[Senate Hearing 114-568]
[From the U.S. Government Publishing Office]









                                                        S. Hrg. 114-568

 MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR 
                            FUTURE THREATS?

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE, FOCUSING 
                           ON FUTURE THREATS

                               __________

                           FEBRUARY 26, 2015

                               __________

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                                Pensions




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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman

MICHAEL B. ENZI, Wyoming             PATTY MURRAY, Washington
RICHARD BURR, North Carolina         BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia              BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky                  ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine                 AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska               MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois                  SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina            TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah                 CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas                  ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana

               David P. Cleary, Republican Staff Director
                  Evan Schatz, Minority Staff Director
              John Righter, Minority Deputy Staff Director

                                  (ii)

  







                            C O N T E N T S

                               __________

                               STATEMENTS

                      THURSDAY, FEBRUARY 26, 2015

                                                                   Page

                           Committee Members

Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     1
Murray, Hon. Patty, a U.S. Senator from the State of Washington..     3
Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     4
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................     4
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................    32
Cassidy, Hon. Bill, M.D., a U.S. Senator from the State of 
  Louisiana......................................................    34
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    45

                               Witnesses

Lurie, Nicole, M.D., MSPH, Assistant Secretary for Preparedness 
  and Response, U.S. Department of Health and Human Services, 
  Washington, DC.................................................     6
    Prepared statement...........................................     8
Robinson, Robin A., Ph.D., Director, Biomedical Advanced Research 
  and Development Authority, Deputy Assistant Secretary for 
  Preparedness and Response, Washington, DC......................    11
    Prepared statement...........................................    13
Redd, Stephen C., RADM, M.D., Director, Office of Public Health 
  Preparedness and Response, Centers for Disease Control and 
  Prevention, Atlanta, GA........................................    17
    Prepared statement...........................................    18
Borio, Luciana, M.D., Assistant Commissioner for Counterterrorism 
  Policy, Director of the Office of Counterterrorism and Emerging 
  Threats, Deputy Chief Scientist (Acting), U.S. Food and Drug 
  Administration, Silver Spring, MD..............................    21
    Prepared statement...........................................    23

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Response by Nicole Lurie, M.D., MSPH, to questions of:
        Senator Alexander........................................    48
        Senator Burr.............................................    51
        Senator Isakson..........................................    55
        Senator Kirk.............................................    56
        Senator Scott............................................    56
        Senator Roberts..........................................    58
        Senator Murray...........................................    59
        Senator Mikulski.........................................    60
        Senator Casey............................................    62
        Senator Franken..........................................    64
        Senator Baldwin..........................................    65
        Senator Warren...........................................    66

                                 (iii)

  

 
 MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND RESPONSE: ARE WE READY FOR 
                            FUTURE THREATS?

                              ----------                              


                      THURSDAY, FEBRUARY 26, 2015

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:05 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr 
presiding.
    Present: Senators Burr, Alexander, Cassidy, Casey, Murray, 
Franken, Whitehouse, and Warren.

                   Opening Statement of Senator Burr

    Senator Burr. The Senate Committee on Health, Education, 
Labor, and Pensions will come to order. I'm delighted to steal 
the gavel this morning from the chair, and I apologize to my 
colleagues. I clearly was the only one that had people that 
were late for their appointments this morning, so it threw me 
back about 5 minutes. I apologize to our witnesses.
    I thank the chairman and Ranking Member Murray, and I want 
to thank my good friend, Bob Casey, for his willingness to work 
with me on this hearing, as well as a number of other 
initiatives that he and I have joined together on. Once we've 
made some opening statements, I'll have an opportunity to 
introduce formally our witnesses today.
    I'm pleased to have the opportunity to chair today's 
hearing on such an important topic that is a key aspect of our 
national security. Our work to strengthen our Nation's medical 
and public health preparedness and response has always been 
bipartisan. It's fitting that Senator Casey, who has been a 
strong partner on these issues over the years, is serving as 
the Ranking Member of today's hearing.
    The American people expect us to do all that we can do to 
protect them from the full range of threats that we face, 
whether they're naturally occurring, as we've seen with the 
emergence of novel influenza strains, or are deliberate man-
made attacks. Regardless of the source of these threats, we 
must be well-prepared to respond and to protect the American 
people.
    In the aftermath of Katrina, Congress, through the Pandemic 
and All Hazards Preparedness Act, established the position of 
the Assistant Secretary for Preparedness and Response. The ASPR 
position was created to clearly answer the question of who is 
in charge during a public health emergency. The statute is 
clear, and there should be no confusion at this point.
    We need to examine why, in the midst of the Ebola response, 
there was uncertainty at this point. This was exactly one of 
the issues that we were trying to avoid by speaking clearly to 
who was in charge in PAHPA and strengthening the role of the 
ASPR in the 2013 reauthorization of the law.
    Today's hearing asks a very simple but critical question: 
Are we ready for future threats? Our recent experience with 
Ebola suggests that there's still room for improvement to make 
sure that we're as prepared as possible. Our healthcare system 
was not fully stressed in those response efforts.
    As with each public health emergency before, we must apply 
what we've learned from our response to Ebola to strengthen our 
overall medical and public health preparedness and response 
efforts so that we are better prepared for the next threat we 
face. We cannot put off taking the steps that we must today to 
be better prepared tomorrow.
    We need consistent and strong leadership and support at all 
levels in carrying out our medical and public health 
preparedness and response efforts. There must be a daily focus 
and urgency to this work, not just when we're in the midst of 
responding to a crisis at hand. These efforts must be 
prioritized. That is how we ensure that we're better prepared 
to respond to the full range of threats we may face.
    Ebola underscores the importance of having medical 
countermeasures as part of our response arsenal. Today, the 
Biomedical Advanced Research and Development Authority not only 
manages the BioShield Special Reserve Fund, our medical 
countermeasure procurement fund, but BARDA is also actively 
helping innovators bridge the advanced research and development 
Valley of Death to bring forward innovative medical products 
and platform technologies that will play a critical role in 
protecting the American people.
    While these efforts have resulted in the development, 
approval, and stockpiling of medical countermeasures that we 
didn't have a decade ago, we know that we cannot let up on 
these efforts because there's much work left to be done. We 
still do not have any vaccines or therapeutics for some of the 
most serious identified threats. We must be prepared for what 
we have already identified while also having the capabilities 
to quickly pivot and execute the development of vaccines and 
treatments for novel and emerging threats.
    The ASPR, BARDA, FDA, and CDC are all before the committee 
today because of the critical coordination that must occur 
between each of these agencies in bringing forward medical 
countermeasures to the strategic national stockpile as well as 
the coordination between all facets of our medical and public 
health preparedness and response efforts, including critical 
partnerships with States and local public health officials and 
our Nation's healthcare providers. Their efforts together with 
the important work of the National Institutes of Health is 
critical for ensuring that we are as prepared as possible.
    There's been improvement in the coordination across these 
agencies. We must ensure that these efforts are as timely and 
seamless as possible. I look forward to hearing from our 
witnesses today on what is working well, where there are still 
areas for improvement, and how Congress and the Administration 
can work together to ensure that we are as prepared as possible 
for the future threats we face.
    Almost 2 years ago, Congress passed with overwhelming 
bipartisan support the Pandemic and All Hazards Preparedness 
Reauthorization Act, legislation I authored with my colleagues 
on this committee and which the President signed into law.
    Today's hearing provides a good opportunity to look at the 
aspects of PAHPA that have not gotten as much attention in 
recent months and years but are very important. I want to take 
this opportunity to underscore that each provision of the law 
was very carefully and intentionally crafted the way that it 
was.
    While the administration has leveraged some provisions in 
the law, such as the FDA utilizing the authorized use 
authorities to more quickly respond to H7N9 and MERS and Ebola, 
including an authorization on another Ebola diagnostic just 
this week, other requirements remain outstanding. The 
deliverables required by PAHPA are not optional.
    Unfortunately, it took moving forward with this hearing for 
a long awaited 5-year medical countermeasure budget plan and 
the latest strategy and implementation plan to be sent to 
Congress. If it's going to take the scheduling of regular 
oversight hearings to ensure timely action and response in 
these areas, then that's something that I am more than happy to 
chair on behalf of you, Chairman Alexander, because the urgency 
of this work cannot be overstated.
    Our actions and inactions in this area impact the health of 
the American people and our Nation's overall security. Medical 
and public health preparedness and response is a matter of 
national security.
    I want to thank each of our witnesses for being here today, 
for taking the time to be here, for the efforts that you put 
into your work, and for your expertise. I look forward to the 
hearing and to your thoughts on how we ensure that we're 
prepared for the future threats.
    I will recognize Senator Casey.
    Senator Casey. I will yield to my senior member.

                  Opening Statement of Senator Murray

    Senator Murray. Let me just say quickly that I really want 
to thank you, Senator Burr and Senator Casey, for spearheading 
this conversation. I really appreciate all of our witnesses who 
are here today.
    As we heard, 2 years ago, the President signed the Pandemic 
and All-Hazards Preparedness Reauthorization Act into law, and 
it was a very important step forward in terms of advancing our 
national health preparedness, from providing support for States 
and local communities facing public health emergencies to 
promoting a very robust pipeline of medical countermeasures 
including drugs and vaccines that help us combat threats to 
public health.
    I'm really pleased that today, we have an opportunity to 
look to the lessons learned over the past few years and talk 
about what we need to do going forward to prevent and, when 
necessary, respond quickly and effectively to public health 
emergencies. As events like the Ebola cases last fall and the 
difficult flu season we've had made clear, this is a very 
important time for a discussion about protecting communities' 
health and having effective systems in place when risks do 
emerge.
    I want to thank all of our witnesses who are here today. 
I'm very delighted that Senator Casey is running this committee 
for us on this side and is going to do a great job on these and 
many issues, and I want to thank him for that. I just want to 
let the committee know that I have several hearings today, 
including one in the V.A. that's very important on our budget. 
Senator Casey is taking the lead on our side today, and I will 
turn it over to him.
    Senator Casey. Senator Alexander, do you want to go next?

                     Statement of Senator Alexander

    The Chairman. Thank you, Senator Casey. I'll just reiterate 
what Senator Murray said. This committee has a long reputation 
for bipartisan commitment to ensuring that our country is 
prepared for any and all threats.
    Senator Burr has been a real leader in that. He was the 
author of the Pandemic and All-Hazards Preparedness Act of 2006 
and its 2013 reauthorization, which is why I asked him to chair 
this hearing. He and Senator Casey have worked together very 
effectively, and I thank both of them for their leadership.
    I look forward to being a part of the hearing today and to 
continuing with whatever oversight is necessary to make sure 
that we do our job.
    Thank you, Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Mr. Chairman, thank you, and I want to thank 
Ranking Member Murray for this opportunity, and I certainly 
want to commend and salute the work of Senator Burr on these 
issues over many years in our working together. I'll be brief 
because I want to get to our witnesses.
    I do want to say a word of thanks to our witnesses for your 
testimony, for your presence here today, for the expertise that 
you bring to bear on these issues, and, of course, for your 
public service.
    We've convened today, not just a panel of witnesses but a 
panel of expert witnesses to examine the progress we've made 
since the passage of the Pandemic All Hazards Preparedness 
Reauthorization Act known as PAHPRA. I'll try to call it the 
Preparedness Act so we don't get too caught up in a lot of 
acronyms; I wonder if people listening are always following 
them. I'll call it the Preparedness Act to make it easier.
    As we look ahead to challenges that confront the country, 
at the same time we have to learn from experience that we've 
derived over the last decade. I think it's safe to say that we 
cannot hope to adequately be prepared for medical or public 
health emergencies if we lurch from crisis to crisis, piecing 
and patching together a response when we're already in the 
middle of an emergency. I think we all agree on that.
    Public health preparedness requires a sustained commitment 
and investment at the Federal, State, and, indeed, at the local 
level as well. We should also acknowledge that public health 
preparedness does not exist in a vacuum separate from the rest 
of our public health and medical infrastructure.
    The healthcare providers and hospitals that provide care 
for us and the public officials working with us to keep us safe 
are the same ones who would be providing care for us and 
working to respond in the case of a public health emergency. 
Ensuring a basic level of access to care and supporting efforts 
that help Americans be healthier every day will also help us to 
be more resilient in the face of a pandemic, a natural 
disaster, or a terrorist attack.
    The public health challenges our Nation must prepare for 
are considerable and diverse, as we've seen. In only the last 
several months, we've seen concerns about antibiotic-resistant 
superbugs, Ebola, and a worse than usual flu season.
    The Preparedness Act is a framework for our medical and 
public health preparedness infrastructure which addresses the 
need for a coordinated response from multiple Federal agencies 
and also State and local governments as well as community 
partners. The law also recognizes and addresses the challenges 
in developing medical countermeasures and ensuring we are able 
to deploy those resources as needed.
    With our witnesses here today, I hope to learn more about 
the progress we've made, and there has been lots to be positive 
about. We also have to make sure we're checking and ensuring 
that that progress continues. We must ensure our Nation is 
prepared for all medical and public health threats.
    I want to thank Chairman Burr for this hearing.
    Senator Burr. Thank you, Senator Casey.
    At this time, I'd like to introduce our witnesses and 
welcome them. First is Dr. Nikki Lurie. She is the Assistant 
Secretary for Preparedness and Response with the Department of 
Health and Human Services. In this capacity, she serves as the 
Secretary's principal advisor on matters related to 
bioterrorism and other public health emergencies.
    Her office is the lead agency for Federal public health and 
medical preparedness and response, helping the Nation prepare 
for, respond to, and recover from disasters. She has also 
served with HHS as the Principal Deputy Assistant Secretary of 
Health.
    Prior to her work at the Department, Dr. Lurie was a senior 
natural scientist and a professor of health policy at the Rand 
Corporation and served in Minnesota State government. Dr. Lurie 
attended college and medical school at the University of 
Pennsylvania and completed her residency and master's at UCLA. 
She continues to practice medicine in Washington, DC.
    We welcome you, Dr. Lurie.
    Let me introduce all of you, and then I'll come back to Dr. 
Lurie and let her start.
    Dr. Robin Robinson is the first and current Director of the 
Biomedical Advanced Research and Development Authority and the 
Deputy Assistant Secretary in the Office of the Assistant 
Secretary for Preparedness and Response at HHS. Dr. Robinson 
has vaccine and private sector experience and joined HHS in 
2004 to establish the medical countermeasures policy for the 
national strategy for pandemic influenza.
    Dr. Robinson received his bachelor's degree from Millsaps 
College and a doctoral degree from the University of 
Mississippi Medical School in medical microbiology. He 
completed an NIH post-doctoral fellowship with the State 
University of New York at Stony Brook in molecular oncology.
    Robin, welcome.
    Dr. Stephen Redd, Rear Admiral Stephen Redd, is with us 
today--welcome--from the Centers for Disease Control and 
Prevention, where he serves as the Director of the Office of 
Public Health Preparedness and Response. Before this role, Dr. 
Redd was the Director of Influenza Coordination Unit and served 
as the Incident Commander during the H1N1 pandemic.
    He has served as a commissioned officer for 29 years. Dr. 
Redd is a graduate of Princeton and Emory Universities, and he 
received his medical degree and trained in medicine at Johns 
Hopkins. He has received numerous awards, including the Public 
Health Distinguished Service Medal and Meritorious Service 
Medal.
    Again, welcome, Rear Admiral.
    Dr. Luciana Borio--am I close?
    Dr. Borio. Lu Borio.
    Senator Burr. Lu Borio joined the FDA in 2008 and is the 
Assistant Commissioner for Counterterrorism Policy and Director 
of Food and Drug Administration's Office of Counterterrorism 
and Emerging Threats. She heads the FDA medical countermeasures 
initiative and is the acting Deputy Chief Scientist.
    Dr. Borio--correct? I thought you stuck another part in 
there, but--also serves at HHS as the advisor on biodefense 
programs. In addition to her various roles at FDA and HHS, Dr. 
Borio was also a senior associate at the UPMC Center for 
Biosecurity and assistant professor of medicine at the 
University of Pittsburgh.
    She received her M.D. from George Washington University and 
completed her residency at New York Presbyterian Hospital 
Cornell Medical Center. She continues to practice medicine at 
Johns Hopkins Hospital.
    Doctor, welcome.
    With that, I'll turn to you, Dr. Lurie, for any opening 
statement you might want to make.

STATEMENT OF NICOLE LURIE, M.D., MSPH, ASSISTANT SECRETARY FOR 
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN 
                    SERVICES, WASHINGTON, DC

    Dr. Lurie. Thank you and good morning, Senator Burr and 
Ranking Member Murray and acting Ranking Member Casey and other 
distinguished members of the committee.
    I'm Dr. Nicole Lurie, the Assistant Secretary for 
Preparedness and Response, or ASPR, at HHS. As you know, I'm 
joined by my colleagues today from BARDA, CDC, and FDA. I 
appreciate the opportunity to talk to you today about our 
Nation's preparedness and ASPR's successful implementation of 
the Pandemic and All Hazards Preparedness Acts.
    These critical pieces of legislation arose from lessons 
learned following several disasters and created ASPR, providing 
the Federal Government with better mechanisms to coordinate 
preparedness and response activities and support State and 
local authorities throughout the disaster cycle. ASPR has 
successfully executed its responsibilities, leveraging the 
authorities that you have provided.
    We've improved the Federal personnel and logistical 
capabilities deployed in responses, expanded training for our 
responders, and changed the way we conduct drills and exercises 
to ensure we're coordinated when disaster strikes. We've also 
spearheaded new coordination among Federal preparedness grant 
programs, formally incorporated mental health into response, 
built regional preparedness coalitions, and developed new 
guidance to give States flexibility in deploying their human 
resources in emergencies.
    We've dramatically enhanced our focus on children and other 
potentially at-risk populations, including through a novel 
collaboration with CMS to better identify and prepare for the 
needs of electricity dependent and dialysis patients.
    To advance the development and procurement of new medical 
countermeasures, ASPR created an interagency body called the 
Public Health Emergency Medical Countermeasures Enterprise--
it's a mouthful, so I say PHEMCE--developed a multiyear medical 
countermeasure budget, and used critical authorities to 
encourage strong partnerships with industry. As you will hear 
from Drs. Robinson and Borio, these flexibilities have made a 
tremendous difference.
    The National Health Security Strategy provides strategic 
direction to ensure that efforts to improve the Nation's health 
security are guided by a common vision, based on sound 
evidence, and carried out in an efficient and collaborative 
manner. In ASPR, we believe that strong day-to-day systems are 
the backbone of strong preparedness and response.
    We have reoriented the Hospital Preparedness Program so our 
programs better link public health and healthcare and encourage 
healthcare entities in every community to work together through 
healthcare coalitions. Healthcare coalitions now include nearly 
three-quarters of the hospitals in the United States as well as 
EMS providers, emergency management organizations, long-term 
care facilities, behavioral health, public health agencies, et 
cetera.
    We've witnessed the benefits of these coalitions time and 
time again, with community responses in Joplin after the 
tornado, in North Carolina after Hurricane Irene, in West, TX 
after a chemical plant fire, and along the East Coast after 
Hurricane Sandy, to name a few. We need to look back no further 
than Ebola to see how critical it is that public health and 
medical care work closely together while at the same time 
recognizing the unique capabilities that each system 
contributes.
    We recognize, however, that communities can be quickly 
overwhelmed, and when that happens, they need to count on their 
Federal partners to come through. To that end, we revamped the 
National Disaster Medical System, and our teams are now on the 
ground within hours, not days, of requests for help. Over the 
past 9 years, our operation centers coordinated 120 Federal 
public health and medical responses.
    PAHPA also authorized programs to develop and make 
available new countermeasures. I will say that 2010 marked an 
important turning point. Our review of the entire Medical 
Countermeasures Enterprise resulted in improvements across the 
entire PHEMCE in the way partners work together and get things 
done.
    The PHEMCE strategy and implementation plan lays out 
priorities, and the first ever PHEMCE multiyear budget was 
recently provided to Congress. Together, PHEMCE agencies have 
over 160 product candidates in the pipeline, and we've added a 
dozen products to the strategic national stockpile. Eight 
products have been approved by FDA since 2012. As you'll hear, 
new capabilities we have up and running have been central to 
getting Ebola countermeasures into West Africa for clinical 
trials now underway.
    In the years since the passage of PAHPA, we've learned many 
things about how to become more prepared, how to respond more 
effectively, how to help communities recover faster and better. 
However, the most important lesson is that there is no end 
point to preparedness, no point at which we can dust off our 
hands, stand back, let down our guard, and say we're done. Our 
nation's health security requires continuous improvement and 
constant vigilance. PAHPA and PAHPRA have been critical to 
these advances in our preparedness.
    Before I close, I just want to say a special thank you to 
you, Mr. Burr, the poppa and grandpoppa of all of these 
efforts. Thank you, and I'm happy to answer any questions that 
you might have.
    [The prepared statement of Dr. Lurie follows:]
             Prepared Statement of Nicole Lurie, M.D., MSPH
    Good morning Senator Burr, Ranking Member Casey, and other 
distinguished members of the committee. I am Dr. Nicole Lurie and I 
serve as the Assistant Secretary for Preparedness and Response at the 
Department of Health and Human Services (HHS).
    I appreciate the opportunity to talk to you today about the Office 
of the Assistant Secretary for Preparedness and Response (ASPR) and its 
accomplishments in moving the country forward in preparing for, 
responding to, and recovering from the adverse health effects of 
emergencies and disasters. Recognizing lessons learned from disasters 
including the terrorist attacks on 9/11, the anthrax attacks in 2001, 
and Hurricane Katrina, ASPR and its predecessor agency were established 
to improve coordination and direction across the spectrum of HHS 
preparedness and response activities. Under the Public Health Service 
Act, as amended by the Pandemic and All-Hazards Preparedness Act of 
2006 (PAHPA) and the Pandemic and All-Hazards Reauthorization Act of 
2013 (PAHPRA), ASPR was established as the lead for HHS emergency 
preparedness and response and serves as the principal advisor to the 
Secretary regarding Federal public health and medical preparedness and 
response to public health emergencies.
                              introduction
    Over the past 6 years, ASPR has significantly advanced the Nation's 
preparedness, contributing to enhanced response and more resilient 
communities that are better prepared to recover from an emergency or 
natural disaster. We have found innovative ways to identify and protect 
vulnerable populations, including targeted approaches for children, 
pregnant women, and people with special medical needs, like those who 
need dialysis or electrically dependent durable medical equipment. We 
restructured the National Disaster Medical System teams so they are 
more flexible, are pediatrics capable, and can provide other 
specialized capabilities to assist communities after disasters. We 
developed and now use innovative approaches to stimulate private sector 
interest in partnering with us to develop medical countermeasures to 
protect against threats to health. ASPR and the Centers for Disease 
Control and Prevention (CDC) aligned preparedness grants to State and 
Local partners to reduce their administrative burden and maximize the 
return on investment and are building new tools to assist hospitals and 
other healthcare coalition members in meeting the medical and public 
health needs of their communities. Today, we integrate behavioral 
health into our response to every disaster, recognizing that community-
level recovery depends on individual ability to cope with the impacts 
of disasters. We are galvanizing the scientific community to be ready 
to conduct research quickly to answer the tough questions your 
constituents will have for you about their health after disasters.
    These advances--vital to our Nation's health security--have been 
supported and made possible by the authorities provided in PAHPA and 
PAHPRA and an incredible team of men and women who comprise ASPR. Under 
these authorities, ASPR's responsibilities are broad, and include: 
overseeing advanced research, development, and procurement of resulting 
medical countermeasures, coordinating with health care systems, and 
providing integrated policy and strategic direction under the National 
Response Framework. In addition, ASPR directs medical and, with CDC, 
public health grants and cooperative agreements, provides leadership in 
international programs and policies with global impact, and has 
developed and submitted a 5-year budget plan for countermeasure 
priorities. ASPR oversees the National Disaster Medical System (NDMS), 
the Hospital Preparedness Cooperative Agreement Program (HPP), and the 
Biomedical Advanced Research and Development Authority (BARDA). Through 
guidance documents like the National Health Security Strategy (NHSS) 
and Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) 
Strategy and Implementation Plan (SIP), ASPR leads the path forward for 
our partners and stakeholders.
    Since PAHPRA was passed in 2013, ASPR has provided to the Congress 
critical requested deliverables including a new National Health 
Security Strategy for 2015 to 2018, and a National Health Security 
Review for 2010 to 2014. In addition, ASPR provided a 5-year Medical 
Countermeasure budget plan, a new PHEMCE SIP, an Interagency 
Coordination Plan with the Department of Defense regarding medical 
countermeasures, established a new National Advisory Committee on 
Children and Disasters, and issued guidelines for temporary 
reassignment of State and tribal public health personnel, State 
pandemic influenza plans, a public health and medical situational 
awareness strategy, and an annual review of the Strategic National 
Stockpile (SNS).
            improving the medical countermeasure enterprise
    Recently, my office released the 2014 PHEMCE SIP, which guides 
medical countermeasure priorities for short, middle, and long-term 
projections. The PHEMCE is one of many great examples of ASPR's whole-
of-government approach. In 2006, ASPR established the PHEMCE to be the 
single Federal coordinating body that oversees the entire medical 
countermeasure lifecycle across the various Federal departments and 
agencies. My office manages the PHEMCE in partnership with other HHS 
agencies including the National Institutes of Health (NIH), the Food 
and Drug Administration (FDA), CDC, and BARDA, along with interagency 
partners such as the Department of Defense (DoD), the Department of 
Homeland Security (DHS), the Department of Agriculture (USDA), and the 
Department of Veterans Affairs (VA). Prior to the PHEMCE, Federal 
efforts were fragmented, and collaboration with our industry partners 
was limited. With a variety of potential threats requiring substantial 
investment, we needed a method to make sure we were not wasting 
resources on duplicative ventures. The resulting governance process and 
decision framework provides means to coordinate across government, 
prioritize investments, and get results.
    As you know, HHS recently provided estimated funding requirements 
for HHS PHEMCE agencies, including NIH, ASPR/BARDA, FDA, and CDC, in 
the first-ever PHEMCE multi-year budget. The multi-year budget 
describes a plan for funding BARDA's Advanced Research and Development 
programs and Project BioShield over 5 years; to maintain the current 
level of preparedness at the SNS; to continue the NIH investments in 
biodefense basic research and development; and to sustain FDA's Medical 
Countermeasure Initiative, initially recommended by the 2010 PHEMCE 
Enterprise Review. It is a critical companion to the PHEMCE SIP in 
accurately projecting the resource estimates required for end-to-end 
medical countermeasure life-cycle management as a product, or candidate 
product, moves through development, licensure, acquisition, and 
stockpiling.
       the biomedical advanced research and development authority
    Coordination made possible through the PHEMCE continues to drive 
progress and success in making medical countermeasures available. BARDA 
has made great progress, from a time when there were almost no medical 
countermeasures in the pipeline, to a robust pipeline with over 160 
candidate medical countermeasures for chemical, biological, 
radiological, and nuclear (CBRN) threats and pandemic influenza. Eight 
of these products have received FDA approval in the last 3 years 
including countermeasures for anthrax, botulinum and pandemic 
influenza. Moreover, BARDA procured 12 novel medical countermeasures 
for the SNS through Project BioShield, including those for smallpox, 
anthrax, botulinum, radiologic/nuclear emergencies and chemical events. 
Since 2007, BARDA has supported the development of 18 influenza medical 
countermeasures, including those used during the 2009 H1N1 pandemic and 
others stockpiled for potential avian influenza H5N1 and H7N9 
outbreaks.
    We are on a trajectory to make available 12 new medical 
countermeasures through Project BioShield procurements in the next 5 
years. These medical countermeasures include next generation anthrax 
vaccines, new smallpox vaccines, biodosimetry diagnostic devices, 
thermal burn radiation drug and skin replacement therapies, radiation 
cell therapies, new antibiotics to counter the ever growing public 
health threat from antimicrobial resistance, and new chemical 
antidotes.
    We have moved from a one-bug, one-drug approach in countermeasure 
development, to a capabilities-based approach in which we are able to 
make novel medical countermeasures when they are most needed during an 
emergency. With the establishment of the three Centers for Innovation 
in Advanced Development and Manufacturing in 2012 and a Fill Finish 
Manufacturing Network comprised of four aseptic filling manufacturers 
in 2013, we are developing, manufacturing, and filling medical 
countermeasures for CBRN threats like anthrax, for emergency situations 
like pandemic influenza like the H7N9 vaccines in 2013, and for 
emerging infectious diseases. In keeping with the parameters of our 
public-private partnership, these state-of-the-art facilities may also 
be used by our private sector partners to develop new vaccines and 
drugs for the open market.
    We've also made huge progress in pandemic influenza preparedness. 
In 2004, the Nation had a single domestic influenza vaccine 
manufacturer. Due to planning, foresight and support across the Federal 
Government, and robust public-private partnerships, we now have robust 
and rapid domestic manufacturing capacity for pandemic influenza 
vaccines, capable of rapidly producing vaccines and other biologics 
against pandemic influenza and other emerging threats.
                  emergency preparedness and response
    HHS is the coordinator and primary agency for the Public Health and 
Medical Services Emergency Support Function of the National Response 
Framework. Our day-to-day work involves supporting local and State 
partners to build stronger, more resilient communities. Ultimately, 
communities should be able to respond to a wide-range of threats to 
public and medical health emergencies on their own, limiting the need 
for Federal assets to augment response. Critical to this effort is the 
National Hospital Preparedness Program--or HPP, which strengthens the 
day-to-day activities necessary to maintain readiness by providing 
resources to State, territorial, and local awardees.
    Over the last few years, ASPR has shifted the focus of HPP from 
preparing one hospital at a time to preparing all of the healthcare 
entities in a community through Health Care Coalitions. Health Care 
Coalitions are formal, collaborative networks of hospitals, health care 
organizations, public health providers, emergency management, emergency 
medical services, and other public and private sector health care 
partners within a defined region. We saw the importance of this first-
hand, during Hurricane Sandy, when nursing homes and hospitals needed 
to evacuate, and mobile satellite emergency units funded in part by HPP 
were used to relieve pressure on the remaining facilities. Further, 
hospitals can now communicate with other responders through 
interoperable communications systems; track bed and resource 
availability using electronic systems; protect health care workers with 
proper equipment; train health care workers on how to handle medical 
crises and surges; develop fatality management, hospital evacuation, 
and alternate care plans; and coordinate regional training exercises. 
There are many more examples of how HPP has demonstrated a return on 
investment, notably during the outbreak of fungal meningitis in 
Michigan; the ammonium nitrate explosion at a fertilizer facility in 
West, TX; and during the bombings at the Boston Marathon.
         aspr has foucused on the needs of at-risk populations
    The underlying goal of my office is to make sure our Nation is 
secure and resilient when confronting diverse incidents with 
challenging health consequences. The National Health Security Strategy 
guides the Nation in achieving that goal. The first NHSS was submitted 
to the Congress in 2009. The second quadrennial report builds on the 
lessons of the first 4 years, and was submitted to the Congress, on 
time, in December 2014.
    Central to the NHSS is the understanding that resilient communities 
include healthy individuals and families with access to health care, 
both physical and psychological, during routine and emergency 
situations. Enhanced resilience is critical to mitigating 
vulnerabilities, reducing negative health consequences, and rapidly 
restoring community functioning. ASPR provides subject matter 
expertise, education, and coordination to make sure the functional and 
access needs of at-risk individuals and behavioral health issues are 
integrated with national public health and medical emergency 
preparedness, response, and recovery activities, as required by PAHPA 
and PAHPRA.
    ASPR works to promote strategies for building individual and 
community resilience that are inclusive of both behavioral health and 
the functional needs of at-risk individuals. Such strategies will 
improve communities' ability to maximize resources, meet needs, and 
recover from the adverse health consequences of public health 
emergencies and disasters at the individual and community levels. 
PAHPRA provided my office with the tools necessary to strengthen our 
capabilities and highlighted the need to address the risks and 
challenges faced by children during emergencies and disasters. Just 
this past year, we established the National Advisory Committee on 
Children and Disasters to further address the public health needs of 
children affected by disasters, a critically important component of our 
response efforts.
                               conclusion
    In the past 6 years, we have learned many things about how to 
become more prepared, how to respond more effectively, and how to 
recover faster. However, it is critical that we recognize that there is 
no end point in preparedness--and that maintaining a strong, steady 
State of preparedness is our new normal. Our objective has been to 
create a system of flexible and nimble capabilities which can be used 
in response to the range of threats we face. PAHPA and PAHPRA have 
given us many of the tools we need, from programs like HPP and BARDA to 
authorities like emergency use authority (EUA) flexibility. We have 
used each and every one of them, including in the Ebola crisis. We 
appreciate the support and partnership we have had with this committee 
and with the Congress and look forward to continuing to work together 
to enhance our Nation's health security.

    Senator Burr. Thank you, Dr. Lurie.
    Dr. Robinson.

  STATEMENT OF ROBIN A. ROBINSON, Ph.D., DIRECTOR, BIOMEDICAL 
 ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT 
    SECRETARY FOR PREPAREDNESS AND RESPONSE, WASHINGTON, DC

    Ms. Robinson. Good morning, Chairman Alexander, Ranking 
Member Casey, Senator Burr, and other distinguished members of 
the committee. First, thank you for your continued support in 
our mission to make the Nation better prepared and for the 
opportunity to update you today on medical countermeasures for 
public health preparedness and response.
    I'm Dr. Robin Robinson, Director of the Biomedical Advanced 
Research and Development Authority, or BARDA, the Deputy 
Assistant Secretary for the ASPR, Dr. Lurie, as well as a 
former vaccine developer in industry. BARDA is the full-time 
Federal Government agency created in 2006 by the Pandemic and 
All Hazards Preparedness Act to support advanced research and 
development and procurement of novel and innovative medical 
countermeasures that address the needs of the entire Nation for 
man-made threats and emerging infectious diseases, like the 
2009 H1N1 pandemic and the current Ebola epidemic.
    Medical countermeasure development is risky, lengthy, and 
expensive, with many inexperienced developers failing, and, in 
the past, many larger pharmaceutical companies avoiding the 
sector completely. BARDA serves as a bridge over a critical gap 
referred to as the Valley of Death in medical countermeasure 
development by transitioning product candidates from early 
development at NIH to advanced development toward FDA approval 
and potential procurement through direct funding, public-
private partnerships, and technical core service assistance 
programs.
    Seven years ago, I agreed to take up the mantle as BARDA's 
first director because I believed that the country needed 
medical countermeasures for protection against bioterrorism and 
pandemic diseases. I also believed that PAHPA's creation of 
BARDA was the appropriate course adjustment for the long 
journey to win this fight. Last, I believed that BARDA's 
talented and dedicated scientist staff and I could succeed in 
this mission.
    Today, I am pleased to report to you that BARDA is living 
up to PAHPA's vision of making our country better prepared and 
secure against these threats with the right medical 
countermeasures. I'll briefly walk you through what we have 
done pre- and post-PAHPA and what we plan to do going forward.
    PAHPA directed BARDA to promote countermeasure advanced 
research and development. Before PAHPA, our medical 
countermeasure product development pipeline was very small, 
primarily for anthrax, smallpox, and pandemic influenza. Now 
there are more than 160 medical countermeasures for all known 
CBRN threats and pandemic influenza, including those for 
special populations.
    Nearly 20 of these medical countermeasures have been 
approved by the FDA since 2007 with many more products expected 
to receive approval in the next several years. Before PAHPA, 
only three BioShield products were in the strategic national 
stockpile. Now there are 12 products for biothreats, chemical 
threat agents, radiation illnesses, and 12 more new products 
expected within the next several years.
    Under the national strategy for pandemic influenza and 
using PAHPA authority, BARDA expanded domestic pandemic 
influenza vaccine manufacturing capacity multifold, stockpiled 
H5N1 and H7N9 vaccines, and provided influenza medical 
countermeasures for the 2009 H1N1 pandemic. Today, BARDA is 
supporting development and manufacturing of promising Ebola 
vaccine and therapeutic candidates.
    For the future, we are launching major new initiatives to 
address antimicrobial drug resistance and biothreats primarily, 
with secondary benefits for high-priority public health 
pathogens and to enhance pandemic preparedness with new 
universal influenza vaccines and immunotherapeutics that will 
also benefit seasonal influenza.
    PAHPA directed BARDA to promote innovation to reduce the 
time and cost of countermeasure advanced research and 
development. Prior to PAHPA, there were no innovation 
investments under Project BioShield. Since PAHPA, we have 
stimulated innovations like synthetic biology in the 
development and manufacturing of vaccine and therapeutic 
candidates and helped modernize the vaccine industry.
    Going forward, we will work with our partners on a 
transformative and cost-saving innovation called continuous 
manufacturing that may change how and where and how much we 
spend for medical countermeasures.
    PAHPA directed BARDA to facilitate collaboration with 
respect to medical countermeasure advanced research and 
development. Under PAHPA, BARDA has collaborated closely with 
our Federal partners in both medical countermeasure 
preparedness and response. Further, BARDA has made public-
private partnerships with industry a standard business practice 
by partnering with more than 90 companies, large and small, and 
more than 25 academic institutions.
    Cost-sharing public-private partnership examples include 
the utilization of the other transactional authority authorized 
under PAHPA to create a novel model for the development of new 
antibiotics and the establishment of three Centers for 
Innovation in Advanced Development and Manufacturing. The 
centers are part of our overall core service assistance 
programs that help medical countermeasures daily and provide a 
national medical countermeasure response.
    In conclusion, State- and terrorist-sponsored actors using 
CBRN agents of mass destruction and recurring infectious 
diseases like pandemic influenza and Ebola are real threats to 
our national health security. BARDA's progress in medical 
countermeasure preparedness and response to these threats 
through our product development acumen, public-private 
partnerships, and commitment to innovation may also serve as a 
model to help make Americans healthier.
    However, the job is not yet done. Continued and more 
vigorous investment into BARDA's mission will ensure that our 
partners and we are able to better prepare the Nation for the 
next known and unknown threat.
    Thank you.
    [The prepared statement of Ms. Robinson follows:]
             Prepared Statement of Robin A. Robinson, Ph.D.
    Good morning, Senator Burr, Ranking Member Casey, and distinguished 
members of the committee. Thank you for the opportunity to speak with 
you today about our Government's public health preparedness and 
response medical countermeasure efforts and challenges. I am Dr. Robin 
Robinson, Director of the Biomedical Advanced Research and Development 
Authority (BARDA) and Deputy Assistant Secretary for Preparedness and 
Response (ASPR). I am happy to testify today with the ASPR, Dr. Nicole 
Lurie, and my other HHS colleagues.
    BARDA is the Federal Government agency, within the Office of the 
Assistant Secretary for Preparedness and Response (ASPR), created in 
2006 by the Pandemic and All-Hazards Preparedness Act (PAHPA) and 
reauthorized by the Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2013 (PAHPRA) to support advanced research and 
development and procurement of novel and innovative medical 
countermeasures. These medical countermeasures--vaccines, therapeutics, 
antiviral and antimicrobial drugs, diagnostics, and medical devices--
address the needs of the entire nation to mitigate the medical 
consequences of man-made chemical, biological, radiological, and 
nuclear (CBRN) agents of terrorism and naturally occurring and emerging 
threats like the 2009 H1N1 pandemic, the 2013 H7N9 influenza outbreak, 
and the current Ebola epidemic.
    Medical countermeasure development is risky, lengthy, and costly 
with many inexperienced developers failing and many larger 
pharmaceutical companies avoiding the sector completely. BARDA serves 
as a bridge over a critical gap in medical countermeasure development. 
BARDA transitions product candidates from early development into 
advanced development toward potential Food and Drug Administration 
(FDA) approval and stockpile procurement through direct support, 
public-private partnerships, and technical core service assistance 
programs.
    The Public Health Emergency Medical Countermeasure Enterprise 
(PHEMCE) establishes product specific requirements for CBRN medical 
countermeasures based on threat scenarios and Material Threat 
Assessments performed by the Department of Homeland Security (DHS). The 
National Institutes of Health (NIH) launch discovery and early stage 
development of product candidates from academic and industry partners 
for transition to BARDA. In turn, BARDA supports and assists these 
product candidates through advanced research and development toward FDA 
approval, until they are sufficiently mature to be acquired and 
potentially stockpiled under Project BioShield at the Centers for 
Disease Control and Prevention's (CDC) Strategic National Stockpile 
(SNS) or at commercial vendors. Upon FDA approval, the financial 
responsibility of purchasing medical countermeasures transfers from 
BARDA under Project BioShield to the CDC/SNS for the stockpile and 
delivery phases. Finally, in public health emergencies, like we saw in 
the H1N1 influenza pandemic and today during the Ebola epidemic, BARDA, 
under the emergency management authorities of ASPR, assumes a response 
posture, interfacing with other Federal agencies and manufacturers to 
develop, produce, and test products for FDA review and approval and 
distribution by CDC to State and local providers.
    BARDA is the only Federal Agency that operates in the advanced 
development space of product development. Advanced development includes 
critical steps needed to transform a candidate to a product that is 
ready to use. These steps include: optimizing and validating 
manufacturing processes such that products can be made at commercial 
scale; optimizing product formulations, storage, and product longevity 
and effectiveness; creating, optimizing, and validating assays to 
assure product integrity; conducting late-stage clinical safety and 
efficacy studies; and carrying out pivotal animal efficacy studies that 
are often required for approval of CBRN medical countermeasures.
    PAHPA directed BARDA to promote countermeasure and product advanced 
research and development. Since its creation, BARDA has built a 
comprehensive and formidable advanced development product pipeline 
comprised of more than 160 medical countermeasures for CBRN threats and 
pandemic influenza. Eight of these products from influenza vaccines to 
anthrax antitoxins have received FDA approval in the last 3 years 
alone; a total of nearly 20 have been approved since 2007. The anthrax 
and botulinum antitoxin products were the first Project BioShield 
products approved by FDA under the Animal Rule. Twelve of these 
products, ranging from anthrax and smallpox vaccines to anti-
neutropenia cytokine therapeutics for radiation illness have been 
procured under Project BioShield with another 12 ready for Project 
BioShield procurement between now and the end of fiscal year (FY) 2018. 
Many of these Project BioShield medical countermeasures were made 
possible through use of Advanced and Milestone Payment Authorities 
designed by PAHPA to provide small companies with greater financial 
stability. Further BARDA has supported the development and 
manufacturing of 18 influenza vaccines, antiviral drugs, and 
diagnostics that were used in the 2009 H1N1 pandemic and stockpiled for 
avian influenza H5N1 and H7N9 outbreaks; a set of industry and academic 
partnerships enhanced through our PAHPA authorities (e.g., antitrust 
exemption). To better serve the needs of special populations, BARDA has 
led the development of many medical countermeasure candidate 
formulations for children, like Prussian Blue, a treatment for internal 
radiation contamination, and solithromycin, a new antibiotic, as well 
as a smallpox Modified Vaccinia Ankara vaccine for immuno-
compromised individuals, which was transitioned from the National 
Institute of Allergy and Infectious Diseases. BARDA is currently 
supporting development and manufacturing of several Ebola vaccine and 
therapeutic candidates destined for clinical trials in West Africa. 
BARDA's work on Ebola medical countermeasures has marked a milestone, 
as the medical countermeasure development pipeline now includes at 
least one product candidate for each of the DHS's Material Threat 
Determinations and pandemic influenza.
    PAHPA directed BARDA to promote innovation to reduce the time and 
cost of countermeasure and product advanced research and development. 
BARDA has stimulated innovation in the development and manufacturing of 
vaccine and therapeutic candidates across the pharmaceutical industry. 
Innovation investments have transitioned a platform technology using a 
novel bacterial expression system into a next generation anthrax 
vaccine candidate by coupling that expression system with rational 
genetic design technology; the objective of which is an anthrax vaccine 
with increased stability and production yields, and thus a lower 
overall product cost. BARDA partnered with industry to use synthetic 
biology technology to generate influenza vaccine seed strains. In 2013, 
this technology was pivotal in making pre-pandemic H7N9 bulk vaccine 
for stockpiling in record time by cutting several weeks off the usual 
timeframe to make influenza vaccines. BARDA began working with industry 
partners last fall to develop new Ebola monoclonal antibodies rapidly 
using the latest innovations in monoclonal antibody development; now we 
are testing these new Ebola antibody candidates in non-human primate 
challenge studies; if these studies are successful, these products will 
move into clinical trials later this year. BARDA has kept a keen eye on 
and supported innovative technologies that may enhance existing medical 
countermeasures or generate new transformative medical countermeasures 
at lower costs and with longer shelf lives.
    PAHPA directed BARDA to facilitate collaboration between the 
Department of Health and Human Services and other Federal agencies, 
relevant industries, academia, and others, with respect to such 
advanced research and development. BARDA has established its medical 
countermeasure development pipeline by collaborating with Federal 
partners, primarily NIH, CDC, FDA, and the Department of Defense, and 
by making many public-private partnerships with industry and academia. 
BARDA partnerships have included nearly 90 pharmaceutical and 
biotechnology companies, both large and small, and more than 25 
academic and other institutions since 2006. BARDA, with vaccine 
manufacturers, has established the first and largest pre-pandemic 
influenza vaccine stockpile in the world, one that could, if necessary, 
vaccinate tens of millions of Americans against potential H5N1 and H7N9 
pandemics. BARDA utilized the Other Transaction Authority authorized 
under PAHPA to create a novel cost-sharing public-private partnership 
with industry for the simultaneous development of multiple new classes 
of antibiotics for biothreats and high-priority public health 
pathogens. Further, BARDA, industry, and academia have entered into 
partnerships designated as the Centers for Innovation in Advanced 
Development and Manufacturing (CIADM) to assist inexperienced medical 
countermeasure developers, expand modernized domestic pandemic 
influenza vaccine manufacturing capacity, ensure nimble and flexible 
manufacturing capabilities for emerging infectious threats in public 
health emergencies, and provide workforce training to the next 
generation of vaccine developers and manufacturers. Today the CIADMs 
are working on anthrax and Ebola medical countermeasures.
    Building on the National Strategy for Pandemic Influenza, BARDA has 
collaborated with industry and Federal partners to: (1) support 
advanced development of new influenza vaccines, antiviral drugs, and 
diagnostic devices leading to multiple FDA approvals for the U.S. 
market; (2) improve influenza vaccine manufacturing resulting in 
greater vaccine production yields and availability sooner; (3) build 
and maintain stockpiles of pre-pandemic influenza vaccines for the 
critical workforce and antiviral drugs at the Federal and State levels; 
and (4) expand domestic and global pandemic influenza vaccine 
manufacturing infrastructure and capacity multifold.
    To save cost and time in product development and manufacturing, 
BARDA has established a medical countermeasure infrastructure comprised 
of core service assistance programs to assist product developers on a 
daily basis while ensuring rapid and nimble response in a public health 
emergency. BARDA has employed this medical countermeasure 
infrastructure for development of CBRN medical countermeasures on a 
routine basis and is now using them in the current Ebola response by 
supporting the development and manufacturing of several Ebola 
therapeutics and vaccines. BARDA's Nonclinical Studies Network (NCSN), 
which was established in 2010 and is comprised of 17 high-
biocontainment laboratories in the United States and the United 
Kingdom, has developed qualified animal models for CBRN threats, 
performed animal-challenge studies for CBRN medical countermeasures, 
and evaluated potential CBRN medical countermeasure candidates in these 
animal models prior to BARDA investment. Today NCSN is conducting 
critical animal challenge studies for promising Ebola monoclonal and 
antiviral drug therapeutic candidates. BARDA's three CIADMs are helping 
to develop anthrax vaccines and are expanding the production of new and 
existing Ebola monoclonal antibodies similar to ZMapp in mammalian 
cells. BARDA's Fill Finish Manufacturing Network, established in 2013 
with four contract manufacturing organizations having aseptic filling 
capabilities in the United States, is now being used to formulate and 
fill multiple Ebola antibody and vaccine candidates into vials for 
clinical efficacy studies in West Africa. Two contract research 
organizations among the five members of our clinical studies network 
are working with BARDA scientists and with CDC in-country to conduct 
Ebola vaccine clinical trials in Sierra Leone. BARDA's modeling unit, 
which routinely provides medical consequence modeling of CBRN threats 
to inform medical-countermeasure requirements, generated key models and 
forecasts on the impacts of medical-countermeasure intervention on the 
epidemiology of the 2009 H1N1 pandemic, the 2013 H7N9 outbreaks, and 
the current Ebola epidemic in West Africa. The investments that BARDA 
has made in our national medical-countermeasure infrastructure since 
2010 are playing a major role in the Nation's response to the current 
Ebola epidemic and will become even more vital for medical-
countermeasure responses to public health and national security 
emergencies in the coming years.
    Since PAHPA, FDA and BARDA have greater scientific and regulatory 
engagement, both in regard to the requirements for Emergency Usage 
Authorization and Animal Rule, as well as all aspects of regulatory 
approval throughout the medical countermeasure development pipeline. 
Currently BARDA and FDA are working together to implement a framework 
for selection of medical countermeasure candidates needing Regulatory 
Development Plans as required in PAHPRA.
    BARDA has developed multiple opportunities for government, 
industry, and academic stakeholders to engage us with regard to medical 
countermeasure research, development, innovation, and stockpiling. The 
PHEMCE's website,\1\ managed by BARDA, serves as a portal for updated 
information on medical countermeasure goals, priorities, programs, 
funding opportunities, meetings, and procurement policies and 
processes. Through this portal, stakeholders can arrange meetings with 
BARDA and other PHEMCE partners via the BARDA-coordinated Tech Watch 
program that enables companies and others to discuss product candidates 
in detail and to understand PHEMCE goals, priorities, and procurement 
processes. Through the TechWatch program, BARDA has met with an average 
of more than 150 stakeholders each year on CBRN and pandemic influenza 
medical countermeasures; in the last year, we've met with an additional 
130+ stakeholders on Ebola medical countermeasures. Data have shown 
that those companies that visit BARDA through the Tech Watch program 
have a much greater chance of success than those not meeting with BARDA 
for assistance on technical issues and procurement processes. 
Additionally, BARDA hosts Industry Day, an annual 3-day event in 
Washington, DC, where BARDA presents to 700+ stakeholders a status 
report on the BARDA-funded medical countermeasure portfolio, new 
programmatic initiatives and funding priorities. Industry Day also 
offers a concentrated series of TechWatch-like sessions to meet 
individually with stakeholders. ASPR's contracting office also provides 
presentations on current procurement policies and processes and 
provides assistance on contracting issues. BARDA also meets regularly 
with medical associations, industry alliances, State and local health 
department associations, and first-line end users across the United 
States to seek their input on BARDA medical countermeasure programs and 
initiatives. BARDA's stakeholder outreach demonstrates further our 
commitment to partnerships with many different sectors and fulfills 
PAHPA's directive to facilitate collaboration on medical countermeasure 
development.
---------------------------------------------------------------------------
    \1\ medicalcountermeasures.gov.
---------------------------------------------------------------------------
    PAHPRA extended, reauthorized, or amended many of the authorities 
that were initially enacted in PAHPA and that BARDA has utilized 
successfully to establish an advance-development medical-countermeasure 
pipeline, invigorate Project BioShield with new products, and enable 
BARDA to meet pandemic influenza medical countermeasure goals. More 
importantly, PAHPRA reauthorized funding for BARDA Advanced Research 
and Development programs and the Special Reserve Fund for Project 
BioShield through fiscal year 2018. The recently released PHEMCE Multi-
Year budget details BARDA's plan for utilizing these resources. 
However, substantial returns on investment seen already in medical 
countermeasure candidate development and innovative technologies are 
leading to mature and FDA-approved products and national medical 
countermeasure infrastructure assets are becoming mature. Major new 
initiatives in the coming years will include development of products 
that address our core mission space--man-made and emerging infectious-
disease threats--that also will pay dividends in everyday public 
healthcare. Specifically, BARDA's focus will expand toward development 
of new classes of antibiotics and new diagnostics to combat 
antimicrobial drug resistance primarily for biothreats but also public 
health pathogens, as appropriate; universal influenza vaccines to 
afford more effective control of seasonal influenza and better 
preparedness for pandemic influenza; influenza immunotherapeutics to 
mitigate the emergence of drug resistance to the present classes of 
influenza antiviral drugs; and continuous manufacturing of 
pharmaceutical products that may transform where and how we make 
medical countermeasures in the next 20 years. These new initiatives and 
the lessons learned from Ebola coupled with BARDA's medical 
countermeasure advances provide a compelling argument for BARDA to 
create a new Emerging Infectious Disease program in the coming year.
                              conclusions
    State- or terrorist-sponsored actors using chemical, biological, 
nuclear and radiological agents of mass destruction, and recurring 
natural events including pandemic influenza and emerging infectious 
diseases like Ebola present real and present health threats to the 
Nation. BARDA has made significant progress in developing and acquiring 
medical countermeasures that can address the catastrophic medical 
consequences of many of these threats. BARDA's progress has been not 
just in medical countermeasure preparedness, but in the establishment 
of a rapid and nimble response national infrastructure to develop, 
manufacture, and test in animals and humans new medical countermeasures 
for known and unknown emerging infectious diseases. Authorities and 
responsibilities created by the Project BioShield Act, PAHPA, and 
PAHPRA including the establishment of BARDA have demonstrated a 
successful model to address market failures and high priority USG 
needs.
    Going forward, it is important that we maintain our medical 
countermeasure preparedness in areas where we have succeeded against 
key threats, continue medical countermeasure development and 
manufacturing where we are not yet finished, and reach forward toward 
transformational medical countermeasure innovations that may bring both 
more rapid and better preparedness and response capabilities at less 
expense to these threats. Advancing BARDA's mission will help ensure 
that we are prepared to face the next Ebola epidemic, influenza 
pandemic, anthrax attack, or unknown pathogen. BARDA is prepared to 
meet those challenges and provide resources, expertise, and technical 
assistance for promising and transforming vaccine, therapeutic and 
diagnostic candidates.

    Senator Burr. Thank you, Dr. Robinson.
    Dr. Redd.

 STATEMENT OF STEPHEN C. REDD, RADM, M.D., DIRECTOR, OFFICE OF 
 PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE 
              CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Redd. Good morning, Senator Burr, Senator Casey, and 
Senator Alexander. It's a pleasure to be here today to talk 
with you about our efforts to improve the state of public 
health preparedness. I am Rear Admiral Stephen Redd. I'm 
Director of CDC's Office of Public Health Preparedness and 
Response.
    I'll focus my remarks on two programs this morning. The 
first is the support to State and local governments, and the 
second is the strategic national stockpile. I'll also focus on 
mechanisms or processes that we use to coordinate those 
activities.
    The terrorist attacks of September 11th and the anthrax 
attacks that followed shortly thereafter brought to light key 
weaknesses in the U.S. public health infrastructure. In 
response, the U.S. Government increased efforts to ensure that 
public health was part of emergency responses and also part of 
planning and preparing for those responses.
    Since 2002, CDC has awarded more than $9 billion to improve 
preparedness at the State and local level through a cooperative 
agreement program known as the Public Health Emergency 
Preparedness program, and that's commonly known by its acronym 
of PHEP, but I will limit my use of that acronym. This program 
supports 62 awardees, all 50 States, 8 territories, and 4 
directly funded cities. The funds support staff, they support 
planning, exercises, training, and the procurement of 
equipment.
    I'm going to now talk about what else these grantees do. 
They're required to conduct at least one exercise per year and 
evaluate their performance with an after-action review. They 
also use real world events to test their operational readiness.
    I'll give an example of how this process has led to an 
intervention through PAHPRA. In the H1N1 influenza pandemic, 
State governments recognized that they had people working for 
them that were funded by Health and Human Services but in 
programs that weren't related to response, and they couldn't 
move them from those activities to the higher priority.
    Through PAHPRA, this problem was corrected, and now when 
there's a federally declared public health emergency, it's 
possible to move people from the work that they were doing to 
respond to public health emergencies with the appropriate 
oversight.
    I'll turn now to the strategic national stockpile. As you 
know, this is a Federal asset that manages and delivers 
lifesaving medical countermeasures. It contains 
pharmaceuticals, critical medical supplies, Federal medical 
stations, and medical equipment. It's currently valued at $6.3 
billion, and we work closely within the Public Health Emergency 
Medical Countermeasure Enterprise to prioritize investments in 
the strategic national stockpile as well as in the upstream of 
development and production.
    We also offer training and technical assistance to State 
health departments which are the recipients of these materials 
when they're deployed. We make sure that the knowledge and the 
skills are available at the State and local level to actually 
use these products when there is a need.
    To conclude, public health threats are everywhere, from the 
reemergence of measles, which was eliminated from the United 
States in the year 2000, to Ebola, a threat from the other side 
of the world, to an earthquake that can strike suddenly. The 
public health system must be ready to respond.
    Due to investments made by Congress, the Nation is better 
prepared to prevent and respond to public health emergencies 
now than before September 11th. As you've heard from the other 
speakers, preparedness requires ongoing work. We have to learn 
from our responses and adapt and be ready to adapt as we face 
new threats.
    CDC will continue to work in this system, coordinating with 
State, tribal, and local health departments and within the 
Federal family to keep the public safe. I look forward to our 
continuing to work together in this important area, and I'd be 
glad to answer any questions.
    Thank you.
    [The prepared statement of Dr. Redd follows:]
           Prepared Statement of Stephen C. Redd, RADM, M.D.
    Good morning Chairman Burr, Senator Casey, and members of the 
committee. I am Rear Admiral Stephen Redd, Director of CDC's Office of 
Public Health Preparedness and Response. I am pleased to appear before 
the committee today to discuss the state of public health preparedness 
in the United States and the role that the Pandemic and All-Hazards 
Preparedness Reauthorization Act of 2013 (PAHPRA) and other legislation 
play in improving the health security of the Nation.
    CDC advances the health security of the Nation by helping 
communities prepare for, respond to, and recover from all hazards, 
including chemical, biological, radiological, and nuclear threats; 
natural disasters; and epidemics (Influenza). Whether the hazard is 
naturally occurring (Ebola, Middle East Respiratory Syndrome, and 
hurricanes), accidental (the 2014 West Virginia chemical spill) or 
intentional (Boston Marathon bombings and anthrax attacks), effective 
public health emergency response depends on building, maintaining and 
constantly improving the capability of State and local health 
departments to prepare for and respond to public health emergencies. 
The all-hazards approach to public health preparedness and response 
fosters development of emergency-ready public health departments that 
are flexible and adaptable to the needs of a particular event.
    In support of the National Strategy to Combat Antibiotic Resistance 
Bacteria (CARB) released in September 2014, CDC is also working with 
other HHS agencies and executive branch departments to address the 
growing threat of antibiotic resistance. Without rapid and coordinated 
action, antibiotic resistance threatens public health progress made 
over the last century from the discovery and development of antibiotic 
drugs, thereby threatening patient care, economic growth, public 
health, agriculture, economic security, and national security. The 
President's fiscal year 2016 budget supports implementation of the 
National Strategy by nearly doubling the amount of Federal funding for 
combating and preventing antibiotic resistance to more than $1.2 
billion. The funding will improve antibiotic stewardship; strengthen 
antibiotic resistance surveillance and prevention capacity; and drive 
research innovation in the human health and agricultural sectors.
             role of state and local public health agencies
    State and local public health agencies are the lead entities in 
public health preparedness and response. CDC provides ongoing technical 
assistance and, if requested, will provide on-the-ground personnel to 
assist with a state's response effort. For example, CDC personnel are 
providing laboratory capacity and communications support to California 
public health agencies in response to the current measles outbreak. 
Investments in preparedness since 2001 have greatly increased the 
Nation's public health preparedness for all hazards. One of the lessons 
learned as a result of responding to the 9/11 and anthrax attacks was 
that State and local health departments lacked critical capabilities 
needed to mount an emergency response, and the Nation's public health 
system also was unable to provide essential public health services 
during an emergency. Health departments lacked laboratory networks, 
electronic disease surveillance systems, risk communication networks, 
and emergency operations centers.
    Successful State and local response to public health emergencies 
depends upon many factors, including a capable State and local public 
health and healthcare system. Since 2002, CDC has awarded more than $9 
billion to improve preparedness at the State and local level, first 
through the Cooperative Agreement for Preparedness and Response to 
Bioterrorism, and then through the Public Health Emergency Preparedness 
(PHEP) cooperative agreement authorized by the Pandemic and All-Hazards 
Preparedness Act of 2006 (PAHPA) and reauthorized as PAHPRA in 2013. 
PHEP currently supports 62 awardees--including all 50 States, 8 
territories and freely associated States, and directly funded cities 
(New York City; Washington, DC; Chicago; and Los Angeles)--according to 
a base-plus population formula prescribed by statute, which ensures a 
minimum amount of funding to each awardee. These funds support staff, 
enable exercises, provide for training, pay for equipment, and provide 
other services essential to maintaining preparedness. In addition, CDC 
personnel help PHEP awardees improve their performance by sharing 
knowledge, useful practices and lessons learned along with the tools 
and resources needed to identify and address gaps in preparedness 
capabilities. Congress appropriated $571 million to CDC to enhance 
domestic preparedness and response for Ebola including State and local 
preparedness, laboratory capacity, and expanded entry screening. 
Cooperative agreements under CDC's PHEP program and the Hospital 
Preparedness Program (HPP), overseen by the Assistant Secretary for 
Preparedness and Response (ASPR), are managed through a joint funding 
opportunity announcement. This collaboration reduces the administrative 
burden on the awardees through a single application process for both 
cooperative agreements.
    In 2011, CDC published the Public Health Preparedness Capabilities: 
National Standards for State and Local Planning to better focus the 
preparedness activities of State and local health departments.\1\ The 
15 capabilities serve as national public health preparedness standards 
and help ensure Federal preparedness funds are directed to priority 
areas. State, local and territorial health departments allocate PHEP 
funds based upon their strategic priorities. Awardees devote nearly 50 
percent of their funding to building and sustaining Public Health 
Surveillance and Epidemiological Investigation and Public Health 
Laboratory Testing capabilities, core public health activities that 
help protect their communities. Remaining funds are invested in the 
other 13 capabilities--Community Preparedness, Community Recovery, 
Emergency Operations Coordination, Emergency Public Information and 
Warning, Fatality Management, Information Sharing, Mass Care, Medical 
Countermeasure Dispensing, Medical Materiel Management and 
Distribution, Medical Surge, Non-Pharmaceutical Interventions, 
Responder Safety and Health, and Volunteer Management.
---------------------------------------------------------------------------
    \1\ http://www.cdc.gov/phpr/capabilities/index.htm.
---------------------------------------------------------------------------
    Each year the 62 PHEP awardees report data on their current status 
for each capability. The data and supporting documentation are 
validated by CDC's Office of Public Health Preparedness and Response. 
Aggregate awardee scores show increases in 14 of the 15 capabilities 
over the past 3 years. The 2014 response to Ebola cases in the United 
States illustrates one of the impacts of PHEP funding throughout the 
past decade. Through that funding, State and local health departments 
across the country built their capability to perform effective contact 
tracing to help identify individuals who may have been at a higher risk 
for infection due to contact with a person with Ebola or due to travel 
from one of the highly affected countries in West Africa.
                 lessons learned from real-life events
    While training and skill development are important, exercises and 
real-life events provide opportunities to put those skills to work. 
PHEP awardees are required to demonstrate their capabilities at least 
once a year by conducting an exercise and evaluating their performance 
through an after-action review process. Oftentimes, jurisdictions are 
able to use real incidents in their communities to test operational 
readiness to respond to public health emergencies. After-action reviews 
collect data about successes and areas for improvement identified 
during unexpected incidents, exercises, and planned events such as 
festivals or concerts that draw large crowds. Data from these reviews 
are used to identify strengths for sustainment and gaps for future 
capability development. Use of this information is key to improving 
performance for the next incident.
    The review process following the 2009 national response to the H1N1 
Influenza pandemic provides a good example of how identification of an 
obstacle encountered during a response can be a catalyst for changes 
that improve preparedness for future events. At the State and local 
levels, employees supported through Department of Health and Human 
Services (HHS) grants that were funded by non-influenza programs were 
not able to assist in response to the flu outbreak due to restrictions 
on performing tasks outside of the funding for their normal work. In 
some areas where there were not enough staff for the H1N1 response, 
this restriction prevented additional State and local staff from 
performing surveillance or providing vaccinations. Federal and State 
partners identified this issue, and the Congress provided new 
authorization in PAHPRA in 2013 that provides a mechanism for States to 
request that a worker at the State or local level who is funded under 
programs authorized by the Public Health Service Act be allowed to 
assist, based on specified criteria, in a response to a federally 
declared public health emergency. This provides additional flexibility 
and scalability to support quick and effective responses to public 
health emergencies.
                      a strong laboratory network
    Rapid identification of disease is critical to addressing public 
health threats before they become a crisis. CDC's Laboratory Response 
Network (LRN) maintains an integrated network of State and local public 
health, Federal, and international laboratories that can respond to 
biological, chemical, and other public health threats. The linking of 
State and local public health laboratories, veterinary, agriculture, 
and water- and food-testing laboratories is unprecedented and provides 
for rapid testing, timely notification and secure messaging of 
laboratory results. The LRN demonstrates a scalable and flexible asset 
to address public health threats.
    In response to the West Africa Ebola outbreak, CDC collaborated 
with the Department of Defense (DoD) to equip select LRN laboratories 
around the United States with the ability to quickly and accurately 
test specimens for the outbreak strain of Ebola virus. Prior to the 
current outbreak only two LRN laboratories were capable of performing 
an Ebola test--DoD's U.S. Army Medical Research Institute of Infectious 
Diseases and CDC laboratories. By August 1, 2014, CDC provided the FDA 
emergency use authorized DoD assay to 13 LRN public health laboratories 
in States chosen based on geography and the number of travelers 
arriving from West Africa. Currently, 55 laboratories in 43 States have 
completed proficiency testing with the DoD Ebola assay, and CDC 
continues to work with LRN laboratories to acquire and maintain 
capacity to handle Ebola specimens.
          medical countermeasures for public health responses
    CDC's Strategic National Stockpile (SNS) manages and delivers life-
saving medical countermeasures during a public health emergency. Valued 
at approximately $6.3 billion, it is the largest federally owned 
repository of pharmaceuticals, critical medical supplies, Federal 
Medical Stations, and medical equipment available for rapid delivery to 
support Federal, State, and local response to health security threats. 
If a biological, chemical, radiological, or nuclear event occurred on 
U.S. soil tomorrow, the SNS is the only Federal resource readily 
available to respond once State and local medical countermeasure 
supplies are depleted.
    CDC works with ASPR and with other Federal agencies, through the 
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), to 
prioritize Federal investments in medical countermeasures based on 
analysis of risk and support of critical markets. SNS procurements and 
the advanced development and procurement mechanisms managed through 
ASPR are critical to maintaining production capacity for products with 
no commercial market and products for which commercial supplies may be 
insufficient to meet demands during an emergency.
    Just as important as having the right medical countermeasure on the 
shelf in the SNS is knowing our public health partners at the State and 
local levels will be able to effectively and efficiently receive those 
assets from the SNS and get them to the individuals in need of 
treatment or protection in time. For this reason, CDC offers training 
programs to ensure that our partners have the knowledge and skills they 
need to distribute and dispense SNS assets in a timely manner, and CDC 
supports exercises to test the skills of trained responders and 
evaluate plans for possible improvements. These trainings and exercises 
help our partners improve their preparedness and establish confidence 
in their ability to respond.
    Jurisdictions face ongoing challenges when planning to dispense 
medical countermeasures to large populations. Whether it is the 
availability of staff or infrastructure to support dispensing of 
medical countermeasures to large populations, few State or local public 
health agencies have the resources at their disposal to meet the 
required dispensing timelines. For this reason, CDC engages with the 
private sector to establish agreements for support of medical 
countermeasure dispensing. These partners, who range from nationwide 
retail, pharmacy and hospitality chains to faith-based and community 
organizations, all make commitments to support dispensing of 
countermeasures in the communities they serve. These partnerships, when 
working with local public health officials, improve efficiency, provide 
additional means to dispense medical countermeasures to populations 
within the community and reduce the burden on local public health 
responders during times of urgent need.
                               conclusion
    Public health threats are everywhere. From the reemergence of 
measles, which hadn't been a problem in the United States for years, to 
the Ebola virus, a threat from the other side of the world, to an 
earthquake that can strike without warning, the public health system 
must remain vigilant to protect U.S. residents.
    Preparedness is not a destination. It is a process of skill 
development, using lessons learned to help us adapt to the current 
environment and better prepare us to address future threats. CDC will 
continue to work with our Federal, State, territorial, local and tribal 
partners to ensure necessary capabilities are maintained to keep the 
public safe. I look forward to our continued partnership with the 
Congress and would be glad to answer any questions you may have.

    Senator Burr. Thank you, Dr. Redd.
    Dr. Borio.

 STATEMENT OF LUCIANA BORIO, M.D., ASSISTANT COMMISSIONER FOR 
      COUNTERTERRORISM POLICY, DIRECTOR OF THE OFFICE OF 
 COUNTERTERRORISM AND EMERGING THREATS, DEPUTY CHIEF SCIENTIST 
 (ACTING), U.S. FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Borio. Good morning, Chairman Alexander, Senator Burr 
and Senator Casey, and thank you for calling this hearing. I'm 
grateful for the opportunity to appear before you today to 
discuss FDA's preparedness and response efforts.
    I can say with confidence that we are much better prepared 
today because of this committee's actions and your leadership, 
Senator Burr. PAHPRA established key legal authorities to 
strengthen our Nation's readiness for public health 
emergencies.
    In 2010, FDA launched its Medical Countermeasures 
Initiative to deepen our engagement in medical countermeasure 
activities. This engagement and new authorities, both codified 
in PAHPRA, have improved FDA's readiness and has allowed us to 
mount an extraordinary response to the Ebola epidemic in West 
Africa.
    There are currently no treatments or vaccines that have 
been shown to be safe and effective for Ebola. The FDA is 
taking tremendous steps to speed the development, manufacture, 
and availability of these medical products. We have established 
continuous lines of communication with commercial developers 
and U.S. Government agencies.
    We are reviewing data as they are received. We have worked 
with product sponsors, international regulators, and the NIH to 
launch Ebola vaccine trials in record time. We are leveraging 
our authorities under PAHPRA. We issued EUAs for eight Ebola 
diagnostic tests, and as mentioned earlier, just 2 days ago, we 
authorized the first point of care rapid diagnostic test for 
Ebola.
    We collaborated with the NIH on the design of innovative, 
adaptive, and scientifically rigorous clinical trial protocol 
to evaluate investigational drugs for Ebola. This clinical 
trial, which will first test ZMapp, is now positioned in the 
United States and in Liberia.
    These accomplishments were made possible by the hundreds of 
frontline FDA scientists and medical officers engaged in this 
response. I would like to thank them for their tireless efforts 
and unwavering commitment to service. Congressional investment 
in our FDA program has also led to improved preparedness in a 
broader way of threats. For example, under our EUA authority, 
we authorized the use of diagnostic tests for the H7N9 avian 
influenza virus and the Middle East Respiratory Syndrome 
coronavirus. In this time period, FDA approved medical 
countermeasures for anthrax, botulism, plague, seasonal and 
pandemic influenza. I may add that virtually all of these also 
carry a pediatric indication, thanks in part to regulatory 
science.
    Just yesterday, we approved an antibiotic drug combination 
to treat some very serious infections that may involve bacteria 
resistant to other drugs. Developing countermeasures is highly 
complex, as you know, and the Ebola epidemic has demonstrated 
how critical it is to respond with speed and flexibility, but 
also how important it is to get it right.
    When investigation of products are still in the early 
stages of development, it is possible that some that at first 
seemed promising may ultimately have little or no effect. The 
fastest and most definitive way to determine whether a product 
is safe and effective is through properly designed scientific 
investigations and clinical trials. In emergencies like this, 
the urgency to do something may be used as an excuse to conduct 
studies that are not scientifically sound and may fail to 
detect harm.
    It must be remembered that investigational drugs can have 
side effects that may harm patients. This is particularly 
important for Ebola, where many patients survive with basic 
medical care, and administering a drug that lacks activity and 
that has significant side effects to vulnerable patients could 
have disastrous and even fatal consequences.
    It's very important that decisions about using 
investigational products need to be carefully considered. It's 
essential for safeguarding patient safety and also maintaining 
the trust of affected populations.
    I want to conclude by emphasizing that close cooperation 
and coordination are essential, and the strong engagement that 
is evident among the agencies here today is an example of 
public health synergy at its best. There is still a tremendous 
amount of work for us to do, and we are fully committed to 
leveraging our deep expertise and all of our authorities to the 
fullest extent to support our Nation's readiness for these 
serious public health threats.
    Thank you for making this happen.
    [The prepared statement of Dr. Borio follows:]
               Prepared Statement of Luciana Borio, M.D.
    Good morning Mr. Chairman, Ranking Member, and members of the 
committee. I am Dr. Luciana Borio, Assistant Commissioner for 
Counterterrorism Policy, Director of the Office of Counterterrorism and 
Emerging Threats, and Acting Deputy Chief Scientist at the Food and 
Drug Administration (FDA or the Agency). Thank you for the opportunity 
to appear today to discuss FDA's efforts to prepare our Nation to 
mitigate chemical, biological, radiological, and nuclear (CBRN) threats 
as well as threats from naturally emerging infectious diseases like 
pandemic influenza and antimicrobial-resistant pathogens.
                 fda's medical countermeasures mission
    FDA plays a critical role in facilitating the development and 
availability of medical countermeasures to protect the United States 
from CBRN and emerging infectious disease threats. FDA works closely 
with its interagency partners through the Public Health Emergency 
Medical Countermeasures Enterprise (the Enterprise) to build and 
sustain the medical countermeasure programs necessary to respond 
effectively to public health emergencies. We also work with the U.S. 
Department of Defense (DoD) to facilitate the development and 
availability of medical countermeasures to support the unique needs of 
the military. The mission of my office is to facilitate the development 
and availability of these lifesaving products.
    In 2010, FDA launched its Medical Countermeasures Initiative (MCMi) 
to focus increased resources on facilitating the development and 
availability of medical countermeasures. FDA's scope of operations 
within its medical countermeasures mission covers a broad range of 
activities vital to facilitating the development of and access to safe 
and effective medical countermeasures, including:

     Reviewing medical countermeasure marketing applications 
and approving those that meet applicable standards for safety and 
efficacy;
     Providing regulatory advice, guidance and--when 
appropriate and needed--technical assistance to medical countermeasures 
product sponsors, U.S. Government partners, international regulators, 
and international organizations such as the World Health Organization 
(WHO);
     Supporting efforts to establish and sustain an adequate 
supply of medical countermeasures, including averting supply 
disruptions when feasible and, in certain situations, allowing products 
to be used beyond their expiration dates when supported by our 
scientific analyses;
     Supporting the development of advanced manufacturing 
technologies by collaborating with the Department of Health and Human 
Services (HHS) Biomedical Advanced Research and Development Authority 
(BARDA) on their Centers for Innovation in Advanced Development and 
Manufacturing;
     Facilitating access to medical countermeasures that are 
not yet approved, licensed, or cleared for use, if circumstances 
warrant, through an appropriate mechanism such as an Emergency Use 
Authorization (EUA);
     Ensuring that FDA regulations and policies adequately 
support medical countermeasures development and enable preparedness and 
response activities;
     Fostering the professional development of our scientists 
to ensure that FDA personnel maintain the skills and abilities to 
support the medical countermeasures mission;
     Proactively identifying and resolving regulatory 
challenges associated with medical countermeasures; and
     Supporting regulatory science to develop the tools, 
standards, and approaches necessary to assess the safety and efficacy, 
including quality and performance, of medical countermeasures.
                          measures of success
    The additional resources that Congress provided to FDA for the MCMi 
have enabled FDA to hire expert staff and become more deeply and 
thoroughly engaged in medical countermeasure activities.
    This increased engagement, along with new authorities gained under 
the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) 
of 2013, which, for example, provided FDA greater flexibility in the 
issuance of EUAs, has enabled FDA to better respond to emerging public 
health threats. For example, FDA worked proactively with U.S. 
Government partners, international partners, and product developers to 
help facilitate the development and availability of medical 
countermeasures to respond to the avian influenza A (H7N9) virus and 
the Middle East Respiratory Syndrome coronavirus (MERS--CoV). FDA 
authorized the use of three diagnostic tests for the H7N9 virus and one 
diagnostic test for MERS-CoV, under its EUA authority.
    FDA has also taken extraordinary steps to be proactive, flexible, 
and highly responsive to the Ebola epidemic in West Africa, which has 
presented a complex range of issues. FDA's efforts include:

     Working to help expedite the development and availability 
of medical products to detect, prevent, and treat Ebola virus disease, 
by providing scientific and regulatory advice to commercial developers 
and U.S. Government agencies that support medical product development;
     Working with product sponsors, international regulators, 
WHO, and the National Institutes of Health (NIH) to launch Ebola 
vaccine trials in record time;
     Collaborating with NIH to help with the design of an 
innovative and robust common clinical trial protocol to evaluate 
investigational treatments for Ebola;
     Collaborating extensively with WHO and our international 
regulatory counterparts to exchange information about investigational 
products for Ebola in support of international response efforts and to 
achieve regulatory harmonization, where possible;
     Facilitating access to investigational medical products 
for patients with Ebola, when requested by clinicians;
     Authorizing the use of seven diagnostic tests for Ebola 
under our EUA authority; and
     Actively monitoring for fraudulent products that claim to 
diagnose, prevent, or treat Ebola infection and taking action, as 
warranted, to protect public health (for example, FDA issued Warning 
Letters to six firms marketing products that claim to prevent, treat, 
or cure infection with the Ebola virus).

    FDA's increased engagement under the MCMi has also helped to 
resolve many challenges and impediments associated with the U.S. 
Government's medical countermeasures pipeline so that development 
programs continue to move forward. For example, this has resulted in 
the approval of several medical countermeasures, including a 
therapeutic for inhalational anthrax, a botulism antitoxin, two 
antibiotics for the treatment and prophylaxis of plague, and a next-
generation portable ventilator. Of note, FDA was able to approve the 
anthrax therapeutic for use in children as well as adults, despite the 
fact that pediatric patients were not studied due to ethical concerns 
during the development of this product. This achievement was made 
possible by the application of regulatory science.
    FDA has also continued its efforts to support the establishment and 
sustainment of an adequate supply of medical countermeasures. For 
example, FDA supports the Shelf Life Extension Program (SLEP), a 
Federal fee-for-service program, for extending the useful shelf life of 
military-significant and contingency-use medical products, including 
medical countermeasures that are owned by components of DoD or other 
Federal program participants, such as the Strategic National Stockpile 
(SNS).\1\ FDA laboratory personnel test and evaluate drugs submitted 
for shelf-life extension to ensure stability and quality before a 
shelf-life extension is approved.
---------------------------------------------------------------------------
    \1\ SLEP is designed to defer drug replacement costs for date-
sensitive stockpiles of drugs by extending their useful shelf life 
beyond the manufacturer's original expiration date.
---------------------------------------------------------------------------
    In addition, FDA has continued to work to ensure that the U.S. 
Government is as prepared as possible to rapidly deploy medical 
countermeasures when necessary. For example, FDA has readied stockpiled 
medical countermeasures for potential use under its EUA authorities 
against a diverse array of threats including smallpox, anthrax, and 
pandemic influenza.\2\
---------------------------------------------------------------------------
    \2\ To facilitate the issuance of EUAs, FDA has developed a pre-EUA 
submission process. FDA works with product sponsors or government 
agencies, such as CDC and DoD, to develop pre-EUA packages that will 
form the basis of an EUA request and decision, when circumstances 
justify. Pre-EUA packages contain data and information about the safety 
and efficacy of the product, its intended use under an EUA, and 
information about the potential emergency situation that might unfold.
---------------------------------------------------------------------------
    In the area of pandemic influenza preparedness, FDA has approved 
several influenza diagnostic tests, which can help facilitate an 
effective response to an influenza pandemic by rapidly identifying 
infected persons and facilitating appropriate containment measures and 
clinical care. In addition, FDA has approved several seasonal influenza 
vaccines, which helps increase and sustain pandemic influenza vaccine 
production capacity, including the first seasonal influenza vaccine 
licensed in the United States, produced using modern cell culture 
techniques, and the first seasonal influenza vaccine made through 
recombinant deoxyribonucleic acid (DNA) technology. Both of these 
vaccines offer an alternative to the egg-based process and a potential 
for a faster manufacturing startup in the event of a pandemic. FDA also 
approved the first adjuvanted influenza vaccine for use in people 18 
years of age and older, who are at increased risk of exposure to the 
avian influenza H5N1 virus subtype contained in the vaccine. This 
vaccine is not for commercial distribution but will be part of the 
national stockpile in the event it is needed. Furthermore, FDA has 
collaborated closely with BARDA, the National Institute of Allergy and 
Infectious Diseases (NIAID), and CDC on developing avian influenza H7N9 
virus vaccine candidates.
    Additionally, FDA has approved the first intravenous antiviral drug 
to treat acute, uncomplicated influenza infection in adults and has 
expanded approval for use of an influenza antiviral, oseltamivir, to 
treat children as young as 2 weeks of age. Prior to this action, 
oseltamivir was only approved to treat influenza in children ages 1 
year and older. FDA was able to expand the approved use of oseltamivir 
in children younger than 1 year old based on the extrapolation of data 
from previous studies of adults and older children, and additional 
supporting studies sponsored by both industry and academic researchers.
    Consistent with the President's September 18, 2014, Executive order 
and the national strategy for combating antibiotic resistant bacteria, 
FDA is working hard to help ensure the development of new products in 
preparation for threats from naturally emerging infectious diseases 
from antimicrobial-resistant pathogens. Toward this end, FDA will 
evaluate new antibacterial drugs for patient treatments, streamline 
clinical trials, help phaseout the use of medically important 
antimicrobials in food-producing animals, develop better vaccines for 
antibiotic resistant organisms, and strengthen capacities to detect 
antibiotic resistance.
    On the regulatory science front, FDA has established a broad and 
robust portfolio of cutting-edge research under MCMi's Regulatory 
Science Program to help develop the tools necessary to support 
regulatory decisionmaking. A few examples of ongoing projects include 
supporting the Wyss Institute for biologically inspired engineering at 
Harvard University as it develops models to assess radiation damage in 
lung, gut, and bone marrow, and then using these models to test 
candidate medical countermeasures; collaborating with DoD and the 
National Center for Biotechnology Information to establish a publicly 
available, well-curated, high-quality, whole microbial genome sequence 
reference data base from clinically important pathogens, which 
diagnostic test manufacturers will be able to use to advance their 
sequence-based test development programs; and examining the scientific 
basis for the instability of the protective antigens that has hindered 
efforts to develop next-generation anthrax vaccines and using protein 
engineering to stabilize the antigen.
                               conclusion
    Developing and enabling ready access to medical countermeasures to 
mitigate CBRN and emerging infectious diseases is highly complex. Close 
cooperation and collaboration within FDA and with U.S Government, 
international, and private sector partners are essential, and without 
this cooperation and collaboration, progress to address this growing 
public health challenge would be very limited. The deep engagement that 
is evident among the agencies represented here today is an example of 
public health synergy at its best. FDA is fully committed to continuing 
to work closely with our partners, using our authorities to the fullest 
extent possible to protect and promote public health, both domestically 
and abroad, in response to public health threats.
    Thank you and I am happy to answer your questions.

    Senator Burr. Thank you, Dr. Borio.
    Let me say to all of our witnesses that as I look at the 
response and our capabilities over this period of time that 
we're looking at, we've gotten better every time. The level of 
cooperation that exists interagency is remarkable compared to 
where it was at the start.
    I think that we have tried to work with every agency to 
identify those impediments that either needed a push or a 
legislative remedy to overcome, that stood in the way of either 
further collaboration or a quicker response or a more effective 
outcome. I plead with all of you if there are additional things 
that you see, having just, hopefully, gone through the Ebola--
this version of the Ebola crisis--I don't want to be 
presumptuous--that are further changes that we need to make, 
then, by all means, make sure that we're fully briefed on what 
they are.
    Our attempt is to continue to refine the legislation so 
that not only is it seamless, but it is the most expeditious 
that we possibly can present. I understand, especially to Dr. 
Borio, that there's a huge difference between your mission and 
Dr. Robinson's mission from a standpoint of core 
responsibilities of the agency. All of them have to work 
together for us to maximize the outcome, and that's what we're 
all after.
    Dr. Lurie, one of ASPR's duties, as set forth by the law, 
is to provide leadership in international programs, 
initiatives, and policies that deal with public health and 
medical emergency preparedness and response. Yet over the past 
year as the Ebola outbreak grew in urgency and attention, the 
question of who's in charge was once again raised.
    I'll ask you what specific steps are you going to take to 
make sure that the role of the ASPR is clear and fulfilled 
consistent with the statutory intent so that there is no future 
confusion on who is in charge?
    Dr. Lurie. Thank you, Mr. Burr. I appreciate your question. 
I also appreciate all of your letters over the last few months 
to be sure that we, in fact, remembered our authorities and 
were in a position to leverage every single one of them that we 
needed to leverage for Ebola, and I believe that we did.
    I'll answer your question in a couple of ways. To begin 
with, within ASPR, we have a group that very specifically deals 
with preparedness for international public health emergencies 
of different kinds--our collaboration with other countries were 
the focal point for the international health regulation 
reporting and others. We are positioned very much at that 
interface.
    Within the department, as this unfolded, as I think you 
know, it unfolded first as a global or an international event 
in West Africa. I'll say for starters that if anyone ever 
needed any reminding that what happens somewhere else is 
important to U.S. domestic national health security, I hope 
they need to look no further than this past year as any 
reminder for that.
    In a complex emergency where multiple departments and 
agencies are involved, as you first know, the President is in 
charge, and within the department, the Secretary is in charge. 
Throughout this event, the Secretary took full advantage of all 
of the different kinds of roles and expertise at CDC, at NIH, 
at FDA and ASPR and BARDA and beyond, pulling together people 
every day.
    Senator Burr. Let me stop you there, if I can.
    Dr. Lurie. Yes. Sure.
    Senator Burr. Because there was tremendous thought put into 
this as we constructed it originally. As a matter of fact, you 
couldn't find anybody to raise their hand and say ``I'm in 
charge'' when there's a problem.
    Dr. Lurie. I'm in charge.
    Senator Burr. We created the office specifically for this 
purpose. Trust me, I get it. The President is in charge. When 
you get past the President--do you remember the weeks and 
months that we went through of the requests by the public and 
people abroad and people in government going ``Who's in 
charge?'' There was a point that the White House got to where 
they appointed somebody who never made a public statement, and 
they said, ``You're in charge.''
    When I called the White House and asked who was in charge, 
they told me another person. The statute of the law says you're 
in charge, because you're ASPR. Why was that so difficult for 
people to understand? One of the purposes of this whole 
legislation was to map out what we do when something happens. 
Quite frankly, we got from there down pretty good, and this is 
not critical of you, individually.
    I have raised this with the Secretary. I have raised it 
with the chief of staff at the White House. I have raised it 
with Lisa Monaco. We tried to recreate a wheel when we had an 
architecture in legislation already in statute that says if 
something happens, here's what we do--bam, bam, bam, bam, bam. 
It disturbs me only from this standpoint, that every other 
mechanism that we put in place worked almost seamlessly.
    We could make the case, Robin, that maybe we should have 
had some stuff in NIH at a more mature state so that there 
could have already been a handoff.
    I think, Dr. Fauci, you would probably agree with that. It 
got put on a back burner.
    It might be that CDC might have had more assets 
prepositioned somewhere in the world, but they responded to it. 
It may have been that maybe FDA had done further thought about 
how do we expedite a review on things that are critical to 
whether somebody lives or dies. They've done that.
    I still get the impression that we're not sold on who's in 
charge. What does it take?
    Dr. Lurie. I take your point, and, as you know, we are not 
totally through this event. We still have a lot of action going 
on in West Africa. We hope we don't have more Ebola cases here, 
but we are focused and vigilant and prepared.
    Even though we're not yet through, we have already begun 
both a series of in-process progress reviews as well as a 
process for us to step back and look at lessons learned and 
take corrective actions, both within the department, and I 
think it's fair to say that every part of government that was 
involved in Ebola is really looking at lessons learned and how 
to do better the next time. I will look forward to sharing 
those and discussing those with you as we move forward.
    Senator Burr. Well, I hope you will also raise your hand 
and say, ``You know what? I was supposed to do all this.'' As 
you know----
    Dr. Lurie. Absolutely. I hear you.
    Senator Burr [continuing]. I think so much of the 
Secretary. The Secretary, by design, wasn't put in charge, 
because the Secretary has all sorts of other things. For this, 
to at least be tried, we have to get to the point where we 
execute what the statute of the law says. I thank you for the 
work that you do.
    Senator Casey.
    Senator Casey. Thanks very much, Mr. Chairman.
    I wanted to start with something that I could have 
mentioned in my opening, but we've got two panel members that 
have Pennsylvania connections. The committee, I'm sure, will 
indulge me.
    Dr. Lurie, as Senator Burr introduced you--both college and 
medical school at the University of Pennsylvania. I want to 
note that for the record.
    Dr. Borio--senior associate at University of Pittsburgh 
Medical Center for Biosecurity and assistant professor of 
medicine at the University of Pittsburgh from 2003 to 2008.
    I just had to say that, and I'm sure Dr. Robinson and Dr. 
Redd would want to retire in Pennsylvania or have some 
connection so we can mention it at a hearing.
    [Laughter.]
    I wanted to focus initially on one broad topic as it 
relates to all of your mandated responsibilities and the 
obligation you have to implement the Preparedness Act, 
including both the original act and then the new reauthorized 
act. I want to talk about children in a broad-based way.
    A lot of great advocates for children over many years have 
often said that children are not small adults, that we have to 
often have different strategies, different approaches, and 
different treatment regimens to deal with the impact on 
children when we have a disaster or an outbreak. In particular, 
I wanted to ask each of you--and maybe just starting with Dr. 
Lurie and go from my left to right--to ask you how are you 
ensuring in your work that the needs of children are being 
met--and I know, Dr. Lurie, you mentioned children in the 
opening part of your testimony and it's in your prepared 
testimony.
    How do you ensure that the needs of children are included 
in both preparedness and in terms of response planning efforts?
    Dr. Lurie. Great. I'm so glad you asked the question. I 
came into this job, No. 1, as a mom, and No. 2, recognizing 
that children are a quarter of the population, and they're a 
very diverse population, and the area of children is an area 
that I feel very, very proud of our progress.
    Let me just give you a couple of examples. To start with, 
we now have something we didn't have before, which is that all 
of our national disaster medical teams are pediatric-equipped 
and pediatric-capable. We took a look at where we were in terms 
of mental health in response and realized that we really fell 
short, in general, and fell short for children, and we've 
remedied that situation.
    With regard to countermeasures, we took----
    Senator Casey. Let me just stop you there. Remedied in what 
way?
    Dr. Lurie. Well, first of all, we have a formal operational 
plan now for how we do this, and we have formal components, 
formal guidance, and staff that deal with children. We took a 
good hard look at our countermeasure portfolio and both put 
together an ongoing pediatrics-obstetrics group to look at 
countermeasures, but, more importantly, made specific 
countermeasures and formulations for children, both for the 
stockpile and for products in development.
    These are anywhere from kinds of flu vaccines to radio-
nuclear countermeasures and antibiotic formulations, all the 
way to a portable ventilator that is suitable for neonates.
    We have a children's advisory committee now that just got 
up and running. One of the things I asked them to do first off 
was take a look at the issue of children at large and help us 
think about, No. 1, all the areas where children are not small 
adults, but also areas in which children, particularly youth, 
are poised to contribute to preparedness and response in a 
variety of different ways, because, as you know, we have to 
meet kids where they are along the whole developmental 
spectrum.
    And, finally, just let me say with regard to Ebola, one of 
the things I went way out of my way to do was to be sure that 
we had children's hospitals that were prepared and will be 
funded as Ebola treatment centers. That's just a quick 
smattering. I could go on with a long list. I'm happy to 
provide more information.
    Senator Casey. I appreciate that.
    Dr. Robinson and the rest of the panel, you're left to 
speak in sound bites now.
    Ms. Robinson. In addition to the medical countermeasures 
that Dr. Lurie mentioned, we actually have pediatricians on 
staff that are able to help us with those medical 
countermeasures and work with FDA and CDC and ASPR on that.
    Senator Casey. Thanks.
    Dr. Redd. In the strategic national stockpile, we include 
formulations that are specific for children, for example, 
oseltamivir suspension.
    Senator Casey. Doctor, when you say formulations, explain 
what that means.
    Dr. Redd. It's essentially the form that the drug is stored 
in. It's as a suspension so children don't have to be able to 
take tablets or capsules. We have a children's team when we 
respond in the emergency operation center, and that is linked 
tightly with the American Academy of Pediatrics.
    We also understand your question. In fact, we have a 
monthly public health grand rounds, and the one in March, this 
coming March, will be on issues for children. In fact, Dr. 
Lurie will be a speaker at that grand rounds.
    Senator Casey. Thank you.
    Dr. Borio.
    Dr. Borio. In addition to what was already previously said, 
we also have a pediatric action team that works in tandem with 
BARDA to provide input on these issues, and I think that in the 
last 5 years, we've seen tremendous progress in the capability 
to develop and make sure that new countermeasures that are 
being approved today carry the pediatric indication. Even 
sometimes when studies cannot be done in pediatric populations, 
we'll use regulatory science to be able to extrapolate a dose, 
given the important need of children during disasters.
    Senator Casey. Thank you very much.
    Thank you, Mr. Chairman.
    Senator Burr. Chairman Alexander.
    The Chairman. Thank you, Senator Burr.
    To all the witnesses, we have an ongoing priority in this 
committee, a project on innovation to try to identify how to 
move treatments, cures, and devices from early stage 
development into medicine cabinets, and to do that more rapidly 
and still do it safely. We're doing that in a bipartisan way.
    We're doing it in parallel with an effort in the House 
called 21st Century Cures. President Obama is very interested 
in it because of his interest in precision medicine. I've 
talked with him about it.
    What I'd like to say to the four of you and to your 
agencies is that the train is moving through the station this 
year. We expect to finish that work this year. We already have 
a bipartisan working group of staff members that Senator Murray 
and I have constituted.
    If there are specific legislative things that you need us 
to do, now is the time to do it. We need specific 
recommendations.
    For example, Dr. Borio, if you need new tools to develop 
medical countermeasures that we've overlooked, I wouldn't wait 
a year or two. I would offer suggestions within the next few 
weeks.
    I think we will succeed with this. There's no reason we 
shouldn't because of the broad interest and support we have 
both from the administration and from the Democrats and 
Republicans on the committee.
    I have two questions I want to ask, but I want to go back, 
Dr. Lurie, to this ``who's in charge'' question. When I was a 
Governor, I used to have a phrase, ``Who's on the flagpole?'' 
If nobody was on the flagpole, nothing got done. If somebody 
was on the flagpole, usually we'd show up the next week and it 
got done, because it would be that person's responsibility.
    I think of Hyman Rickover, who would tell the captains of 
the nuclear subs two things when they'd have a 7-minute 
interview with him. One is, ``You're in charge of the ship. 
You're in charge of the reactor. If anything happens to the 
reactor, your career is over.'' We have never had a death as a 
result of a Navy reactor problem in the last 60 years in this 
country because of accountability.
    We didn't have that with Ebola. Maybe it was our fault for 
not seeing it. I expected someone to step up and say who was in 
charge and maybe this is the President's fault. Somebody should 
have said, ``Dr. Lurie is in charge here. She's on the 
flagpole.'' If it had been a military operation, we would have 
had a daily briefing.
    We had a near panic in the United States over Ebola. I 
thought for a while that if I had announced, or if you had 
announced, that if you'd take your flu shot, you wouldn't get 
Ebola, about 9,400 lives could have been saved, because people 
would go take a flu shot, an Ebola shot, because people were so 
afraid of Ebola.
    In Tennessee, public health departments were turned upside 
down because all they were doing was Ebola. In hospitals, they 
were spending all their time and money buying personal 
protective suits for Ebola. All that was good, and the reaction 
was good. It needed to be put in perspective, and people were 
afraid.
    I think we should consider if the Assistant Secretary of 
HHS can't be seen in an epidemic as in charge, then maybe we 
should change the law. I know you have thought about this.
    First, it was Dr. Frieden. Next it was NIH. Then the 
President appointed a czar who became the phantom of the White 
House and disappeared and was never seen again. Maybe he did a 
good job, but none of us would know it. He wasn't available to 
testify before this committee or any other committee because he 
was a White House czar. This is something we should think about 
before we have another incident like that.
    Let me go to you, Dr. Robinson. I visited Dr. James Crowe 
at Vanderbilt University. He's developing antibodies for 
Ebola--one of the most advanced centers for that kind of work. 
It was very, very impressive. He did some of the work with Mapp 
Biopharmaceutical that has been mentioned.
    He talked about the ``Valley of Death,'' and his antibodies 
for Ebola are many years away from being available to help cure 
someone. What else can we do about the so-called ``Valley of 
Death,'' which is generally described as the space between 
studies in the lab and human clinical trials? How can we 
compress that, both for identified threats and emerging 
threats, like--Dr. Crowe was working on something called 
chikun.
    Ms. Robinson. Chikungunya.
    The Chairman. Yes. That's not an identified threat. That's 
another one of these things that could come at us from out of 
left field, and it's not even in line with an identified 
threat. What else can we do about the ``Valley of Death?'' I'd 
conclude by saying again if there are legislative things we 
need to do, this year is the time to do it.
    Ms. Robinson. Thank you for the question. There are two 
things I would say. First is that BARDA has been able to mature 
programs for CBRN and pandemic influenza. The third part of 
what PAHPA put us in charge of doing was making medical 
countermeasures for emergent infectious diseases.
    We haven't until the Ebola epidemic actually been able to 
really get into that space. We now are fully there with all our 
response capabilities and everything that we've done for the 
others. We are setting up an emergent infectious disease 
division that will have response and preparedness 
responsibilities, and we need to be able to afford to do that 
and prioritize those high threats for emergent infectious 
diseases to do that.
    The second thing is our Centers for Innovation in Advanced 
Development and Manufacturing were for advanced development. 
What we had to do because candidates were so early in 
development--we had to reach back very early. We realized 
that's something that we do well and we can go forward with in 
actually being able to take, with response capabilities, early 
development, even almost discovery, and bring them forward.
    We did this with Ebola monoclonal antibodies with several 
companies starting from scratch, and they were able to do it in 
4 or 5 months. Now we're being able to go into non-human 
primate studies, and we'll be going into clinical studies 
later. We can do that, but we need to be able to have the 
resources to do so.
    Senator Burr. Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Thank you, Mr. Chairman. Infectious 
diseases pose an enormous threat to human health and to the 
world economy. Each time a disease appears, Congress is great 
about spending billions of dollars combating the immediate 
crisis. But Congress is terrible about spending money to make 
sure we're ready for these crises before they occur.
    NIH funds the research that leads to the cures, but it has 
lost nearly 25 percent of its purchasing power since 2005. The 
CDC is responsible for keeping us safe from outbreaks, but 
Congress gives CDC only about $20 per American to be prepared 
for everything from a bad strain of the flu to food poisoning 
to Ebola. Project BioShield, which ensures that we have medical 
countermeasures for emergencies, is subject to the tumultuous 
appropriations process.
    What I'd like to ask is how do robust and stable 
investments in basic research and development help us prepare 
our Nation to deal with known and unknown contagious diseases? 
Maybe I could start with you, Dr. Lurie. If we can, we'll try 
to keep this short. I want to make sure we get this on the 
record.
    Dr. Lurie. Sure. Thank you so much for your question. It's 
terribly important. One of the things that's so challenging is 
that Americans forget quickly, and we do lurch from crisis to 
crisis. The funding lurches from crisis to crisis.
    We need to have sustainable funding that people can count 
on year after year so they can hire employees, so they can make 
investments, so they can continue to train and exercise. I know 
that, initially, Project BioShield was a 5-year commitment. 
We've moved to an annual appropriation. I understand that the 
annual budget cycle sometimes is not exactly what people need 
to have reliable, sustainable investments.
    I think it's worth taking a look at how we fund 
preparedness overall, both the research and development and 
countermeasure parts, but also the routine public health 
emergency preparedness, hospital preparedness, which has had 
significant cutbacks as well, and to be sure that a workforce 
coming up in this field who want to dedicate themselves to 
America's health security know that this is a sustainable 
career path and the rug isn't going to be pulled out from under 
them as soon as they train.
    Senator Warren. A very important point. Not just the 
training of the current workforce but how we develop the people 
who are going to do this work.
    Would you like to add to that, Dr. Robinson?
    Ms. Robinson. Yes. Thank you. I think that Project 
BioShield with the addition of PAHPA made the advanced research 
and development pipeline very robust, and now we're ready to go 
forward and harvest some of that fruit. Without having 
sustainable funding going forward, then our partners in 
industry are really at a standstill as to whether they should 
continue with their portion of the funding going forward.
    Project BioShield was funded under the special reserve fund 
originally under a special appropriations. Industry has asked 
for that, and, certainly, we wanted that to begin with. We 
understood budget austerity, but we still think that that's an 
important message.
    Senator Warren. If I can say it another way, we get maximum 
leverage from the Federal dollars by getting the industry to 
pick up much of this work. That happens better when there is 
robust funding that's guaranteed over a much longer period of 
time.
    Ms. Robinson. I agree.
    Senator Warren. Is that fair?
    Ms. Robinson. I agree.
    Senator Warren. Good.
    Would you like to add to that, Dr. Redd?
    Dr. Redd. Yes, ma'am. What we find in emergency response is 
that the public health systems that are in place all the time 
are the ones that are most able to adapt to be used for an 
emergency response. I'll give you a quick example. During the 
H1N1 pandemic, we distributed the monovalent vaccine through 
the system that's used to send vaccines into the Vaccines for 
Children Program. It worked very smoothly. Physicians were able 
to order doses through their health departments.
    In contrast, the system that was used to distribute 
oseltamivir delivered it to States where there hadn't been the 
same kind of planning and experience in distributing that drug 
further down the line, and it didn't work as well.
    Senator Warren. The short version is we've got to be ready 
all the time. Right?
    Dr. Redd. Yes, ma'am.
    Senator Warren. All right. Good point, Dr. Redd.
    Dr. Borio, would you like to add anything?
    Dr. Borio. Thank you for the opportunity. Our resource 
requirements are of a different magnitude because we are not 
developing and purchasing products. For the health of the 
pipeline, the FDA plays a very critical role. Our expert staff 
and our regulatory science need to be supported to be able to 
support the entire pipeline.
    This staff that works in these areas are highly, highly 
expert and experienced. We need to be able to hire and retain 
them.
    Senator Warren. All right. Thank you all very much. We're 
falling behind in our preparation for known threats, and we're 
not laying the intellectual and the scientific groundwork to 
prepare for the next round of threats.
    If Congress is truly concerned about the very real threat 
of contagious diseases, then we need to start making some smart 
decisions right now, and that means supporting basic research 
at NIH. It means supporting preparation by CDC, and it means 
supporting long-term planning by BARDA. We spent decades 
building these agencies, and now it's time for Congress to step 
up and make sure they have the resources that are necessary to 
protect us from the next biological threat.
    Thank you, Mr. Chairman.
    Senator Burr. Thank you, Senator Warren.
    Senator Cassidy.

                      Statement of Senator Cassidy

    Senator Cassidy. Dr. Borio, during the Ebola outbreak, 
several agencies, including USAID, the Defense Threat Reduction 
Agency, issued broad agency announcements seeking proposals for 
devices and diagnostics to respond to and contain the Ebola 
outbreak. Did the FDA implement an expedited approval process 
for these devices? How long would the expedited review process 
take, if they did? And can the FDA trigger it with existing 
authority, or do you need specific requests from another 
Federal agency?
    Dr. Borio. Well, our outreach in the diagnostics has been 
one of the most active. As a result of PAHPRA authorities, 
we've been able to issue EUAs for now eight diagnostic tests.
    Senator Cassidy. So your existing authority is adequate?
    Dr. Borio. Yes, and our staff basically stand ready to 
review submissions as they are received. As an example, the 
first test for Ebola that was authorized for use under an EUA 
was a DoD developed test. We were able to authorize it within 
24 hours. The most recent EUA was issued after staff on standby 
worked through the weekend to review the application.
    Senator Cassidy. Well, a hat tip to you all for being so 
prompt. Thank you, and I mean that sincerely.
    Dr. Borio. Thank you.
    Senator Cassidy. Dr. Redd, March 2014, Guinea had 
reported--as I review the literature, I think it was back in 
Zaire long ago that there was an outbreak of Ebola that was 
contained, and we knew how to contain it. In March 2014, Guinea 
had reported 49 cases--which within weeks spread to Liberia.
    I remember seeing an MMWR report on this, and sometime--I 
couldn't dig it back up, but sometime early summer, CDC had 
field workers in the affected countries. You all were aware of 
this and were in the process of responding. It wasn't, though, 
until the cases reached the thousands and Americans were 
getting infected that we really triggered that huge response.
    You all mentioned that you are doing kind of a postmortem. 
I don't mean that in a grisly sense, but, a kind of after-the-
fact analysis of what's going on. It begs a question, though. 
You've got trained public health there. You know how to stop 
it, but you see the genie coming out of the bottle. Why did it 
take this sort of dramatic increase before the hammer went down 
and those resources were fully requested?
    Dr. Redd. Yes, sir. The outbreak was identified in March 
2014. A large team responded to that, a multinational team led 
by the World Health Organization. The disease was brought under 
some measure of control, but not enough. The entire team 
redeployed in May-June, and----
    Senator Cassidy. Wait, there's something you left out. 
Redeployed--meaning they were yanked out?
    Dr. Redd. They came back. Yes, sir.
    Senator Cassidy. What was the incident rate, and what was 
the geographic spread and the interval between when they were 
pulled out and it began to spread once more?
    Dr. Redd. I can get you the exact numbers. I don't have 
those on hand right now, but I think I would take your main 
point that that was a mistake.
    Senator Cassidy. It's easy with a retrospective to look 
back and say it was a mistake. Reasonably speaking--again, I'm 
asking, because CDC--you're good. You're real good. You had--
no, wait a second. There's a case over here that previously has 
not been contained. Maybe we should not pull out. Did you have 
the ability to not pull out if World Health said ``yes'' but 
you said ``no''?
    Dr. Redd. I think in retrospect, we would not have pulled 
out. Let me just continue on, because the emergency operations 
center at CDC was activated at the beginning of July, and that 
was as cases in Liberia and Sierra Leone were detected. We've 
been activated since that time, our highest level of activation 
since early July. Cases really--there was an exponential 
increase that began in August and September.
    Senator Cassidy. The exponential increase--just 
intuitively, you know that there was a slope that began to 
ascend, and this is a curvilinear slope, so it's going to begin 
like that and then it's going to rocket-ship up. Right?
    Dr. Redd. Yes, sir.
    Senator Cassidy. I guess the question I come back to--
Senator Alexander has left--but it seems like there should have 
been somebody on the ground, saying, ``Listen, we're seeing a 
curvilinear increase in the number of cases. This thing is 
about to take off.'' It shouldn't have taken an American 
missionary to get infected. Do you follow what I'm saying?
    Dr. Redd. I do. I do. Actually, I wanted to say that the 
recognition of the problem did not coincide with the people 
coming back with infections. It was before that----
    Senator Cassidy. Well, believe me, I understand that. You 
guys are so good. You saw that graph, that incident rate, 
beginning to increase, and that begs the question, though: Did 
it fall on deaf ears? Did people there make a mistake in not 
asking for more help? Because there was a critical time where 
you could have stopped it, and yet it took off.
    Dr. Redd. I think that there was a period in May and June 
when a more vigorous response could have made a big difference.
    Senator Cassidy. Again, I come back to my question, and 
maybe you can't answer it. Were the resources requested and not 
given? Or were the resources not requested?
    Dr. Redd. In July, when we went back in, we recognized that 
there was a problem. The actual request for large resources--
and I think probably the full recognition of the problem--was 
not until September. That was when, as you'll recall----
    Senator Cassidy. August is when the exponential increase 
began. Did I hear that correctly?
    Dr. Redd. There was a lot of work trying to figure out what 
was going on during that period of time.
    Senator Cassidy. You're not answering my--I don't mean----
    Dr. Redd. Well, I'd say that I think that the period when 
the exponential increase was recognized was in early September, 
and the resources were requested shortly thereafter.
    Senator Cassidy. The American returned in August, and 
that's when I think it started garnering a large amount of 
attention. I assume there was a death rate. You could just look 
at the Liberia version of an obituary and have a sense of the 
death rate. It was so deadly.
    I guess what I'm not fathoming is since your death rate is 
such a ready indicator of something bad happening, your death 
rates increasing--I don't understand the lag time between 
requesting additional resources and the body bags filling up, 
so to speak.
    Dr. Redd. Well, all I can say is as soon as we recognized 
the extent of the problem, we began to work harder and to try 
to define what resources were going to be needed. As soon as 
that request was formed, it was made.
    Senator Cassidy. OK. I yield back.
    Senator Burr. Thank you, Senator Cassidy. Let me--I'll wait 
for Senator Franken to come back, but I'll take some time in 
the interim.
    In fact, to Senator Cassidy's answer, Dr. Frieden went in 
August, and when Dr. Frieden came back, all of a sudden the 
request was made.
    Dr. Redd. Yes, sir.
    Senator Burr. I mean, it triggered the director being on 
the ground. It triggered somebody in that multiple leadership 
level--and I'd go back to Dr. Lurie. That's why it is so 
important that there be somebody driving the train.
    I guess I would ask this, Robin. When did the vaccine alarm 
bell go off?
    Ms. Robinson. Last summer, probably the middle of the 
summer, because we had been looking at a number of different 
candidates at the NIH, also at DoD, and we went out and 
immediately started looking at procuring those for development. 
NIH and CDC were moving forward with putting together the 
initial clinical trials with Walter Reed, which actually 
started in September and in October, and we made investments at 
that time, not only in vaccines, but also in August, in fact, 
we went forward with ZMapp as a major investment for 
countermeasures.
    Senator Burr. I want to point out that this is why we know 
what we had in place works, because the alarm bell went off for 
vaccines before Dr. Frieden was on the ground, before the 
request.
    Dr. Lurie.
    Dr. Lurie. Yes. Let me provide a little bit more 
information about timeline and some activities.
    Back in the spring, as we saw the epidemic unfolding in 
Liberia, one of the things that I did was pull together all the 
members of the Countermeasure Enterprise, including all of HHS, 
DoD counterparts, DHS counterparts, others, and said, ``What do 
we have anywhere in the pipeline? What's buried in there? Let's 
talk to our international partners.''
    Through that, we identified the two vaccine candidates. We 
identified ZMapp and some other candidates, and we had a number 
of Enterprise meetings and said, ``What is it going to take to 
put our foot on the gas, pick who we think we can get--the 
candidates we think we can get forward with faster? '' By the 
time that we really sounded the alarm bell, there was already a 
huge amount of work in progress, because now the Countermeasure 
Enterprise is working together so well.
    I will comment--I'm sorry Mr. Cassidy is not here to do 
this. Throughout this whole Ebola episode, we have been racing 
to catch up with FDA. They have been amazing in their speed and 
their flexibility and their real outreach to work with 
companies.
    Similarly, back in the spring/early summer, as we looked at 
the Ebola trajectory, we said, ``We need to start waking up our 
U.S. healthcare system and preparing them,'' and began working 
with CDC to develop and push out lots of guidance and 
information. In fact, while this was still in Africa, and the 
epidemic curve was still going up, Dr. Frieden was on the 
ground.
    We were taking many, many steps here in this country to 
advance our preparedness and to get the countermeasure work 
going. That's, in fact, why we've got two vaccines in clinical 
trial right now in West Africa and a ZMapp trial which will 
start any day.
    Senator Burr. I'm not going to be as diplomatic as Senator 
Cassidy was, because I think what he was alluding to--and I'm 
not surprised you won't go there--was the WHO an impediment? 
I'm not asking you. I don't want you to comment on it. The fact 
was that the WHO was the lead on the ground, and CDC, even with 
great insight as to what the potential was down the road, 
wasn't in a position to make a decision to trump the World 
Health Organization.
    The reason I'm less diplomatic and go ahead and mention 
those three letters--folks, this is something we have to think 
about. I can't tell you how many times I was on the phone, 
saying, ``Forget about them. Bypass them.''
    When we see the threat as seriously as we did, then we have 
an obligation to this country to do whatever we need to do in 
conjunction--and I think this is where we ended up--with the 
countries affected and not with some health architecture that 
probably had never modeled something quite like this. I only 
hope that this is one of the discussions internally that we 
will have: How do we react next time if, in fact, we run up 
against an impediment that looks like this?
    Let me just move very quickly--Dr. Borio, as you know, 
human efficacy studies are not feasible for some medical 
countermeasures. Therefore, FDA's animal rule is particularly 
important for such products. The 2013 PAHPA reauthorization 
required FDA to finalize guidance on animal rules.
    We're coming up on the 2-year anniversary of the enactment 
of PAHPA, and this final guidance is already past due. When 
will the animal rule guidance be finalized as required by law?
    Dr. Borio. Senator Burr, first I'd like to thank you for 
bringing this issue up, because I share your sense of priority 
for the animal rule, and I sense the frustration for this 
animal rule guidance not having been completed as of yet. We 
did issue the revised guidance in May 2014. The comment period 
closed in August 2014.
    I don't mean this as an excuse, but we have been very 
engaged with stakeholders on the guidance, as well as providing 
some additional training, and the feedback we have received is 
overwhelmingly positive. Having said that, I also requested a 
timeline and additional action items that are required to bring 
this to closure, because, again, I share your priority, and 
I'll do everything I can to bring this to closure as soon as 
possible.
    Senator Burr. I appreciate that. Please carry the message 
back that we are watching. My only regret here is that it 
doesn't take EPA as long to promulgate rules and to put 
authorizations out as it does at FDA.
    Dr. Redd, less than 24 hours before today's hearing, CDC 
updated its website to include information on the influenza 
antiviral that was approved over 2 months ago and is 
highlighted in FDA's testimony here today. This countermeasure 
was supported by BARDA and played a role in the H1N1 response. 
I'm concerned that in the midst of one of the worst flu seasons 
in recent memory, it took CDC more than 2 months to update its 
website. What took so long?
    Dr. Redd. Sir, I can't answer that question directly. I can 
get back to you with an answer. I think 2 months is a long 
time.
    Senator Burr. Well, let me say get back to us with an 
answer and also what steps, if any, is CDC taking to ensure 
that this type of delay in providing the most up-to-date and 
complete information to healthcare practitioners, whether it's 
in the midst of a flu season or not--it could be an emerging 
threat like Ebola, and this would seem like it's a fairly easy 
thing to try to accomplish. So please take that back.
    Senator Casey.
    Senator Casey. Thanks, Mr. Chairman. I wanted to get back 
to a broader question, make a brief statement and then go to 
some followup questions.
    The urgency that Senator Burr is talking about is essential 
and not just in the heat of the challenge or the crisis. We've 
got to have a sense of urgency that's maintained month to 
month, year to year, long before we face that challenge.
    I was not at all satisfied in the initial weeks, of the 
Ebola outbreak, with how the administration was communicating 
about this. I just thought it wasn't where it needed to be. 
That was unfortunate. I hope, not just this administration, but 
a lot of folks can learn from some of the shortcomings of the 
response.
    Doctor Lurie, when you have a title like yours, Assistant 
Secretary for Preparedness and Response, I think it's critical 
that that be made known quickly, and that people in the 
administration, or the next administration, or 20 years from 
now--that they identify you as the point person, and that 
that's very clear. I think the communication has to be much 
clearer.
    Having said that, there was a problem at the time this was 
playing out, in my judgment. It is my opinion that because you 
had the combination of some shortcomings on communication 
combined with a political season, and then the third element, 
unfortunately, was some irresponsible statements by folks here 
in Washington--I won't say who, but a few Members of Congress--
that added to the problem. That's just my opinion.
    I was asked at the time what should be the response from 
Members of Congress in the midst of a crisis like that. Unlike 
Senator Burr, some Members of Congress weren't looking at 
science, and they weren't looking at constructive proposals. I 
came up with a radical idea that Members of Congress should 
make constructive proposals based on science. I hope we can do 
that next time.
    Along the way, Senator Warren's point about funding is very 
important. I really am grateful for the way in which Senator 
Burr has engaged with me on preparedness issues, and also with 
other members over many years. I think we can all be better 
prepared next time. Even though I think the results by and 
large were positive, when you look at what happened here and 
what could have happened, it could have been a lot worse than 
it was.
    Let me just ask you, Dr. Lurie, you don't have to agree 
with my assessments--but if someone walked up to you, or to 
me--let's say I'm walking down the street in Pennsylvania, and 
someone says,

          ``Well, look, generally, I think we were pleased with 
        what happened, and that we didn't have the kind of 
        horror that we saw in West Africa, but I'm a little 
        concerned about how we dealt with it.''

    What would you say to that constituent of mine when they 
said,

          ``What did you learn? What did we do well? What needs 
        improvement, and what are the areas where Congress can 
        play a more constructive role?''

    Dr. Lurie. Great. I appreciate you asking that question. I 
would agree with your constituent that, certainly, early on, it 
was pretty bumpy. There were some missteps. I think we were all 
able to pivot and get ourselves on a good course. I think 
that's just how it was.
    We're still in the process of learning lessons. I think 
there are a couple of things that are important to highlight 
now. We already talked about our interconnected world, but I do 
want to highlight that that's why funding for the global health 
security agenda, which really strengthens our ability to have 
good situational awareness and respond anywhere in the world, 
has been part of the President's fiscal year 2016 budget.
    The other thing I'll say is when we have an emergency that 
doesn't invoke the Stafford Act, as we did with Ebola and as we 
have many times before, there are a lot of questions about 
where money comes from. We have not had----
    Senator Casey. Can you explain that so people understand 
what you mean.
    Dr. Lurie. When the Stafford Act is invoked, then money is 
available through FEMA to respond, both federally and at the 
State and local level. When you have these other kinds of 
emergencies, largely when something doesn't go boom or terrible 
weather doesn't come through, we need to respond with the 
current appropriation that we have on hand. Usually that's 
already planned for and spoken for.
    We don't have an emergency fund that we can turn to, to get 
going. We saw this very much in this event. Congress was 
terrific, you know, ultimately in providing this emergency 
funding. As you know, we all needed to start to respond both in 
West Africa and here long, long before that happened.
    You'll see again in the President's fiscal year 2016 budget 
that there's a request for a sizable emergency fund that I 
think we all agree would sit there until there is the next 
really bad crisis. Then we don't have to wait for lots and lots 
of other processes to run their course to find the funds to get 
going. That's important both at the Federal level and it's 
critically important for our State and local partners, who get 
asked to do a huge amount in these emergencies and, similarly, 
don't have the funding to hire staff or turn on the apparatus.
    As a place where I think we could make some immediate 
improvements and from a policy perspective have a way to go 
forward, for me, that's probably No. 1. I think there are some 
other smaller things that you'll also find in the President's 
budget.
    For example, we couldn't send our national disaster medical 
system responders into harm's way with Ebola because we had 
never been able statutorily to solve this issue about 
disability and death benefits should they get hurt or injured 
in service. Again, you'll see a proposal and request to do that 
in the President's budget.
    I think at all three levels, the global level, how we 
respond nationally with immediate funding, and then at the 
smaller responder level, we all have identified already many 
steps to take to improve going forward.
    Senator Casey. I know we're over time, but does anyone else 
want to weigh in on lessons learned and what you hope we'd be 
able to do better together?
    Dr. Redd. Just repeating Dr. Lurie's emphasis on the global 
health security agenda. Working with these countries 
bilaterally to develop the capability to detect, and once 
detection occurs to respond effectively could have stopped this 
problem long before it got to where it did.
    Senator Casey. Thanks very much.
    Senator Burr. I think it's only appropriate while we're 
having this hearing that there is a news flash that an 
Arlington County individual has been taken by EMS--a potential 
Ebola case. We've been through that many times and found it to 
be not the case.
    Dr. Lurie. This is a place, though, where the system now 
works extraordinarily well, and I want people to really 
understand that.
    Senator Burr. I'm convinced it is, and I think, 
specifically, for you, I'll put this out as a thought. At some 
point, we're going to have to explain exactly how we came up 
with the hospitals designated to handle, because there are a 
lot of institutions out there that felt they should have been 
included in that. Maybe there are a lot that hoped that they'd 
never been included in it--I think that's a question for 
another day.
    Given what we know today about the amount of contaminated 
waste that had to be delicately taken care of, when we say this 
hospital has the capacity for 10 Ebola patients or 10 
infectious disease patients in the future, yet we look at the 
capacity to dispose of the waste, meaning two patients, haven't 
we done an injustice by suggesting we've got 10 beds when we've 
only got 2 beds that we can fill and adequately take care of? I 
know this is going to trigger a lot of things for you.
    Dr. Lurie. It is, and I look forward to as wholesome a 
discussion as you would like about the strategy, about 
designation, and the way we've approached Congress' request to 
have a regional strategy going forward. I actually feel that 
it's quite sound.
    Senator Casey really talked about the importance of 
science-based decisions. Clearly, at the beginning of this, 
there were some things we didn't know about the science. It 
also got, as I think we've all pointed out, very confused with 
the fear and other factors.
    Yes, a hospital that is an Ebola treatment facility has to 
be able to handle waste. We also know that there are facilities 
in this country that handle waste all the time, including 
things like deactivated chemical weapons from Syria or the 
Middle East, that were unwilling to take incinerated, not 
infectious ash from an Ebola patient.
    We have to put some science behind this and some 
rationality behind this as we solve the problem. It's an area 
where my office has been working very closely with CDC, with 
EPA, the Department of Transportation, and we'll have some good 
solutions going forward.
    Senator Burr. Well, I appreciate that, and let me just make 
this comment that I was telling Senator Casey when others were 
asking questions. I can still remember Senator Mikulski and I 
going through table-top exercises prior to writing the 
legislation and how many times we got to a point where you 
looked around the table and the question was, ``Who's in 
charge?'' Nobody had an answer to it. That's why most of what 
went into BARDA was the direct result of going through and 
gaming these things out and knowing the difficulty.
    I hope that the after-action process that is initiated from 
this exercise in Ebola, regardless of which agency it's at, is 
that we're sitting down, taking those things that we now know 
are difficult, those things we now know are inciting for the 
public, and we're figuring out a way to structurally make sure 
that we've either minimized them or eliminated them for the 
next round of this, because that's absolutely important. I 
would tell you it starts right at the top, that somebody is 
securely in charge of the whole process right from the 
beginning.
    Dr. Lurie. Yes, and let me make two comments. No. 1, that 
has already begun. I've taken responsibility for this review 
process. We already have a long list. Some of these corrective 
actions are already in progress, and I'm sure we will surface 
more along the way.
    Senator Burr. Good.
    Dr. Lurie. I also don't want to leave you or anyone else 
with an impression that this whole response hasn't been 
coordinated. I mean, I want you to be really----
    Senator Burr. I feel confident that it has been. Please do 
understand----
    Dr. Lurie. I understand.
    Senator Burr [continuing]. That when I call six different 
places, one of them being the White House, and nobody can 
answer the question of who's in charge, I have every legitimate 
reason to sit up here and question at what point was there one 
person who was moving the pieces and making the requests. I'm 
hopeful we won't have that problem again.
    Dr. Lurie. Yes.
    Senator Burr. That was my most recent experience, and it 
became very personal, because I thought we did a very good job 
of stating in the statutory language exactly how it was----
    Dr. Lurie. Because you are the poppa and the grandpoppa, 
yes.
    Senator Burr. Robin, as you know, BARDA intentionally has a 
very specific and targeted medical countermeasure mission, and 
this is to ensure that BARDA is staying focused on bringing 
forward the medical countermeasures we need to protect the 
American people from a range of chemical, biological, 
radiological, and nuclear threats. The statute that governs 
BARDA is clear on the focus of this mission with all of BARDA's 
work being tied to this threat context.
    I understand the concerns about increasing resistance to 
certain antibiotics. Just this week, there have been reports of 
an antibiotic-resistant superbug surfacing in North Carolina. 
Clearly, antibiotic resistance is a significant public health 
concern. However, I want to take this opportunity to clarify 
that BARDA's work in this area is tied to its overall work to 
advance medical countermeasures against CBRN threats and not 
outside of this context.
    Would you please take a moment and explain why BARDA is 
working to bring forward broad spectrum antibiotics to address 
the CBRN threats we may face and why it's so important that 
BARDA's mission not be diluted by matters or mandates that 
would require BARDA to work on areas outside of those tied to 
threats we have discussed here today?
    Ms. Robinson. Certainly. We have a material threat 
assessment and determination from the Department of Homeland 
Security that says antimicrobial resistance could occur in 
these biothreats, like anthrax. That is a threat for us, and 
that was the impetus for us in 2010 moving forward toward 
developing new classes of antibiotics that would be able to 
address antimicrobial resistance in biothreats.
    I want to make really clear where we are on this. Our 
mission was primarily for biothreats. It will remain there with 
this development of antibiotics. They will have benefits for 
other high-priority community pathogens. In fact, we see one of 
the drugs that we have been developing, plicamycin, that has 
been working for a number of different biothreats, is actually 
being used--can be used for CRE and may be actually being used 
in the outbreak in UCLA hospitals.
    Saying that, our funding for broad spectrum 
antimicrobials--because there are a number of those different 
pathogens that are biothreats--we want to make sure that we 
have coverage for those. There are several burkholderia species 
that cause glanders and melioidosis that--we have drugs, but 
they certainly could be made much better, and we want to make 
sure if they're wild type, not antimicrobial resistant--that we 
can address those wild type pathogens and have better drugs for 
that. That's the main impetus of this.
    We certainly want to make sure that the benefits that we 
have in those investments can be made for multiple indications 
that can help public health, too.
    Senator Burr. Dr. Redd, as you and your colleagues at CDC 
and BARDA know, it's very important to make sure that BARDA and 
CDC are coordinating on strategic national stockpile needs so 
that we're bringing forward medical countermeasure candidates 
that will meet the identified requirements. There are few 
mechanisms by which HHS can produce countermeasures.
    For example, BARDA is responsible for executing the 
BioShield Special Reserve Fund, which is used to procure 
security countermeasures in the strategic national stockpile, 
and CDC also receives funding to manage the strategic national 
stockpile, including replenishing expired products.
    How is CDC transparent to stakeholders regarding what 
opportunities may exist to be considered for the strategic 
national stockpile outside of the BioShield procured product?
    Dr. Redd. Yes, sir. There are a couple of ways that we do 
that. First on the internal coordination, I mentioned the 
Public Health Emergency Medical Countermeasure Enterprise, 
where the strategic national stockpile budget is reviewed and 
recommendations are made. There's internal coordination, 
particularly between BARDA and CDC.
    The multiyear budget that I believe this committee 
requested is part of making the future needs apparent, and I 
think that was just released within the last few weeks. That 
would be a way of forecasting what the future requirements 
would be.
    Senator Burr. Let me ask you, how does the handoff occur 
for products that may have been procured or received from BARDA 
in advanced research and develop funding but are not procured 
by BioShield but could still be potential stockpile candidates?
    Dr. Redd. I think, in general, when a product is licensed, 
it moves into the strategic national stockpile responsibility, 
and at that--there may be a first delivery through BioShield, 
but then it's transferred to the strategic national stockpile 
responsibility.
    Senator Burr. Senator Casey.
    Senator Casey. I wanted to just note something for the 
record, but then ask one question about the Hospital 
Preparedness Program. The three countries that have had the 
most deaths from Ebola were, as everyone knows, Sierra Leone, 
Liberia, and Guinea.
    Total deaths as of February 21 are 9,556, a huge number, 
and we are mindful of that today, especially in light of the 
fact that our country had a capacity and an ability that those 
countries didn't have.
    Getting back to the circumstances here, one of the best 
things that the Congress did over the years was to not only 
authorize but fund the Hospital Preparedness Program.
    Dr. Lurie, I meant to ask you earlier about the 
announcement that was made with regard to both hospital 
preparedness and the other program--the so-called PHEP, the 
Public Health Emergency Preparedness Program. Can you talk 
about the awards? I know that Pennsylvania got a little more 
than $15 million allocated. Could you walk through that for us?
    Dr. Lurie. Sure. The Public Health Emergency Preparedness 
Program is a program that strengthens the capabilities of 
health departments to do essential public health functions. It 
is administered at CDC, and I think to Dr. Redd's point, it's 
one of those things that builds the strong day-to-day system 
that we have to count on during an emergency.
    The Hospital Preparedness Program is the part that funds 
the healthcare system administered through my office. We've 
worked very closely together over the past couple of years to 
align these administratively and in terms of the capabilities 
that we require both from the public health system and the 
healthcare system. They're very efficient programs.
    Having said that, if you look at the funding for these 
programs over the last decade and over the last X years, you'll 
see a steady decrease, and that gets to our point about always 
needing to be prepared and not having the sort of roller 
coaster shape to this.
    With regard to this most recent funding, States put out a 
lot of money and need to continue to do lots of monitoring. The 
Public Health Emergency Preparedness money funds that. Senator 
Burr just talked about a suspected case in Virginia. That funds 
the State and local capability to deal with that.
    The Hospital Preparedness money funds the capability to be 
sure that every hospital can recognize, detect, and safely 
isolate somebody until they're transferred, that there are 
hospitals that can assess these patients and decide if they 
have Ebola or not, and to the extent that somebody has Ebola, 
that those patients can be safely transferred to an Ebola 
treatment center for treatment.
    Both Congress and our stakeholders gave us very strong 
advice about a regional strategy going forward. The 
announcement that just came out basically calls for 10 
regional--I almost want to call them supercenters--but regional 
Ebola treatment centers, like Emory, like Nebraska, one in each 
HHS region.
    Underneath that, all of the hospitals that have been so 
designated would be the surge capacity for those Ebola 
treatment centers regionally, so that we really develop these 
hospitals that are centers of excellence, so that if we have 
more Ebola, we'll really have a lot of experience with it. 
They'll be prepared to take care of more than one patient at a 
time. They are super-prepared for other kinds of infectious 
diseases, and they have to be ready within a matter of a few 
hours to take a patient, not to then have to spend lots of time 
tooling up to be ready.
    I'm afraid Ebola could be with us for a very, very long 
time, which means that we are at risk here for a very, very 
long time, and we have to stay prepared and vigilant. We cannot 
let our guard down.
    Senator Casey. Well, I'll say just one thing in closing. I 
complain loudly and frequently and will continue to complain 
when you have an authorization level for hospital preparedness, 
your program under your jurisdiction, when there's a huge gap 
in the tens of millions of dollars between authorization and 
appropriation. It made no sense, and we'll continue to monitor 
that.
    Dr. Lurie. I appreciate it.
    Senator Casey. Thanks very much.
    Senator Burr. Thank you, Senator Casey.
    Let me just add to what Senator Casey said, because he read 
the official death numbers. I don't think there's anybody at 
the table that believes that that is an actual number of how 
many deaths there were in West Africa, and the unfortunate 
thing is we may never know exactly the extent of this outbreak.
    I'm going to recognize Senator Whitehouse for no more than 
5 minutes.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thank you very much, Mr. Chairman. I 
appreciate it.
    I guess my question is twofold. I have heard that when a 
biological agent is delivered in weaponized form at extremely 
high dosage--more than would occur in a natural propagation of 
the illness--the characteristics of the disease and the 
characteristics of its propagation change, that it's dosage 
sensitive in that sense. My first question is: Is that true?
    The second thing is that I have heard that there are 
strategies for developing countermeasures that are more cutting 
edge than cooking them in batches, but that the technical 
effort to get there is lagging a bit, and that there may be a 
lot of incumbency pressure not to allow these disruptive 
technologies to emerge. I'd love to hear the witnesses' 
response to those two observations. Am I being given good info 
on those?
    Dr. Lurie. Well, certainly, we always worry about 
weaponized forms of biothreats. That's, in fact, part of why we 
exist, that's why BARDA exists, and we take those things very 
seriously. It is very often the case that the more of something 
you're exposed to, and get in your system, the sicker you get. 
This is a really significant issue for us. We work on this 
issue all the time.
    In terms of the disruptive technologies in innovation, a 
huge focus of our efforts is on innovation and on new and 
better ways to do things--faster, better, cheaper. Since the 
countermeasure review in 2010, we've moved away from one-bug-
one-drug to platforms, to new technologies that can make 
countermeasures quickly, and we are always on the lookout for 
these.
    There's a whole part of BARDA that Robin can speak about 
called Tech Watch, where innovators can come in at any time and 
talk to us and propose those ideas, and we've been able to 
support a whole number of those. BARDA has, frankly, been the 
catalyst for a number of those new technologies that we're 
seeing play out right in front of us with Ebola, in terms of 
new ways to make monoclonal antibodies, and flu, in terms of 
new ways to make vaccines that we just saw in H7N9.
    Senator Whitehouse. Let me get a few other answers, if I 
may, before my time expires, and I gather there'll be a firm 
gavel.
    Dr. Robinson.
    Ms. Robinson. As we're going forward, we're actually 
looking at influenza at what we call the holy grail, working 
with NIH and our partners at CDC and FDA to actually have 
universal influenza vaccines. We're also looking at 
immunotherapeutics, these monoclonal antibodies that may work 
against multiple strains of influenza and they're not 
vulnerable to emergent drug resistance.
    With our other drugs, for biothreats and radiation 
illnesses, we are looking at stem cell therapies that one would 
have never even thought about. We're looking also at pre-
symptomatic diagnostics going forward, so that before you 
present with a disease, we actually have a way of looking at 
people and knowing what direction they're going to go into and 
if they're actually going to be in harm's way for that 
particular disease. Again, we are at the cutting edge of 
innovation.
    Senator Whitehouse. Dr. Redd, 1 minute remaining.
    Dr. Redd. Let me pass to Dr. Borio, then.
    Dr. Borio. We love innovation in products as well as how we 
approach the assessment of those products. Just to give you an 
example, a couple of weeks ago, we hosted a colleague from 
DARPA who came to socialize and began to engage with the FDA 
scientists on ideas that were very innovative and 
unprecedented. We are always looking forward to ways to engage 
and to be able to support development of those products.
    Senator Whitehouse. In my last 30 seconds, on the question 
of there being a different illness response at high weaponized 
doses that may require a different countermeasure, is that 
factual?
    Dr. Redd. I think that may be something that's particular 
to each of the pathogens and exactly the way that it has been 
weaponized. For example, if anthrax spores are made smaller, 
they float around longer and, therefore, are easier to acquire. 
I think it might be something that would be somewhat true, in 
general, but there would be specific issues with each of the 
possible pathogens.
    Senator Burr. I thank Senator Whitehouse. Senator 
Whitehouse has a deep interest in this, and we're working to 
gather a number of initiatives, and we'll have further hearings 
on some of those.
    Robin, I did want to allow you 2 minutes, just if you want 
to highlight anything for the record that you would point to 
and say, ``Here's a success at BARDA that absolutely is the top 
of the flagpole for us.''
    Ms. Robinson. I think that having actually 12 new products 
in the strategic national stockpile under Project BioShield, 
when many people 5 or 6 years ago didn't think that we would 
ever have more than three--I think that's extraordinary, and 
it's not just for anthrax and smallpox, but against a number of 
different threats and chemical and radiation illnesses. I think 
that's one.
    On my pandemic influenza side, we have created an 
infrastructure in the United States that can provide a vaccine 
for everyone that wants one and during a pandemic, unlike we 
were able to do in 2009. We're able to do that now. I think 
this is a major achievement and, certainly, the American people 
can feel more secure about that. Again, as Dr. Lurie said, we 
make those faster and in greater quantities and, hopefully, as 
we go forward, even much better, not only in a pandemic, but 
also for seasonal influenza.
    I think we've now shown with emergent infectious diseases 
that we can rapidly prepare and rapidly respond, and actually 
doing things much earlier in the pipeline than we normally 
would, and that we're capable of doing that and taking that 
transition even earlier if need be. We look forward to, I 
think, a very bright future, but we still have a long way to 
go.
    Senator Burr. Great. Thank you for that.
    I just want to, for the record, say the hearing record will 
remain open for 10 days so members can submit additional 
information for the record, additional questions, within that 
time if they'd like to.
    Again, I thank all of our witnesses for being here. This 
was educational and enlightening, and if there's a takeaway for 
each one of you, it's that the committee is interested in this, 
and we will continue to watch in hopes that we continue to 
perfect the process even better.
    Thank you.
    The hearing is adjourned.
    [Additional Material follows.]

                          ADDITIONAL MATERIAL

Response by Nicole Lurie, M.D., MSPH to Questions of Senator Alexander, 
  Senator Burr, Senator Isakson, Senator Kirk, Senator Scott, Senator 
   Roberts, Senator Murray, Senator Mikulski, Senator Casey, Senator 
              Franken, Senator Baldwin and Senator Warren
                           senator alexander
    Question 1. We thought the United States was prepared for threats 
like Ebola, but this fall showed us that we actually were not as ready 
as we should be. Issues like how to handle infectious waste and the 
type of health units capable of caring for and treating patients with 
Ebola showed vulnerabilities in our public health system.
    Has this prompted a review of the extent to which our preparedness 
plans, scenarios, and drills truly do account for all-hazards, as is 
called for by the Pandemic and All-Hazards Preparedness Reauthorization 
Act? What has been the process for making sure we are prepared for 
these types of emergencies?
    Answer 1. As required by Presidential Policy Directive 8 (PPD-8), 
the Department of Health and Human Services (HHS) participated in the 
development of the National Preparedness Goal and National Preparedness 
System. The National Preparedness Goal, released in September 2011, 
defines what it means for the whole community--from individuals, 
schools, businesses, and all levels of government--to be prepared for 
disasters and emergencies. Specifically, the National Preparedness Goal 
is defined as,

          ``A secure and resilient Nation with the capabilities 
        required across the whole community to prevent, protect 
        against, mitigate, respond to, and recover from the threats and 
        hazards that pose the greatest risk.''

    In order to realize this goal, the National Preparedness System has 
established an organized, systematic process for the whole community to 
move forward in preparedness activities. All Federal partners are 
utilizing the National Preparedness System to ensure that the Nation is 
prepared for all emergencies and disasters. The National Preparedness 
System ensures planning and preparedness initiatives to: identify and 
assess risk at multiple levels; estimate the capabilities needed to 
address such risks; build or sustain the required levels of capability; 
develop and implement plans to deliver those capabilities; validate and 
monitor progress; and review and update efforts to promote continuous 
improvement.
    Specific to all-hazards planning, development of an HHS all-hazards 
plan started after the release of PPD-8 in September 2011. This plan 
includes general assumptions for all types of emergencies and disasters 
and ensures the Nation is prepared for all threats. The development of 
the HHS all-hazards plan was done in conjunction with the development 
of the National Response Framework and the Federal Interagency 
Operational Plans to make sure the concepts did not conflict with each 
other and to facilitate changes as planning documents were finalized. 
The HHS all-hazards plan and functional appendices were completed in 
April 2014.
    HHS is also engaged in a number of other planning efforts to 
further preparedness and response to public health and medical threats. 
A number of efforts related to planning for both natural and 
international infectious disease outbreaks have been completed or are 
in progress. Specific efforts by HHS include:

     A joint HHS and Federal Emergency Management Agency (FEMA) 
interagency coordination plan for H7N9/MERS-CoV called the Interagency 
Pandemic Operations Plan (PanCap). This plan was completed in November 
2013.
     Development of a Unified Coordination Group Plan to 
address the surge in unaccompanied children. This included a medical 
annex to address infectious disease detection, screening, and 
monitoring.
     A Biological Incident Annex to help planning for the 
Response and Recovery Federal Interagency Operational Plans, an effort 
HHS co-led with FEMA. The BIA will serve as a support document for the 
Pandemic Crisis Action Plan and the Federal Medical Countermeasures 
Plan, as well as existing regional, State, and local plans. A final 
review is expected by the end of August 2015 with a target completion 
date of the end of September 2015.
     In collaboration with FEMA, the development of Federal 
medical countermeasures (MCM) support plans for the Urban Area Security 
Initiative. These plans enhance existing mass MCM dispensing plans and 
support responses to naturally occurring pandemics and deliberate 
biological outbreaks in these high-threat, high-density Urban Areas.
     The Department of Defense Operation Vigilant Sentry 
appendix which describes how ASPR collaborates with DHS to conduct 
medical screening, triage, provide medical treatment, and implement 
public health measures necessary to prevent the introduction or spread 
of communicable diseases into the United States.
    Related to Ebola planning:

     HHS, in collaboration with its Federal Emergency Support 
Function partners, is developing the U.S. Government Ebola Virus 
Disease Plan. The purpose of the plan is to describe the integrated 
concept of operations, processes, and organizational constructs that 
the U.S. Government will utilize to prevent, protect against, mitigate, 
respond to, and recover from EVD. The plan will guide the U.S. 
Government in preparing to manage and contain Ebola domestically in 
support of State, local, tribal and territorial governments, and 
internationally in support of partner nations. It also will clarify the 
roles and responsibilities of Federal interagency partners and other 
supporting entities to establish clear lines of responsibility and 
eliminate duplication of effort. This plan is scheduled to be completed 
in fall 2015.
     Participation in the interagency Latin America/Caribbean 
EVD planning process to help foreign partners deter mass migration, 
assist the Department of Homeland Security (DHS) Customs and Border 
Protection in determining medical screening/processing support, and 
assist the United States Coast Guard in determining maritime medical 
screening and treatment guidance for para-professional medical 
providers.
     HHS Support Plan for the First Case of Ebola Diagnosed in 
the United States in August 2014.

    Question 2.  After the failure to correctly diagnose Mr. Thomas 
Duncan on his first visit to the emergency department in Texas, several 
areas were identified for improvement to ensure that hospitals around 
the Nation are prepared to recognize a potential case of Ebola, isolate 
the individual, and provide a timely diagnosis. A key component is 
awareness among health professionals about the importance of a travel 
history to an Ebola epidemic country.
    Please identify actions you took to improve awareness among health 
professionals, including working with associations and professional 
organizations.
    Answer 2. An important lesson learned in the U.S. response to Ebola 
was that the safety of health care workers, from clinicians and 
laboratory workers to ancillary staff, must be a foremost 
responsibility during health care system preparedness and response 
activities. Health care worker safety is best achieved through the 
implementation of infection control, appropriate use of personal 
protective equipment (PPE), continuous training, demonstration of 
competencies, and participation in frequent exercises. Moreover, we 
must ensure that Ebola patients are safely and well cared for in the 
U.S. health care system and that frontline health care workers are 
trained to recognize and isolate a person with suspected Ebola. These 
are the cornerstones of the Hospital Preparedness Program (HPP) Ebola 
funding opportunity announcement (FOA): EP-U3R-15-002: HPP Ebola 
Preparedness and Response Activities.
    On April 15, 2014, the Office of the Assistant Secretary for 
Preparedness and Response's (ASPR's) HPP program circulated frequently 
asked questions concerning Ebola. These questions were developed by 
physicians associated with HPP-supported health care coalitions and 
U.S. health care professionals to improve outreach and awareness about 
the Ebola virus. During the summer of 2014, in collaboration with the 
Centers for Disease Control and Prevention (CDC), ASPR began developing 
and disseminating checklists to prepare health care providers for 
Ebola. These checklists provide practical and specific suggestions to 
make sure health care workers, facilities, and health care coalitions 
are able to detect possible Ebola cases, and that employers are able to 
protect their employees, and respond appropriately. These checklists 
are updated regularly and are available on both ASPR's and CDC's Web 
sites.
    Further, beginning in August 2014, ASPR coordinated, participated 
in, and contributed to numerous webinars, conference calls, and 
trainings with public health and health care professionals, 
associations, professional organizations, and health care facility 
leaders. Participating external stakeholder groups include State and 
local public health departments, the Association of State and 
Territorial Health Officials, the American Hospital Association, the 
Association of American Medical Colleges, nursing professional 
organizations, emergency medical service providers, and health care 
coalitions. These direct outreach efforts reached over 160,000 
individuals in the health care and public health fields.
    ASPR has also promoted the use of National Standards for Culturally 
and Linguistically Appropriate Services (CLAS Standards) in Health and 
Health Care and in education to ensure language access and to avoid 
stigma.\1\
---------------------------------------------------------------------------
    \1\ See https://www.thinkculturalhealth.hhs.gov/content/clas.asp 
and https://www.thinkcult-
uralhealth.hhs.gov/Content/ContinuingEd.asp.

    Question 3. How are you working with hospitals in the Hospital 
Preparedness Program to review surge capacity for all-hazards? What are 
the specific goals for setting up Ebola Treatment Centers and how does 
this fit within an all-hazards framework?
    Answer 3. In order to prepare the U.S. health care system to 
respond to events in a coordinated and collaborative manner, rather 
than facility-by-facility, ASPR has been providing resources to 62 
State, territory, and local awardees through HPP. In 2012, HPP 
transitioned from facility-based capacity building to coalition-based 
capability development. This includes eight health care preparedness 
capabilities: (1) healthcare system preparedness; (2) healthcare system 
recovery; (3) emergency operations coordination; (4) fatality 
management, (5) information sharing; (6) medical surge; (7) responder 
safety and health; and (8) volunteer management. The medical-surge 
capability is the ability to provide adequate medical evaluation and 
care during incidents that exceed the limits of the normal medical 
infrastructure within the community. This includes the ability of 
health care organizations to survive an all-hazards incident and 
maintain or rapidly recover operations that were compromised.
    HPP awardees must maintain all-hazards public health emergency 
preparedness and response plans as part of their cooperative agreement. 
Awardee performance in regards to health care preparedness is evaluated 
annually through annual program evaluations, progress reporting, and 
site visits. Further, HPP awardees must ensure that hospitals have all-
hazards and hazard-specific preparedness and response plans, as well as 
the space, staff, and supplies needed to provide immediate bed 
availability. This is necessary to assure appropriate early medical 
care for individuals affected by disasters and public health incidents.
    To assist hospitals in their medical surge efforts, HPP released a 
new hospital surge evaluation tool in December 2014 that was designed 
to identify gaps in a hospital's preparedness and help assess its 
ability to respond to a mass casualty event. The tool takes the form of 
a no-notice drill and incorporates real-life health care considerations 
in acute care settings. The tool is intended for use by hospital 
emergency managers, hospital administrators, and clinical staff to 
assess and improve their hospital's surge plans. Hospitals need to 
exercise their preparedness for a mass casualty incident regularly. 
This tool can help hospital emergency managers make recurring tabletop 
exercises a reality by providing a fully developed tabletop exercise 
that can be used at their facilities. In some respects, this tool can 
be thought of as ``Surge Evaluation in a Box.'' HPP also is developing 
a companion surge evaluation tool for health care coalitions.
    A total of $194.5 million was awarded through the HPP Ebola FOA 
(EP-U3R-15-002: HPP Ebola Preparedness and Response Activities) to 
ensure our Nation's health care system is ready to safely and 
successfully identify, isolate, assess, transport, and treat patients 
with or under investigation for Ebola. While the primary focus is on 
preparedness for Ebola, as required by Title VI of Division G of the 
Consolidated and Continuing Appropriations Act, 2015, it is likely that 
preparedness for other novel, highly pathogenic diseases will also be 
enhanced through these activities.
    In December 2014, HHS released its Interim Guidance for U.S. 
Hospital Preparedness for Patients under Investigation or with 
Confirmed Ebola Virus Disease: A Framework for a Tiered Approach, which 
outlines the different roles U.S. acute health care facilities can 
assume in preparing to identify, isolate, and evaluate or treat 
patients with possible or confirmed Ebola. These responsibilities 
include serving as Ebola treatment centers, assessment hospitals, and 
frontline health care facilities. In addition to outlining the roles 
these facilities can assume, the guidance provides minimum standards 
each facility must meet in order to help State health officials assess 
facilities and assist with the designation process. Building upon the 
tiered State and jurisdiction based hospital approach and meeting 
Congress' regional directive, HHS provided a portion of the total HPP 
Ebola resources to establish a nationwide, regional treatment network 
for Ebola and other infectious diseases. This regional treatment 
network balances geographic need with differences in health care 
institutional capabilities and accounts for the potential risk of 
needing to care for an Ebola patient. This overall Ebola health care 
treatment and assessment network currently consists of:

     Nine regional Ebola and other special pathogen treatment 
centers that can be ready within a few hours to receive a confirmed 
Ebola patient from their region, across the United States, or medically 
evacuated from outside of the United States, as necessary. These 
hospitals will also have enhanced capacity to care for other highly 
infectious diseases.
     State or jurisdiction Ebola treatment centers (61 as of 
July 21, 2015) that can safely care for patients with Ebola in the 
event of a cluster of Ebola patients that overwhelm a regional Ebola 
and other special pathogen treatment center. Clinical judgment, 
available logistical resources, and patient preference may indicate the 
patient should receive treatment at a state/jurisdiction Ebola 
treatment center rather than be transferred to a regional Ebola and 
other special pathogen treatment center.
     Assessment hospitals that can safely receive and isolate a 
person under investigation for Ebola and care for the person until an 
Ebola diagnosis can be confirmed or ruled out, and until a discharge or 
transfer has been completed.
     Frontline health care facilities that can rapidly identify 
and triage patients with relevant exposure history and have symptoms 
compatible with Ebola. These facilities would then coordinate patient 
transfer to an Ebola assessment hospital.

    With funding provided in the HPP Ebola FOA, all HPP awardees will 
develop and implement a health care system concept of operations 
(CONOPS) for care of Ebola patients. This CONOPS must link State 
activities related to the active monitoring of returning travelers to 
designated assessment or treatment hospitals. From there, they would 
ensure patients can be safely transported to a regional Ebola or 
special pathogen treatment center and/or a State or jurisdiction Ebola 
treatment center. Each awardee's health care system CONOPS for Ebola 
will be maintained and exercised annually throughout the 5-year project 
period.
    Further, HPP Ebola FOA awardees will assure readiness of regional 
Ebola and special pathogen treatment centers, State- and jurisdiction-
based Ebola treatment centers, assessment hospitals, and health care 
coalitions (with, at a minimum, frontline health care facilities and 
EMS) through quarterly or annual trainings and exercises, depending on 
their respective roles. Exercises in the first year should be specific 
to Ebola. If in subsequent years there are no global outbreaks of 
Ebola, exercises may address other infectious diseases, such as MERS-
CoV and measles. The PPE trainings that health care facilities around 
the Nation have been conducting for Ebola, such as training covering 
donning and doffing of PPE, have relevance to other and more common 
infections. While the PPE (e.g., Tyvek suits) might be different for 
other infectious diseases, the actual process for removing the PPE, 
such as gloves, without contaminating oneself is the same and will 
assist with health care acquired infections and other pathogens.
                              senator burr
    Question 1. PAHPRA set forth a new requirement for the ASPR to 
brief the President's National Security Advisor on a periodic basis. 
Since being confirmed to serve as the ASPR, how many times have you 
briefed the National Security Advisor?
    Answer 1. The Assistant Secretary for Preparedness and Response 
(ASPR) annually updates the National Security Advisor, and the National 
Security Staff on the status of the Strategic National Stockpile (SNS). 
This is a report that is required both by statute\2\ and by Homeland 
Security Presidential Directive (HSPD-21), which directs the HHS 
Secretary, through the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE), to comprehensively examine the SNS formulary each 
year to ensure the most effective use of the limited resources 
available to stockpile those critical medical countermeasures that will 
be required in an emergency. The recommendations, developed by subject 
matter experts and senior policy leaders, inform resource management 
and procurement policy for the most appropriate set of medical 
countermeasures to acquire and maintain in the SNS.
---------------------------------------------------------------------------
    \2\ 42 U.S.C. 247d-6b(a).
---------------------------------------------------------------------------
    Furthermore, ASPR represents the HHS Office of the Secretary on a 
variety of National Security Council Interagency Policy Committees, 
which serve to inform the National Security Advisor and staff regarding 
policy and technical issues related to naturally occurring as well as 
deliberate public-health emergencies on a regular basis. The ASPR meets 
regularly to update the Deputy National Security Advisor on any new or 
potential event(s) that may present a risk to the health security, 
including Middle East Respiratory Syndrome (MERS-CoV) and avian 
influenza A (H7N9).

    Question 2a. The ASPR is responsible for the hospital preparedness 
program and our Nation's medical surge capacity. We have a handful of 
special treatment units and beds that we have used to provide treatment 
to Ebola patients in the United States. The experiences that these 
facilities gained in providing care to these patients underscored the 
significant challenges in providing treatment to patients with Ebola 
and similar conditions, including the high volume of medical waste they 
produced.
    Is ASPR reexamining any facets of our medical surge capacity based 
on our experiences with Ebola treatment?
    Answer 2a. A few important lessons learned in the recent response 
to Ebola include: health care worker safety from clinicians and 
laboratory workers to ancillary staff, recognizing that care for Ebola 
patients is clinically complex and demanding, and understanding that 
early case recognition is critical for preventing spread and improving 
outcomes. These lessons highlight the importance of adequate and 
sustained preparedness funding and the need for a national network of 
hospitals for treating highly pathogenic infectious diseases.
    The Hospital Preparedness Program's (HPP) preparedness and response 
strategy is concerned with making sure HPP awardees can meet eight 
national health care preparedness capabilities. These capabilities 
provide flexibility and address all-hazards, including: (1) health care 
system preparedness, (2) health care system recovery, (3) emergency 
operations coordination, (4) fatality management, (5) information 
sharing, (6) medical surge, (7) responder safety and health, and (8) 
volunteer management. Health care system preparedness, emergency 
operations coordination, and health care system recovery address the 
planning and preparation required to support efforts in all stages of 
an incident (preparedness, response, recovery, and mitigation). 
Fatality management and medical surge capabilities focus on rapid 
health care coordination, the ability to scale up operations, and 
resource allocation during an emergency. Information sharing highlights 
the need for the health care system to share information during an 
emergency with both system members and the public. Responder safety and 
health identifies and procures resources needed to protect health care 
workers. Volunteer management is the ability to coordinate and utilize 
volunteers to augment incident operations.
    Research and history demonstrate that if HPP awardees strengthen 
their local health care preparedness capabilities, they will be ready 
to respond to any given disaster or public health event. It is vital 
that health care systems maintain a baseline level of preparedness on 
all capabilities, so that for whatever the event (Ebola, terrorist 
attack, or natural disaster) local systems can respond quickly and 
effectively to save lives.
    HPP awardees originally targeted all eight health care preparedness 
capabilities when the program transitioned to a health care coalition-
based approach in 2012. As a result of funding reductions in 2014, many 
awardees have had to prioritize their efforts by targeting five of the 
eight capabilities. An HPP impact assessment of this reduction showed 
that 68 percent of awardees were not able to sustain progress made 
since 2012 on responder safety and health. Furthermore, 90 percent of 
awardees reduced exercises, evaluations, and corrective actions. 
Seventy percent reduced health care worker education and training. 
Responder safety and health was not among the five prioritized 
capabilities for many awardees and problems with health care worker 
safety during the Ebola outbreak underscored the need to re-emphasize 
responder safety.
    To re-emphasize responder safety and health, funding from both the 
Ebola emergency supplemental and the annual cooperative agreement 
program will support activities to enhance this capability including 
exercises, health care worker trainings, and optimizing the planning 
and management of PPE for health care workers.
    Additionally, strong regional coordination through health care 
coalitions (HCCs) can mitigate challenges associated with scarce 
supplies and resources during an outbreak or other public health event. 
For example, if a regional health care system has extra PPE available 
in some of its facilities, this equipment can be dispersed to local 
health care providers in need. The need for a national network of 
hospitals that are capable of treating highly pathogenic infectious 
diseases is addressed through the HPP Ebola funding awarded in May and 
June 2015. The capabilities and capacity of HPP awardees, and the 
health facilities and HCCs they will support through the supplemental 
Ebola funding, will be maintained for the full 5-year project period 
through quarterly or annual exercises and trainings, according to their 
respective roles. While the focus is on preparedness for Ebola, as 
required under Title VI of Division G of the Consolidated and 
Continuing Appropriations Act, 2015, it is likely that preparedness for 
other novel, highly pathogenic diseases will also be enhanced through 
these activities.

    Question 2b. How is ASPR ensuring that our projected medical surge 
capacity is sufficient for the threats we may face?
    Answer 2b. HPP awardees must maintain all-hazards health care 
system emergency preparedness and response plans to meet requirements 
within the HPP cooperative agreement. Awardee performance on the health 
care preparedness capabilities is evaluated annually through program 
evaluations, progress reporting, and site visits. Further, HPP awardees 
must make sure hospitals have all-hazards and hazard-specific 
preparedness and response plans, as well as the space, staff, and 
supplies needed to provide immediate bed availability and assure 
appropriate early medical care for individuals affected by disasters 
and public health incidents.
    HPP annually collects planning information from awardees on eight 
health care preparedness capabilities. Information sharing and medical 
surge were ranked as the most important capabilities by HPP awardees in 
each budget year 2012-15. Additionally, medical surge and health care 
system preparedness, which includes health care coalition development, 
were the most highly prioritized capabilities in awardees' funding 
allocations in 2012-15.
    To assist hospitals in their medical surge efforts, HPP released a 
new Hospital Surge Evaluation Tool in December 2014 that was designed 
to identify gaps in a hospital's preparedness and help assess its 
ability to respond to a mass casualty event. The tool takes the form of 
a no-notice drill and incorporates real-life considerations in acute 
care settings. The tool is intended for use by hospital emergency 
managers, hospital administrators, and clinical staff to assess and 
improve their hospital's surge plans. Hospitals need to exercise their 
preparedness for a mass casualty incident regularly. This tool can help 
hospital emergency managers to make recurring tabletop exercises a 
reality by providing a fully developed tabletop exercise that can be 
used at their facilities. In some respects, this tool can be thought of 
as ``Surge Evaluation in a Box.''

    Question 2c. How is ASPR ensuring that the lessons we learn from 
our experiences with Ebola are being taken into consideration and 
reflected in our preparedness and response strategies? For example, how 
do we ensure that the medical waste issues are not an issue in future 
response efforts?
    Answer 2c. While most of the Ebola outbreak has occurred in West 
Africa, HHS and other critical public health preparedness stakeholders 
have been working to strengthen domestic preparedness, should this or 
another infectious disease become an epidemic domestically. Many 
components of HHS have partnered together to support the response in 
West Africa and strengthen domestic preparedness. Partners include: the 
Centers for Disease Control and Prevention (CDC), the National 
Institutes of Health (NIH), the Food and Drug Administration (FDA), and 
operational divisions within the HHS Office of the Secretary such as 
the Office of the Assistant Secretary for Preparedness and Response 
(ASPR), the Office of the Assistant Secretary for Health, and the 
Office of Global Affairs.
    Representatives of these components recently met to discuss an 
after action review and report process to identify successes and 
identify any gaps in planning and response efforts. As this effort 
moves forward, HHS will gather information, draft an after-action 
document, and develop an improvement plan to strengthen preparedness 
and response to not only Ebola but other potential infectious disease 
outbreaks that have the potential to impact public health.
    A few important lessons learned throughout the national health care 
system in response to Ebola include health care worker safety from 
clinicians and laboratory workers to ancillary staff, recognizing that 
care of Ebola patients is clinically complex and demanding, and 
understanding that early case recognition is critical for preventing 
spread and improving outcomes. These lessons highlight the importance 
of adequate and sustained preparedness funding and the need for a 
national network of hospitals for treating highly pathogenic infectious 
diseases.
    HHS, in partnership with Federal and State partners, has made 
significant advances in the safe removal and transport of medical waste 
during the Ebola response, all of which can be applied in a future 
event. ASPR, working closely with CDC and the Department of 
Transportation, developed a mechanism that allowed for the safe removal 
and legal transport of contaminated medical waste from civilian health 
care facilities treating confirmed cases of Ebola. This led to the 
Pipeline and Hazardous Materials Safety Administration issuing a 
nonsite specific special permit (Special Permit DOT-SP 16279) to 
certain waste haulers, which authorizes the transportation and disposal 
of waste contaminated with or suspected of being contaminated with 
Ebola.
    As part of the HPP Ebola FOA (EP-U3R-15-002: HPP Ebola Preparedness 
and Response Activities), awardees are directed to take a number of 
steps that address infectious waste for the full 5 years of the Ebola 
cooperative agreement project period. These include:

     Assuring the readiness of all nine regional Ebola and 
other special pathogen treatment centers, the 61 State or jurisdiction 
Ebola treatment centers and assessment hospitals across the country by 
making sure their capability to handle Ebola-contaminated or other 
highly contaminated infectious waste. This can be done through contract 
with a waste management facility within the State or jurisdiction 
willing and able to incinerate and dispose of Ebola waste or by 
purchasing an onsite, high-volume autoclave capable of sterilizing 
hospital waste used in the care of a patient with Ebola. This can also 
be done by having a written agreement with another State willing to 
assume these responsibilities.
     Ensuring that EMS and interfacility transport systems are 
included in Ebola coalition planning. This includes making sure medical 
waste generated through the care of Ebola patients for EMS is safely 
managed through their own plans, a hospital's plan, or a separate 
coalition plan.

    While focus remains on preparedness for Ebola as required under 
Title VI of Division G of the Consolidated and Continuing 
Appropriations Act, 2015, it is likely that preparedness for other 
novel, highly pathogenic diseases will also be enhanced through these 
activities.
    Further, the National Ebola Training and Education Center (NETEC), 
which was awarded funding in July 2015 through a separate FOA (EP-U3R-
15-003) will offer expertise, training, technical assistance, peer 
review, monitoring, and recognition to State health departments, 
regional Ebola and other special pathogen treatment centers, State and 
jurisdiction based Ebola treatment centers, and assessment hospitals. 
The NETEC is a consortium of all three U.S. hospitals that successfully 
and safely treated patients with Ebola: Emory University in Atlanta, 
GA; University of Nebraska Medical Center/Nebraska Medicine in Omaha, 
NE; and Bellevue Hospital Center in New York, NY. One of the activities 
required of the NETEC is to create and maintain a comprehensive suite 
of timely and relevant educational materials (e.g., curricula, 
training, templates, train-the-trainer modules, tools, simulations, 
online resources, webinars) for policies and procedures related to the 
care of patients with possible Ebola and other special pathogens. 
Resources must align with government guidance and evolving scientific 
and clinical evidence bases. One topic they will address is handling 
Ebola-contaminated or other highly contaminated infectious waste.

    Question 3. How is the ASPR ensuring that the drills and exercises 
the ASPR is leading are training to the most appropriate protocols and 
across various threat scenarios so our Nation is better prepared for 
the full range of threats we may face?
    Answer 3. The Secretary of Homeland Security conducted a strategic 
national risk assessment to help identify types of incidents that pose 
the greatest threat to the Nation's homeland security. Representatives 
from Federal interagency offices have supported this effort and 
released the Strategic National Risk Assessment (SNRA) in December 
2011. The SNRA describes a wide range of threats and hazards that 
warrant national attention--threats include animal disease outbreaks, 
earthquakes, floods, pandemic outbreaks, chemical spills, dam failures, 
aircraft as a weapon, biological terrorists attacks, and explosive 
terrorist attacks, to name a few.
    ASPR's drills and exercises are based on the threats and hazards 
identified in the SNRA. ASPR also bases current drills and exercises on 
the findings contained within the Department of Homeland Security's 
National Preparedness Report. The National Preparedness Report is 
published annually and summarizes progress in building, sustaining, and 
delivering the core capabilities outlined in the National Preparedness 
Goal.
    In order to ensure response teams are adequately prepared and 
trained, the National Disaster Medical System (NDMS) utilizes the NDMS 
Fundamentals 100 series course designed and administered in 
collaboration with the Department of Homeland Security's Center for 
Domestic Preparedness in Anniston, AL. This week-long course provides 
didactic and hands-on, full-context training for response to a mass 
casualty situation. Specifically, the course targets training in: 
National Incident Management System (NIMS) command, control, and 
coordination structures; health and safety hazard assessments; 
dissemination of guidance and resources to support environmental health 
and safety actions for response personnel; recognition of cache 
equipment; and the capability of NDMS teams to provide medical care to 
patients with access and/or functional needs. Current programmatic 
resources enable approximately 20 percent of the NDMS workforce to 
attend the Fundamentals courses annually.

    Question 4a. Emergency Support Function #8 sets forth the 
coordination of medical and public health services as part of the 
National Response Framework, which was updated in May 2013. The 
previous document ESF #8 clearly set forth that the Secretary of Health 
and Human Services leads all Federal public health and medical response 
to public health emergencies and incidents covered by the National 
Response Framework and that the ASPR coordinates national ESF #8 
preparedness, response, and recovery actions, which is also set forth 
by PAHPA.
    Was the office of the ASPR involved in updating this document? If 
not, why considering the subject matter at hand?
    Answer 4a. ASPR's Office of Emergency Management (OEM) was involved 
in updating this document. OEM led a workgroup comprised of HHS 
divisions to review and update the annex.

    Question 4b. Why did this updated document remove the reference to 
the ASPR?
    Answer 4b. Ultimately, the content of all of the ESF Annexes to the 
National Response Framework (NRF) were updated to reflect the direction 
contained within the Presidential Policy Directive 8 (PPD-8) 
Implementation Plan that:

    1. The Planning Frameworks are intended to provide succinct 
descriptions, at a high level, of the steps taken to prepare to deliver 
the necessary capabilities, and;
    2. The Planning Frameworks are not intended to be traditional 
operations plans, concept of operations plans or detailed plans for 
action.

    Under these guidelines and in the process of aligning to the second 
edition of the NRF, all internal departmental policies, 
responsibilities, and procedures were removed from ESF Annexes.

    Question 5. Since 2006, limited PREP Act declarations have been 
issued for various threats. The current PREP Act declaration related to 
anthrax, smallpox, and other threats is set to expire on October 1, 
2015. What steps are being taken to renew these declarations to ensure 
there is no gap in the PREP Act protections contained within the 
current declaration?
    Answer 5. PREP Act declarations covering medical countermeasures 
against anthrax, smallpox, botulinum toxin, acute radiation syndrome, 
and pandemic influenza A viruses expire on December 31, 2015, the PREP 
Act declaration for certain vaccines against Ebola expires on December 
3, 2015, and the PREP Act declaration for a therapeutic against Ebola 
expires on April 8, 2016. This summer, HHS, through the PHEMCE, has 
been reviewing options and will develop recommendations for the 
Secretary regarding extension of PREP Act coverage under these 
declarations past 2015.

    Question 6. How is the 5-year medical countermeasure plan that was 
recently submitted to Congress being shared with outside stakeholders?
    Answer 6. ASPR's Biomedical and Advanced Research Development 
Authority (BARDA) has provided briefings on the PHEMCE multiyear budget 
on several occasions across various forums. BARDA Director Dr. Robin 
Robinson has presented to biodefense organizations (e.g., Alliance for 
Biosecurity), to industry conventions (e.g., BIO), at BARDA Industry 
Day, at international biodefense meetings (e.g., chemical, biological, 
radiological, nuclear, and explosives conferences), at congressional 
staff briefings, and during other formal and informal speaking 
engagements.
                            senator isakson
    Question 1. Secretary Lurie, I was pleased to see that ASPR 
released its FOA last Friday regarding the emergency funding allocated 
in the CRomnibus. The FOA released $194 million to be channeled through 
the State departments of public health for hospital preparedness.
    This is less than half of the money that Congress provided for this 
purpose. I hope that ASPR has plans to spend more of the remaining 
funding, which I understand to be about $375 million, directly to our 
hospitals that are on the front line.
    Can you please outline your plan for this remaining funding that 
Congress directed to hospital preparedness?
    Answer 1. The Hospital Preparedness Program (HPP) is awarding 
$201.5 million of the total funding appropriated to the Department of 
Health and Human Services under Title VI of Division G of the 
Consolidated and Continuing Appropriations Act of 2015. This includes:

     $194.5 million through the HPP Ebola Preparedness and 
Response Activities funding opportunity announcement (FOA), and
     $7 million (together with $5 million from CDC for a total 
of $12 million) for the National Ebola Training and Education Center 
(NETEC) FOA.

    The remaining funding is not allocated to specific activities 
either in the statute or in report language. The language allows 
resources to be used for Countermeasure Injury Compensation Program 
expenses, reimbursement of domestic transportation and treatment costs 
for individuals treated in the United States for Ebola, Ebola patient 
treatment cost reimbursement, and other preparedness and response 
needs. The statute also provides transfer authority of funds 
appropriated under title VI to specific Departmental components to meet 
critical needs that may arise rapidly. For example, resources could be 
used to scale-up Ebola response efforts in Guinea, Sierra Leone, and 
neighboring countries if the outbreak spreads or if the caseload 
dramatically increases. As HHS continues its work to develop an Ebola 
vaccine, these resources could also be used to scale-up production and 
support initial activities for a potential vaccination campaign.
                              senator kirk
    Question 1. Guidance from the National Strategy on Pandemic 
Influenza recommends maintaining enough antivirals to treat 25 percent 
of the U.S. population. Do you have plans to replace existing product 
in the Strategic National Stockpile based on changes to its patent 
exclusivity? Do you have plans to replenish existing stock that will 
soon expire to maintain preparedness? How are you engaging the private 
sector to address both issues?
    Answer 1. By 2007, the Biomedical Advanced Research and Development 
Authority (BARDA) in the Office of the Assistant Secretary for 
Preparedness and Response (ASPR) met the domestic influenza antiviral 
drug stockpile goals established in the National Strategy for Pandemic 
Influenza (2005). Today, the Centers for Disease Control and 
Prevention's (CDC) Strategic National Stockpile (SNS) maintains an 
influenza antiviral drug stockpile that continues to address this 
function in preparation for a potential influenza pandemic.
    During 2009, the United States distributed more than 11 million 
treatment courses of influenza antiviral drugs to the States, 
replenished those products accordingly, and subsequently replenished 
stockpiled products that had expired. In addition, the shelf life of 
these products has been extended by the Food and Drug Administration 
(FDA) in light of data from applicants supporting stability and 
demonstrating longer shelf life (e.g., 5 to 10 year expiry dating for 
Tamiflu). During annual reviews of the SNS formulary, as required by 
the Pandemic and All-Hazards Preparedness Act (PAHPA), the inventory of 
influenza antiviral drugs are assessed and adjusted as needed based on 
strategic goals, product composition, expiring product, and general 
population needs. SNS acts on these recommendations by acquiring 
additional influenza antiviral drugs. CDC and BARDA have met with 
companies that may have generic versions of influenza neuraminidase 
inhibitor products and will consider them in replenishment procurement 
plans if/when generics are approved by the FDA in coming years.
                             senator scott
    Question 1. In December, it was announced that after less than 3 
months on the job Ebola Czar Ron Klain would be leaving his post and 
returning to the private sector. When Klain was first appointed to this 
position I know everyone had serious questions as to whether the 
Administration had picked the right man for the job, given the fact he 
had zero public health experience. Dr. Lurie, given that you are the 
Assistant Secretary for Preparedness and Response, and have the 
credentials necessary for responding to an Ebola or any public health 
crisis, did you have any input into this decision? Will you have a roll 
in future appointments, should another public health crisis arise?
    Answer 1. The Secretary of the Department of Health and Human 
Services (HHS) convened daily (or more) meetings with a diverse team of 
senior department leadership officials that included, but was not 
limited to: the Assistant Secretary for Preparedness and Response 
(ASPR), the Assistant Secretary for Health, the National Institutes of 
Health (NIH), the Centers for Disease Control and Prevention (CDC), and 
the Food and Drug Administration (FDA). This was done to make sure the 
Department did everything possible to respond to Ebola both 
domestically and in West Africa.
    ASPR, as the principle advisor to the HHS Secretary, regularly met 
with Ron Klain and continues to meet regularly with senior government 
officials to support the government's comprehensive response to Ebola. 
ASPR's operating divisions continue to provide leadership, expertise, 
and support for the implementation of numerous preparedness, response, 
and recovery activities. For example, throughout the Ebola response, 
ASPR has led and supported the development of medical countermeasures 
and policies pertaining to use and clinical trials; the development of 
standards of care for Ebola patients and clinical guidance; the 
advancement of domestic health care system preparedness; interagency 
coordination for patient movement issues and repatriation; and 
interagency and international coordination to support response efforts 
in West Africa and to discuss and harmonize domestic response policies 
with allied countries. ASPR also led a series of focused domestic 
preparedness and response readiness, modeling, and science and budget 
activities.
    As you know, ASPR serves at the request and privilege of the 
President of the United States and under the leadership of the 
Secretary of HHS. Ebola required a multifaceted Government response and 
the President chose Mr. Klain to coordinate this effort. Mr. Klain led 
a successful response and has transitioned to a new endeavor. ASPR is a 
leader in preparing our Nation and its communities to respond to and 
recover from public health and medical disasters and emergencies. With 
that in mind, ASPR stands ready to lead our Nation during the next 
public health crisis and will remain available to the President and to 
the Secretary for any advice and guidance they request.

    Question 2. During the height of the Ebola outbreak, I'm proud to 
say that South Carolina hospitals stepped up to the challenge and 
quickly created a statewide response system that included Greenville 
Health System, Spartanburg Regional Healthcare System, Palmetto Health, 
and the Medical University of South Carolina. Our hospitals and their 
staff went above and beyond to prepare, and remain prepared, for a 
worst case scenario. Though the CDC has not officially designated any 
hospital in South Carolina an official ``Ebola Treatment Center,'' I'm 
confident our hospitals would be able to deliver the highest quality of 
care should any public health crisis arise. However, I am concerned 
about preparedness in the rural areas in our State, where providers 
have fewer resources to prepare and local coordination is often more 
difficult.
    What is being done to assist these rural areas in their response 
readiness? Related to this is the overall cost issues that arise during 
a sudden public health crises. What is being done to ensure appropriate 
reimbursement for large and rural hospitals, not only for rapid stepped 
up preparation but also for the expensive treatment of patients?
    Answer 2. The Hospital Preparedness Program (HPP) awarded $162 
million in May 2015 through funds made available through the Ebola 
supplemental appropriation. This funding was distributed via formula to 
all 62 HPP awardees. This includes the 50 States, DC, select 
metropolitan jurisdictions (Chicago, Los Angeles County, and New York 
City), U.S. territories, and freely associated States to support health 
care facilities that are capable of serving as Ebola treatment centers 
and assessment hospitals for their States or jurisdictions. The funding 
will also support health care coalitions (HCCs) to prepare frontline 
hospitals (including those in rural areas), emergency medical services 
agencies, and the overall health care system. The funding formula for 
the HPP Ebola awards took into account Ebola risk, based on the travel 
patterns of individuals coming from the affected countries. It also 
reflected West African diaspora population centers and jurisdictions 
with enhanced airport entrance screenings. This was done to make sure 
those States and localities most likely to have a case of Ebola are 
fully prepared.
    For Part A of the HPP Ebola FOA (which includes the $162 million 
described above), awardees must limit their direct costs (excluding 
sub-awards to HCCs and health care facilities) to no more than 10 
percent of their allocation. Of the funds for sub-awards, at least 30 
percent was allocated to health care coalitions in their jurisdiction 
and no more than 70 percent was used to provide funding directly to 
Ebola treatment centers and/or assessment hospitals.
    One of the required Part A activities is for awardees to develop 
and implement a health care system concept of operations (CONOPS) for 
the care of Ebola patients. This CONOPS links State activities related 
to active and direct active monitoring of returning travelers to 
designated assessment hospitals and treatment hospitals, and ensures 
that patients can be safely transported to a regional Ebola and other 
special pathogen treatment center and/or a State or jurisdiction Ebola 
treatment center in the event that they are not the same or the 
regional facility cannot accept patients. Each awardee's health care 
system CONOPS for Ebola will be maintained and exercised annually 
throughout the project period.
    The 30 percent set aside for HCCs is intended to develop the 
capabilities of HCCs and enable their members to care for Ebola 
patients. HCCs incentivize diverse and often competitive health care 
organizations with differing priorities and objectives to work 
together. HCCs collaborate to ensure that each member has the necessary 
medical equipment and supplies, real-time information, communication 
systems, and trained health care personnel to respond to an emergency. 
Nationwide, HCC membership is growing rapidly; between 2013 and 2014, 
there was a 47 percent increase in membership and there are currently 
about 24,000 health care and public health partners participating, from 
local health departments to hospitals, EMS, and emergency management 
agencies. Strong regional coordination through HCCs can mitigate 
challenges associated with scarce supplies and resources during an 
outbreak or other public health event and help each patient receive the 
right care at the right place at the right time. For example, if a 
regional health care system has extra PPE available in some of its 
facilities, this equipment can be dispersed to local health care 
providers who need it.
    As part of the HPP Ebola FOA, HCCs will:

     Ensure that all coalition partners have access to 
personnel protective equipment (PPE), trainings, and exercises 
according to their respective role in the health care system.
     Purchase PPE or support facility purchase and stockpile, 
preferably using vendor-managed inventories and mutual aid agreements 
at the coalition, community, or regional level.
     Rapidly distribute or re-distribute PPE to a facility 
within their coalition as needed. At a minimum, coalitions will 
coordinate with partners to obtain visibility of the PPE supplies 
available at health care facilities in their communities and ensure it 
can be moved rapidly as needed.
     Ensure the competency of health care workers to identify, 
assess, and treat suspected or confirmed patients with Ebola through 
annual training.
     Conduct annual coalition level exercises with, at a 
minimum, frontline facilities and EMS. Exercises in the first year 
should be specific to Ebola. If in subsequent years, there are no 
global outbreaks of Ebola, exercises may address other infectious 
diseases, such as MERS-CoV and measles.
     Conduct training and assist coalition partners in final 
preparations to assure State or jurisdiction Ebola treatment centers 
and assessment hospitals are able to accept a patient (in the event of 
a small cluster of cases) within 72 hours of accepting a confirmed 
patient from the region's Ebola or other special pathogen treatment 
center. This includes coordination with EMS and interfacility transport 
agencies.
     Ensure that EMS and interfacility transport systems and 
911/Public Safety Answering Points are included in Ebola coalition 
planning.
     Provide funding, as necessary, to EMS agencies for Ebola 
preparedness activities, such as purchasing PPE, training on PPE and 
other Ebola-related protocols, and exercises.
     Ensure that medical waste generated from the care of Ebola 
patients by EMS is safely managed through their own plans, a hospital's 
plan, or a separate coalition plan.
     Integrate health care system preparedness and infection 
control through health care coalition engagement with State Healthcare-
Associated Infection/Infection Control advisory groups, established 
with funding and guidance from CDC's Epidemiology and Laboratory 
Capacity for Infection Control program. This is also done to consider 
how a regional emergency preparedness structure could support improved 
infection control for coalition members.

    Awardees can use their discretion to provide supplemental funds to 
sub-recipient health care facilities and coalitions for previous Ebola 
preparedness costs incurred since July 2014; however, awards may not be 
used to reimburse health care facilities for direct patient treatment 
costs. HPP seeks to build capabilities within the entire health care 
system to better prepare communities for future outbreaks of Ebola and 
other highly pathogenic diseases illnesses.
    A separate process has been developed to reimburse health care 
facilities for uncompensated costs associated with the domestic 
treatment and transportation of confirmed patients with Ebola. Health 
care facilities began submitting claims on April 15, 2015.
                            senator roberts
    Question 1a. According to many of your industry partners, the move 
in authority of BARDA contract's to ASPR's Office of Acquisitions 
Management, Contracts and Grants (AMCG) has caused unnecessary delays 
and uncertainty regarding the time sensitive review of BARDA's medical 
countermeasures (MCM) development contracts.
    Do you think BARDA should be allowed to negotiate and award its own 
advanced R&D contracts as it has done in the past?
    Answer 1a. The Biomedical Advanced Research and Development 
Authority (BARDA) in the Office of the Assistant Secretary for 
Preparedness and Response (ASPR) always seeks the best approaches for 
preparing contracts, grants, cooperative agreements, and Other 
Transaction Agreements (OTAs) with industrial and academic partners to 
support advanced development, manufacturing, testing, and purchase of 
medical countermeasure candidates and products for preparedness and 
response to the medical consequences of chemical, biological, 
radiological, and nuclear (CBRN) threats, pandemic influenza, and 
emerging infectious diseases.

    Question 1b. Would you be willing to examine the possibility of re-
instating BARDA's contracting authority as a means to accelerate the 
development of critical MCM projects?
    Answer 1b. ASPR and BARDA are constantly seeking ways to improve 
the efficiency and quality of the procurement process and we welcome 
any suggestions you have for improvement. Maintaining a separate 
contracting office benefits ASPR as a whole, including BARDA and other 
operating divisions. Thus far, it has been an effective process. From 
the 2009-10 H1N1 pandemic influenza response through the current Ebola 
outbreak, ASPR and BARDA has benefited from senior-level, experienced 
contracting officers executing timely contract actions.

    Question 2. When Project BioShield was created, OMB independently 
reviewed all procurement contracts since the funds were derived from 
DHS but the program was administered by HHS.
    Now that BioShield funds are also housed at HHS, would you support 
removing this additional step of OMB approval in an effort to 
streamline the process and reduce wait times for these MCM contracts?
    Answer 2. ASPR and BARDA are always looking for ways to improve our 
efficiency and we welcome your suggestions. OMB provides valuable 
oversight and helps maintain our quality and the whole of Government 
approach to these important issues. Similarly, according to the Project 
BioShield Act of 2004, DHS continues to play an important role in 
reviewing and recommending use of these funds.
                             senator murray
    Question 1. PAHPRA made critical advances in ensuring that the full 
range of our national preparedness efforts take the unique needs of at-
risk populations into consideration--such as children, pregnant women, 
seniors, and others who may need additional response assistance, in the 
event of a public health emergency. I know a number of these advances 
are addressed in strategy and implementation plans released recently.
    Dr. Lurie, what are some areas of real progress with regards to at-
risk individuals and where do you think further advances are needed?
    Answer 1. The Office of the Assistant Secretary for Preparedness 
and Response (ASPR), in collaboration with the Centers for Medicare & 
Medicaid Services (CMS), has utilized limited administrative claims 
data to evaluate the impact of prolonged power outages on health care 
delivery, and individuals that rely on electricity-dependent medical 
equipment and health care services. In addition, ASPR and CMS are 
creating maps to inform and support State and local health department 
emergency planning and response. Pilot programs in the city of New 
Orleans and in Broome County, NY successfully demonstrated that limited 
administrative claims data can be securely disclosed to and used by a 
health department to rapidly identify and conduct potentially 
lifesaving outreach to at-risk individuals that live independently and 
rely upon electricity-dependent oxygen medical devices. Building on 
these successes, ASPR and CMS are launching the Department of Health 
and Human Services (HHS) At-Risk Resiliency Initiative that will be 
comprised of three national data and mapping capabilities that can 
inform and support all U.S. territories, State, local, and community 
partners in emergency planning for and/or assisting electricity-
dependent at-risk populations. Finally, ASPR is also collaborating with 
CMS and other partners, to identify medications that may be needed by 
at-risk populations prior to a disaster and explore mechanisms that can 
expedite advance or rapid medication refills for those that may need 
them after a disaster. In addition, ASPR has worked on the following 
activities to address at-risk populations during disasters:

     Publishing the 2012-2013 Report of the Children's HHS 
Interagency Leadership on Disasters (CHILD) Working Group.\3\ This 
report documents the significant progress HHS has made in addressing 
the needs of children in disasters since 2011 and highlights three new 
focus areas: pregnant and breast feeding women and newborns, children 
at heightened risk, and interdepartmental and non-governmental 
organization collaboration.
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    \3\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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     Developing the ``Guidance on Integrating People with 
Access and Functional Needs into Disaster Preparedness Planning for 
States and Local Governments.''
     Developing the ``Pediatric Preparedness for Healthcare 
Coalitions (Part I)'' Webinar and Resources, as well as a Part II 
Webinar.
     Developing the ``Disaster Preparedness Planning for Older 
Adults Web page.''
     Developing ``Promising Practices for Communication with 
Persons with Access and Functional Needs'' Webinar with DHS.
     Developing ``Disaster Preparedness for Family Caregivers'' 
Webinar.
     Developing the ``2014 HHS Human Services Concept of 
Operations.''
     Launching the HHS Preparedness for Pregnant Women Working 
Group. The goal of this working group is to integrate the needs of 
pregnant women across all disaster and public health emergency 
preparedness, response, and recovery activities. The working group will 
focus on opportunities to identify, develop, and update tools and 
resources within HHS including infographics, job aids, and other 
actionable products that can easily be disseminated and utilized by 
health care providers, public health practitioners, human services 
agencies, advocacy groups, and emergency management officials.
     Launching ASPR and the Administration for Community Living 
Working Group to integrate the Aging Network into Public Health and 
Medical Response (ESF #8). The goal of this working group is to 
increase awareness of the Incident Command System and develop tools and 
training to improve coordination of the Aging Network (long-term care, 
home and community-based services, meal delivery services, etc.) with 
ESF #8 and health care coalitions to ensure that the health and medical 
needs of older adults who may be impacted by public health emergencies 
and disasters are addressed.
     Publishing the ``Disaster Response Guidance for Health 
Care Providers: Identifying and Understanding the Health Care Needs of 
Individuals Experiencing Homelessness.'' This HHS-led document is part 
of a larger collaboration with the Department of Veterans Affairs, the 
Department of Housing and Urban Development, and other Federal partners 
to develop a Homeless Disaster Planning Toolkit.\4\
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    \4\ http://www.vemec.org/assets/1/6/Toolkit_Project_One-Pager.pdf.
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     Developing and publishing a website and fact sheet on 
``Cultural and Linguistic Competency in Disaster Preparedness and 
Response'' and development of the ``American Indian & Alaskan Native 
Disaster Preparedness Resource.''
     Coordinating and leading the Interagency Coordinating 
Council on Emergency Preparedness and Individuals with Disabilities 
(ICC) Health Subcommittee to promote the safety, security, and equal 
access to services for people with disabilities during emergencies.
                            senator mikulski
    Question 1. As you know, I authored the provision in the PAHPA 
Reauthorization that created the HHS National Advisory Committee on 
Children and Disasters (NACCD). I felt the creation of the NACCD was 
important because of the continued need to ensure that our Federal 
disaster preparedness and response programs are adequately addressing 
the needs of our most vulnerable, children. This year marks 5 years 
since the National Commission on Children and Disasters issued its 
final report looking comprehensively at each of our Federal agencies, 
States, and non-governmental entities to make recommendations for ways 
each can improve its readiness to meet children's unique medical and 
mental health needs during and in the aftermath of a disaster. While 
much progress has been made, many gaps remain in our level of 
preparedness for children. We can and should be doing all we can to 
ensure we as a nation are prepared to meet the needs of children, who 
represent 25 percent of the population.
    I want to commend you for selecting such a distinguished group of 
experts from inside and outside the Federal Government for the NACCD 
including its Chair, Dr. Michael Anderson, a pediatric critical care 
medicine doctor from Cleveland, OH, and Linda MacIntyre, the Chief 
Nurse at the American Red Cross. I have high hopes and expectations for 
the NACCD and I look forward to receiving their recommendations and 
guidance.
    Can you tell me how you are utilizing the expertise of the NACCD as 
HHS, ASPR and CDC respond to outbreaks and threats such as Ebola, 
Enterovirus D-68, and now measles?
    Answer 1. The NACCD was tasked with examining the current State of 
readiness to address the ability of the pediatric healthcare system to 
surge in the case of an outbreak of an infectious disease. This surge 
capacity task examines the current state of readiness across the Nation 
for a surge of pediatric patients in the event of an infectious disease 
outbreak such as influenza, measles, or Enterovirus D-68. Crises such 
as these could overwhelm local pediatric capabilities and the NACCD has 
been asked to focus on how health care organizations would cope in the 
near-term with large numbers of ill or infectious pediatric patients. 
To date, committee members working on this task have gathered pertinent 
information from several pediatric health care experts around the 
country. This includes insight and understanding of the issues 
concerning pediatric surge capacity as well as local and national 
readiness gaps for a large number of infectiously ill children. The 
members are synthesizing this information in a report with 
recommendations for improving pediatric transport, children's and non-
children's hospital capacities, as well as tools to strengthen 
pediatric health care coalitions. The NACCD Surge Capacity Report 
(Near-Term Strategies to Improve Pediatric Surge Capacity During 
Infectious Disease Outbreaks) was considered at a public meeting on 
April 30, 2015.\5\
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    \5\ The report can be found at: http://www.phe.gov/Preparedness/
legal/boards/naccd/Pages/recommendations.
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    The Health Care Preparedness Task looks across the broad health 
care system to care for large numbers of ill or injured children in the 
aftermath of public health threats, medical disasters, and mass-trauma/
casualty emergencies. Topic areas that the committee members will 
examine include the current State of facility preparedness, quality 
control programs, granting structures, innovation, communication 
streams, and medical counter measures. The members will propose 
strategies for mitigating identified gaps and suggest best practices 
and tools for increasing pediatric health care readiness. Members are 
finalizing the framework for a report of recommendations, as well as 
identifying subject matter experts to engage and gather insights that 
will inform the report's content. The NACCD plans to provide a report 
of its findings in October 2015.
    Question 2. Can you describe how you are best utilizing the 
existing Federal funding mechanisms through the Hospital Preparedness 
Program (HPP) and the Public Health Emergency Program (PHEP) to ensure 
grantees are prepared to meet the needs of children?
    Answer 2. As aligned cooperative agreements, ASPR's Hospital 
Preparedness Program (HPP) and CDC's Public Health Emergency 
Preparedness (PHEP) program include a number of joint and specific 
program requirements that address the particular needs of at-risk 
individuals and those with special medical needs, including children, 
in public health and medical emergencies. Awardees must:
     Complete jurisdictional risk assessments to identify 
potential hazards, vulnerabilities, and risks within the community, 
including interjurisdictional (e.g., cross-border) risks that 
specifically relate to public health, medical, and behavioral health 
systems and the functional needs of at-risk individuals, including 
children.
     Conduct an annual public health and medical preparedness 
exercise or drill that includes the access and functional needs of at-
risk individuals, including children. Awardees must also provide a 
report in the following year's funding application on the strengths and 
weaknesses identified and corrective actions taken to address material 
weaknesses. HPP awardees were required to consider the access and 
functional needs of at-risk individuals, including children, and engage 
these populations as they planned for Budget Period 4 (July 2015-June 
2016) health care coalition-based exercises.
     Maintain updated plans describing activities they will 
conduct with respect to pandemic influenza as required by Sections 
319C-1 and 319C-2 of the Public Health Service Act. This also includes 
efforts to address the needs of at-risk individuals, including 
children.
     Describe the structures or processes in place to ensure 
that access and functional needs of at-risk individuals, including 
children, are included in public health/health care and behavioral 
health response strategies and are identified and addressed in 
operational work plans.
     Obtain public comment and input on public health emergency 
preparedness and response plans and implementation using existing 
advisory committees, or similar mechanisms, to ensure continuous input 
from other State, local, tribal stakeholders, and the general public. 
This includes those with an understanding of at-risk individuals, 
including children, and their needs.
     Coordinate emergency preparedness and response with 
designated educational agencies and lead child care agencies in their 
jurisdictions.
     Include the ``Pediatric Preparedness for Healthcare 
Coalitions (Part II)'' Webinar in Budget Period Four HPP Supporting 
Documents. This two-part webinar describes resources, partnerships and 
strategies that HPP Directors and Healthcare Coalitions have 
implemented to strengthen pediatric components within their 
jurisdiction's healthcare preparedness capabilities. Topics discussed 
include Federal policy and efforts to address the needs of children in 
disasters; Superstorm Sandy lessons learned; putting the pieces 
together on pediatric response planning; Los Angeles County pediatric 
surge plan; and pediatric lessons learned (Alaska Shield/Hale Borealis 
2014 National Capstone Exercise).
                             senator casey
    Question 1. This year is the fifth anniversary of the National 
Commission on Children and Disasters. What progress has been on the 
Commission's recommendations from 2010?
    Answer 1. In February 2015, ASPR published the 2012-2013 Report of 
the Children's HHS Interagency Leadership on Disasters (CHILD) Working 
Group.\6\ This 82-page report documents the progress HHS has made in 
addressing the needs of children in disasters since 2011 and highlights 
three new focus areas: pregnant and breast feeding women and newborns; 
children at heightened risk; and interdepartmental and non-governmental 
organization collaboration.
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    \6\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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    The first chapter of the report provides a descriptive list of 
departmental activities supported by CHILD Working group member 
agencies since 2011. All activities are grouped into the following 
categories: behavioral health; medical countermeasures; child physical 
health, emergency medical services, and pediatric transport; and child 
care, child welfare, and human services.
    These four categories were created by the 2010-2011 CHILD Working 
Group members upon careful review of the NCCD's recommendations and 
internal policy and programmatic initiatives already begun across HHS.
    In order to demonstrate continued progress, HHS will continue to 
monitor and report all HHS activities related to children and 
disasters. For example, in August 2015, HHS launched a new data call 
for the 2014-2015 Report of the CHILD Working Group.

    Question 2. How are BARDA, CDC and FDA working together to ensure 
smooth transitions of products under development, through FDA review, 
and into the Strategic National Stockpile?
    Answer 2. The Biomedical Advanced Research and Development 
Authority (BARDA) in the Office of the Assistant Secretary for 
Preparedness and Response has transitioned more than 85 medical 
countermeasure (MCM) candidates for chemical, biological, radiological, 
and nuclear (CBRN) threats from early development at the National 
Institutes of Health (NIH), the Department of Defense (DoD), and 
industry into advanced development toward Food and Drug Administration 
(FDA) approval and potential acquisition under Project BioShield. 
Twelve of these MCMs have been purchased since 2005 under Project 
BioShield and another 12 will become mature enough for purchase by 
2018. Four Project BioShield MCMs [Raxibacumab anthrax antitoxin 
(2012), HBAT botulinum antitoxin (2013), Neupogen for ARS (2015), and 
AIG anthrax antitoxin (2015)] have been approved by the FDA under the 
Animal Rule. The Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE) governance structure includes: Integrated Program 
Teams, the Enterprise Executive Committee, Enterprise Senior Council 
oversight bodies, MCM portfolio reviews, a multiyear budget process, 
joint MCM projects, and monthly meetings between leadership and staff 
from BARDA, the Centers for Disease Control and Prevention (CDC), and 
NIH's National Institute of Allergy and Infectious Diseases (NIAID) to 
ensure continuous coordinated communication and seamless transition 
among these HHS agencies.

    Question 3. CDC has ranked CRE and Clostridium difficile as urgent 
antibiotic resistance threats, the highest level of resistance threat, 
but these organisms are not on PHEMCE's list of high priority threats. 
How does PHEMCE determine which organisms to include on the list? 
Should these resistant organisms be added?
    Answer 3. The PHEMCE addresses high priority threats, determined by 
the Secretary of Homeland Security, that pose a material threat 
sufficient to affect national security. This includes a material threat 
determination (MTD) issued by the Secretary of Homeland Security and/or 
a threat that PHEMCE leadership has determined has the potential to 
seriously threaten national health security.
    The PHEMCE recognizes the threat posed by naturally occurring and 
accidental threats to national health security that are outside the 
realm of the Department of Homeland Security (DHS) threat and risk 
assessment processes. For example, pandemic influenza was included in 
the PHEMCE high priority threat list based on PHEMCE leadership's 
consensus that it posed a serious threat to national health security 
and warranted investment in targeted MCM-related planning and response.
    To better standardize the process by which such decisions are made 
for particular naturally occurring threats, including antibiotic 
resistant organisms, the PHEMCE is currently developing a risk 
assessment methodology and process to examine emerging infectious 
diseases (EIDs). This process, anticipated for completion in fiscal 
year 2016, will inform PHEMCE leadership decisions on which EID threats 
require PHEMCE response at the research and development, requirement, 
advanced research and development, large-scale production, stockpiling, 
and/or utilization planning levels. While the intention of this 
framework is to review EIDs, it will be designed in a way that allows 
for the evaluation of a wide variety of organisms including health care 
associated infections such as Clostridium difficile and CRE.
    In the meantime, the PHEMCE will continue efforts to combat drug-
resistant bacteria in general. As noted in the 2014 PHEMCE Strategy and 
Implementation Plan, it is a PHEMCE programmatic priority to support 
Executive Order 13676, ``Combating Antibiotic-Resistant Bacteria,'' 
which calls for, among other actions, development of new and next-
generation MCMs that target antibiotic-resistant bacteria that present 
a serious or urgent threat to public health.

    Question 4. The amount that has been spent on the development of 
rapid diagnostics is small compared to the antimicrobial development 
budget. Since there is evidence that we can conserve our antibiotics if 
we are able to rapidly diagnose an infection, should we focus more 
resources on the development of rapid diagnostics? What are some of the 
barriers to the development of rapid diagnostics?
    Answer 4. BARDA values and supports development in diagnostics for 
biothreats, radiation exposure (i.e., biodosimetry), influenza, drug-
resistant bacteria and viruses, and EIDs. BARDA is currently supporting 
the development of multiple diagnostic candidates in these areas: four 
for biothreats (e.g., anthrax); five for biodosimetry; four for 
influenza and antiviral drug resistance; and one for Ebola. In fiscal 
year 2016, as funds become available, BARDA plans to add diagnostic 
candidates for antimicrobial drug resistance. BARDA's support focuses 
on rapid diagnostics for point-of-care throughout institutional usage. 
BARDA partners with CDC to set strategic diagnostic goals and plans, 
and to support development for many of these diagnostic candidates. 
Thus far, BARDA support has led to FDA clearance and marketing of five 
diagnostic assays for detection of influenza.
    Primary barriers to the development of rapid diagnostics for 
pathogenic bacteria include the following:

     poor clinical sample collection methods;
     availability of validated reference reagents and samples;
     assays with high enough specificity for reliable and 
reproducible clinical diagnoses;
     acceptance and widespread usage by the medical community; 
and
     limited commercial marketplace.

    Question 5a. I understand that HHS is working with the Department 
of Homeland Security to conduct a reassessment of certain material 
threat assessments and, by extension, the medical countermeasures 
requirements for threats such as anthrax and smallpox.
    Could you please provide a timeline of this threat reassessment 
process?
    Answer 5a. On January 20, 2004, the Department of Homeland Security 
(DHS) issued a Material Threat Determination (MTD for Bacillus 
anthracis (anthrax). Subsequently, Material Threat Assessment (MTA) 1.0 
for Anthrax was published in April 2005.
    On September 23, 2004, DHS issued a MTD for smallpox. The most 
recent Smallpox MTA was published February 2012.
    MTA 2.0 for Anthrax began fall of 2013 with the development of a 
working group comprised of interagency subject matter experts to frame 
the approach. Modeling efforts began August 2014. While weather 
selection, indoor transit, and integrated modeling efforts have already 
concluded, outdoor modeling, Intelligence Community elicitation, and 
development of the illustrative scenario matrix are concurrent 
activities. A draft report for MTA 2.0 is expected to be ready for HHS 
review by July 2015 with finalization by the end of 2015.
    Upon receipt, BARDA's modeling unit will utilize these assessments 
(anthrax being the first threat for analysis), develop scenario-based 
computer models on the medical consequences of these threats, and 
determine their impacts relative to non-medical and MCM interventions. 
Results from these analyses will inform PHEMCE product-specific 
requirements, MCM development, and product procurement for stockpiles.
    Discussions focused on prioritization and planning for future MTA 
efforts are ongoing.

    Question 5b. When do you expect this process to be complete?
    Answer 5b. DHS draft MTA 2.0 became available in July 2015 for HHS 
review for anthrax medical consequence modeling and analysis. The final 
version should be completed by the end of 2015. Others like smallpox, 
ionizing radiation, and chemical agents will follow upon receipt of 
MTAs from DHS.

    Question 5c. Would these reassessments have the potential to change 
BARDA's plans for anthrax and smallpox MCM advanced research and 
development or stockpiling?
    Answer 5c. Potentially, the MTAs may change and thus impact 
development and procurement of CBRN MCMs by PHEMCE partners at NIAID, 
BARDA, and CDC.
                            senator franken
    Question. When news of the Ebola outbreak spread, hospitals in 
Minnesota responded quickly and took key steps to ensure that they were 
prepared to screen, diagnose, and treat affected patients. These 
hospitals incurred significant expenses for things like personal 
protective equipment and staff training--most of which they have not 
been compensated for up to this point. Congress provided HHS with the 
authority to use Ebola emergency funding to reimburse hospitals 
directly for care that they provided to Ebola patients.
    Given all the resources that hospitals in Minnesota and elsewhere 
expended to make sure that they were prepared to treat Ebola patients, 
my question is, how you are determining eligibility for reimbursement 
under this authority?
    Answer. The Hospital Preparedness Program (HPP) provided $162 
million in Ebola preparedness and response funds through a funding 
formula to all HPP awardees in May 2015. These awardees are the public 
health departments in all 50 States, DC, select metropolitan 
jurisdictions (Chicago, Los Angeles County, and New York City), U.S. 
territories, and freely associated States. The majority of the funds 
will be further sub-awarded to support health care facilities that are 
capable of serving as Ebola treatment centers and assessment hospitals 
for their States or jurisdictions. The funding will also support health 
care coalitions prepare frontline hospitals, emergency medical services 
agencies, and the overall health care system. The funding formula for 
the HPP Ebola FOA takes into account Ebola risk, which is based on the 
travel patterns of individuals coming from the affected countries. It 
also reflects West African diaspora population centers and 
jurisdictions with enhanced airport entrance screenings to ensure that 
the States and localities most likely to have a case of Ebola are fully 
prepared. As a high risk State for Ebola, Minnesota's allocation was 
among the largest at $5,513,716. Hospitals designated as Ebola 
treatment centers by State health officials as of February 14, 2015 
will receive no less than $500,000 through this FOA, including four in 
Minnesota: Allina Health's Unity Hospital, Fridley, MN; Children's 
Hospitals and Clinics of Minnesota--St. Paul Campus, St. Paul, MN; Mayo 
Clinic Hospital--Rochester, St. Mary's Campus, Rochester, MN; and 
University of Minnesota Medical Center, West Bank Campus, Minneapolis, 
MN.
    State awardees have the discretion to provide additional funding to 
the Ebola treatment centers as their allocation allows.
    In addition, nine State or local health departments, along with 
their health facility partners, were awarded funding on June 12, 2015 
to establish regional Ebola and other special pathogen treatment 
centers (1 in 9 of the 10 HHS regions). As necessary, these centers can 
be ready within a few hours to receive a confirmed Ebola patient from 
their region, across the United States, or medically evacuated from 
outside of the United States. These hospitals will also have enhanced 
capacity to care for other highly infectious diseases. The Minnesota 
Department of Health, in partnership with the University of Minnesota 
Medical Center, Minneapolis, MN, was one of the recipients of these 
competitively awarded funds, to serve as the regional Ebola and other 
special pathogen treatment center for HHS Region Five. Funding will be 
distributed to these awardees incrementally over the full 5-year 
project period in order to sustain and maintain readiness for Ebola and 
other highly pathogenic infectious diseases. The total funding to 
establish regional Ebola and special pathogen treatment centers across 
the country is $32.5 million.
    Awardees can use their discretion when providing supplemental funds 
to sub-recipient health care facilities and coalitions for previous 
Ebola preparedness costs incurred since July 2014. However, awards may 
not be used to reimburse health care facilities for direct patient 
treatment costs. HPP seeks to build capabilities within the entire 
health care system to better prepare communities for future outbreaks 
of Ebola and other novel, highly pathogenic diseases.
    The office of the Assistant Secretary for Preparedness and Response 
(ASPR) has established a program to reimburse hospitals and other 
health care providers for direct and uncompensated treatment and 
domestic transportation costs accrued while caring for a confirmed 
Ebola patient in the United States. This program reimburses care 
provided to patients treated since the start of the Ebola response and 
remain in place should additional patients require treatment during the 
5-year funding period, as set forth in the Consolidated and Further 
Continuing Appropriations Act, 2015. Health care facilities began 
submitting claims on April 15.
                            senator baldwin
    In the House of Representatives, I worked to include language in 
the Pandemic All-Hazards Preparedness Reauthorization Act of 2013 that 
added the critical care system to the Federal Government's medical 
preparedness and surge capacity goals to ensure that critical care is 
included in emergency planning efforts. I also recently introduced the 
bipartisan Critical Care Assessment and Improvement Act to evaluate our 
critical care infrastructure, as the recent Ebola outbreak and severe 
flu season has underscored the importance of critical care systems.
    Question 1. Dr. Lurie, what methods are currently being used by the 
Department of Health and Human Services to identify and deploy surge 
medical providers with critical care expertise, like intensivists, 
nurses and respiratory therapists, as well as those that are able to 
care for children and infants in need of critical care?
    Answer 1. The Office of the Assistant Secretary for Preparedness 
and Response (ASPR), in collaboration with the Centers for Medicare & 
Medicaid Services (CMS), has utilized limited administrative claims 
data to evaluate the impact of prolonged power outages on health care 
delivery, and individuals that rely on electricity-dependent medical 
equipment and health care services, such as dialysis. Following 
Hurricane Sandy, dialysis studies have allowed us to see how dialysis-
dependent Medicare beneficiaries were adversely impacted and have 
identified clinical preparedness practices which can help us better 
anticipate, plan for, and respond to needs in a disaster.\7\ For 
example, our studies provided evidence that Medicare dialysis-dependent 
patients who received early dialysis in anticipation of Sandy's 
landfall had their odds of an emergency department visit reduced by 20 
percent, hospitalization in the week of the storm reduced by 21 
percent, and 30-day mortality reduced by 28 percent.\8\ ASPR, in 
collaboration with CMS, is actively disseminating these important 
findings across the dialysis community as well as encouraging 
healthcare and public health officials to encourage and prioritize 
early dialysis, where appropriate, in advance of a notice emergency 
such as a hurricane or blizzard.
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    \7\ http://www.ncbi.nlm.nih.gov/pubmed/25156306.
    \8\ http://www.ncbi.nlm.nih.gov/pubmed/26120039.
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    ASPR and CMS have also established the HHS emPOWER Initiative, a 
data and mapping collaboration to help inform and support Federal, 
State, local, and community emergency planning and response activities 
for those in need of electricity-dependent medical and assistive 
equipment and oxygen, home health, and dialysis healthcare services. 
This information is made available to State and local health 
departments and the community partners and appropriately balances the 
need to support emergency planning and response with the need to 
protect privacy. One component is the HHS emPOWER Map,\9\ a publicly 
available and interactive map that provides de-identified and 
aggregated population data down to the zip code level for Medicare 
beneficiaries that rely upon electricity-dependent medical and 
assistive equipment. Another component provides State and local health 
public health authorities with more de-identified and granular data 
(e.g., type of medical equipment, home health services, oxygen-tank 
use, dialysis-dependence) that can support more detailed emergency 
planning and response activities. Public health authorities that meet 
certain Health Insurance Portability and Accountability Act 
requirements can also request secure access to more detailed 
information, such as addresses, to facilitate life-saving assistance 
and outreach as part of an emergency response. Finally, ASPR is also 
collaborating with CMS and other partners, to identify medications that 
may be needed by at-risk populations prior to a disaster and explore 
mechanisms that can expedite advance or rapid medication refills for 
those that may need them after a disaster.
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    \9\ http://www.phe.gov/empowermap/.
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    Specific activities include:

     Publishing the 2012-2013 Report of the Children's HHS 
Interagency Leadership on Disasters (CHILD) Working Group.\10\ This 82-
page report documents the significant progress HHS has made in 
addressing the needs of children in disasters since 2011 and highlights 
three new focus areas: pregnant and breast feeding women and newborns, 
children at heightened risk, and interdepartmental and non-governmental 
organization collaboration. A comprehensive summary of HHS activities 
related to medical countermeasures, child physical health, emergency 
medical services, and pediatric transport is found on pages 11 through 
20 of the report.
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    \10\ http://www.phe.gov/Preparedness/planning/abc/Documents/child-
wg-report2012-2013.pdf.
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     Developing the ``Pediatric Preparedness for Healthcare 
Coalitions (Part I)'' Webinar and Resources, as well as a Part II 
Webinar.

    Question 2. In response to the Ebola outbreak last year, Wisconsin 
designated three Wisconsin health systems to care for patients who may 
be diagnosed with the Ebola virus. These hospitals have invested a 
significant amount of staff and financial resources to ensure that they 
are ready to provide the best and safest care in the event that 
Wisconsin must care for a patient with Ebola. It is critical that our 
Federal efforts support these important investments.
    How much of the $162 million in emergency funding being provided to 
States for Ebola preparedness will be provided directly to hospitals, 
and how will such funds prioritize State-designated treatment centers, 
such as the three in Wisconsin?
    Answer 2. The Hospital Preparedness Program (HPP) provided $162 
million in Ebola funding through a funding formula to all HPP awardees 
in May 2015. These awardees are in all 50 States, DC, select 
metropolitan jurisdictions (Chicago, Los Angeles County, and New York 
City), U.S. territories, and freely associated States to support health 
care facilities that are capable of serving as Ebola treatment centers 
and assessment hospitals for their States or jurisdictions. The funding 
will also support health care coalitions (HCCs) to prepare frontline 
hospitals, emergency medical services agencies, and the overall health 
care system.
    Awardees must limit their direct costs (excluding sub-awards to 
HCCs and health care facilities) to no more than 10 percent of their 
allocation. Of the funds for sub-awards:

     At least 30 percent must be allocated to health care 
coalitions in the jurisdiction (Wisconsin has eight health care 
coalitions across the State).
     No more than 70 percent may be used to provide funding 
directly to Ebola treatment centers and/or assessment hospitals.

    Hospitals that have been designated by State health officials as 
Ebola treatment centers as of February 14, 2015 will receive no less 
than $500,000 through the HPP awards, including three in Wisconsin: UW 
Health--University of Wisconsin Hospital, Madison and the American 
Family Children's Hospital, Madison, WI; Froedtert and the Medical 
College of Wisconsin--Froedtert Hospital, Milwaukee, WI; and Children's 
Hospital of Wisconsin, Milwaukee, WI. States and awardees have the 
discretion to provide additional funding to the Ebola treatment centers 
as their allocation allows.
                             senator warren
    Question 1a. The Ebola outbreak in West Africa has raised questions 
about whose responsibility it is to lead, coordinate, and finance 
international infectious disease response efforts, especially when 
local governments are ill-equipped to handle a crisis alone. There are 
many international groups, including the World Health Organization, 
non-governmental organizations like the Gates Foundation and Doctors 
Without Borders, and initiatives like the Global Health Security Agenda 
which brings together U.S. Government agencies and partner nations to 
make strategic investments to develop a better system of preventing, 
detecting, and responding to disease threats worldwide.
    Who do you think is ultimately responsible for the coordinating and 
financing international outbreak response efforts?
    Answer 1a. International-Level Coordination.--The United Nations 
(UN) Cluster Approach was established in June 1992 by the U.N. Inter-
Agency Standing Committee to strengthen humanitarian assistance during 
complex, multi-sectoral responses. More specifically, it strengthens 
response to situations where humanitarian needs are of sufficient scale 
and complexity and require the coordination and engagement of a wide 
range of international stakeholders. Within the U.N. Cluster Approach, 
the World Health Organization (WHO) leads the Health Cluster and has 
the ultimate responsibility for coordinating response efforts to 
international emergencies with a public health component, including 
efforts among WHO Member States, other U.N. Agencies, and non-
governmental organizations.
    Additionally, WHO has a leading role under the 2005 International 
Health Regulations (IHR), which includes determining whether particular 
events constitute a public health emergency of international concern 
(PHEIC). Other WHO responsibilities include disseminating information 
to State Parties, building and strengthening core public health 
capacities for surveillance and response to PHEIC, developing and 
recommending measures for surveillance, and the prevention and control 
of public health emergencies of international concern. WHO's leading 
role in emergencies was strengthened by Article 2(d) of WHO's 
Constitution and World Health Assembly Resolutions 34.26, 46.6, 48.2, 
58.1, 59.22, 64.10, and 65.20.
    WHO has also established an Emergency Response Framework\11\ and a 
Global Emergency Management Team to provide overall policy, strategy, 
and management guidance. This is important to coordinate an effective 
health sector response as the Health Cluster Lead Agency and in line 
with responsibilities under the 2005 IHR. In this role, WHO has the 
responsibility for coordinating global financing and resources 
contributed to public health responses (direct funding and in kind 
support). A proposal to establish a contingency fund to support public 
health emergency responses will be considered by the Sixty-eighth World 
Health Assembly. When this happens, the WHO Director-General will be 
asked about options regarding the size, scope, sustainability, 
operations and sources of financing for such a fund. In addition, the 
Director-General will be asked about accountability mechanisms 
including possible internal sources of funding from within WHO's 
existing program budget. This is done taking into account other 
relevant financing mechanisms and emergency funds already in operation 
or being considered, at regional and global levels.
---------------------------------------------------------------------------
    \11\ http://www.who.int/hac/about/erf_.pdf.
---------------------------------------------------------------------------
    In addition to HHS's full support of the implementation of the IHR 
(2005) through numerous public health emergency and response capacity 
building arrangements and public health activities internationally, HHS 
participates in a number of specific international partnerships that 
serve to strengthen global capacity to prevent, detect, respond, and 
recover from international public health emergencies, as well as to 
foster technical and policy coordination among key stakeholders prior 
to and during a response. Among others, these partnerships include the 
Global Health Security Agenda, the Global Health Security Initiative 
(which consists of the G7 countries, Mexico, and the European 
Commission, as well as the WHO as an expert advisor), the North 
American Plan for Animal and Pandemic Influenza (NAPAPI), and the 
United States-Canada Beyond the Border Initiative.
    U.S.-Government-Level Coordination.--In accordance with the 
Presidential Policy Directive (PPD)-1 process for coordinating 
executive departments and agencies as they develop, integrate, and 
implement national security policy, the National Security Council (NSC) 
typically convenes Interagency Policy Committees as the U.S. 
Government-wide policy coordination structure. This is done to support 
the response to public health emergencies. A number of recent 
frameworks were recently developed to coordinate the provision of 
international assistance in response to international emergencies that 
pose a risk to the United States including for chemical, biological, 
radiological, and nuclear (CBRN) incidents, and pandemic influenza. 
These frameworks specifically address the deployment of medical 
countermeasures and personnel in response to a request for assistance 
from another government or the WHO/international organizational. 
However, no U.S. Government policy framework outlines the respective 
roles and responsibilities of U.S. Government departments and agencies 
in response to public health events of international concern that 
require full-spectrum public health intervention (i.e., epidemiologic 
investigation, healthcare services, risk communication, community 
coordination, environmental services and international border controls) 
to prevent regional and global spread.
    The National Response Framework establishes the U.S. Department of 
Health and Human Services (HHS) as the leader for coordinating response 
to domestic public health and medical emergencies under Emergency 
Support Function #8 (ESF-8). Within HHS, the Pandemic and All-Hazards 
Preparedness Act (PAHPA) provides the Assistant Secretary for 
Preparedness and Response (ASPR) with a mandate to ``provide leadership 
in international programs, initiatives, and policies that deal with 
public health and medical emergency preparedness and response.'' 
Additionally, other U.S. agencies, such as the U.S. Agency for 
International Development and the Department of Defense, have legal 
authorities and funding to lead, coordinate, or implement international 
assistance and disaster response. However, there is no overarching U.S. 
Government coordination framework that describes the roles, 
responsibilities, or the legal and funding authorities of all relevant 
U.S. Government stakeholders during such an international response with 
potential domestic implications not covered by a Stafford Act 
declaration.

    Question 1b. What changes need to occur to empower such a system?
    Answer 1b. International-Level Coordination.--Based on lessons 
learned from the Ebola response, efforts are underway to strengthen 
global preparedness and ensure that WHO has the capacity to prepare for 
and respond to future large-scale outbreaks and health emergencies. 
Accordingly, a number of reform proposals were brought before and 
adopted by the Sixty-eighth World Health Assembly in May 2015. Areas of 
focus include reaffirming WHO's role and leadership as the Global 
Health Cluster Lead Agency, improving surveillance and information 
sharing, calling for WHO and Member States to further efforts to 
strengthen health systems establish capacities for public health 
preparedness and response under the 2005 IHR, establishing mechanisms 
for rapid medical assistance (including establishment and deployment of 
foreign medical teams), and strengthening efforts to ensure access to 
drugs and vaccines and developing a WHO-managed $100-million 
contingency fund to provide financing for in-field operations for up to 
3 months.
    U.S. Government-Level Coordination.--The USG should consider the 
development of a generic USG-wide framework that contemplates a variety 
of scenarios and describes the roles, responsibilities, funding, and 
legal authorities of relevant stakeholders during the different phases 
of a response to public health and medical emergencies with a domestic-
international interface. This framework should include triggers 
allowing responsibilities and leadership to shift from one U.S. 
Department or Agency to another depending on their specific mission and 
authorities. This includes events caused by CBRN threats, pandemic 
influenza, emerging or re-emerging infectious diseases, and natural 
disasters that originate abroad but potentially impact U.S. national 
health security.
    Under the role and authorities given to ASPR by PAHPRA, ASPR, in 
collaboration with key HHS stakeholders, should also develop an 
overarching HHS framework for responding to public health emergencies 
with a domestic-international interface. The Framework should highlight 
the leading role of HHS and specifically ASPR in coordinating the 
public-health aspects of emergencies abroad that can have an impact in 
U.S. health security. It should also clarify the roles and 
responsibilities of the different HHS offices during a response and 
(e.g., CDC, NIH, FDA) align these roles with existing roles during 
domestic responses.

    Question 2. In order for the United States to have the capacity to 
respond to outbreaks at home and abroad, we need to have individuals 
who are trained and experienced in handling infectious agents. 
Biosafety training programs are essential to prepare both governmental 
and nongovernmental personal to effectively respond to epidemics. Do 
ASPR and CDC currently, or have plans to, leverage nongovernment 
physicians and researchers, capabilities, and infrastructure to enhance 
the Nation's clinical and research capacities for future outbreaks?
    Answer 2. To reduce cost and save time in product development and 
manufacturing, the Biomedical Advanced Research and Development 
Authority (BARDA) in the Office of the Assistant Secretary for 
Preparedness and Response (ASPR) has established a National Medical 
Countermeasure Response Infrastructure comprised of core service 
assistance programs to assist product developers on a daily basis while 
ensuring rapid and nimble response in a public health emergency. BARDA 
has employed this medical countermeasure (MCM) infrastructure for 
development of CBRN MCMs on a routine basis and is now utilizing them 
in the current Ebola response by supporting the development and 
manufacturing of several Ebola therapeutics and vaccines. BARDA's 
Nonclinical Studies Network (NCSN), which was established in 2010 and 
is composed of 17 high-biocontainment laboratories in the United States 
and the United Kingdom, has developed qualified animal models for CBRN 
threats, performed animal challenge studies for CBRN MCMs, and 
evaluated potential CBRN MCM candidates in these animal models prior to 
BARDA investment. Today, the NCSN is conducting critical animal 
challenge studies for promising Ebola monoclonal and antiviral drug 
therapeutic candidates.
    BARDA's three Centers for Innovation in Advanced Development and 
Manufacturing are helping to develop anthrax vaccines and are expanding 
the production of new and existing Ebola monoclonal antibodies similar 
to ZMapp in mammalian cells. BARDA's Fill Finish Manufacturing Network, 
established in 2013 with four Contract Manufacturing Organizations 
having aseptic filling capabilities in the United States, is now being 
used to formulate and fill multiple Ebola antibody and vaccine 
candidates into vials for clinical efficacy studies in West Africa. Two 
Contract Research Organizations among the five members of BARDA's 
Clinical Studies Network are working with BARDA scientists and CDC to 
conduct Ebola vaccine clinical trials in Sierra Leone. BARDA's modeling 
unit, which routinely provides medical consequence modeling of CBRN 
threats to inform MCM requirements, generated key models and forecasts 
on the impacts of MCM intervention on the epidemiology of the 2009 H1N1 
pandemic, 2013 H7N9 outbreaks, and of the current Ebola epidemic in 
West Africa. All together, these programs constitute an active and 
seasoned infrastructure able to respond to known and unknown emerging 
infectious diseases. BARDA investments to our national MCM 
infrastructure since 2010 have played a major role in our national 
response to the current Ebola epidemic. Moreover, these investments 
will become even more vital for MCM response to public health and 
national security emergencies in the coming years.
    In 2012, ASPR established a science preparedness initiative to 
develop a framework for the integration of scientific research and to 
mobilize clinical and scientific research responders during HHS 
disaster-response efforts.\12\ Once fully developed, the science 
preparedness framework will include a network of pre-identified 
scientists, including those with expertise in biosafety, applied 
biosafety research, and infection control training, who can rapidly 
initiate research in response to all hazards. The framework will also 
establish procedures for rapid institutional review of clinical 
research involving human subjects, and the development of pre-scripted 
clinical and scientific research protocols.
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    \12\ http://www.phe.gov/Preparedness/planning/science.
---------------------------------------------------------------------------
    ASPR is also managing the S3 (Science, Safety, and Security) 
program, which addresses biosafety, biosecurity, biocontainment, and 
bio-risk management. The S3 program promotes transparency and broader 
awareness about the evolving nature of biological agents that can be 
hazardous and instructs how to handle and use these agents safely and 
securely. Resources provided on the program's website\13\ are directed 
toward laboratory personnel who work with potentially hazardous 
biological agents, their supervisors, management personnel at their 
institutions of employment, policymakers, and the public.
---------------------------------------------------------------------------
    \13\ http://www.phe.gov/s3.
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    Recognizing a need to prepare the U.S. health care system to safely 
assess and care for patients with suspected and confirmed cases of 
Ebola, ASPR and CDC jointly awarded $12 million on July 1, 2015, to 
establish a National Ebola Training and Education Center (NETEC). While 
the focus of this funding is on preparedness for Ebola, as required in 
the appropriations language, it is likely that preparedness for other 
novel, highly pathogenic diseases will also be enhanced through these 
activities. The NETEC is a consortium of all three U.S. hospitals that 
successfully and safely treated patients with Ebola: Emory University 
in Atlanta, GA; University of Nebraska Medical Center/Nebraska Medicine 
in Omaha, NE; and Bellevue Hospital Center in New York, NY. NETEC will 
offer expertise, training, technical assistance, peer review, 
monitoring, and recognition, to State health departments, regional 
Ebola and other special pathogen treatment centers, State and 
jurisdiction-based Ebola treatment centers, and assessment hospitals. 
However, recipients may not use funds for research or clinical care.
    More specifically, NETEC will build a comprehensive set of 
activities and deliverables for public health departments, U.S. health 
care providers, and facilities to safely and successfully identify, 
isolate, assess, transport, and treat patients with Ebola, or persons 
under investigation for Ebola. In addition, it will develop and lead a 
national peer review and recognition program for the regional Ebola and 
other special pathogen treatment centers. Throughout the 5-year project 
period, NETEC will modify materials developed (e.g., curricula and 
templates) as the Ebola outbreak evolves and the science advances.
    NETEC will develop metrics to measure facility and health care 
worker readiness (including health care worker training). Using these 
metrics, NETEC will conduct peer review assessments, monitoring, and 
recognition reporting. These metrics should complement and build from 
the capabilities detailed in CDC's Interim Guidance for Hospital 
Preparedness, and other additional capabilities necessary for NETEC. 
Regional Ebola and other special pathogen treatment centers will be 
assessed annually while the State and jurisdiction Ebola treatment 
centers and assessment hospitals will be assessed as mutually agreeable 
over the 5-year project period. ASPR and CDC will assist NETEC with 
prioritizing requests from health departments and hospitals, in the 
event that requests are unmanageable. In order to address gaps, NETEC 
will provide HHS with detailed reports concerning each facility's 
assessment results, including a summary of all NETEC-provided 
assistance.
    NETEC will develop a training curriculum and will continuously 
update a comprehensive set of educational materials, resources, and 
tools to build and maintain health care worker readiness for Ebola-
virus diseases and other novel, highly pathogenic diseases. Under this 
capacity, NETEC will focus on the knowledge, skills, and abilities 
needed to safely and successfully identify, isolate, assess, transport, 
and clinically treat a suspected Ebola patient in accordance with U.S. 
Government guidelines.
    More specifically, NETEC will provide technical support to train 
staff at public health departments and health care workers at regional 
Ebola and other special pathogen treatment centers, State and 
jurisdiction designated treatment centers, and assessment hospitals. 
The NETEC will facilitate the planning and observation of facility and 
regionally based exercises through a variety of methods, including but 
not limited to:

     Full immersion training at the NETEC or requesting 
facility location;
     Exercises at an NETEC or requesting facility location on a 
regular basis (e.g., annually);
     Clinical consults and technical assistance via secure 
video or telemedicine information technology;
     Onsite and virtual clinical simulation training; and
     Subject matter expert technical assistance visits (e.g., 
conference calls, webinars), training courses, and exercise templates.

    [Whereupon, at 11:57 a.m., the hearing was adjourned.]

                                   [all]