countermeasure priority review vouchers which explains how fda implements the program to invent size the development of certain drugs and biolodgic medical countermeasures. I look forward to working with congress to increase to increase our readiness for emergencies and look forward to answering your questions today. Thank you, scott. Dr. Ed . Senator burr, chairman alexander, Ranking Member murray, i am dr. Steven redd, director of the office of Public Health preparedness and response at centers for Disease Control and im pleased to be here to talk with you today about the role cdc plays in Public Health preparedness and response, including those responsibilities under the pandemic and all hazards preparedness reauthorization act. Cdc is the common defense of the country against Health Threats. Our work to prepare and respond to Health Emergencies require that we build on our day to day work in two particular areas. Number one, our Longstanding Partnership with state and local Health Departments and number two, our medical, scientific and Program Expertise. I will describe the three pillars of our defense strategy, science, surveillance and service. First, cdc has a unique collection of scientific expertise that exists nowhere else in the world. We have the ability to identify agents causing illness whether that illness is the cause caused by an infectious microbe or chemical or radiation exposure. Ready to respond to a broad range of threats, including diseases like ebola, smallpox and influenza. Cdc plays a key role in discovering new and emerging 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. The second pillar enabling cdcs common defense of the country is surveillance. Public Health Surveillance is the collection, 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 influenza, the National Syndromic Surveillance system and the global Disease Detection. Influenza is probably the greatest natural Health Threat we face. Influenza viruses change continuously and require vigilance to detect these changes. Cdc provides support to every state, to several major cities and to a number of ministries of health throughout the world to conduct influenza surveillance and laboratory work. With the National Syndromic Surveillance program, cdc collects deidentified Health Information on causes of emergency room, urgent care and hospital visits. We along with state and local Health Departments use the data in realtime to detect abnormal situations requiring Public Health response. Cdcs global Disease Detection Operation Centers monitors 30 to 40 outbreaks every day across the globe, 24 7, and assesses the potential risk to the United States from these events. In addition to science and surveillance, service is the final pillar supporting cdcs common defense of the country. Let me focus on three particular programs. Public Health Emergency Preparedness Program, the Strategic National stockpile 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 to cdcs scientific expertise. The Public Health Emergency Preparedness grants go to every state and support staff, enable exercises to test and validate capabilities and pay for laboratory and communications equipment. The Strategic National stockpile is a 7 billion repository of pharmaceuticals, medical supplies and medical equipment thats available for rapid delivery to support responses to Health Emergencies. The Cities Readiness Initiative enhances preparedness in the nations 72 largest cities where nearly 60 of the u. S. Population resides. These funds are used to develop, test and maintain plans to receive countermeasures from cdcs Strategic National stockpile and rapidly dispense them. I would like to leave the committee with three primary points about cdcs role in Public Health Emergency Preparedness and response. First, cdc is the common defense of the country against Health Threats. Two, cdcs preparedness work is built on a day to Day Foundation of our broad and deep scientific medical and Program Expertise and three, cdcs Longstanding Partnerships with state and local Health Authorities are essential. Thank you for the opportunity to testify today. Doctor, thank you very much. You won the award for getting the closest to the five minutes of all our witnesses today. The chair would recognize himself and the Ranking Member, then senator alexander, senator casey and then members in the order of attendance to todays hearing. Dr. Bob, my first questions simple. Are we prepared for Public Health threats we face . Sir, i would have to say equivocally for some, but not all. I think the reality is when this concept first came up in 2005, we had witnessed the terrorist attacks of 9 11, we were anticipating potentially a pandemic and we had just kind of experienced katrina, but those are all kind of in the rear view mirror in terms of the threats that we are prepared to deal with. Quite frankly, if you had to look at a nation state threat that we are considering today, or multiple nation states that are willing to use terrible weapons against us, both physical as well as potentially cyber, i think we are not prepared. Quite frankly, those are the things that keep me up at night as well as a pandemic that could emerge again from asia, as well as the risks that come up that dr. Gottlieb identified with Synthetic Biology tools now that allow nefarious people to do unimaginable things, potentially. So i think we have a long way to go. We have done very well in some areas. Again, a compliment to the effort that was done by the federal government in support of state and local authorities and again, for those three hurricanes nearly consecutively, i think that was a great commitment of effort by everyone, but theres no time to rest on our laurels in that respect. The statutes very clear on the specific and targeted medical Countermeasure Mission to ensure that barta is staying focused and bringing forward the countermeasures we need to protect the American People from a range of chemical, biolodgic, rad radiologic threats. All our work should be tied to this threat context. Why is it important the mission not be diluted by matters or mandates that would require it to work on areas outside of those tied to the threats specifically and how does the comment of 34 innovations out of barta relate to focus on its mission . Yes, sir. I think the key thing here is remember what the mission was originally. Again, barta was only part of the puzzle here. Project bioshield which was a tenyear advanced appropriation was another critical element of that formula of success which was a guaranteed market to manufacturers should they get across the finish line. But the key issue that you have raised, sir, is that we cant boil the ocean. Quite frankly, the barta model works. The resources that have been given to barta to date have been somewhat limited. We have had literally in some circumstances to rob peter to pay paul, given events that have transpired with ebola and other events. We dont have a sustained level of funding necessarily a line item for pandemic influenza, for example, that would give us great confidence that we would have a sustained, uninterrupted funding stream. So the answer is arguably you could do more things, but the answer is you cant do more things with limited resources. If we focus on the National Security mission, which i think is vital, again, vital to the role of barta, then i think we have to stick to our lane and highlight the fact that right now, to use a defense analogy, we are operating with about half an Aircraft Carrier of resources to basically do this mission. A National Security mission to basically protect 320 Million People. Thats a challenge. Dr. Gottlieb, in your experience, whats working well in the agencys review of medical countermeasures, and what challenges have you seen in the medical countermeasure pipeline . I think we are doing a much better job now. I look at this over a 15year period. I came into the agency shortly after the admiral rule was implemented in 2002, between my two tours at the agency. I think we are doing a much better job at leaning in with respect to trying to bring some of these technologies forward, trying to look at ways that we can lean forward and develop the models that will form the basis of some of these product approvals, trying to put out prospective guidance and talk to manufacturers, provide more regulatory clarity. I think there are still challenges around the incentives in this market, frankly. I think having been on the other side of this in the private sector, the prospect of being able to commercialize something just for sftockpiling purposes sometimes isnt enough of an incentive to offset the enormous capital cost of some of these endeavors. I think we are also looking at we focused on some of the immediate danger, some of the pathogens we knew, we were developing countermeasures for them. I think we are looking at a future where it will be much easier to bioengineer some of these things in ways which we cant fully anticipate and create very new risks. 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 for Emergency Response, including, for example, making sure that theres adequate medical Countermeasure Development and dosing guidance for children and pregnant women. P. A. P. A. Acknowledges there must be specific attention paid to atrisk individuals and we want to build on that last reauthorization because i think we can do better. I wanted to ask each of you to briefly describe your agencys efforts to meet the needs of all people and what more can we do to ensure that when it comes to Public Health preparedness, we are prepared for everyone. Dr. Redd, let me start with you and we can just go down the panel. Thank you for that question. Let me just highlight a couple of things that we are doing at cdc. First of all, our guidance through 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 the emergency is, but work with them to make sure that those needs are being covered. I would also say in 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 doses in suspension form targeted for children. What can we do better . I think there is always more work to do. I think that we need to make sure that these plans are exercised and that we have actually covered all the bases and that theyre not just written on paper, but that we actually are able to execute the plans that we have made. Doctor . I would just highlight that we are given new authority to put forward, to your point, treatment guidelines that can help guide the application of some of these therapeutics, particularly with respect to pediatric dosing, which we have used. We have approved 12 drugs under the admiral rule. Seven have been approved with pediatric dosing requirements. I think this is something we can continue to do better. I think one of the ways we are going to do that is to have Better Development of animal models that have better natural histories associated with the pathogens in those animal models that allow us to predict what the therapeutic impacts going to be on a pediatric population. So this is some basic research that we need to do to develop those models that will allow us to then extrapolate into a pediatric population and other populations, for that matter, other vulnerable populations to your point allow us to have dosing guidelines for those populations. Is there anything we can do to help improve that . I think to senator burrs point as well, i think this is a scientific basis, still needs further development. P. A. P. A. Gave the Agency Resources and we have developed some discrete expertise in this area as a result of the legislation. I think thats a place we can continue to make more investment. Dr. Kadlec . Thank you for the question. I would just like to highlight during the hurricanes we actually did some very specific things around people with functional disabilities. I dont know if any of the members have heard of empower. Its a program that allows us to basically identify in the cms data base for medicare, people who are dependent on Durable Medical Equipment so based on requests from states, we can provide actually very specific information where these people live by zip code and by address, in cases of irma, florida was able to do a reverse 911 call to those people at risk well before any evacuation orders were put out to the general public to advise them that they should consider leaving before things got worse. In the cases of maria, we actually used that data to identify on the islands of st. Thomas, st. Croix, people who were dialysis dependent and after the storm passed, we were able to basically link up with the urban search and rescue teams and actually recover dialysis dependent people and basically evacuate them to safety. So theres that part of it. One of the limitations currently is thats only for medicare data. The state medicaid data is limited. We can do that if we have access to that and provide the same information so thats one area that we can probably benefit from working with yall to see how we can have the states work collaboratively to use that information prospectively. To add to the points that were made by the other gentlemen, clearly our barta has looked at specific products for pediatric patients as well as people with immunocompromise and there are products in the stockpile today to benefit both of those populations. One of the areas and i highlighted it in my testimony, is on the National Disaster Health Care System. One of the specific areas we would like to do is take the learning or Lessons Learned from ebola, where we created a national excellence, center of excellence at Nebraska University for Infectious Disease and replicate that for other very important trauma related or disaster related areas like pediatrics. We think that that would be a way where not only can you create the necessary, if you will, Critical Mass of expertise, but also teach through telemedicine and through teleconsultations to provide support during disasters. And the last area i would like to do, a shoutout to our va colleagues, the va was a very significant contributor to our response to harvey. Hhs responded and took care of 36,000 patients. Va provided care to 21,000 patients. Many of those were va beneficiaries, but some of those were, many of those were families of va beneficiaries and a larger number was actually the general public. So the va has unique capabilities as relates to geriatric populations and thats one area we can probably benefit from in terms of utilizing some of their expertise. Thank you very much. Thanks, mr. Chairman. Dr. Kadlec, 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 and 56,000 americans die as a result of seasonal flu. We heard last week in our opioids hearing that opioids kills more americans than car accidents, and those statistics that i just read would suggest that in a severe year, so could the flu. Dr. Collins, the head of the National Institutes of health, has made the prediction before our committees that if we keep up our investments in biomedical research, which senator blunt, senator murray, the rest of us have been doing pretty well the last three years, that we may have a universal flu vaccine as well as a vaccine for zika within the next decade. Dr. Fauchi at nih said the most effective method for protecting americans against another pandemic influenza is to encourage and invest in the development and stockpiling of influenza vaccines that will broadly protect against the virus. In tennessee right now, the hospitals are filling up with people with the flu. So doctors, if researchers at nih or any sort of partner with them discover a Platform Technology that could speed the development of a universal flu vaccine, what would barta 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 new and Innovative Vaccines . I have three minutes. Chairman, i will be very brief, then, in the sense that there is an integrated portfolio with nyad so once a program gets through phase 2a clinical trials, they would be transitioned to barta. That would take the advanced development through to fruition. So that part of it is done. They have the capacity to basically identify manufacturers who could produce that either in eggs or tissue cell culture or emerging technologies. I would quickly add, we already have in Development Vaccines that might be universal flu vaccines that presumably elicit a tcell response and could achieve what you are outlining. We continue to provide advice to clinical developers and manufacturers on the proper pathway for looking at trying to bring those new technologies through. I would point to one place where the legislative suite that we have adopted to try to address some of these biological threats has been helpful is in the development of manufacturing capacity that could greatly aid in these new vaccines, particularly cellbased manufacturing which we have made a lot of investments in, as you know. That could provide the proper platform for the development of these vaccines. Doctor, this is a related matter. We are all concerned about puerto rico and the impact of the hurricane there. I think you told me at one point that maybe onethird of the economy of puerto rico has to do with medical technology, is that right . Thats about right. About 30 . And many of those facilities as you described were destroyed. Are they rebuilding in puerto rico . Or are they rebuilding other places . Do you know yet, because that could have a major effect on puerto ricos future. Right. You know, we are obviously very concerned about the situation in puerto rico for a host of reasons, not least of which is that puerto rican economy is very dependent upon the skilled manufacturing base. Im happy to tell you all the facilities we were concerned about that produced products that we were worried could go into shortage at the facilities continue to remain offline and are now back on the grid. So the facilities themselves actually didnt sustain a lot of damage. It was the power grid, and the infrastructure in between the facilities to try to move equipment in and off the island that sustained a lot of the damage. The facilities actually were fairly hardened but the ones we were worried about are back on the grid. There are still some facilities that arent, but they have such redundant electric generation capacity that we dont really have concerns about the product supply coming out of those facilities. The situation now looks a lot better than it did four months ago. Mr. Chairman, i think my time is about up. I will give the rest of it back. Senator casey . Thank you, mr. Chairman. I wanted to start with the reference that i made earlier to the Train Derailment in philadelphia as an example of good preparation. Part of that has its origin in the fact that it happened in an urban area, where you have not just the resources but you have hospitals and Health Care Infrastructure which is close by way of distance as well as by way of coordination. I represent a state that has st Rural Counties out of a total of 67 counties. We have small towns and 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, so when you have this type of gap or potential gap where some communities may be particularly vulnerable id start with dr. Cad lek and go to dr. Red d, how do those programs attempt to close the gap and preparedness among states and regions . Thank you, sir for the question. I think the point is is that the way we are structuring right now were trying to build health care promote health Care Coalitions which are collections of hospitals as well as other entities like Emergency Medical Services so you can build a regional and thats why we like to expand that effort to basically do it so not only would it cover specific regions within the state but statewide and across states so you can develop a much stronger backbone to do this. The idea of basically building out the National Academy of study of sciences basically had a study on trauma systems which is worthy of reviewing because it highlights the Important Role that has a foundational capability for the country not only for daytoday routine activities but for these extraordinary events, Train Derailments that happen in not only pennsylvania but the state of washington as an example, become a central piece of that. My interest in this is seeing how we can leverage all those pieces together with some of the federal assets, the v. A. Identified the Army Medical Center was a critical First Responder in the Train Derailment in Washington State. How do we basically build a private partnership for those purposes that can basically strengthen it . So not only do you have the transport mechanism with Emergency Medical Services but also tell la medicine and tell la consultation that would be available to the specialty services, hospitals or level one expert hospitals like nebraska to basically deal with a range of topical areas. I just want to inject another question. This is an authorizing committee and a reauthorization process, but i want to specifically ask in light of the question i posed, are there additional authorities you need or additional dollars . Sir, i would suggest both. We have a 3. 3 trillion Health Care System for which right now we invest 250 million approximately annually for preparedness and resilience. I think it highlights the fact that its a drop in the bucket. I dont think its necessarily the role of the federal government to pay for the whole bill, but certainly we need to look at a variety of incentives whether thats through csm reimbursements, whether thats through insurance programs, tax benefits that would incentivize hospitals to do it. Our conversations with some of the outside partners, we held a listening session with 35 stakeholders last week, including hospital associations is that theyre all willing and we have the hospitals volunteering to help. Theyre just looking for means to do this in a way thats mutually beneficial. Thanks, doctor. Dr. Redd, i only left you 45 seconds. We actually met with selected state Health Officials last spring to ask this exact question that you asked, are there things that we should be doing differently to support rural Health Departments and the conclusion was it was a little bit surprising to me that the capabilities that are needed for rural districts and urban are largely the same, detection capability, communications, incident command or the structure to run responses but there are additional as you mentioned there are additional layers of challenge with transport, access to medical care. I think that this is an issue a little bit beyond Emergency Response and i think the idea of tell medicine is a tool but how do we make sure that those communities have access to medical care during and not during emergencies. Thank you, mr. Chairman. Senator isaacs . Thank you. Its very valuable. The committees worked a long time. I appreciate chairman alexander and senator murray in the work theyve done and thank dr. Kadlec for calling out the v. A. , ive learned a lot of things about our Delivery Systems and capabilities in terms of v. A. Health care which is the second largest employer in the United States government. Thats how big and pervasive the v. A. Is and they provide Significant Health care to seniors by virtue of the Delivery System, so your call out for them and what they did in houston is appreciated. Id say that most of the Research Dollars that are invested by the United States government in control groups are through the v. A. Because you have a control group of patients where you can do a Good Research sample and our veterans and our Veterans Administration provides a Great Service which brings me to admiral redd, the v. A. You have your Emergency Preparedness grants that you give to local governments and as we had happened in hawaii last week where he had a false alarm on a missile attack which was unsettling to the people in hawaii and quite unsettling to me. Thats a where you get the wrong information going out from a designated agency at the wrong time. Do we constraint a lot on that to protect ourselves from Bad Information getting out on pandemics or on diseases . I think that really gets to one of the core requirements that we have, which is to be sure that the information that were providing is as valid as it can be and if were not certain but we believe people need to know, we make sure that those caveats are expressed. It really gets to some of the basic principles of Risk Communication to tell people what we know, what we dont know and what were doing to find out those things that we dont know. Dr. Gottlieb, i appreciate your mention of priority review vouchers. Senator casey and i worked on them for Rare Diseases that effect children successfully passed legislation and i think the first drugs been approved now. It was issuedpy the department and we appreciate that. Your use of that expand expand the use of prvs to encourage the development of drugs that are either very costly to develop or hard to develop is very important. How do you intend to use that to expand the development in terms of new pharmaceuticals . As you know, the prv Program Provides an additional incentive for manufacturers to try to develop products for these purposes and so i think its one of the tools that congress contemplated to try to address some of the challenges that weve already talked about that i mentioned which is that sometimes this isnt a typical market where you have the usual market based incentives to try to make the Capital Investments to develop these products. Theres ork going on to look at what impact the prvs have had. Weve implemented the programs and seen responses come forward. Sell them in a secondary market as a way to recoup some of the investment. On that same subject ive done a lot of work on a disease called battens which is an incurable disease of young people. I had a personal situation that peeked my interest in my district and i remained interested in that. Its a very difficult disease for which there is no cure but with the Gene Therapy Development and the Delivery System of pharmaceuticals to specific parts of the body and the brain in particular there is hope and promise for that. Do you issue guidance letters to Research Hospitals or Research Facilities to give them guidance on how they can test or develop to work on a breakthrough drug for a disease like battens . I think one of the areas of the most promise right now that ear looking at when we look across our portfolio where we have the ability to cure inherit inherited disorders that werent treatable just a short time ago. Were putting this out in the start of spring, a suite of products on specific guidances on how sponsors can address certain disorders with the gene therapy to help provide as much as regulatory clarity as possible. Were going to try to work through some of these more some of these rarer diseases to make sure Product Developers have a lot of clarity with what the pathway forward would be. Ive commend you on the leadership youve shown that already. Thank you very much. Thanks to all of you testifying. Senator smith . Thank you very much, senator burr and chair alexander and senator murray, im so pleased to be able to serve on this committee. Thank you very much. Id like to come back to something that senator murray and i think several others have talked about which is the importance of connection to local connection and support to local Public Health organizations. In the past year in minnesota we have dealt with three Infectious Disease outbreaks, measles, multidrug resistance tuberculosis and syphilis. Theyve required Immediate Response as well as a sustained response as weve gone forward. Minnesota has traditionally as im sure you know invested heavily in Emergency Preparedness and dealing with Infectious Diseases because of our history in ag chul more than anything. But in these particular situations, the Financial Resources that we had were not enough and so we turned to the cdc for support and of course, nofault of yours, there were no resources there. So what we did is we moved forward with the state legislator to pass an emergency Public Health response account so that we could respond quickly because speed is of the essence when youre dealing with these kinds of outbreaks. So my question is my question is in what ways do you think that an Emergency Response fund would strengthen our federal and state efforts during an outbreak or after a disaster and maybe if you could just talk a little bit about that that would be helpful. Thank you very much. I think that resources are critical in responding to an emergency. We had lengthy delays both in the Ebola Response and zika response before funding became available and i think that hindered had a we were able to accomplish. Theres been discussion both in congress and in the administration about how to do that and i think that that those discussions will continue but i think something along those lines would be quite helpful. Let me mention one thing that weve done specifically once funds are available to make sure that theyre used more quickly. We had a notice of funding opportunity that we opened to our grantees through the Public Health emergency Preparedness Program, allowed them to apply for funds. There were no funds in this award but we have an approved but unfunded grant mechanism so that we dont get delayed at the federal level once funding is appropriated. Okay. Thank you. If i could just add, there exists already in authorizing language for a fund for hhs, has 57,000 in it. Obviously its not an authorization problem but i just want to highlight the fact that yes, there is a fund thats needed. It should be a fund that necessarily is managed by the secretary that based on a Public Health emergency there can be, if you will, distribution of funds from that from that resource and that it can be used across hhs or to fund states and locals in a way that would be rapid. Obviously theres going to be a need for it would be the medical equivalent of the Disaster Relief fund, i think but there would be obviously a requirement to notify congress in those situations and basis of reporting back on some occasions to make sure the funds are being spent appropriately so that would be my right. Thank you. So we need to make sure we do have good accountability that the funds are being spent the way they are supposed to which i completely agree with. I realize this is an authorizing question and not an appropriating discussion here but would dr. Kadlec, if such a fund would be made available, what would you advise in terms of the level of funding that would be necessary to have this actually be workable . Well, maam, i would have to get back to you on a firm number. What you probably looked at is what happened with the ebola or the original pandemic influenza appropriation which are on the order of 2. 5 or 3. 5 billion. Had a you need to hedge is the opportunity for congress to weigh in fully and again on the basis of time, so obviously there are a lot of factors to be considered in there but theres a rich historical record that could be drawn upon to identify appropriate level that would get us through the initial crisis to the point where congress can basically perform its fid deutschry responsibilities. Thank you very much. Senator burr i was struck by what you said and how important it is to think about the processes that we have in place with this authorized legislation to make sure it works well and so i appreciate your comments. I think it gives us some good food for thought as we consider how we can respond as quickly as possible when theres an emergency. Thank you. We again welcome you to the committee. Senator young . Thank you, chairman. The World Organization for Animal Health estimates that roughly 60 of known human diseases are transmitted from animals to people. There are socalled zonotic origin. Ebola, hiv and new strains of influenza, three of which are our zonotic. We suffered considerable losses in the widespread bird flu outbreak, one that led to the destruction of 400,000 turkeys and this followed 2015 in the outbreak that led to the loss of 48 million poultry. So dr. Kadlec what are we doing now to prevent the spread and transmission of diseases from animals to human beings . Sir, i have to say that, quite frankly, we need to do more. The one Health Concept which youre outlining is an important one with. Influenza is not the only one thats more than. I think i need to really defer to admiral redd to talk about the role of cdc and their role of surveillance because quite frankly theyre on the cutting edge to insure you can recognize those events rapidly as they thank you, dr. Kadlec and senator young. Were working very closely with usda on this issue and particularly on influenza. We were really joined at the hip in the response to this importation of the influenza viruss. Our role was to make sure that we understood the biology and that, if any, human infections occurred that those were rapidly detected and treated and to protect workers in the process of the calling that was going on. You no doubt do the best you can with the resources and the authorities you have. Number one, how are we doing with respect to tracking and the responding . Two, these situations and preparing for the next one and then secondarily, any options you need to better your resources . Given the strategy that we have which is a reactive one, i think were doing well at detecting and containing imporitations. I think that that predicate caught my attention given that our strategy is a reactive one. Right, right. I think the ability of to prevent the importation of influenza viruss that can be transmitted by mieg tri water foul for example, very challenging. Theres a lot being done on the Animal Health side. I think that it is a challenge and the basic strategy is identify and limit to the extent possible to one flock or a small an area as possible and through that process to prevent human infection should the virus have the capability to be transmitted or to be infectious to humans. If i may just for 15 seconds, i would also talk about the importance of thinking about animal drugs in this in our approach and extended the eoa authority to animal drugs. We might also contemplate and how we creatively incentives for the development of animal drugs targeted to animal threats. To make sure thats part of our approach as well. Thank you. I look forward to working with each of you. Ill probably have followup questions ill submit in writing and hopefully we can improve our current systems for dealing with these matters. Dr. Gottlieb, you just once again mentioned incentives in the animal context but id like to pivot to our antibacterial resistance threats. Every year at least 2 Million People in the u. S. Acquire serious bacterial infections that are resistant to one or more type of antibacterial drugs. As i understand it there are very few companies that are developing new antibiotics and those focused on the most serious bacterial threats is even fewer. Is additional action needed to immediately incentivize the development of drugs to combat this growing global problem and if if so, what might new incentives look like and what might we do as members of the congress to provide those incentives . Senator, thank you for the question. As you know, cure is created a number of new vehicles and some incentives for development in this space. Were encouraged by the early interest were seeing in those pathways, things like the l pad pathway and i think well have more information soon on how well theyre working. We can always contemplate additional policy steps and id be happy to talk to your office and work with you on that. I think that this is an area to your point that we need to think about what more we can be doing. Congress has done taken some steps recently that were very encouraged by. Were seeing a lot of good early interest in them. Thank you. Senator kaine . I have great confidence in this committees ability to work on this authorization in a bipartisan way and i have two observations and a concern so an observation is this, some of you have alluded to it in senator isaksons questions. One of the tasks of Emergency Preparedness is to prepare for attack and youve talked about chemical, biological. Senator isakson talked about the incident in hawaii. I want to say for the record and for the public, the prospect of nuclear war is being discussed with a lot of frequency in this building to a degree that i havent seen in the time ive been in the senate. Weve had im on the Armed Services and Foreign Relations committee, weve had a series of hearings even opened where there have been discussions about the prospect of land war on the korean peninsula. We had an Arms Services hearing recently where a witness volunteered in public, as a member of the administration about why the likely cost of reconstructing kansas city would be after a Nuclear Attack and i noticed an article in the the New York Times a few days ago, the cdc wants to get america prepared for nuclear war. It was supposed to happen yesterday. The centers for Disease Control and prechs will present a workshop titled, Public Health response to a Nuclear Detonation for doctors, government officials, Emergency Responders and others whom if they survive would be responsible for overseeing the Emergency Response to a Nuclear Attack. Quote, while Nuclear Detonation is unlikely, the cdc stated, it would have devastating results and there would be limited time to take critical protection steps despite the fear surrounding such an event. Planning and preparation can lesson deaths and illness. Join us for this session on a federal state and local level to prepare for Nuclear Detonation. Learn how planning and preparation efforts for Nuclear Detonation are similar and different from other Emergency Response planning efforts. Thats off the cdc website and the article goes on to say the agenda for the day includes, quote, preparing for the unthinkable, quote road map to radiation preparedness, end quote, using data and decision aids to drive responsiveness. I understand they restejed that from yesterday and had a roundtable on flu instead, but this sort of, you know, realistic discussion about these prospects and that add to it the dr. Strange lovelike incident over the weekend where a state sent out a mass email telling people there was a Ballistic Missile incoming to hawaii which brought 38 minutes of panic and on tuesday the nhk put out a warning that north korea had fired a Nuclear Missile and urged japanese citizens to take cover. That was retracted within a very few minutes. Theres a lot of discussion, some very intentional and some frightened about the prospect of nuclear war thats happening and this is in the province of your agency and i want to put that on the record that that is sort of a normal area for discussion these days i find incredibly frightening in the normality of it i find incredibly frighten. Second observation i want to make is this, this is a discussion about National Security. Were involved in a budget debate right thousand. Right now, spending bill ends january 19th and one of the points of argument is whether we might fund defense accounts over the budget caps, nondefense accounts. You are about National Security. You are about National Defense and all of your agencies are funded through the nondefense accounts of the federal budget and so any suggestion that we would increase defense budgeting but hold the line and put nondefense agencies subject to their caps would not really fund the National Security priorities that youre hear about and thats something weve got to grapple with. Heres my question, im very worried about this hawaii incident because in a time of heightened tension we know from history that wars often start accidently. Theres a miscommunication and a misunderstanding, theres an overreaction. Thats how world war i started. Thats how most wars start. I know theres going to be a hearing later in the week i think on the house Arms Service Committee about this. Im sure there is an investigation at the state level but part of the responsibility and dr. Kadlec i guess this is mostly directed to you, part of the responsibility in the Emergency Preparedness and response side is accurate communication and as a former mayor and governor that depends heavily upon communication between federal, state and local officials. So as you approach this thought thinking about reauthorize in this climate where things can sometimes be pretty tense, how do you look at that state, local, federal coordination effort especially as it deals with communication of Accurate Information and knocking down inAccurate Information as quickly as you can . Well, sir, one seriously we take it very seriously. Number two the experience we had with the hurricanes, particularly Hurricane Maria highlighted some of the challenges. In my testimony i identified some of the incident command issues that we have to address which really is not only information out but information in. I think the issues that we need to work with not only with our cdc brethren but with state and local authorities as well as with fema, met with them as of just yesterday talking about how we integrate our efforts closer toso that we have Better Information Exchange on these kinds of issues, whether the hurricanes pandemics or whatever is one that quite frankly you need to kind of think through, learn through, not only experience as we did with the hurricanes but exercises as we did so just to highlight one thing since ive been around the block on these set of issues going back to 2000, its been a routine practice in the u. S. Government, the federal government at least to exercise the idea of a Nuclear Detonation, most concerning them was terrorism as a matter of improvised nuclear device. Its not necessarily new. Obviously the context is different. The point here to your issue is it does require a closer lashup with our federal partners on these issues to make sure we have good cross lateral horizontal flow of information as well as with our state and local folks and so were investigating with fema just as another example how we can basically Work Together in bed both our health and disaster people in state and local state eocs to again work more seamlessly with our state colleagues. So were looking at all kinds of options right now to that effect. I appreciate. Mr. Chair, thank you for letting me go over. I hope youll follow the investigation of the hawaii incident for your own purposes because for purposes of having good information in that coordination, i suspect there will be some lessons that will come out of that that will be relevant to other circumstances as well. Senator collins . Thank you, mr. Chairman. And i want to applaud you for your leadership in this area. More than a decade ago, we established a Port Security program that led to radiation portal monitors being installed at our major ports so that they could screen incoming and outgoing cargo, trucks and individuals for rad logical materials and i contrast that Port Security effort with what i perceive to be a real vulnerability in our ability to detect and effectively and quickly respond to an attack using biological or chemical agents. So dr. Kadlec and dr. Redd, id like you both address the level of preparedness that we have to respond to defect, first of all, to detect a biological or chemical attack and to respond to it . I would like specifically to know whether cities have used some of the federal funds that the admiral referred to to install sensors that would be able to detect these agents and id also like you both to comment on the preparedness of our hospitals to cope with the victims of a biological or chemical attack. I remember being in israel many years ago and being so impressed with their preparation and their ability to convert their hospitals to respond to that kind of attack. Dr. Kadlec, why dont we start with you and then admiral . Thank you, senator collins. I think one of the issues and again i have some incites on this historically but currently the watch run by the homeland of security provides Area Protection for cities, so i think theres a real desire and ive met with the director at over at dhs about improvements we can make to our chemical and biological attack detection. Quite frankly, our capabilities are fairly Still Limited and primitive, quite frankly. And i think theres a sincere desire on the part of dhs and hhs between ourselves to basically do improvements to do that. To your second issue, how well prepared we are, certainly we have a Strategic National stockpile that can address many but not all of these threat agencies so theres work to do there. But one of the critical areas that collectively cdc and our office are considering is really on the last mile of distribution as mentioned by senator murray, we can move Strategic National stockpile resources anywhere in the country within 12 hours. The question is, from that point forward getting it into the hands and mouths of every american, person whos at risk is a significant challenge that i think collectively we need to work on but ill defer to admiral redd for his comments. Thank you. I think this is a really important question. If we are attacked in this way, the effectiveness of our response will depend on the speed and the scale with which we respond. I think that the way that a biological attack would manifest itself would probably be different than a chemical attack. A chemical attack would primarily require a local near instain takenus local response. The cdc Strategic National stockpile has deployed ant dotes for nerve agents over 1,000 different locations have pal yets of these ant dotes that are available to supplement the treatment that would be available immediately. We also have very getting ever better capability to determine exactly which toxin has been used so theres a laboratory element the cdc is also responsible for. On the biological side, weve made Great Strides with the Laboratory Response network. Every state has at least one laboratory thats able to use advanced techniques to diagnose these infections. There are a total of 150 laboratories around the world, including laboratories that can test food, can test water, environmental samples from animals. Looking to the future, the technology of whole gee nome sequencing is something we need to continue to pushout that would allow very rapid we talk about faster and more accurate. This is actually more information than we can get from current technology, things like resistance to antibiotics or relationships of certain organize ichls to others, where did it come from kinds of questions. Thank you. Maam, can i just add one thing and your question about how are hospitals would do . Yes. I think it was noted by the chairman that even a bad flu season as the current one we have is overwhelming our hospitals. Exactly. Thats one reason that i asked the question. Thank you. Thanks, senator collins. Senator jones, welcome. Were glad to have you a apart of this committee. I acknowledged your new membership a little earlier. This is a committee that has made different points of view but works well together. So this is another subject that we intend to have some bipartisan success on. Senator warren . Thanks, mr. Chairman. So were here today to talk about poppa, the framework for our response to all sorts of emergencies, natural disasters, accidents with hazardous materials, terrorist attacks, pandemics, you name it so i returned just a few days ago from a trip from puerto rico and i know some of my colleagues have also been to puerto rico recently, and during my trip it was clear that nearly four months after the storm, the crisis in puerto rico is a daily reality for tens of thousands, hundreds of thousands of people. So dr. Kadlec, youre the top official in charge of preparedness and response at hhs. What is the biggest thing youve learned from this situation in puerto rico and the u. S. Virgin islands about how we need to strengthen our preparedness and response capabilities . Thank you, maam. I think there are a couple levels to go here. One is improving the resilience of our innate Hospital Health care structure. Thats one area. The other thing is really the resilience of our Public Health system, which is a separate piece but related piece. In puerto rico in particular there were an initial stages after that terrible devastation that literally devastated the whole island and every life was touched, it was very difficult for the local Public Health and medical infrastructure to stay. Theres some incredible heroic stories of doctors, nurses, laboratoryions who basically responded, Public Health officials who left their families, left their houses in disarray and basically went to respond to help their neighbors and communities but i think thats one piece of this that needs to be addressed. What happens before the storm, the second piece is how quickly can we move in . We deployed teams to puerto rico advance of both irma and maria to be available uns the storm passed, both storms passed to basically respond quickly but even so with the level of devastation that was a huge piece of it and a huge piece of it was the lingering devastation. Not only loss of communications and electricity but also the damage to the ports and the airfields that limited some of the movement. One of the Lessons Learned was you want to go in aggressively before the storm if you can and we put peoples lives at risks from our Response Team including people from massachusetts, massachusetts one that responded to all three storms. Yes. Theyre great people and again representative of your constituents from other states around the country that responded, but also theres a piece of this that we have to somewhat remove some of the dependences in the responses. Seeing how we can move quicker and faster if thats possible. A lot of it was dependent upon being able to transport through air or barge. Responding to an island is a tough one. So, i appreciate this and im glad were trying to think about what we need to do and what we need to do better and to acknowledge heroic efforts but we need a better structure here. But to apply these lessons, we also need good data. We need to know not just what we got right or had a we got wrong but when we got it right or when we got it wrong and by how much and what difference it would make on the ground. One of the things that struck me during my trip last week was how sketchy the data are. So for example, i met with the federals at femas field office and they said no more issues with potable water. No water borne diseases. All the water is drinkable and i asked this specifically. You turn on the taps, hold a glass under it, the water is drinkable everywhere on the water. Sounds great. Not so much, though. I met with the Massachusetts State Police volunteers who told me theyd observed raw sewage in the water at the Public Health center that i visited. They still dont have potable water, no drinkable water for their patients and they said they serve 100,000 people and that none of them have drinkable water. We heard the same kind of contradictions when it came to statements about how many people lacked power. So dr. Kadlec, i get that Public Health emergencies are really challenging circumstances and its hard to get good data, but how do hhs and other agencies collect data in a that is reliable so that you can deploy your resources effectively, hold yourselves accountable to get the job done that needs to be done . Maam, we learned a lot from the experience in puerto rico and trying to rectify that because of the loss of communications, cell towers and the like, the ability to get information from local authorities was nil. We went to the point at one time to basically use runners from the National Guard who would have satellite phones to basically go to hospitals and clinics and report information out but thats a major consideration and lesson that were still learning that we have to address because its a major shortfall because if you were to add, again, terrible event like this, a terrible earthquake or nuclear or radio logical event, you could imagine the circumstances would even be more challenging but thats an area of great intense concern quite frankly and more work that we have to do. Very concerned about this and i dont have time. Im out of time so i cant ask admiral redd and dr. Gottlieb about their work in puerto rico. Senator cassidy and i sent a letter to chairman alexander signed by seven other members of this Committee Asking for a hearing on the Recovery Efforts in puerto rico and the u. S. Virgin islands and i hope well be able to hold that hearing. Puerto rico might not be in front pages any more, but it is a humanitarian crisis and we have a moral and a constitutional responsibility to exercise responsibilities here. Thank you, mr. Chairman. Thank you, senator warren. Senator cassidy. Thank you. Im going to put you on the payroll will man. Earlier responding to senator smith regarding a possible bill. We have that bill. Public Health Emergency fund actually stimulated by conversations with dr. Freeden and he said that in the ebola crisis there was ten different authorizations that had to be signed off on before he could get somebody to travel to africa. Kind of crazy. Which was cumbersome and slow without before and after katrina. Before katrina fema had to come to get the additional dollars. After Katrina Congress recognized thats not the best way toso theres a pot of money that can be immediately be accessed, if it goes over that, they come back and get another authorization. Dr. Shots and i, so you can deploy people and secondly based upon and dr. Kadlec this is where you nailed it, upon the previous 14 years of Public Health emergencies we take the average of that expenditure and we make those dollars available up front to be immediately drawn down. Still accountability, gos going to do a report to make sure the cdc doesnt use it to go to hawaii for a conference as opposed to africa to fight ebola, no offense dr. Redd. The point being that we would have the accountability built in but we think its a good bill. Let me move on to something different. Dr. Redd, i was struck speaking to people after zika hit that in retrospect and of course everything in retrospect, if i could do things in retrospect but in retrospect could have per dicted what was going to happen because brazil was flying in folks from the South Pacific to work on their olympic stadiums that zika had been breaking out in the South Pacific where these workers were coming from, brazil is like a petri dish for zika and you couldve predicted it. Its retrospect. A thought occurs to me with big data, we can put in travel patterns and areas of receptivity and make first blush guess as to where the next epidemics going to be. Is that just me sort of wouldnt it be brate sort of thing or is this something thats practical and if its practical is the cdc doing it . I agree with your overall statement. Another way to look at this is the pathway that zika followed was very similar to chicken where it existed in the pacific and it caused big outbreaks in brazil and south american. Another point that is the same when we had outbreaks in the caribbean we knew the locations of lots of travel to the u. S. And where the vector was the mosquito lived. Its the same place that weve seen small dingy outbreaks in the past can we use this predictively, because if we could see, well, brazilians are going to be having this problem, lets go down there and encourage them to spray for mosquitos, et cetera . I think its hard to do that. I think the vector is very resilient and there were some questions i was just begin the examples as a concrete action what im asking about is the vector of resilient, can we use big data just to look at travel patterns of where theres an outbreak and guess where there might be a spread of such an outbreak . I think we can. The challenge is what do you do with that information and is there a way to use that for example, to have prevented the zika outbreak in miamidade county. I think that the things that you do youre ahead of us, what you use the information is different than if you can actually acquire the information . If its practical and right, if you will, to acquire the information, are we putting such systems in place . Well, just to take the zika example, theres a lot of communication with texas and florida, louisiana, the gulf coast areas that have the mosquito recognizing youre still after me because thats after it hit brazil and after we knew theres going to be travel from brazil up. Im trying to go proactively before that in that we could see the brazilians were bringing in lots of workers from the South Pacific and therefore it was predictable that whatever was breaking out there was going to break out here. That is taking the battle to the enemy, if you will. Are we doing that . Do we have a worldwide map, and ive seen such a map of hot spot of Infectious Diseases overlayed with travel patterns to guess whether or not i understand cdc has worldwide outposts, so again im asking something more kind of closer to the point. Sure. Than whether it gets to texas . The quality of information is variable. I dont think for example, the inflammation we have about influenza is better than all the mosquitoborne diseases that are out there. We know what viruss are circulating in china because of the known importance of influenza and the risk it poses for a global pandemic. I have seen maps im over time but i have seen maps put out by cdc and world health in which it shows, oh, yeah, heres this and there is that and its a hot spot of a particular virus. Can that not be overlayed with travel patterns . There are parts of the world that some of the discussion earlier about the number of diseases that are detected that cause infections in humans, there are certain parts of the world that are more prone to those emergencies. I think again your questions how do we use that information. We certainly do have travel maps of where people travel to and from. We have information about where various diseases occur at variable disease degrees of granularity and those two things do go together. How we would use that to take a preemptive action thats the question that youre getting at. Okay. I yield back. Thank you, very much mr. Chairman. This is incredibly informative. Thank you to all of the witnesses. I want to raise two concerns that i have emanating from conversations ive had with companies in connecticut that operate in the Pandemic Response field, the first is regarding response to an influenza outbreak and this is either for dr. Kadlec or dr. Redd. Dr. Kadlec, in your testimony you write that we have sufficient domestic vaccine manufacturing capacity to produce bulk vaccine for every american within six months but i want to ask either of you about the question of vaccine delivery and this comes from conversations with a manufacturer in connecticut which is one of the bigger syringe manufacturers. My understanding is that if you needed to get vaccine to everybody youd need about 600 million Drug Delivery devices. B. D. Is one of the biggest but it would take them six years to do 600 million units. What are our thoughts on preparation to make sure we not only have the right amount of vaccine but the right amount of vaccine delivery devices . Thank you, sir. That is one of the issues in the problems that has to be addressed, quite frankly. I have my direct from barta if he wants to make a comment. Part of the strategy were looking at also is how can we innovate and either have better delivery devices or specifically can we make better vaccines that only require one dose . The 600 million doses is for two per person and the third thing is there are maybe new vaccine technologies that allow you to do it orally or intranaz alley or a variety of other means besides subcutaneously with a needle. All those issues are being kind of evaluated and pursued, but yes, there are some very significant shortfalls in terms of other disposables as a matter of concern when you will get into that kind of circumstance. Im sorry. I just want to make sure if i left something out before dr bright could offer it. I think this is a modeling problem and particularly from the supply standpoint making sure that we are tapping into the existing commercial market and were able to leverage that system in addition to stock piling what that market cant produce. Dr. Kadlec, back to you on my second concern. Barta as weve talked about is such a wonderful model and working with industry. Youve developed 34 approved medical countermeasures, 23 influenza vaccines. Again, coming back to a company that barta has worked with in connecticut, which as you may know has come up with an innovative way to develop a vaccine not the traditional egg based vaccine but a Dna Technology mechanism, theyve raised the issue of how you make sure that having spent the money to develop these vaccines theres a market, so that they can continue to develop processes and make sure theyre available. Whats the responsibility of barter or hhs or cdc wants to weigh in on how you make sure that the money being spent on research ends up in a marketable vaccine and that youre working with companies to make sure that a bridge market exists so that there available in case you need them . Clearly, thats one of the factors that goes into this Public Private partnership and i would also invite dr. Gottlieb because it is been the case with the prvs and the vouchers, if you get through that you get some benefits we need to look at the whole variety of incentives to not only get companies into the market but keep them in the market and keep them viable going forward. There is this issue of the Second Valley of death which has been raised at some point in time, once youve delivered your vaccine and if you dont get either the opportunity to replenish it or use the technology for some other commercial purpose that the company may still be at risk and you may still basically be confronted with the limitations that you have that you dont have the producer so these are issues that are still pretty thorny and, quite frankly, thats one of the areas i think that probably deserve a little more i dont mean to keep dr. Gottlieb out of this conversation. You raised this in some of your earlier testimony. I think you raise a very valid point, senator. If youre talking about a countermesh that doesnt have a dual use youre only markets going to be in preparedness and presumably the only markets going to be for stock piling. If its not something that turns over a lot that you constantly have to replenish the stockpile, depending on what youre developing, the cost of capital to try to develop that product might not might be too high to justify the investment. I saw this when i was on the other side of this equation. We tried to offset some of that with the prvs but i will say that the value of the prvs in the marketplace have diminished as weve had more prvs. The value has gone down over time. This is something we should all contemplate. Thank you, mr. Chairman. Senator murkowski. Appreciate the discussion here this morning and dr. Kadlec, you recognized in response to senator warrens question that the challenge that puerto rico faced after the devastating hurricane, its difficult in an island area where youre not connected, where youre remote, well that brings it close home to me. Were note an island but were not connected to the continental United States and we are really big and we dont have a lot of roads. It was just about 75, 78 years ago that we had a Diphtheria Outbreak in nome and we were able to deliver the serum by dog sled. Were not doing that any more thankfully but it does speak to the reality of how you respond when you do have an outbreak and your ability to movein quickly is limited either because of weather or just access limitations, and we were reminded of this at 911 when all the air spaces shut down. You now have 80 of your communities that have no way to get things in and out, a major earthquake that can take out the major port that serves access or air ports and so for us particularly in alaska, weve had to be our own Little Island when it comes to response but when youre trying to get stock piles of vaccines or the like, that makes it very, very challenging. I think i dont recall whether it was you dr. Kadlec or admiral redd mentioned that you can get stockpiles, i believe, of vaccines anywhere in the United States within 12 hours. Did i hear that correctly . And so should i be worried in a small remote not accessible by road shutout by weather. We cant even get a state trooper in for three days into certain of our villages at certain points in time. What can you do to assure me that we can be that responsive in our more rural areas . Thats one part of the question. The other part is when it comes to infrastructure itself. Several years back we had the first sizeable cruise ship going through the arctic. We had all kinds of emergency preparation drills and it was not because we were most fearful of an oil spill from a ship that might hit the ice but an issue on the ship where you now have 500 passengers who need some level of health care and theres no Health Care Facilities to be had in the region. So for purposes of how we can be responsive when there is a Public Health crisis whether its an outbreak or some kind of disaster manmade, natural or otherwise, what assurances can you give us from these rural states . Ill turn to dr. Kadlec and you, admiral. Thank you, maam. That is a challenge. I think the reality is the stockpile can get anywhere to be delivered to the state authorities within 12 hours. So that would get to our to anchorage for example, and its the states responsibilities to get those products or those vaccines or drugs to the last terminal mile to those people who need them and that is an issue that, quite frankly, the cdc share the concern that thats an area where concerted work has to be done because there are other places in the country that probably would have similar challenges. Admiral redd . Yes. I think this is a very challenging scenario and i think that if it were a challenge to move product to a location there would be other challenges as well. Understanding the problem of the disease in that location, we might have Tell Communication but access to laboratories, access to epidemiologic investigation, those would be things that are limited. This needs to be thought of as a broad railroad set of capabilities that are needed to assure the protections of these really Situational Awareness as to whats happening in those locations. It is something, of course, that we clearly think about. The last thing im going to leave you with, the state of alaska just conducted an Alaska Health impact assessment. It was the framework based on the Current National Climate Assessment predictions and the impact to alaska as a state that is seeing the impact of Climate Change as warming temperatures, you might not feel it here in the east coast but its warmer back home and it outlines some of the potential health affects that could be coming our way several decades out. We recognize that. But one of the concerns, of course, is vector borne or Infectious Diseases that are particularly associated with vector borne, usually were able to freeze those nasty mosquitoes and they cant move these levels of outbreaks but it is something that as we think about Public Health emergencies were so focused on the here and the now and the disaster of the day but i do think its important that we be we be thinking longterm about the changes that might be headed our direction. Thank you, senator murkowski. Senator jones . Thank you, mr. Chairman. Once again, thank you for your time to this committee. Following up on i think senator casey may have highlighted and senator murkowski was talking about the rural health areas. I can understand that the challenges when theres a pandemic and you need to get access but ive got a state thats also very rural but weve got roads. Weve got the ability to get serum in and things like that but yet were in Tornado Alley and hurricane alley. It comes through and so my concern is the preparedness for Health Care Delivery on an immediate basis when you have those disasters because in alabama like so many other states, Rural Health Care is disappearing and thats a real challenge. Id like to address have you address whats being thought about, whats being done to prepare for those type of emergencies for those communities who are not have the Daily Health Care theyve got that Immediate Health care needs can be given to them. One of the areas i touched in my written testimony is on this idea of creating a National Disaster Health Care System really taking advantage of the trauma system that we have in our country that clearly needs to be amalgated or if you will unified. We want to use the Hospital Preparedness Program as a means to it certainly would need more resources to do that. But basically create expand the regional coalitions to not only cover states but regions. Mississippi, alabama, that part of the country, where you can actually share resources and basically do better coordination, mutual aid in those kind os situations. Build a kind of relationship where you know about bed availability. Work with the ems systems in terms of transportation to basically identify the appropriate places to take people with different injuries or different kinds of casualties to the right place to ensure their survival. So there is a lot that can be done, and, quite frankly, we think by regional easiizeing. Mobile, there are great facilities there as well as other parts of the state as well as adjacent parts in mississippi. If you can build that coalition on a regional basis, you can probably address some but not all of those issues. A little bit beyond preparedness, but one of the things that weve done as cdc is examine rural health and the way that weve done that as a first step is to actually examine the data that we have. There are a series of publications on issues related to rural health in our inhouse journal, the morbidity and mortality weekly report wed be happy to get those to you to find the problem. That would be great. I was also going to ask a similar questions about citizens with disabilities. Do you have specific guidelines, things that you do to take care of those with disabilities, whether its a physical disability, a mental disability or whatever. Sir, we have a problem at the hhs that used medicare data to basically identify people in different regions or different states by zip code, by home address, by phone number to identify people dependent on Durable Medical Equipment. In advance of a hurricane, for example, we provide to states like florida and i believe alabama prior to norm, before that hit, that we identified people who would be at risk to Power Outages or who would need probably special assistance if they needed to be evacuated. And thats one piece of the problem. Quite frankly, we dont have that data for medicaid, from individual states, so that would be another way to enhance that if we could get data on that. Thats just one way to basically preidentify people at risk and it goes a long way to basically take care of folks. All right. Just three quick things. We require our state grantees to include a section on vulnerable populations in their Emergency Response plans. So thats one thing. The second is that we work with professional associations, predominately im thinking more of American Academy of pediatrics, the American College of gynecology when there is an emergency to make sure were addressing those situations. Also when we activate our Operations Center for an Emergency Response, there is a functional desk on vulnerable populations to try to deal with the kinds of issues that come up. All right. Great. Thank you. Thank you, gentlemen. Thank you for your testimony. Thank you, mr. Chairman. Thank you, senator jones. Senator casey, do you have any questions or concluding remarks youd like to make . I want to thank our witnesses obviously for their insights and expertise today and their ongoing work as part of the federal government to develop and maintain the necessary Public Health preparedness capabilities. Ill have some questions for the record. In addition to the ones i asked already. Next week, we look forward to hearing from nongovernmental stakeholders about how we can continue to strengthen our readiness for future Public Health emergencies and keep the American Public safe. As we heard today, preparedness is continuous and must evolve to face new and different types of threats. I remain committed to ensuring we sustain the progress weve already made and preparing for Public Health emergencies, or i should say while continuing to work to anticipate the next threat. Weve got a strong bipartisan history of working together on this committee to improve our communities ability to respond to all manner of Public Health threats and i look forward to continuing that tradition in the months ahead. Mr. Chairman, i want to thank you for your work on this as well as Ranking Member murray and senator burr, of course. Thank you. Thank you, senator casey. Senator caseys exactly right. This is one of the many areas this committee has effectively worked on, both in the authorization and reauthorization of legislation to prepare our country for the unexpected. Disaster that might occur to us. A lot of progress has been made and i want to thank senator casey and senator burr especially for their leadership over the years in this area. As he indicated, well be having our second hearing on this topic next tuesday, january 23rd, 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 committee this spring and present it to the senate for bipartisan action. So i thank the witnesses for coming today. The testimonys been very helpful. The attendance has been good. The hearing record will remain open for ten days. Members may submit Additional Information within that time if they would like. Our committee will meet again tomorrow on a different topic. At 10 00 a. M. , for a hearing entitled reauthorizing the Higher Education act, Financial Aid simplification and transparency. Weve been working for more than four years on taking a new look at the federal governments relationship to our colleges and universities. There are 6,000 of them. Our major role is that we appropriate about 34 or 35 billion a year in grants for students to attend colleges. And there are more than 100 billion of new Student Loans each year. And in connection with all of that money, there is a lot of opportunity and a lot of need for us to take a look at accreditation innovation, simplification, getting through the jungle of red tape and another whole set of activities. That will be our major focus during this year. And we hope also to have that partisan legislation to the senate floor some time this spring. Thank you for being here today. The committee will stand adjourned. Cspan, where history unfolds daily. In 1979, cspan was created as a Public Service by americas Cable Television companies and is brought to you today by your cable or satellite provider. Tonight on cspan 3,ment pa administrator scott prosecute testifies before the Senate Budget committee. Then cbo budget director keith hall and the Uk Youth Parliament debates issues affecting young people in britain. Scott pruitt, the head of the Environmental Protection agency, testified at a Senate Hearing on epa regulations. He answered questions about
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