[Senate Hearing 117-]
[From the U.S. Government Publishing Office]



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022

                              ----------                              


                        WEDNESDAY, MAY 19, 2021

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10 a.m. in room SD-138, Dirksen 
Senate Office Building, Hon. Patty Murray (chairwoman) 
presiding.
    Present: Senators Murray, Durbin, Reed, Shaheen, Merkley, 
Schatz, Baldwin, Murphy, Manchin, Blunt, Shelby, Graham, Moran, 
Capito, Kennedy, Hyde-Smith, Braun, and Rubio.

  REVIEW OF THE FISCAL YEAR 2022 BUDGET BLUEPRINT FOR THE CENTERS FOR 
                     DISEASE CONTROL AND PREVENTION


               opening statement of senator patty murray


    Senator Murray. Good morning. The Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education, 
and Related Agencies will come to order.
    Today we are having a hearing on the Biden administration's 
fiscal year 2022 Budget request for the Centers for Disease 
Control and Prevention. It is our first subcommittee hearing 
this Congress, and our first hearing on the CDC's annual 
funding request since 2014.
    Senator Blunt and I look forward to continuing to work with 
you and our colleagues on both sides of the aisle, to build on 
the progress we have made previously, and help families in 
Washington State, Missouri, and across the country.
    And I intend to follow the example you set when it came to 
chairing hearings, Senator Blunt, and making sure that every 
member has an opportunity to ask a question.
    Senator Blunt and I will each have an opening statement. 
And then I will introduce our witnesses, Director Walensky, and 
Principal Deputy Director Schuchat. And after the witness' 
testimony, Senators will each have 5 minutes for a round of 
questions.
    Before we begin, I do want to walk through the COVID-19 
safety protocols in place. We are all very grateful to our 
clerks, and everyone who has worked hard to get this set up and 
help everyone stay safe and healthy.
    Given the new guidance from the Centers for Disease Control 
and Prevention and the Office of the Attending Physician, I 
will be working with Senator Blunt, committee members and 
staff, going forward, to follow the new guidance.
    For today, we will be conducting this hearing following 
similar COVID protocols to what we have used in the past. 
Committee members are seated at least 6 feet apart. Some 
Senators are participating by video conference, and while we 
are unable to have the hearing fully open to the public, or 
media for in-person attendance, live video is available on our 
committee website.
    And if you are in need of accommodations, including closed 
captioning, you can reach out to the committee or the office of 
Congressional Accessibility Services.
    I always say a budget is a reflection of your values and 
your priorities. And I think Americans can breathe a sigh of 
relief knowing this budget shows they have a President who 
values science and public health. COVID-19 has offered a stark 
reminder of why we must make and maintain robust investments in 
public health.
    Experts at CDC (Centers for Disease Control and Prevention) 
have been on the frontlines of this crisis from day one, and 
every day since. We have seen first-hand how critical it is CDC 
be equipped to effectively collect and analyze data in real 
time, communicate science-based public health guidance, help 
communities across the country get tests, and vaccines, and 
clear, reliable information to people, and address inequities 
that undermine the health of people of color, people with 
disabilities, rural communities, and others.
    That is why I have pushed for more funding for public 
health throughout this crisis. The tens of billions of dollars 
we have provided through six COVID bills so far, are supporting 
invaluable public health work at every level so we can finally 
end this pandemic.
    It has helped update and modernize data systems needed to 
track infections, variants, tests, vaccines, and inequities 
among demographic groups. It has helped fight misinformation 
and promote simple protective measures that have saved 
countless lives, like wearing masks and social distancing.
    It has helped expand our testing efforts, get vaccines into 
arms, and build partnerships with trusted voices in hard-to-
reach communities. And I was pleased to hear the Biden 
administration announced last week, it was investing over $7 
billion from the American Rescue Plan, through CDC, to create 
tens of thousands of jobs in public health at the State and 
local level to fight COVID-19, and to help transition some of 
those workers to permanent careers as public health 
professionals.
    With new cases and deaths both down over 80 percent from 
their winter peaks, nearly three in five Americans vaccinated 
with their first dose, and over a third of Americans fully 
vaccinated, we can see the light at the end of the tunnel. But 
even as we get closer to ending this crisis, we know we are not 
there yet, and we cannot afford to come up short. That is why 
after years of underinvestment in CDC and attempted cuts to CDC 
by President Trump, this budget request is such a breath of 
fresh air.
    President Biden's request of $8.7 billion would increase 
CDC's budget authority by nearly a quarter. I have been pushing 
for more public health funding for years now. And I am excited 
to say this would be the largest budget authority increase for 
CDC in nearly two decades. These investments will help us 
finish strong when it comes to this pandemic, prepare for the 
next one, and make progress on other public health challenges.
    Investments in CDC, as well as requested increases for the 
Substance Abuse and Mental Health Services Administration will 
help address the record number of drug overdose deaths, and the 
spike in mental health issues, we have seen as a result of this 
pandemic. COVID-19 has also put a painful spotlight on how 
racism, sexism, ableism and bigotry hurt so many people in this 
country.
    CDC's recent announcement of a 2-year plan to invest more 
than $2 billion to work on COVID-19-related health disparities 
was an important step towards addressing this reality, and the 
administration's request to dramatically increase the social 
determinants of health program, Congress established at CDC 
last year from 3 million to 153 million will help make sure our 
response to health inequities is truly comprehensive, because 
there are so many challenges we need to tackle head-on.
    For example, Black, American Indian, and Alaska Native 
women are two to three times more likely to die from pregnancy-
related causes than White women. And our overall maternal 
mortality rate is the worst in a developed country, so I am 
glad the administration budget request includes $200 million to 
reduce maternal mortality nationwide, and address disparities, 
an increase of 140 million.
    It also invests in other public health threats that have 
gone too long with too little attention. It doubles funding for 
gun violence prevention research, and establishes a new 100 
million community-based violence intervention program between 
CDC and the Department of Justice. And it increases funding for 
CDC's climate and health program by $100 million dollars.
    Of course, the challenges we face are bigger than any one 
budget. Before this pandemic hit, only half of Americans were 
served by a comprehensive public health system. Our public 
health workforce has lost 56,000 people, and State health 
officials estimated a quarter of their workforce was eligible 
to retire.
    So we have a lot of work ahead, not just to end this 
pandemic, but to build and maintain a public health system 
capable of addressing other pressing public health challenges 
and, of course, preparing for future ones.
    That is why earlier this year I reintroduced the Public 
Health Infrastructure Saves Lives Act, which would finally end 
the dangerous cycle of crisis and complacency in public health 
funding by providing dedicated annual investments in public 
health.
    Director Walensky, Principal Deputy Director Schuchat, I 
look forward to hearing from both of you about how investments 
like this, and like those put forward in the administration's 
budget request, can help families and States across the 
country. And I look forward to working with my colleagues to 
make the investments we need a reality.
    Finally, Dr. Schuchat, I understand you are leaving CDC 
this summer after 30 years with the agency. And I know I speak 
for absolutely everyone on this committee, when I say I am 
grateful, grateful that we have had your expertise and 
leadership, helping to see our Nation through so many public 
health challenges. Thank you for your service, from all of us.
    And with that, I will turn it over to Senator Blunt for his 
remarks.


                     statement of senator roy blunt


    Senator Blunt. Well, thank you, Chair Murray. This is your 
first hearing as the Labor, Health and Human Services chair. I 
certainly look forward to working with you in this role. We 
have had a lot of success working together in the past 6 years 
on this subcommittee, and I am sure we can continue with that 
this year.
    I also want to share your welcome to the CDC director and 
the principal deputy director.
    Dr. Schuchat, thanks for your service to our country, and 
your incredible time at CDC. As I mentioned to you earlier as 
we were visiting, I am sure there is not a single person who 
knows as much about CDC as you do. And there may never be a 
person who knows as much as you do after a 33-year career 
there, and that long list of things that we have worked 
together on in the last several years, but a list that goes 
beyond that.
    So Dr. Walensky, Dr. Schuchat, this is really an important 
opportunity for us to hear about the CDC's budget proposal, and 
understand more about CDC's priorities for this year. I don't 
think there has been a year that CDC got more attention than it 
got in the last year. And so the profile of CDC, the 
understanding of the importance of CDC I think, is at a high 
point.
    I want to recognize the tireless efforts of the CDC staff, 
working across the country during the pandemic. It has been a 
challenging year for all Americans, but particularly for those 
in public health.
    Dr. Walensky, I look forward to hearing your testimony 
today on the administration's fiscal year 2022 Budget. 
Unfortunately, your comments will be limited somewhat by the 
fact that we are really waiting for more information about that 
budget. But from what we do know from the limited details 
released last month, there are several areas of alignment where 
we can work together.
    For example, addressing the needs of the hard-hit public 
health infrastructure, responding to the opioid crisis, which 
has been exacerbated during the pandemic, along with other 
mental health and behavioral health challenges, and continuing 
the Ending the HIV Epidemic Initiative are important to both of 
us.
    These are critical areas that may need even more attention 
as we emerge from the pandemic and gain an understanding of the 
full impact, of the health impact, and the behavioral health 
impact that the pandemic has had.
    It also appears that Global Health Security and 
Preparedness programs will continue as a priority for this 
administration, as it has been for this subcommittee over the 
past 6 years. During that time the subcommittee invested 
heavily in these programs, increasing funding across the 
department of HHS (Department of Health and Human Services) by 
46 percent. Unfortunately, the so-called ``skinny budget'' also 
includes what I believe are excessive areas of increases in 
areas that are extremely partisan. I hope we can set those 
issues aside and invest in areas of common ground that benefit 
all Americans.
    As this subcommittee thinks about the priorities for fiscal 
year 2022, I hope we can spend time learning from the lessons 
of the pandemic.
    In 2020, Congress passed five bipartisan COVID relief 
bills, total more than $16 billion for CDC. During the 
infectious disease pandemic, that funding was critical for 
State and local public health preparedness and response. I 
think we would all agree that our focus on local public health 
in this country is not what it was just a few decades ago, and 
we can do better. Certainly those agencies and State 
governments, generally, have been critical in the vaccine 
distribution and planning.
    Now, the other point to make is that $16 billion is a lot 
of funding to absorb. To put it in perspective that is about 
double your annual budget, or more than $50 million per day for 
the CDC's response efforts last year.
    Pretty hard to spend all of that as effectively as this 
committee would like, but I think we understood that when we 
were sending money to CDC to try to respond to a pandemic that 
was unlike anything we had dealt with before.
    We also really need to incorporate the lessons learned from 
the pandemic, moving forward. It is important we highlight what 
went right, when communities stepped up, when neighbors helped 
neighbors, when innovators came forward to provide novel 
solutions to some of the problems that plagued the pandemic.
    Senator Durbin, and I, and seven of our colleagues went out 
Monday to NIH (National Institutes of Health), and we saw what 
happened there with testing and other things that, clearly, I 
think as we look down the road, those are going to be great 
advantages for us. In Missouri we saw a lot of those unique 
things happen.
    For example, the pandemic brought out innovation with 
Washington University in St. Louis--Dr. Walensky, where you got 
one of your degrees--developing their own COVID test, when 
there was a nationwide shortage of testing, there was a test 
that was developed at the Washington University campus to be 
used on that campus.
    Other resilience came through, other resourcefulness came 
through. Throughout Missouri, independent and rural pharmacists 
would drive 200 miles, some of them, to be sure they had the 
vaccine that would be available at their location the very next 
day, literally, going the extra mile, and the University of 
Missouri developed a cutting-edge technology to track COVID 
variants through wastewater epidemiology.
    So I am proud of Missourians. I am proud of Americans 
across the country, as we reached out to deal with this. We are 
clearly not out of the woods yet. We need to continue to 
understand and learn from the mistakes we made to figure out 
where we fell short or missed the mark.
    Also to understand, frankly, that there were lots of things 
we know now that we did not know then. And looking back at 
decisions where you don't have the same information, or 
anything like it that we did now is a challenge. We need to 
figure out what we learned from that, how we could have found 
out more, earlier. I expect the budget to do just that. I want 
to work with Senator Murray and others on this committee to do 
that.
    But under your leadership Dr. Walensky, I hope the agency 
will make the difficult decisions necessary to make great 
strides toward the enormous opportunity that I think public 
health has at this moment, for the rest of this century. So 
thank you for being with us today.
    Chair, again, let me say, I look forward to your leadership 
and the things that we can do together, and I really appreciate 
where we are now compared to where we were 6 years ago. And I 
think our partnership was an important part of that.
    [The statement follows:]
                Prepared Statement of Senator Roy Blunt
    Thank you, Chair Murray. This is your first hearing as the Labor/
HHS Chair and I look forward to working with you in this role. We have 
had a lot of success the past six years working together on this 
Subcommittee and I'm sure it will continue this year. I also want to 
share your welcome to the CDC Director and the Principal Deputy 
Director.
    Dr. Walensky and Dr. Schuchat, this is an important opportunity for 
us to hear about the CDC's budget proposal and understand more about 
the CDC's priorities for this year. I also want to recognize the 
tireless efforts of the CDC staff working across the country during the 
pandemic. This has been a challenging year for all Americans, but 
especially those who work in public health.
    Dr. Walensky, I look forward to hearing your testimony today on the 
Administration's fiscal year 2022 budget. Unfortunately, I think your 
comments will be limited because we are still waiting for the 
Administration to release their budget. What we do know, from the 
limited details released last month, is that there are several areas of 
alignment where we can work together. For example, addressing the needs 
of the hard hit public health infrastructure; responding to the opioid 
crisis, which has been exacerbated during the pandemic; and continuing 
the Ending the HIV Epidemic initiative, are important to both of us. 
These are critical areas that may need even greater attention as we 
emerge from the pandemic and gain a better understanding of its full 
impact on our nation's public health.
    It also appears that global health security and preparedness 
programs will continue as a priority for this Administration, as it was 
for the Labor/HHS Subcommittee over the past six years. During that 
time, this Subcommittee invested heavily in these programs, increasing 
funding across the Department of Health and Human Services by 46 
percent.
    Unfortunately, the so-called ``skinny'' budget also includes 
excessive increases in areas that are extremely partisan. I hope we can 
set those issues aside and invest in areas of common ground that 
benefit all Americans.
    As this Subcommittee thinks about priorities for fiscal year 2022, 
I hope we will spend time learning from the lessons of the pandemic. In 
2020, Congress passed five bipartisan COVID relief bills, totaling more 
than $16 billion for the CDC. During a global infectious disease 
pandemic, that funding was critical for state and local public health 
preparedness and response; for public health data modernization; and 
for COVID-19 vaccine distribution.
    However, $16 billion is a lot of funding for the CDC to absorb. To 
put it in perspective, that is about double your annual budget or more 
than $50 million per day for the CDC's response efforts last year. Our 
Subcommittee has a responsibility to provide oversight and ensure 
accountability of that funding for the taxpayers.
    We also must incorporate the lessons learned during the pandemic 
moving forward. But as important, we should highlight what went right. 
When communities stepped up. When neighbors helped neighbors. And when 
innovators came forward to provide novel solutions to some of the 
problems that plagued the pandemic.
    And in Missouri, we saw a lot of that.
    For example, the pandemic brought out innovation, with Washington 
University in St. Louis developing their own COVID-19 diagnostic test 
when there was a nationwide testing shortage.
    It brought out resilience and resourcefulness. Throughout Missouri, 
independent and rural pharmacists will drive 200 miles a day to provide 
vaccines to vulnerable and underserved populations. They are literally 
going the extra mile to ensure communities and rural areas across our 
state have access to the vaccine.
    And it brought out ingenuity. The University of Missouri is 
developing cutting-edge technology to track COVID variants through 
wastewater epidemiology.
    I am proud of how Missourians, and Americans across the country, 
stepped up to respond during this crisis.
    But, we are not out of the woods yet. We need to continue to 
understand and learn from the mistakes we made. Figure out where we 
fell short or missed the mark. And I would expect the CDC's fiscal year 
2022 budget to do just that. This is the time to think about a long-
term strategy and not continue to jump from one disease outbreak to the 
next.
    The CDC is facing unprecedented challenges, but the agency is also 
presented with an enormous opportunity to bring public health into the 
21st Century. Under your leadership, Dr. Walensky, I hope the agency 
will make the difficult decisions necessary to make great strides to 
that end. Thank you for being with us today and I look forward to your 
testimony.
    Thank you.
    Senator Murray. Thank you, Senator Blunt. And yes, I do 
look forward to working with you on this as we always have. So 
I appreciate it.
    I want to welcome both of our witnesses again. Thank you 
for being here.
    Dr. Rochelle Walensky is the director of the Centers for 
Disease Control and Prevention, and the administrator of the 
Agency for Toxic Substances and Disease Registry.
    Dr. Anne Schuchat is the principal deputy director of CDC, 
and has twice served as acting director of the agency. Welcome 
to you both.
    Dr. Walensky, we will begin with you for your opening 
remarks.
STATEMENT OF DR. ROCHELLE WALENSKY, DIRECTOR, CENTERS 
            FOR DISEASE CONTROL AND PREVENTION
    Dr. Walensky. Chairman Murray, Ranking Member Blunt, and 
everyone on the committee, I am grateful for the committee's 
support of the CDC.
    I am here today, as you noted, with Dr. Anne Schuchat, 
CDC's principal deputy director. I have enormous gratitude for 
Dr. Schuchat's leadership and contributions over three decades, 
as well as during this very challenging period during our--for 
our country, and for her rock-solid support of me in my 
transition into this role.
    Anne embodies selfless public service, the pinnacle of 
scientific and intellectual standards, and has given her heart 
to our agency and the public health community. I will be 
forever grateful that our paths crossed even for such a short 
period of time.
    The COVID-19 pandemic threw the United States and the world 
into a health, economic, and humanitarian crisis. As the crisis 
unfolded, it put a spotlight on the fragility of our public 
health infrastructure. It illuminated great disparities in 
health outcomes by race and ethnicity; reminding us that--thus 
far--we have failed to address the systemic racism that results 
in poorer health for people of color in the United States.
    I am committed to working with you, the administration, and 
our public health partners to ensure that every lesson from 
this horrible crisis is used to build a better, stronger, 
healthier America.
    I also commit to using our public health expertise and 
experience in partnership with the global community to move the 
world into a safer, healthier future. CDC's fiscal year 2022 
Discretionary Budget Request of $8.7 billion is an increase of 
$1.6 billion over fiscal year 2021--the largest increase CDC 
has received in nearly 20 years.
    The increase is focused on four critical areas: building 
public health infrastructure, reducing health disparities, 
using public health approaches to reduce violence, and 
defeating diseases and epidemics.
    These increases build on the investments made in the COVID-
19 supplementals, and are an important first step in addressing 
deficits in the public health infrastructure. COVID-19 not only 
exposed the vulnerabilities within the United States public 
health infrastructure, but also how underlying chronic 
conditions and lack of access to healthcare, put too many 
Americans at great risk.
    Across the globe we see billions of people without access 
to vaccines and medical care, which means that SARS-CoV-2, its 
variants, and other infectious disease threats will continue to 
threaten us all. Experts had warned for years that a pandemic 
of this scale was coming, and we must expect additional 
diseases to emerge.
    We need to ask ourselves, are we ready? We must have a 
strong infrastructure that can identify and detect outbreaks at 
their source and can take quick action before diseases take 
hold.
    Over the last 12 years, the United States has faced four 
significant emerging infectious disease threats: the H1N1 
influenza pandemic, Ebola, Zika, and COVID-19; we also 
confronted a drug overdose epidemic with nearly 500,000 people 
dying from an opioid-related overdose between 1999 and 2019. 
This increase continued into 2020 and appeared to accelerate 
during the COVID-19 pandemic.
    These experiences show that public health emergencies are 
here to stay. Each of those threats demanded a rapid and unique 
response, but none resulted in a sustained public health 
improvement. Long-term investments in flexible infrastructure 
will save lives and avert economic losses caused by public 
health emergencies and chronic public health problems.
    The fiscal year 2022 request makes initial investments to 
continue public health data modernization, build the public 
health workforce, enhance global health security, and 
strengthen our immunization infrastructure.
    In addition, we are requesting funds to help states and 
communities be climate-ready and prepare to confront new health 
risks, such as those associated with vector-borne diseases. The 
fiscal year 2022 Budget Request also makes specific investments 
in programs that work to improve health equity, such as 
maternal mortality review committees. With these new outlined 
resources in this request, CDC will also significantly expand 
efforts to address the social determinants of health.
    Proposed increases will address public health problems that 
have been exacerbated by this pandemic, such as opioids, 
violence, HIV, and sexually-transmitted diseases.
    We, at CDC, are grateful for your support and look forward 
to working together to build a sustainable and resilient public 
health system that can respond effectively to emerging threats, 
and meet the public health needs of every American. We will 
work tirelessly to ensure the health of this Nation and the 
world.
    Thank you. Dr. Schuchat and I look forward to your 
questions.
    [The statement follows:]
     Prepared Statement of Rochelle P. Walensky, M.D., M.P.H. and 
                          Anne Schuchat, M.D.
    Chairwoman Murray, Ranking Member Blunt, and distinguished members 
of the Committee, it is an honor to appear before you today to discuss 
how investments in the Centers for Disease Control and Prevention (CDC) 
are protecting American's health, now and in the future. I am grateful 
for this opportunity to address this committee, as well as for your 
long-standing and consistent leadership on issues of critical 
importance to the health of Americans, and the world.
    It is my privilege to represent CDC at this hearing. CDC is 
America's health protection agency. For 75 years, CDC has been trusted 
to carry out its mission to protect America's safety, health, and 
security. Even during the unprecedented circumstances of the past year, 
CDC's scientific expertise, determination, selflessness, and innovation 
has helped the agency continue to advance its mission. We work 24/7 to 
prevent illness, save lives, and protect America from threats to our 
health, safety, and security. Addressing infectious diseases and 
pandemics, like COVID-19, is central to our mission. CDC's expertise 
lies in our ability to study emerging pathogens like SARS-CoV-2, to 
understand how they are transmitted, and to translate that knowledge 
into timely action to protect the public's health. CDC identifies and 
mitigates other causes of morbidity and mortality beyond infectious 
diseases, such as environmental and workplace hazards and intentional 
and unintentiona l injuries (such as those from falls, violence, or 
overdose). CDC promotes healthy behaviors, such as exercise and 
nutrition, to prevent chronic diseases such as diabetes and heart 
disease, and to prevent outcomes such as stroke. We promote healthy 
communities by increasing access to nutritious food and safe walking 
and green space.
    By deploying experts on the ground to support our state, Tribal, 
local, territorial and global partners, we translate science into 
implementing guidance that protects individua ls, communities, and 
populations. In our work with other Federal agencies we ensure the safe 
and appropriate use of medical countermeasures, including vaccines, and 
collaborate with the academic and private sector to further our 
understanding of new diseases and problems that affect health.
    The COVID-19 pandemic threw the United States and the world into a 
health, economic, and humanitarian crisis. As the crisis unfolded, it 
put a spotlight on pre-existing weaknesses and gaps that threaten the 
health of Americans. It brought into stark light the great disparities 
in health outcomes by race and ethnicity. We must acknowledge the long-
standing and too often unstated impact that racism has on public 
health. The pandemic has also highlighted our frail public health 
infrastructure, and the way that frailty impacted our ability to 
respond at thenecessary scale and speed.
    Experts had warned for years that a pandemic of this scale was 
coming. Today, we know to expect additional novel and currently rare 
diseases to emerge and gain footing as a result of our changing 
climate, closer interaction with animals, and globalization. Over the 
last 12 years, the United States has faced four significant emerging 
infectious disease threats--the H1N1 influenza pandemic, Ebola, Zika, 
and COVID-19. These experiences show that public health emergencies 
and, specifically, infectious disease threats, are here to stay. While 
urgency demanded rapid and unique responses to each of these threats, 
none resulted in the sustained improvements needed in our nation's 
public health infrastructure. This lack of robust public health 
infrastructure continues to present significant challenges in our 
ongoing fight against COVID-19. In fact, emergencies have resulted in 
the rapid build-up of infrastructure needed to address the emergency, 
then dissolution of that infrastructure, often leaving no sustainable 
infrastructure in place to address the next threat. This lack of robust 
public health infrastructure continues to present significant 
challenges in our ongoing fight to tackle COVID-19.
    World-wide, billions of people do not and will not have immediate 
access to COVID-19 vaccines. Cases will continue to increase, and 
variant COVID-19 strains are likely to emerge, persist, and cause 
outbreaks. As this becomes more common, our public health system at 
home and abroad must be ready with highly sophisticated detection and 
sequencing, combined with a rapid response at the source. The 
unprecedented investments provided to CDC through COVID-19 supplemental 
appropriations have helped our efforts to control COVID-19, and will 
also go a long way toward addressing deficits in the core components of 
the public health infrastructure that has long been ignored. Our 
ability to respond to the next public health crisis will depend on 
whether we invest in a public health system that is highly functional 
on a day-to-day basis and pivots to meet new threats, rather than 
continue our partial defense, which ramps up in response to an urgent 
and often short-term event.
    A resilient public health system can be realized with careful 
planning that builds on the gains made with COVID-19 emergency 
supplementals and incorporates lessons learned as a result of this 
crisis, including reliable, flexible funding. The FY 2022 Discretionary 
Budget Request for CDC and ATSDR includes a total funding request of 
$8.7 billion, an increase of $1.6 billion over FY 2021 Enacted. This is 
the largest increase in budget authority for CDC in nearly two decades 
and defends Americans' health in four ways: 1) building public health 
infrastructure, 2) reducing health disparities, 3) using public health 
approaches to reduce violence, and 4) defeating other diseases and 
epidemics.
    First, building the public health infrastructure. CDC's FY 2022 
request prioritizes foundational funding to rebuild the public health 
infrastructure needed to safeguard the Nation's health and economic 
security. Drawing on lessons learned, as well as the latest information 
and technologies, CDC will begin to address long-standing 
vulnerabilities in the U.S. public health network by training a larger 
cadre of experts who can deploy and support public health efforts, and 
building capacity to detect and respond to emerging global biologica l 
threats.
    Public health action is driven by data. Earlier improvements in our 
systems for collecting information after other public health 
emergencies, including Ebola and EVALI, facilitated exchange of health 
information, linking local, state, and federal public health systems 
with healthcare systems and the public. With investments in public 
health data modernization in the FYs 2020 and 2021 appropriations and 
the COVID-19 supplementals, CDC increased the scale and speed of these 
systems during the COVID-19 response to protect people who are at risk 
for severe illness (such as older Americans), those with chronic 
medical conditions, and those from racial and ethnic minorities. These 
advancements must be applied across the public health system and at all 
levels of government. The funds requested in FY 2022 will be used to 
continue building a modern disease surveillance system at CDC, which 
will catalyze a multi-sectoral, comprehensive, and cohesive approach to 
documenting evidence, using state-of-the-art technology and analytical 
tools. CDC will continue working diligently to ensure its research and 
data are of the highest quality and are disseminated nationally to 
inform decision-making throughout the public health system, while 
supporting advances in data systems at all levels.
    The COVID-19 pandemic made clear the role that CDC labs and public 
health labs across the nation play in conducting critical surveillance 
and responding to outbreaks and emerging threats. CDC and state 
laboratories were required to flex and surge during peak periods of 
illness, far beyond routine clinical testing. In FY 2019, CDC was only 
able to meet 50% of state and local health departments' stated needs 
for epidemiology and laboratory capacity funding, with personnel 
support being the biggest unfunded need, followed by equipment and 
supplies.
    The FY 2022 request will foster innovation, collaboration with the 
clinical system, and a commitment to quality. Improving technologies at 
the state and local levels would enable public health labs to quickly 
utilize and scale up essential laboratory analyses. In a post-COVID-19 
world, investments to maintain and improve laboratories will help 
prevent the failures we experienced while trying to address COVID-19.
    The U.S. needs a workforce of qualified public health professionals 
who will prepare for, respond to, and prevent public health crises. 
Physicians working for states often earn less than$150,000 per year. 
This is after having taken on medical school debt of $200,000 on 
average. The FY 2022 request includes an increase to build a diverse 
and culturally competent workforce who can rapidly develop innovative 
approaches in surveillance and detection, risk communications, 
laboratory science, data systems, and disease containment. With this 
funding, CDC will support critical training programs for public health 
professionals that develop strategic and systems thinking, data 
science, communication, and policy evaluation. Existing cooperative 
agreement mechanisms will be leveraged to support public health jobs 
that meet current needs and attract new personnel to work in 
underserved and rural areas.
    Addressing gaps in capacity across levels of government to detect 
and respond to outbreaks while maintaining and surging in other problem 
areas requires investments to be disease-agnostic and flexible. With FY 
2022 funding, CDC will provide support to health departments to meet 
national quality standards, conduct performance improvement activities, 
increase communication and collaboration across the public health 
system, and reshape health departments to meet changing conditions and 
needs. Funding will help health departments strengthen their abilities 
to effectively respond to a range of public health threats, such as 
COVID-19, and build capacities that do not currently exist.
    COVID-19 is a sobering reminder that a disease threat anywhere is a 
disease threat everywhere. Or as stated by WHO: no one is safe unless 
everyone is safe. We cannot adequately protect American lives and the 
U.S. economy without addressing global disease threats wherever they 
may arise. CDC's strategic investments in global health security are 
critical to U.S. health security by building sustainable global 
capacity to prevent, detect, and respond to emerging infectious disease 
threats. CDC works in more than 60 countries on more than 150 projects 
and is a key implementing agency for the U.S. Government's leadership 
role in the Global Health Security Agenda. With additional resources 
requested in FY 2022, CDC will build on existing partnerships with 
Ministries of Health, public health agencies, infectious disease 
research institutions, and international organizations to strengthen 
global laboratory capacity for early disease detection, enhance disease 
surveillance for accurate data to drive decision making, and foster 
effective regional and global coordination.
    Next, I'd like to talk about reducing health disparities. The 
disparities seen over the past year among communities of color were not 
a result of COVID-19. In fact, the pandemic illuminated inequities that 
have existed for generations and revealed a known, unaddressed, and 
serious public health threat: racism. The well-being of our entire 
nation will be compromised as long as we fail to address this.
    Racism is not just discrimination against one group based on the 
color of their skin or their race or ethnicity, but the structural 
barriers that impact racial and ethnic groups differently to influence 
where a person lives, where they work, where their children play, and 
where they worship and gather in community. The social determinants of 
health (SDOH)--such as high-quality education, stable and fulfilling 
employment opportunities, safe and affordable housing, access to 
healthful foods, commercial tobacco-free policies, and safe green 
spaces for physical activity--are critical drivers of health inequities 
in this country. CDC is building the evidence-base for collaborative 
approaches to SDOH through community accelerator planning and expanding 
a network of community health workers to develop a sustainable 
infrastructure to improve health equity. CDC's FY 2022 budget request 
includes an increase of $150 million to use a social determinants of 
health approach to improve health equity and health disparities in 
racial and ethnic minority communities and other disproportionately 
affected communities around the country.
    This budget directly responds to health disparities recorded in our 
public health data. For example, about 700 women die each year in the 
U.S. as a result of pregnancy or delivery complications, and American 
Indian, Alaska Native, and Black women are two to three times more 
likely to die than White women. Data show that about 2/3 of these 
deaths may be preventable. Children from lower-income and racial and 
ethnic minority households experience a disparate, increased risk for 
lead exposure.
    Achieving health equity is central to addressing the HIV epidemic. 
The U.S. government spends $20 billion per year in direct health 
expenditures for HIV care and treatment. An estimated 1.2 million 
persons have HIV and approximately 15% are unaware they have it. With 
recent advancements in antiretroviral therapy and biomedical 
advancements in HIV prevention, such as pre-exposure prophylaxis 
(PrEP), along with effective care and treatment, we have the tools to 
end the HIV epidemic. An increased investment requested in FY 2022 for 
the Ending the HIV Epidemic (EHE) initiative will enable CDC to advance 
the four key strategies needed to end the epidemic in the 57 EHE focus 
jurisdictions. In addition, CDC will address health equity in the 
entire HIV prevention portfolio, test innovation in service delivery 
models to increase access to prevention services, use syndemic 
approaches to broaden reach to key populations and create efficiencies, 
and strengthen engagement of grassroots community-based organizations 
in implementing EHE initiative.
    Third, the budget request also addresses the public health epidemic 
of violence. We know too well how this epidemic permanently alters the 
lives of its victims and their families and puts enormous strain on our 
communities and local economies. Increases in CDC's FY 2022 budget 
request will help address violence through public health approaches, 
which include improving reporting systems that provide the data needed 
to understand and address violent deaths and injuries in the United 
States.
    And fourth, we must defeat other diseases and epidemics. Just as 
racism underlies a number of public health issues, climate issues 
underlie a number of infectious diseases and have significant health 
impacts. Climate changes are associated with changes in the 
geographical range of mosquitos, ticks, and other disease vectors. 
Climate-related events impact a wide range of health outcomes. Some of 
the most significant climate-related events--such as heat waves, 
floods, droughts, and extreme storms--affect everyone. These climate 
events compromise our access to clean air, clean water, and a reliable 
food supply. In addition, climate events can impact the presence of 
allergens and vectors, like ticks and mosquitoes, and the subsequent 
health outcomes that can result from these changes in exposures. We 
know that a changing climate can intensify existing public health 
threats, and that new health threats will emerge: unequally distributed 
risks (age, economic resources, location), increased respiratory and 
cardiovascular disease, injuries and premature deaths related to 
extreme weather events, changing prevalence and geography of foodborne 
and waterborne illnesses and other infectious diseases, and threats to 
mental health as people feel less safe.
    CDC works with states, cities, and tribes to apply the best climate 
science available, predicting health impacts, and preparing public 
health programs to protect their communities. To do this, CDC developed 
the Building Resilience Against Climate Effects (BRACE) framework to 
help communities prepare for the health effects of climate change by 
anticipating climate impacts, assessing vulnerabilities, projecting 
disease burden, assessing public health interventions, developing 
adaptation plans, and evaluating the impact and quality of activities. 
With the requested increase in FY 2022, we can further expand the 
Climate and Health Program by providing a larger number of health 
departments with technical assistance and funding and finding 
innovative ways to protect health via climate adaptations. As with 
every other public health threat, we will inform our effort by building 
and examining systems that collect data on conditions related to 
climate, including asthma and vector-borne diseases, and coordinate 
programs and communication that improve health outcomes.
    The opioid epidemic has shattered families, claimed lives, and 
ravaged communities across the Nation--and the COVID-19 pandemic has 
only deepened this crisis. Addressing the current overdose epidemic 
remains a priority for CDC. The Administration's strategy brings 
together surveillance, prevention, treatment, recovery, law 
enforcement, interdiction, and source-country efforts to address the 
continuum of challenges facing this country due to drug use. CDC's role 
is to prevent drug-related harms and overdose deaths.
    The additional funding requested in FY 2022 to address the opioid 
epidemic will enable CDC to provide more funding to all States, 
Territories, and select cities/counties. CDC will prioritize support to 
collect and report real-time, robust overdose mortality data and to 
move from data to action, building upon the work of the Overdose Data 
to Action (OD2A) program. To do so, CDC will partner with funded 
jurisdictions to implement surveillance strategies that include 
contextual information alongside data, as well as increase surveillance 
capabilities for polysubstance use and emerging substance threats such 
as stimulants. The additional resources requested will enable CDC to 
support investments in prevention efforts for people put at highest 
risk, for example, supporting risk reduction and access to medications 
for opioid use disorder for people transitioning from alternate 
residence (jail/prison, treatment facility, homeless shelter). CDC will 
also address infectious disease consequences, such as viral hepatitis, 
of the opioid epidemic.
    I look forward to working together to address both the immediate 
challenges ahead in our fight against COVID-19, as well as the 
weaknesses in the public health infrastructure that left our country 
vulnerable to this pandemic. We at CDC are grateful for your support. 
We will continue to work tirelessly to ensure the health of this nation 
and the world. Together, we can build a sustainable and resilient 
public health system that can respond effectively to emerging threats 
and also to ongoing public health needs of every American.
    Senator Murray. Thank you very much. And we will now begin 
a round of 5-minute questions of our witnesses. And I do ask my 
colleagues to keep track of the clock, and if you can stay 
within those 5 minutes.
    Dr. Walensky, COVID has really exposed the importance of 
having a robust and well-funded public system before a crisis 
strikes; which is why I said it is so important that we make 
sustained investments in public health infrastructure and 
workforce a priority, including in CDC.
    Over the last year Congress provided more than $8 billion 
to support public health data modernization and expand the 
public health workforce through six COVID supplemental bills. 
What more needs to be done to sustain our public health 
infrastructure and our workforce, so we don't lose gains when 
the funding runs out?
    Dr. Walensky. Thank you so much, Senator, for that 
question.

                     INFRASTRUCTURE AFTER EMERGENCY

    You have highlighted that we have had challenges with our 
public health workforce, indeed. We have 56,000--we are down 
56,000 jobs just in the last decade. We need to train and 
upskill that workforce, in addition to bolster that workforce 
over the years ahead. We need to keep them trained because the 
science continues to evolve, we need training in 
bioinformatics, in genomic epidemiology, and all of that needs 
to live in our State and localities so that they are well 
informed and trained over time, not just in creating a 
workforce, but in keeping them skilled.
    We need to do data modernization, as you noted, an initial 
investment in data modernization. When I spoke early on in my 
tenure to State and local health officials, I was hearing about 
faxes of test results for COVID, and then manual data entry of 
those results, and that those results were not received with 
racial and ethnic data in them. So we had no way of tracking 
how we were doing with racial and ethnic diversity across this 
pandemic.
    And then we need to build our public health labs. We don't 
have--did not have the capacity to do genomic sequencing in all 
of these labs, we have had to scale that up. And there is many 
more, and in the infrastructure in the machinery, in the 
technology that we need to put and deploy, not just at CDC, so 
we are ready at CDC for this, but also in our public health and 
localities.
    Senator Murray. So I am curious; if we had had all that in 
place before this pandemic, how would have things been 
different?
    Dr. Walensky. I think they would have been extraordinarily 
different. We would have had contact tracers on the ground 
ready to go. We would have been able to identify cases quickly. 
We would have been able to see single, single outbreaks than in 
clusters that we might have been able to pin down to contact 
trace and not have outbreaks expand. I think we would not have 
seen the diverse--the racial discrepancy and what happened with 
this pandemic that----
    Senator Murray. Because we would have known prior and made 
more of a focus?
    Dr. Walensky. Exactly. We would have been able to find it. 
I think the testing, the inability of our public health systems 
to be able to conduct these tests in massive scale up, did not 
allow us to find the disease where it was, certainly, we had 
not done genomic sequencing until January, we did not know 
anything about the variants that were circulating here. There 
are numerable ways that this could have gone better if we had 
had a more robust public health infrastructure across all of 
those domains.
    Senator Murray. Thank you. That is a lot to think about. We 
should all remember. We have now seen a lot of encouraging 
progress against COVID over the last several months, and as 
more people get vaccinated, and case counts, and 
hospitalization, deaths are falling.

                          PANDEMIC TRAJECTORY

    Dr. Walensky, speak to us about where we are in this fight. 
How the funds Congress has provided have helped? And what we 
need to focus on next to bring this crisis to an end?
    Dr. Walensky. Today, I am cautiously optimistic. We have, 
in the last several weeks, seen a stark downward trend in 
cases. The last 2 days we have had case rates that have been 
less than 20,000 per day. Our case rates now are around 30,000 
per day, on average, for the last seven days; death rates, we 
have been seeing at around 500 a day, still too high, but the 
lowest we have seen since this pandemic began.
    We have over 86 percent of Americans over the age of 65 who 
have received their first dose of vaccine. And just yesterday--
today we have now 60 percent of Americans over the age of 18 
having received their first dose of vaccine. I think that we 
have had extraordinary progress, and we have needed the 
resources to get here.
    Senator Murray. So what do we need to focus on next?
    Dr. Walensky. Certainly, a sustainable public health 
infrastructure that is not necessarily just tied to one 
disease, to one outbreak, to one disaster. We need longitudinal 
money so that we are able to have sustainable infrastructure 
that is up to date with the times. We need to focus on our 
racial and ethnic minority groups.
    They were previously under-vaccinated. We have made a huge 
amount of strides just in the last 2 weeks in getting those 
groups vaccinated. But we need to--and we need to get into the 
communities. We need to have a public health infrastructure 
that looks like the communities that they serve, and that 
serves those communities a lot.
    Senator Murray. Should we be worried about the variants?
    Dr. Walensky. I think we would be remiss to say that we are 
out of the woods. This pandemic, this virus has sent us too 
many curve balls to say that we--too early to declare victory. 
Certainly, with the virus circulating in other parts of the 
world that is in high degree that it gives the opportunity for 
more variants to emerge, so I still am--it is among the things 
that keeps me up at night. But right now the variants that we 
see here and we are doing a lot of sequencing now, demonstrate 
that our current vaccines are working.
    Senator Murray. Okay. Thank you very much.
    Senator Blunt.
    Senator Blunt. Thank you, Chair.

                 CHANGES TO MASK GUIDANCE AND REOPENING

    Let's talk about the guidance that came out last week on 
masks for people who have been fully vaccinated. There seems to 
be some concern about how that would be applied. I listened 
this morning to the CEO (Chief Executive Officer) at Target, 
who was on CNBC, and he said that--they had followed all the 
CDC guidance up till now, which meant until last week people in 
their stores had a mask on, this week people in their stores 
don't have a mask on unless they want to have a mask on.
    In the Capitol, the attending physician, who has been the 
person we look to, put out guidance last week that said: on the 
Capitol grounds you would not need to wear a mask if you were 
vaccinated, but the Speaker decided that she was going to keep 
the mask mandate in place for the House until everyone was 
vaccinated.
    What are you seeing there? And what kind of further 
direction have you been able to give? I know just yesterday the 
President had his mask on part of the time, largely based, it 
seemed to me, on what other people around him were comfortable 
with. But give us some more thoughts on that.
    Dr. Walensky. Thank you, Senator, for that question. I 
think the first thing that we should do is celebrate where we 
are in this pandemic, that we can even be having this 
conversation, that cases are now down to 19,000 a day, reported 
this morning. As those cases are coming down, people are 
longing to understand what this means next.
    How do we open up again? How do we take our masks off? With 
those cases coming down, and now the fact that every American 
who wants a vaccine has access to one, if you have not texted, 
text your zipcode to GETVAX (438829), you can find vaccine 
wherever you are in the country. Five pharmacies will show up 
so you can get the vaccine.
    So we now have cases coming down and access to vaccines for 
everyone who wants one. Just in the last 2 weeks, we had 
scientific data emerge in three important areas, (1) that the 
vaccines are working in the public the way they worked in the 
clinical trials. That doesn't always happen, but it happened 
here. And we had one of the largest studies published on Friday 
in the MMWR (Morbidity and Mortality Weekly Report).
    (2) That the vaccines are working against the variants we 
have here circulating in the United States. There have been 
data, neutralizing data that demonstrates against B.1.1.7, 
against B.1.351. These vaccines are working.
    And (3), something that was not studied in the clinical 
trials is, can you--if you were to get infection with SARS-CoV-
2 and were vaccinated, could you give it to somebody else? Were 
you silently able to spread it? Those data were not covered in 
the clinical trials, but now data have emerged again, that have 
demonstrated, even if you were to get infected during post-
vaccination, that you cannot give it to anyone else.
    Senator Blunt. Yes.
    Dr. Walensky. So that scientific data was enough for us to 
move forward. People had said we moved too slowly, people have 
said we have moved too fast, we moved at the speed that the 
science gave us.
    Senator Blunt. Well, I think that is right. I do think on 
the last topic if we--not evaluating, whether we could have 
made that decision quicker. But I do think that decision that 
you don't have to wear a mask once you have been fully 
vaccinated, will encourage people to get vaccinated. I think 
the fact that that is out there is good. I hope we got it out 
there as quick as you were comfortable having it out there.

                           RACIAL DISPARITIES

    On your comments about racial health disparities which, of 
course, I am not for racial health disparities, and more than 
happy to look at that; what about the other obvious health 
disparities, like how low income, health disparities regardless 
of race, or rural health disparities? Are we just going to 
focus on racial health disparities, and leave those others 
behind? Or why were those the disparities you specifically 
mentioned in your comments?
    Dr. Walensky. We have seen a lot of data on racial health 
disparities in this pandemic. But, Senator, you are absolutely 
right. Twenty percent of Americans live in rural areas. As we 
talk about social determinants of health, this is not just 
racial--on racial lines, this is urban and rural.
    We just, yesterday, had an MMWR come out that demonstrated 
that rural Americans were getting vaccinated around 39 percent, 
while non-rural counties were at 46 percent. So we are intent, 
and our values are going to be, to have public health reach all 
areas, all Americans.
    Senator Blunt. I am glad to hear that. My last question 
here before I run out of time would be on drug overdose deaths. 
You know, we saw this committee work really hard on this topic 
for about four straight years, and we felt we were making some 
real progress. And I think we were, the numbers were going down 
every year, but in 2020 we had the highest number to date of 
drug overdose deaths. Just comment briefly on that before my 
time is up here.
    Dr. Walensky. It is tragic. Before being here, I was an 
infectious disease doc on the wards at Mass General, and while 
we were talking about deaths, the people on the wards were also 
talking about chronic infections, endocarditis, epidural 
abscesses, leaving young people paralyzed.
    So we were making some progress, and this pandemic hindered 
that progress. And we, again, need to address this issue.
    Senator Blunt. Thank you.
    Senator Murray. Thank you.
    Senator Durbin.
    Senator Durbin. Thank you, Madam Chairman.
    And Dr. Schuchat, let me join the chorus. Thank you for 33 
years of remarkable service. I have a question for you in a 
minute, but I wanted to start with a little different approach.

                            LESSONS LEARNED

    And let me say that I think this pandemic has not broken 
us, but it has taught us where our system is broken, and there 
are many areas we need to look at seriously. If you take a look 
at the public health scorecard and try to find an objective 
measure, the one that I return to frequently is the fact that 
the United States has less than 5 percent--has less than 5 
percent of the world's population, yet 20 percent of the COVID-
19 infections and deaths. And that tells us we can improve 
dramatically.
    Where did we shine in this effort? Certainly vaccines, the 
quick response as we learned again this week, and the visit to 
the NIH, was because we were prepared, and we had the science 
ready, and we had good fortune in identifying the culprit, and 
in devising an effective strategy to go after it with vaccines.
    I would also add that the Warp Speed program appears to 
have dedicated and invested funds in a dramatic way at a time 
when it was very important. And I think that accelerated the 
availability of the mass vaccines, and I give the Biden 
administration credit for administering them, and distributing. 
So those are the positive sides.
    But one of the messages learned, that I learned out at NIH, 
was now let's get honest about this. We not only have to bring 
this pandemic to an end, we have to prepare for the next 
pandemic, which may be 5 years away or 15 years away. We don't 
know. But history tells us there will be another one. And the 
question is: will we be ready for it?
    The CDC is going to play a critical role in this. And the 
first question I have to ask is to Dr. Schuchat. After 33 years 
of observing this agency and its role in the American scene 
when it comes to public health, there is a fear that it has 
been politicized in the last 4 years, or maybe even before. 
That now public health issues are so political, with the 
division on whether to get a vaccine, or a vaccination or not, 
seems to break out on party lines and political lines. We have 
reached a new stage.
    What is your thinking? And having observed and worked with 
the CDC all these years, about this politicization--if that is 
the word--of public health?
    Dr. Schuchat. Thank you so much for your comments and your 
question. The viruses don't vote, and the pandemic has really 
told us that everyone is vulnerable, everyone in America, and 
everyone around the world. And CDC is a science-based agency, 
and we lead from science. We are data-driven, and we work 
together with State and local partners who reflect the values 
of their communities. So I think that focusing on the science 
and the service mission of the agency is what we need to do.
    Senator Durbin. Have you noticed any change, recent change 
in terms of the political image of CDC, which tries to be 
apolitical?
    Dr. Schuchat. You know, this pandemic has been so difficult 
for--you know, for the Nation, I think for all of us in public 
health, and certainly for our colleagues around the world. The 
messaging has really been difficult, you know, very conflicting 
messages that left Americans confused.
    And so I think we are committed to clear, honest 
communication of what we know, and what we don't know, and what 
we recommend people do. So I do think the messaging environment 
during this pandemic has been really tough.
    Senator Durbin. I would agree with that.

                              GUN VIOLENCE

    Dr. Walensky, I am worried about gun violence. I believe it 
is a public health issue because I represent the State of 
Illinois and the City of Chicago. And we have the equivalent of 
a mass shooting every weekend in Chicago. It is a disaster in 
terms of its impact on the lives of many people, and the life 
of the city.
    You have a proposal to make a-hundred-million-dollar 
investment through the CDC, in community-based violence 
intervention, working with neighborhood organizations and 
hospitals to deliver services. I recommend to you a program, 
which we started in Chicago called the HEAL Initiative. I will 
send you some information on it. But I would like for you to 
say a few words about what you anticipate that $100 million is 
going to be used for.
    Dr. Walensky. Thank you, Senator. Our intent here is to 
look for areas in high-violence cities, where we can accumulate 
data, we can get accurate information, where we have actionable 
interventions to prevent all areas of violence, community 
violence, domestic violence, suicide, to increase public health 
using those resources in areas that have been highly impacted. 
We want actionable interventions for prevention.
    Senator Durbin. Thank you.

                          CHILD MENTAL HEALTH

    Madam Chair, I would just say in closing, you are in a 
unique position being on the Authorizing and Appropriating 
Committee, but one element I hope we don't overlook, and I know 
you feel sensitive to this as I do, is the need in schools to 
have access to counselors, mental health counselors, and maybe 
traditional school nurses, so that any public health effort, 
which should focus first on our children, has the wherewithal 
to do that effectively. I find that we have allowed that to 
lapse in many areas of my State.
    Senator Murray. Thank you, Senator Durbin.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Chairwoman Murray, and 
Ranking Member Blunt for having this hearing. And I certainly 
appreciate the speakers that are here today.
    And Dr. Walensky, I appreciate being able to visit with you 
last week to discuss your work as director at the CDC. I 
thought we had a very good conversation, I certainly admire the 
work that you have done.
    And Dr. Schuchat, I certainly admire the work that you have 
done over the past many years.

                        RURAL HEALTH DISPARITIES

    I will be brief with my questions, but one thing that I am 
really concerned about is rural healthcare. I had the 
opportunity this past Saturday morning to visit with David 
Ready. He is a pharmacist in a town in Mississippi, Monticello, 
Mississippi; that has less than 1,500 people, and the concerns 
that he has about them being able to get their medicines. The 
reimbursements they get, because they are so small, they don't 
buy in bulk.
    So those are things that I am sure that we will be having 
other conversations about. But the COVID-19 pandemic has 
highlighted numerous aspects, obviously, of our healthcare 
system that need improvements. One of them that we all 
recognize is the disparities of Americans living in rural 
health areas.
    Addressing health infrastructure in rural areas is a 
serious concern, and as I said, one of my top priorities, and 
while the CDC has undertaken efforts to address that, there is 
no entity within the CDC tasked specifically with this work. 
And that is concerning to me.
    I believe establishing a new Office of Rural Health within 
the Center of Disease Control would be an important way to 
support rural communities through the end of this pandemic, and 
to prepare for any other future public health crises that we 
could be faced with.
    And, you know, I just envision this office to be empowered 
to look across CDC programs, to ensure the work of the agency 
is properly addressing the health needs of the 57 million 
Americans who live in rural communities.
    Director Walensky, how strongly do you support establishing 
an official Office of Rural Health within the CDC? And how can 
we work together to get this done, if you see that the way that 
I see this?
    Dr. Walensky. Thank you, Senator. As you noted, we have 20 
percent of Americans, 57 million Americans living in rural 
areas. Part of the deep need for investment in a public health 
infrastructure is to develop a workforce that looks like the 
community, that is from these communities, that knows how to 
access and reach these communities, which is exactly one of the 
challenges that has that has occurred during this pandemic. And 
one of the reasons we had a differential distribution of 
vaccines between rural and non-rural communities.
    We also know that there are other issues, outside of COVID, 
where we have learned from COVID, such as telehealth. We had a 
previous MMWR that demonstrated, ironically, that telehealth 
was not reaching rural communities. And that is, in fact, one 
of the areas that we should be using telehealth. So why was it 
not reaching their rural communities? CDC is investigating this 
just by virtue of the fact that they have had several MMWRs in 
the last 2 weeks examining these issues.
    So as part of the public health infrastructure and the 
disease agnostic infrastructure that works on labs, that works 
on workforce that works on data; we are invested in urban 
communities as well as rural communities.

                          FUNDING FLEXIBILITY

    Senator Hyde-Smith. And I think a lot of that is broadband 
issues as well, that we have to get addressed. But I understand 
the CDC has a highly categorical manner for providing funding 
to State health departments, with most funding tightly tied to 
specific diseases, or specific purposes. And I am concerned 
that restricting CDC money to specified activities prevents 
States from being able to address issues that vary from State 
to State, because all of them are different, and it makes it 
difficult to respond efficiently to emerging challenges like 
COVID-19.
    And I have always been big on flexibility because the 
States really know where their needs are, and I believe greater 
flexibility on funding might allow States to better target 
resources. So I just wanted to mention that to you, of the need 
for flexibility there, that we sure saw that our hands were 
tied in some cases during COVID. So I just wanted to address 
that with you.
    Dr. Walensky. I would just echo your thoughts and say, yes. 
That one of the things that has been challenging for us at CDC 
is the line items that have to go to X or Y, when in fact what 
we need is the infrastructure, the disease agnostic 
infrastructure, so that when we see community--this community 
needs this, but they may both need to establish a lab, but one 
needs broadband and the other needs a genomic sequencer that 
we--it is flexible enough to be able to make sure that each of 
the communities can scale up for what they need. Absolutely.
    Senator Hyde-Smith. Thank you. That is very encouraging. 
Thank you.
    Dr. Walensky. Thank you.
    Senator Murray. Senator Reed.
    Senator Reed. Well, thank you, Madam Chairwoman; and thank 
you Director for your extraordinary work.

                        317 IMMUNIZATION PROGRAM

    I have been now working and trying to bolster the Section 
317 Immunization Program for many years. And as we recognize 
this year, because of the pandemic, there has been significant 
increases in vaccination funding going out, and building an 
infrastructure. But I don't want to take our eyes off the long-
term need for Section 317 programs to sustain improvements that 
have been made in terms of routine immunization, which must be 
given.
    And so will the CDC be requesting an increase in funding 
for the 317 Program this year, Madam Director?
    Dr. Walensky. I am going to let Dr. Anne Schuchat take that 
question.
    Dr. Schuchat. I want to thank you for your long-time 
support for the immunization needs of the Nation, and the 
incredible progress we have been able to make, particularly 
among children. COVID, the pandemic, has really highlighted 
that we are not where we needed to be with adults. And that was 
part of the slow start that we had in terms of getting--you 
know, having the scale up of vaccination.
    So there is a lot more work to do to catch up for the 
vaccines that were not given during the pandemic, in children, 
and to strengthen our infrastructure for adults going forward. 
And so that work is part of the priorities for the agency.
    Senator Reed. Thank you very much.

                           SUICIDE PREVENTION

    Dr. Walensky, this is not the first time I think this 
thought has been bridged, but the suicide epidemic has been 
startling across the country related to the pandemic, and 
perhaps related to other factors, and CDC has released some 
startling statistics recently about suicide. And I know that 
the CDC has launched some new suicide prevention efforts over 
the last couple of years, and let me you to continue to do 
that. But I understand only a handful of grant applications 
were able to be funded. And one of those that were not funded 
was from my State, but we were not alone. And what are you 
intending to do with respect to the overall suicide epidemic 
and also the more robust funding for prevention?
    Dr. Walensky. Thank you, Senator. This is such a 
challenging area it was--we had scale-up of mental health 
challenges before the pandemic, right? So these were issues 
that we really needed to tackle before the pandemic. And we saw 
during the pandemic that these have only gotten worse, among 
our youth, among our middle aged, we have seen challenges even 
since the pandemic began.
    So part of our resources that we are requesting are to 
scale up these efforts. Again, we need surveillance data. We 
need to understand how much this is a challenge. How many 
people are presenting to the emergency room. We need toolkits 
to deliver to States, to physicians, organizations, so that 
they can--they are empowered as to how to prevent it. And then 
we need actionable implementation that we can do for prevention 
in areas of mental health.

                       LEAD POISONING PREVENTION

    Senator Reed. Thank you. One final topic is lead exposure, 
which I have been working on through my responsibilities on the 
Banking Committee, and also the Appropriations Subcommittee on 
Housing and Urban Development, over the last year rates of 
screening for lead poisoning have decreased, obviously, as you 
know, movement and these types of activities have been 
curtailed. And then I think the statistics, although it would 
probably be very dubious coming out of the last year because of 
all these other factors, but it is a continuing problem.
    And right now the CDC's Lead Poisoning Prevention Program 
is at a high mark of $39 million. But we know more funding is 
needed, and we also know that this initiative 
disproportionately impacts lower-income communities because of 
the housing circumstances, generally.
    And I would hope that the President's CDC budget will 
prioritize this work, keep increasing funding and focus. I 
would note, he is going after the lead pipes, which I applaud. 
But in many respects, particularly in older communities like 
mine, the issue is not lead pipes, it is housing and lead 
paint, and it is a whole series of issues.
    Dr. Walensky. Thank you. I think this raises a very similar 
point, as was previously raised by Senator Hyde-Smith, that 
each community needs individual things to improve the health of 
their community, which is why the public infrastructure 
flexibility, the funding to be able to get the resources that 
you need in individual communities.
    One will be--you know, we need resources for broadband, but 
one will be, we need resources for lead. And as you note we, 
again, had an MMWR that demonstrated exactly what you said. 
Screening for lead this past year has gone down. We know we 
have missed lead toxicity that we really need to make up for.
    Senator Reed. Thank you very much.
    Thank you, Madam Chairwoman.
    Senator Murray. Thank you.
    Senator Moran.
    Senator Kennedy.
    Senator Kennedy. Thank you. Madam Chair.
    Madam Director, thank you for being here today; I know how 
busy you are. I have been in my office listening to some of the 
testimony of both of you. And I am a little uncertain about 
some of the answers, which is probably a shortcoming on my 
part.

                             MASK GUIDANCE

    Madam Director, could you, in one minute, summarize for me 
what the recommendations are today from your agency about 
wearing masks?
    Dr. Walensky. Absolutely. First of all, can I just say, 
thank you for your YouTube video, for promoting vaccines, which 
I just adored.
    Senator Kennedy. Did you like my singing?
    Dr. Walensky. Yes, I did. Thank you very much for doing 
that.
    Senator Kennedy. You are under oath, now, madam.
    [Laughter.]
    Dr. Walensky. Yes, I did--even so, I did.
    Senator Kennedy. Thank you for that.
    Dr. Walensky. Last Thursday, we released guidance that 
demonstrated for an individual who is able--who is fully 
vaccinated and not immunocompromised, that they are able to 
safely unmask with the exceptions--certain exceptions, of 
course, in travel corridors, healthcare settings, that if you 
are an individual you can safely unmask if you are fully 
vaccinated.
    Senator Kennedy. Inside and outside?
    Dr. Walensky. Inside and outside.
    Senator Kennedy. Okay. What role do the State regulations 
play with respect to that?
    Dr. Walensky. We are working now to update all areas of 
guidance, but here is what is really, I think, important to 
understand. We are not a homogeneous United States. We have 
counties that have less than 20 percent vaccinated.
    Senator Kennedy. Yes, ma'am. But I don't want to get too 
off, off the question here. If I walk over to the House of 
Representatives, do I have to wear a mask?
    Dr. Walensky. Those are locally-driven policies, but we 
felt that it was important for the science to--for us to convey 
the science of what is safe for individuals.
    Senator Kennedy. Well, I am trying to understand the CDC 
recommendations, and I appreciate it. Based on the CDC 
recommendations, if I walk over to the House, are you 
recommending I wear a mask?
    Dr. Walensky. If you are--if you are by yourself walking 
over to the House and you are fully vaccinated?
    Senator Kennedy. No, ma'am. Once I am over there. I am 
vaccinated. Once I am over there and I am talking to some of my 
colleagues?
    Dr. Walensky. We have really encouraged that the policies 
of mask-wearing be locally driven. And the reason for that is 
because every community, every county, has different rates of 
disease and different rates of vaccination. And that is really 
what----
    Senator Kennedy. What is different about the House? Do you 
know?
    Dr. Walensky. I don't actively--I don't know the rate of 
vaccination around the Capitol, nor the rate of disease around 
the Capitol off the top of my head.
    Senator Kennedy. Okay. What about airplanes?
    Dr. Walensky. What is the policy on airplanes? Currently, 
the policy on airplanes is to wear a mask.
    Senator Kennedy. Okay. And why is it different on an 
airplane as opposed to a restaurant?
    Dr. Walensky. So the CDC provides guidance for what is safe 
to do. The Federal policy is obviously an interagency policy 
that we need to look at across different agencies. What I will 
say though, is that there is very little choice when you board 
an airplane as to----
    Senator Kennedy. Right.
    Dr. Walensky  [continuing]. Who is going to be sitting next 
to you, who is around you. And also, airplanes may be a place 
where we have more variants, because of the travel from 
international places.

                             VIRUS ORIGINS

    Senator Kennedy. Okay; last question. What, in your 
opinion, was the origin of the virus?
    Dr. Walensky. This has been studied by the WHO----
    Senator Kennedy. Ma'am, I am asking your opinion.
    Dr. Walensky. I don't believe I have seen enough data, 
individual data, for me to be able to comment on that.
    Senator Kennedy. What are the possibilities?
    Dr. Walensky. Certainly, the possibility is that most 
coronaviruses that we know of are of origin from--that have 
infected the population, SARS-CoV-1, MERS, generally come from 
an animal origin, and----
    Senator Kennedy. Are there any other possibilities?
    Dr. Walensky. Certainly, a lab-based origin is one 
possibility.
    Senator Kennedy. Okay. Is the United States funding gain-
of-function research?
    Dr. Walensky. Not to my knowledge.
    Senator Kennedy. Okay. Can you give an answer to that for 
me, and let us know, let the committee know?
    Dr. Walensky. Dr. Fauci would be the one who knows best, 
and he testified last week----
    Senator Kennedy. Dr. Fauci seems confused. I am asking--
with all due respect--I am asking you to get us that 
information. Where throughout the world, including, but not 
limited to the United States of America, are we doing research 
on these viruses to make them contagious in order to study 
them? That is what I mean by gain-of-function.
    Dr. Walensky. I understand. I understand. We certainly can 
have our staff look into this. I don't know that we have access 
to labs across the world, just the ones that are funded here in 
the U.S.
    Senator Kennedy. Yes. But you are the Head of the CDC. I 
bet if you--I bet that you get your phone calls returned.
    Dr. Walensky. Okay.
    Senator Kennedy. Would you get us that information?
    Dr. Walensky. I would be happy to give you the information 
to the best of my ability.
    Senator Kennedy. Okay. And I am going to do long--a 
complete album of my singing. I will send you--I will send you 
a courtesy----
    Dr. Walensky. Would you sign that, please?
    Senator Kennedy. Sure. Thank you. Thank you, both, for 
being here.
    Thank you, Madam Chair.
    Senator Murray. Senator Baldwin.
    Senator Baldwin. Thank you. Madam Chair.

                          MASKS IN WORKPLACES

    I want to pursue a similar line of questioning that we just 
heard from Senator Kennedy, with regard to masking guidance. 
And when I reflect from the period of time when the pandemic 
was first identified, the Department of Labor and the agency 
charged with occupational safety and health, did not issue any 
sort of emergency temporary standard with regard to workplaces 
relating to this pandemic.
    And, frankly, while there has been much work done on that 
in this new administration, we don't have one yet, and so I am 
just delighted by the progress we are seeing. Generally, I see 
that light at the end of the tunnel, getting brighter, and 
brighter, and brighter, and certainly the CDC's updated mask 
guidance for those who are vaccinated is a reflection of that 
progress.
    But I am concerned about the impact of this guidance on 
workers, and particularly those who work in crowded conditions, 
such as meat-packing facilities, where we have seen horrendous 
outbreaks in the past year.
    So, Dr. Walensky, I am wondering when we can expect perhaps 
more detailed guidance for workplaces, such as meat-packing 
plants, and other crowded facilities where there is going to be 
a mix of vaccinated and unvaccinated workers? And how that is 
going to interact with the very recent CDC guidance on mask use 
for those who are vaccinated? What should workplaces be doing 
right now?
    Dr. Walensky. Thank you so much, Senator Baldwin. The meat-
packing situation was really, really difficult, so many, people 
affected and lives lost. And a real challenge for the Nation to 
react to that.
    Updating guidance for workplaces, including the higher-risk 
ones is a high priority for us that we are actively working on. 
As you know, the initial individual guidance came out last 
week, but updating guidance for particular settings is 
critical. Our National Institute of Occupational Safety and 
Health is working closely with OSHA around getting the best 
science to the Department of Labor who has regulatory 
authority, but we are at CDC, updating our guidance for the 
particular settings in light of the newer science.
    Senator Baldwin. I appreciate that.

                      PUBLIC HEALTH COMMUNICATION

    I want to ask a question of you, Dr. Schuchat, about the 
importance of communication in public health. Early in the 
pandemic, again, we had to get out a lot of information on what 
COVID-19 is, how it is spread, what precautions people can 
take. And, likewise, now we are in the vaccination phase, and 
we have to communicate about its safety, efficacy, 
availability, et cetera.
    Last year, I wrote the CDC requesting that they provide 
information on the spread of COVID-19 in Hmong language. The 
CDC later updated their material, which was extremely helpful 
for Wisconsin's vibrant Hmong community. But we also need to 
make sure that we are doing exactly the same to make 
information on the COVID-19 vaccine accessible and available 
for all communities.
    So, Dr. Schuchat, how is the CDC using what it learned from 
sharing information about the spread of COVID-19 to communicate 
the importance of getting vaccinated, to those who have limited 
English proficiency? And will the CDC be making information on 
the COVID-19 vaccine, and how to get vaccinated available in 
more languages?
    Dr. Schuchat. Yes. Thank you so much for that set of 
questions. I think that communication has never been more 
important, nor more difficult than the past year, and reaching 
people with limited English proficiency has been really 
important.
    We have a toolkit available in 34 languages, and our 
vaccine information, including our V-safe, the little app that 
helps people follow side effects after getting vaccinated, is 
available in multiple languages. But it is not just what we 
say, it is how we say it, and who says it; and so one of our 
strategies is working through trusted messengers and partners 
of the community, from the community, who work with groups day 
in and day out, and so part of our strategy is funding of 
jurisdictions for them to have community-based groups really 
get that message out in ways that are accessible.
    These are really important issues, as we know. You know, 
back to the meat-packing outbreaks, we had people speaking 
multiple languages in very close quarters at risk for spread, 
but also not necessarily knowing who they could trust in what 
they should do. So we clearly want to get the vaccine 
information to them.
    Another thing I would mention is the partnership that CDC 
and the administration has had with HRSA (Health Resources and 
Services Administration), around the federally-qualified health 
programs, because they have--the federally-qualified health 
centers have a real concentration of patients served with 
limited English proficiency, in both mobile clinics for 
vaccination, and through community clinicians--community 
vaccination sites. They have been able to reach those groups.
    Senator Baldwin. And Senator, if I am might add, just real 
briefly. One of the things that would be really helpful for us, 
is working with those industries to encourage employers to get 
their employees vaccinated, that time off, paid time off, to 
ensure that they--when they returned to work they are 
vaccinated.
    Senator Murray. Thank you, Senator.
    Senator Braun.
    Senator Braun. Thank you, Madam Chair.

                MASK GUIDANCE FOR VACCINATED INDIVIDUALS

    Dr. Walensky, I am glad that the recent ruling was made 
that if you are vaccinated, you don't need to wear a mask. I 
think it was getting very confusing for not only getting more 
people vaccinated because they were saying, well, why should I 
get vaccinated if I still have to wear a mask? So thank you for 
that.
    But I do have a question. I know that on March 29, the 
President was criticizing some governors about removing mask 
mandates. And of course that now has changed. And I think the 
reason is what I have just said. But what about, since the 
science now, and the guidance is clear, what about local mayors 
and governors that are not following the science, when that has 
kind of been ballyhooed as the thing to do. I believed in that 
from the get-go as well, especially when the tools were very 
uncertain, distancing and all that stuff, made sense. And I 
thought you were silly not to abide by it.
    What about now? For the places that are--I think there is a 
liberation feeling out there, and thank goodness for the Warp 
Speed, and getting the vaccines in the arms. Is this 
unnecessary for governors and mayors across the country to 
still keep a mask mandate in place?
    Dr. Walensky. Thank you for that question, Senator. We 
released guidance on Thursday that said for individuals, if you 
are vaccinated, fully vaccinated, you can take off your mask 
with several exceptions. One of the things I think that is 
really key in this is to recognize that we are not a 
homogeneous country.
    That there are some areas that--some counties that still 
have less than 20 percent of people vaccinated. There are some 
counties that still have greater than a hundred cases per 
hundred thousand in a seven-day period of time. And so I 
actually think, as I look at the map, a very heterogeneous map 
of how we are doing with cases, how we are doing with 
vaccinations, the decisions about whether to take off a mask 
mandate will have to be made at the local level, have to be 
made at the community level.
    There are still some communities who are suffering. We know 
African-Americans lost 2.9 years of life compared to White 
Americans losing 0.8 years of life. And they are probably the 
communities that got access to vaccines last. We are working on 
that. We have had extraordinary improvements in our access to--
in our racial and ethnic minorities having access to vaccines. 
But I do think that these need to be made at the local and 
community level for exactly that reason.
    Senator Braun. Do you think it will be confusing though, 
even for those places that have lagged in getting their 
citizens vaccinated to see that there is not that incentive in 
place, even in the places that have been slower to do it, that 
would be an encouragement. If they see people without a mask 
and they say, well, they are vaccinated. I want to get one.
    Dr. Walensky. I think it would be really amazing if our new 
guidance got more people vaccinated, and was an incentive for 
more people to get vaccinated. But I don't make CDC guidance, 
my whole agency does not make CDC guidance based on what it 
will help people do. We have to do it based on the disease that 
is out there, the access to vaccines, and based on the science 
that has emerged.
    I really am hopeful that that will help to incentivize 
people to get vaccinated, but that was not the reason for our 
guidance.

                             COVID IN INDIA

    Senator Braun. Okay. Another subject, since we are kind of 
at least ebbing into a situation, it looks like here in the 
U.S., other countries, some places it is still running rampant 
like India. When do we turn the focus? And I think we have been 
lucky that vaccinations have come this quickly, but 
therapeutics would seem to be that final defense for anyone 
that did not have a vaccination available. And now for the few 
cases that could still slip through the cracks to where it is 
impacted with so much data, such a small portion of the 
population, disproportionately, and horrifically, elderly 
predisposed with other conditions.

                           COVID THERAPEUTICS

    When do we start turning our attention to helping them once 
they get it? Because we are going to still have cases, 
depending on variants, how strong they are, to where the 
emphasis goes to therapeutics, and not vaccinations, especially 
for places where the vaccine is generally working, but you 
still want to have tools to help those who get it?
    Dr. Walensky. Absolutely. And I know--first of all, I think 
we are--you know, we are working now, we have said, if anyone 
is not safe, then no one is safe. We really do need to make 
sure that we have resources to other places, if variants emerge 
they will come to our shores. So we have to be able to do that.
    I also know that NIH has invested in making sure that we 
have therapeutics. One of the first things that we had when I 
was rounding on the wards last May, was Remdesivir. And that 
was the first sign of an antiviral.
    We don't have anything really that we can give quickly over 
the--you know, by prescription to outpatients. Right now we are 
relying on monoclonal antibodies. They are hard, they are 
clumsy, they take a lot of resources, and they are expensive. 
And so I do believe that we need, in this next phase, after we 
get the majority of Americans vaccinated, we do need to turn to 
antivirals that are able to be easily administered in an 
outpatient setting.
    Senator Braun. And a final comment. I think that is going 
to be important because we don't know how much variants will 
become an issue. And at some point when we have generally 
tamped it down, I think it is incumbent on us to put focus on 
how to help those that end up getting it, especially that are 
so predisposed with bad outcomes. Thank you.
    Dr. Walensky. Thank you.
    Senator Murray. Thank you.
    Senator Manchin.
    Senator Manchin. Okay. Thank you, Madam Chairwoman. 
Appreciate it very much. And I want to thank all of you for 
being here.
    Dr. Schuchat, first of all, thank you for your service, 
many, many years of service. And I appreciate very much, what 
you have done. And my first question would go to you because 
you probably have the historical knowledge of how we got to 
where we are.

                    VULNERABLE PUBLIC HEALTH SYSTEM

    Over the last decade, the United States has lost over 
50,000 public health jobs. And during that time we have faced 
the H1N1 flu outbreak, Ebola, Zika, and now COVID, within the 
last 5 years alone, West Virginia has lost nearly 30 percent of 
our public health workforce. One thing we know from this 
pandemic is that we were not prepared. While we have been able 
to hire temporary public health workers in the last year, as 
these positions they were not permanent, and are at risk of 
disappearing after the public emergency, health emergency is 
over.
    So can you speak to how we became so vulnerable and fell 
behind the curve in our ability to respond to this pandemic, 
and how can we keep it from not happening again? I know you 
have all touched on it, but I just cannot believe we were 
this--we were this unprepared.
    Dr. Schuchat. Yes. I think the state of our preparedness 
was a real tragedy. And part of that relates to the public 
health infrastructure over and over, we invest in response to a 
crisis, but in ways that haven't provided sustainable capacity 
at that frontline where the problems happen, so----
    Senator Manchin. But these decisions made higher up within, 
whoever the administration may have been, whether they were 
Republican or Democrat. Was it made at that level? Or was it 
made at the Head of the CDC?
    Dr. Schuchat. The biggest funding increases we have gotten 
have been emergency funds from Congress that, you know, happily 
supported response for H1N1, and Ebola, and Zika, and COVID. 
But the dollars that were there day in and day out to provide 
reliable jobs for the local public health workforce were not 
there. And whether it was State budgets or Federal budgets 
that, you know, you cited the statistics of the job loss.
    Beyond that, the jobs were not the same anymore. You know, 
we talked about the data. Our data systems have really not kept 
up with the times. We have very fragmented data systems that 
have not been modernized.
    Senator Manchin. And my time--my time is limited, and I 
want to ask Dr. Walensky this question.
    But on this Dr. Schuchat, what type of time basis would you 
say that we should be looking at for funding? I mean, to have 
confidence in the funding, permanent funding, over what, a 5-
year, a 10-year period? So it is consistent you know what you 
can do and be prepared?
    Dr. Schuchat. You know, I think the approach that was taken 
for NIH to strengthen their capacity for vital biomedical 
research is what needs to happen for the vital public health 
infrastructure in the country, where it is not a feast and 
famine.
    Senator Manchin. Sure.
    Dr. Schuchat. But that local, State, and Federals can plan.
    Senator Manchin. And now will be the time to do it. If we 
are ever going to do it, we should do it now, since it is all 
very fresh in what we have been able to endure.

                        OPIOIDS IN WEST VIRGINIA

    Dr. Walensky, as you are aware, we are facing an epidemic 
within the pandemic, West Virginia is ground zero for the drug 
epidemic, with the highest rate of drug overdose deaths in the 
country. To make matters worse, 2020 was the worst year yet 
with over 90,000 deaths, and we saw at least 47 percent 
increase in the State of West Virginia with overdose deaths. So 
what resources is CDC providing to States to combat the 
epidemic?
    Dr. Walensky. Thank you, Senator, for that question.
    Senator Manchin. And also, I would have made--and the 
second part of that would be: in working on helping--what CDC 
is--are working on helping increasing the testing for viral 
hepatitis and HIV? We have had a tremendous--horrendous 
situation with that.
    Dr. Walensky. I can tell you, just before coming here, I 
spoke to one of my infectious disease colleagues in West 
Virginia, and she was telling me that they have opened neonatal 
detox units, I understand, that it is unbelievable.
    Senator Manchin. Unbelievable, unbelievable.
    Dr. Walensky. It is unbelievable. And so we know that we 
need to tackle this. We need to counter this. We need accurate 
data. We need interventions that can--and we need resources to 
be able to invest in Opioid Naloxone Programs that are reaching 
the community. Community health workers that can do the 
outreach to talk to people and intervene at the local level 
where these are happening, we need toolkits, we need 
information, and mental health support services to intervene.

                     AMERICAN MEDICAL MANUFACTURING

    Senator Manchin. Right. My time is running out. I want to 
ask you that one other thing that--we produce very little of 
the things that we basically needed for medicine, penicillin, 
do you think penicillin should be produced in America? Do you 
think doxycycline should be produced, an antibiotic in America? 
And if so, what should we do in order to do that? Or stockpile 
strategically for our own protection?
    Dr. Walensky. I think we need to have a public health 
infrastructure and a pipeline that allows us to respond to 
pandemics, and to epidemics, and to infectious threats.
    Senator Manchin. Do we have any manufacturers that are 
producing these in America?
    Dr. Walensky. There are limited manufacturers producing 
penicillin, that I can talk to. Because, in fact, we have had 
penicillin shortages, penicillin has gotten extraordinarily 
expensive. And in fact, some colleagues of mine have once said, 
it should be cheaper than the pipe--than the tubing it runs 
through. And in fact, it is not.
    Senator Manchin. Should the CDC basically--I mean, your 
recommendation would be for production. We should be producing 
these in America. You know, we need to have something from a 
professional, like yourself, to get back to producing things in 
American, and not depending on supply chains.
    Dr. Walensky. So one of the things I can just mention for 
penicillin specifically, is it is particularly hard given the 
allergies related to penicillin. It is actually, particularly 
hard to do. There are limited plants that make penicillin. But 
your point is well taken.
    Senator Manchin. Thank you.
    Thank you, Madam Chair.
    Senator Murray. Thank you.
    Senator Moran.
    Senator Moran. Chairwoman, thank you. Thank you and Senator 
Blunt for this hearing. And welcome to our two Doctors, thank 
you for service.

                 COLLABORATION ON BIODEFENSE FACILITIES

    I have four questions I am going to try to accomplish in 5 
minutes. Let me first highlight something that is occurring in 
my home State. Kansas will soon be the home to the National Bio 
and Agro-Defense Facility. It is a $1.25 billion research 
facility, nearing completion. Its mission is to--or the 
facility is to protect U.S. livestock from foreign animal 
diseases, including zoonotic diseases that can pose significant 
threats to human health. NBAF (National Bio and Agro-Defense 
Facility) will be the first bio containment facility in the 
U.S. where there is a BSL4 laboratory, which zoonotic pathogens 
for which there no treatments, currently, exist.
    NBAF is operated by the U.S. Department of Agriculture with 
cooperation from the Department of Homeland Security, right, so 
truly going to be as a state-of-the-art facility, COVID-19, 
which possibly is a zoonotic disease, has only highlighted the 
importance for the U.S. to invest in this type of research.
    Are you engaged with USDA (U.S. Department of Agriculture) 
or Homeland Security on future research that could be conducted 
at NBAF in regard to the zoonotic diseases? What kind of 
research NBAF would be able to provide you with benefits in 
your mission of protecting human life?
    Dr. Schuchat. Let me just say that what we call One Health, 
the idea of human and animal health, and the environment has 
been a global issue for preparedness and response. We have seen 
so many terrible diseases emerge from the animals, and we have 
not been sufficiently ready for them.
    Whether we are dealing with the genetic sequencing of 
strains, and whether the animals' strains have adapted better 
to humans, or research into containment interventions, it is 
really important. And so our principle of collaboration between 
Health and Human Services, and the Department of Agriculture, 
and Department of Homeland Security is very important.
    I can say that the CDC and USDA both have oversight over 
select agents that, you know, are evaluated in those BSL4 
facilities. And we work very closely with them to make sure 
that animal health is protected, and that human health is 
protected, and laboratories that are sending these pathogens do 
so safely without risk to the surrounding community.
    As to exactly where we are with collaboration, I think we 
will have to get back to you, but it's a--congratulations on 
the facility. And I think we will look forward to working 
together.
    Senator Moran. This is a post\1/1\1 development, and 
designed to replace the Plum Island and the research done there 
on a new advanced laboratory. I would welcome the opportunity 
to connect you and the folks at either Agriculture or--and 
those in Kansas as well.

                      INTERNATIONAL COLLABORATION

    What, if anything, is steps that CDC, or perhaps broader, 
the Federal Government should do to bring China into this world 
of helping us combat diseases, the spread of viruses? Is there 
any opportunity for us to get better information, in any way 
that we can insist, encourage or demand that China behave 
differently than what they did, after the arrival of this--the 
evidence of this disease in China?
    Dr. Walensky. I think that we are all a global community at 
this point, and that when there is a threat anywhere, there is 
a threat everywhere. And so when it comes to our health, when 
it comes to science, it is helpful to have these connections we 
have in office, our regional office in China, where we exchange 
scientific information. So I think around the global community, 
it is important that we--that we convey scientific inference.
    Senator Moran. What is your evaluation of what cooperation 
occurred between China and the United States in regard to 
COVID-19? And has anything changed to increase or decrease that 
cooperation now?
    Dr. Walensky. The WHO (World Health Organisation) has done 
a study--has numerous interactions to evaluate this. My 
understanding is that there is another phase of that study 
underway. And I think that that is really critically important, 
because quite honestly, and in my review of that study, and 
many have spent many hours reviewing this study--these studies, 
there was not a lot of transparency in line-level data that is 
able--that we are able to use to interpret.
    Senator Moran. Dr. Walensky, there is probably a longer 
answer than that. And maybe we can have that when you and I 
have a chance to have a conversation.
    A couple of things in the 30 seconds I have left. I would 
highlight that you and I have had this conversation, Dr. 
Frieden encouraged me in regard to the Global Health Security 
Program, and I have tried to be an advocate for that program in 
this appropriations subcommittee, with some success.
    And I just would--I am interested now, you don't have to 
answer this question in the lack of time that I have for you to 
do so, but I would love an answer that tells me how I should 
prioritize. You have said it, what happens elsewhere matters to 
us, and absolutely the truth and we have known that for a long 
time, but how do we prioritize now with the consequences of 
this pandemic in the United States?
    How do we prioritize the appropriations that will go to 
programs that are outside the United States, that are 
protecting us as well as citizens of the world, as compared to 
things that need to be done domestically, which are 
significant? So I would love to have a broader discussion about 
where those priorities should lie.

                      LEARNING LESSONS FROM COVID

    And finally, I would indicate, I am reading a book, which I 
do regularly, The Premonition, and I don't know whether you 
have read it, but I am two-thirds the way through. It is not 
terribly derogatory, but not terribly complimentary of the CDC. 
And I would welcome any suggestions you have of what the 
takeaway should be for the CDC, or if it is a book that is 
worthy of learning something from.
    Dr. Walensky. Thank you, Senator. I would be happy to 
engage in those conversations. I have not read The Premonition, 
although I know of it, and I know many people who are in it. 
And what I will say is, there are many lessons that we can 
learn, some things that we have to do better at the CDC, and 
some things that we have to do better as a country, and 
investing in multiyear public health infrastructure.
    I think among the comments in the book that I am familiar 
with was one of the issues that I heard firsthand, you know, 
labs receiving results by fax and, you know, people working in 
data entry to do that. That is not a public health 
infrastructure of the future. It is not a way to respond to a 
pandemic.
    And so I think the lessons to be learned from the book, are 
yes, we have to understand where things could have gone better 
at CDC, and we need multi-year infrastructure resources to make 
sure that we have, you know, work force, and data, and labs up 
to snuff to tackle whatever they need to tackle in the future.
    Senator Moran. It seems well written to me, and by a 
credible author. And I would encourage you to learn from it, as 
I am trying to.
    Madam Chairwoman, the last comment I would make is. One of 
the things, my takeaway is the failure for CDC to authorize 
testing early on in circumstances in which it appears to me, 
testing should have been occurring.
    Senator Murray. Thank you.
    Senator Shaheen.
    Senator Shaheen. Thank you, Madam Chairman. And thank you, 
Dr. Walensky, and Dr. Schuchat, for your service to the 
country, and for being here this morning.

                        OPIOIDS IN NEW HAMPSHIRE

    Dr. Walensky, I very much appreciated our conversation 
earlier this week. And one of the things we talked about is the 
continuing challenge of the opioid epidemic that we are facing 
in this country. New Hampshire, like West Virginia, has been 
very hard hit. We are one of the 10 States in the country that 
has been hardest hit by the epidemic.
    And I was pleased that Congress provided some new 
flexibility to deal with the epidemic last year, by including 
meth and cocaine as part of the drugs that could be included in 
programs to address opioid--the opioid epidemic. But can you 
talk--one of the things we discussed was the challenge that I 
have heard from providers in New Hampshire that we don't have a 
response for those overdosing on meth in the same way that we 
have Narcan for those who have overdosed on opioids.
    Can you talk about what the CDC is doing to approach this 
issue and what kind of help you might have available for States 
like New Hampshire?

                        COMMUNITY HEALTH WORKERS

    Dr. Walensky. Thank you, Senator. You know, I am thinking 
back to, sort of, 6 months ago and what we needed to do when we 
knew that one of our patients had relapsed, and how we get them 
into care. And it was our community health workers that knew 
where to find them. They knew where they were getting their 
drugs, and they knew where to find them, and to say, somebody 
cares for you, and brought them back.
    And that, I think, is what we need in our public health 
infrastructure. We need the community workers who live in the 
community, who are from the community to make those 
interventions, to find the people. And that is really among the 
things that I think this public health infrastructure is going 
to be able to do. Certainly, we don't have something like 
Naloxone for meth overdose and that, you know, is unfortunate 
right now, and we need to address that.
    And then quite honestly, we have statistics of the 
overdoses and the lethal overdoses. They are terrible. And yet 
we also have statistics of, you know, all these 
hospitalizations that are happening among young people that I 
was taking care of just 6 months ago, 30-year-olds getting 
their second valve replacement.
    So this is something that we have to tackle, and it is not 
just that we have to tackle it with Narcan in a given 
community. We have to tackle it community by community, because 
there are all different kinds of communities, and we need the 
workers to be able to do so.
    Senator Shaheen. Well, thank you. I hope that--and I know 
this is not a CDC issue--but I hope that you will weigh in, if 
you have the opportunity, with the administration on the 
importance of the set-aside funding for States like New 
Hampshire that have been hardest hit, because that has allowed 
us to up a real statewide response to the epidemic.

                           PFAS CONTAMINATION

    I want to go on to PFAS, which is an emerging contaminant 
until we get the EPA (Environmental Protection Agency) to 
designate it as something else. But it is one that we have seen 
very directly in New Hampshire, and especially appreciate the 
response from the Agency for Toxic Substances and Disease 
Registry, which has been so helpful in undertaking a 
comprehensive health study in New Hampshire, Portsmouth, and 
Pease former Air Force base, have been one of the sites 
designated.
    But one of the things we have learned is that too many of 
our members of the medical community don't have any idea about 
PFAS. They don't know what it is. They don't know how to 
respond to it. They don't know whether testing is appropriate 
or not.
    And I worked with Chairman Murray and Ranking Member Blunt 
last year to fund a grant program to help educate our 
physicians. And I am very interested in how that unfolds, and 
the work that the CDC might be doing to help an ATSDR (Agency 
for Toxic Substances and Disease Registry) to educate our 
medical community.
    So I don't know if either of you can speak to that on the 
update on where that effort stands.
    Dr. Schuchat. This has been such a complex and challenging 
area, and I really appreciate the leadership that you have 
shown, and the----
    Senator Shaheen. Thank you.
    Dr. Schuchat [continuing]. Support you have given, and also 
the advocacy for us to learn what we need to learn so that 
people who have been exposed, and the clinicians that they see 
know what to do to get a result, and then not know what it 
means and what you are supposed to do about it is challenging. 
So we really are incredibly grateful for the resources that are 
letting us begin to pave the way to get those answers.
    I don't have specifics on the results of studies yet, but I 
know it is a very high priority for ATSDR and the leadership 
here.
    Senator Shaheen. And do you know that, at one point in the 
last year, there was a suggestion that there was a connection 
between exposure to PFAS and severity of COVID-19. Do we have 
any more information about that?
    Dr. Schuchat. You know, I know that question came up and 
that we were looking into it. I don't believe we have a final. 
But we can get back to you if we do.
    Senator Shaheen. That would be great. Thank you. If you 
could just let me know, either way, what we know about that, I 
would appreciate it. Thank you.
    Thank you, Madam Chair.
    Senator Murray. Senator Capito.
    Senator Capito. Thank you, Madam Chair. And thank you for 
our witnesses today. Both of, Dr. Walensky and Dr. Schuchat, 
and I wish you the best in your--we won't call it retirement--
in your repurposing. How about that? Wherever you may land?
    Let me ask specifically. Senator Shaheen and Senator 
Manchin mentioned, obviously, the overdose rates in the State 
of West Virginia, so I won't go back through that. But I am 
concerned.

                          HIV IN WEST VIRGINIA

    Dr. Walensky, I know you have a focus on ending the HIV 
epidemic. I know this is in your academic career as well. You 
mentioned it in the President's budget. West Virginia received 
a grant in the Integrated Viral Health--or Hepatitis, excuse 
me, Surveillance targeted funds to help us address certain 
areas, hotspots, I guess you would call them. But we are not--
we are not in ending HIV epidemic focused jurisdiction, nor any 
of our counties. And in your testimony, you state that 
increased funding in the budget is for four key strategies in 
the focus areas, but not to increase the amount of focus areas.
    So my question is, I think we need to be a focus area 
because we have some of the highest incidence. And how do you 
expand that footprint? Or, how can you help me with that?
    Dr. Walensky. Thank you, Senator. As I think you noted, my 
20-year career prior to January 20 was in doing exactly that. 
And I was really encouraged by ending the--the mission to end 
the HIV epidemic, really through a diagnosis, prevention, 
treatment and response. And, you know, when the initial tranche 
of HIV and the HIV epidemic money went out, it was to areas 
with the highest numbers, with truly a multi-year plan to 
expand to other areas that we needed to really curb things in 
the areas with the highest numbers.
    Take some of the lessons that we learned and expand to some 
of the other areas. And so I have a vision, and hope that we 
will be able to do that in the--in the years ahead, and to 
continue that expansion.
    Senator Capito. Thank you. Thank you. So expansion into 
areas such as ours, I think that would be welcome. I would make 
note that in the initial disbursement of the vaccine, our State 
of West Virginia did an incredible job working with our public 
health infrastructure. But I think one of the lessons that we 
learned, and that I hope this becomes part of a manual to 
address future issues, is public health infrastructure cannot 
do this by themselves, not to what we saw at the--the breadth 
of what we saw.
    So what happened? We had volunteers, we had county city 
governments, and we had our National Guard. And so I would 
encourage you while, I think, increasing our public health 
infrastructure is absolutely essential. I think growing those 
partnerships could be even more essential because there is a 
roadmap there to success. And so I just put that on your radar 
screen, as you are--as you are looking to expand.

                        MASK POLICY JURISDICTION

    One thing I would like to ask, and Senator Blunt and I were 
in the Oval Office when the announcement was made with the 
President that we were going to lift the mask mandate. And I 
cannot tell you how joyful we all were as we ripped our masks 
off and had a great meeting after that.
    But there is confusion still. And, you know, if we are 
going to get more people vaccinated, which is the ultimate goal 
all the way down through the age levels, we cannot have this 
confusion, because it is just: should I get my child 
vaccinated? You know, should I--how old can my child be to get 
vaccinated?
    Does my child need to wear a mask at school? Who is the 
ultimate decider here? Is that the CDC? Is it the President? Is 
the governor? Is it the NIH? I mean, there is just too much 
coming at young families in particular, I think, to be able to 
feel, number one; that their child is safe, and they are doing 
the right thing for them to go to school. But also to get rid 
of that, I would say not anti-vaxxer, but vaccine hesitation. I 
think that is a large part of the people that are left as yet 
to be vaccinated. So how would you respond to that question?
    Dr. Walensky. Thank you. The guidance that we put out on 
Thursday was individual guidance for people who are fully 
vaccinated can take off their masks.
    Senator Capito. Right. Right.

             COVID-19 VACCINES FOR CHILDREN AND ADOLESCENTS

    Dr. Walensky. I have--or I was pleased actually the day 
before that the FDA (Food and Drug Administration) had 
authorized and the CDC had recommended vaccination with Pfizer 
vaccine for individuals as young as 12 years old, that is now 
recommended. And my 16-year-old has been vaccinated, and we 
have a lot of community workers out there encouraging 
vaccination of youth.
    And, in fact, over 600,000 people between the ages of 12 
and 15 have been vaccinated just in this last week. In terms of 
guidance, the CDC provides science-based, evidence-based 
guidance to anybody who is the consumer of said guidance, 
whether it be industries, jurisdictions, importantly the 
country is not uniform. And so I think you really do need to 
interpret our guidance in the context of what is happening in 
your community. And that is really important in the context of 
a transmissible agent.
    Why is that important? Because the virus is going to be an 
opportunist, if you have a county that has low vaccination 
rates and high rates of disease, that county may interpret our 
guidance differently than a county that has high vaccination 
rates, and low incidence of disease.
    So we really do have to do this at the local level because, 
in fact, the virus will--where there is less vaccination, the 
virus will emerge.
    Senator Capito. So what do you say to the under-12 
population, elementary school? The parents of those children 
who have low vaccination rates, which is probably close to 
nothing, they have low incident of infection and, you know, all 
the studies that show the younger generation is not as affected 
as older and even more senior. What do you--what do you tell 
them? Listen to your governor? Listen to your school Board?
    Dr. Walensky. So what we would say is, vaccines are coming 
for youth. We are hopeful to have, they are doing dose de-
escalation studies now down to 9 years old, soon thereafter 
down to six, soon thereafter down to three, and then down to 6 
months. So we are working towards getting a vaccine that will 
be available for all people.
    Senator Capito. So when would that be?
    Dr. Walensky. Well, some of it depends on how much disease 
is out there in the community. So we cannot exactly predict, 
but we are hoping to have more available in late fall, and by 
the end of the year but through dose de-escalation studies.
    And then of course, I think that the guidance that we have 
had for schools has actually demonstrated that even in the 
absence of vaccinations schools can be a very safe place, given 
the guidance that we have. We have recommended that schools not 
change anything for this school year, because it will be hard 
for our youth to get fully vaccinated before the end of this 
school year. We will be updating that soon. And then given that 
guidance it will be--there will be policies at the local and 
jurisdictional levels.
    Senator Capito. Well, I still think it--I mean, I know you 
probably would agree that it is a bit confusing to folks all 
around the country who have children in school. I would just--
just be as clear, and concise, and definitive, when this 
science comes forward and more vaccinations come forward, 
because I think it really is--it is really difficult, I think, 
for parents to decide how to do the right thing. Thank you.
    Senator Murray. Thank you. That ends our first round of 
questions. And I will start a second round for any Senators who 
wish to ask additional questions.

                     RACIAL AND ETHNIC DISPARITIES

    And Dr. Walensky, I will begin with you. You know, the 
pandemics deadly impact on communities of color show we do have 
a long way to go to address systemic racism and health 
inequities. Black and Latino populations are receiving 
vaccinations at disproportionally low rates, even as some of 
our recent polls suggest both groups are more likely than White 
people to say they want to get vaccinated.
    And according to the CDC website data on race and ethnicity 
is available for just over half of vaccinated people. How is 
CDC working to improve vaccination access and collect more data 
on these demographic issues that we need to see in front of us?
    Dr. Walensky. Thank you very much for that question, 
because we are working hard. We have placed our community 
vaccination centers, or mass vaccination centers in areas that 
have high Social Vulnerability Index, they are doing an 
extraordinarily good job in getting our minority communities.
    Our Federal Retail Pharmacy Program sites were selected 
initially, in collaboration with the State, to see how we could 
get vaccine to the most vulnerable communities, to Black and 
Brown communities. And just this last 2 weeks, Federal Retail 
Pharmacy Programs, 47 percent of vaccines that they delivered 
were to minority communities.
    And then our federally-qualified healthcare centers, in 
collaboration with HRSA, we have been delivering to people who 
are migrant workers, to people in rural communities, and people 
who have less access. One of the things we have been able to do 
to improve our race and ethnicity data, and this has been 
challenging because some people are electing not to report it, 
is to use HIPAA (Health Insurance Portability and 
Accountability Act)-compliant electronic case reporting, so 
that we can use cases--or this is on the case level, not the 
vaccine level, but looking at cases and then match it medical 
records via Cerner, via Epic, to be able to get case-level 
data.
    We are working really hard with the counties to get both 
racial and ethnic minority data at the case and disease level, 
but then also the vaccination level. And this is, again, one of 
the areas where data has--you know, our data infrastructure has 
not been robust enough to deliver this to us in real time.
    Senator Murray. Are you seeing any political ideology plan 
to this decision to get vaccinated?

                           VACCINE HESITANCY

    Dr. Walensky. This is a personal choice. I think once we 
start saying: this group wants vaccine, this group doesn't, 
then we start telling the wrong message. When I was taking care 
of patients with HIV, and I was told--the new patient I had to 
deliver a new diagnosis. They always said to me, you deliver 
the diagnosis and then you pause, and you see what means to 
them, right?
    Could it mean that they are worried about their baby, they 
are going to lose their job, they think they are going to die, 
they can't afford their meds? I think vaccines hesitancy is 
exactly this.
    What is it about the vaccine that is making you hesitant? 
Is it that you are scared? Do you have to take the day off of 
work to get it? Is it that you saw a friend get it and they had 
a reaction? Is it that, wow, how did the science come so fast?
    And so this is not about politics, this is about 
understanding where individuals are, meeting them where they 
are, and understanding what it is that is making them--making 
them hesitant.
    Senator Murray. Okay. Thank you.

                         VACCINES IN PREGNANCY

    Dr. Schuchat, recent research on the impact COVID-19 
infection has on pregnant women is really alarming. One study 
last month showed pregnant women with COVID-19 are 22 times 
more likely to die compared to women who are not pregnant who 
contract the virus. What is the latest vaccine guidance for 
pregnant women?
    Dr. Schuchat. Yes. Thanks so much for that issue. COVID 
complicates pregnancy, so women who are pregnant and get COVID 
have worse experiences with the infection, than do non-pregnant 
women. More time in the intensive care unit, more risk of 
severe outcomes, including those rare deaths. COVID also 
complicates pregnancy by increasing the risk of prematurity, 
and leading to other types of complications.
    While, as you know, clinical trials rarely enroll pregnant 
women, we are fortunate that there has been intense effort to 
get data about women who do get vaccinated while pregnant, to 
understand what happens, so that other women can learn from 
that.
    Based on what we know right now, we recommend that women be 
offered vaccines during pregnancy, that they are eligible to 
get them, and that they make a choice about it; that choice 
might be based on how they value that risk or that unknown. But 
we do have reassuring data right now about vaccines given, 
particularly in the third trimester that have been followed and 
reported. We are continuing to follow and working closely with 
FDA on that. And so we will be expecting this summer to have 
even more data, particularly about vaccines given earlier in 
pregnancy.
    Senator Murray. Is there any research about pregnant or 
lactating women who are vaccinated--who are vaccinated, 
transferring antibodies to their infants?
    Dr. Schuchat. We have emerging data that the antibody is 
transferred. And so we hope it will be like the influenza, 
where, getting vaccinated during pregnancy against influenza is 
really important because newborns and young children are very 
high risk for influenza complications. So, good news so far, 
and continuing to follow that.
    Senator Murray. Thank you.
    Senator Blunt.
    Senator Blunt. Thank you, Chair.

                            VACCINE BOOSTERS

    The issue of a booster vaccine obviously is out there, so 
far most of the people that have said they think we are going 
to need it are from the companies that are making the vaccine. 
Dr. Fauci, former CDC Director Tom Frieden, others have said 
there is growing evidence that there will be enduring 
protection with the vaccine we have.
    Now, I have been a big supporter of the Warp Speed effort 
to invest early in vaccines that were not approved yet, which I 
think made a big difference in availability. I do question the 
BARDA (Biomedical Advanced Research and Development Authority) 
decision to purchase 400 million doses of Moderna and Pfizer as 
a booster dose.
    Were you asked about whether that was the right decision to 
make or not? And if you weren't, should CDC be involved in a 
$7.9 billion decision about a booster before we know whether we 
need one or not?
    Dr. Walensky. Thank you, Senator. I think the first thing 
to recognize, and this has been miscommunicated, so I think it 
is very important, in the media, is that if you have received 
two doses of your Pfizer and Moderna vaccine, you are right now 
protected.
    Senator Blunt. Right.
    Dr. Walensky. What we are looking at is whether we will 
need boosters over time. And I think that this is really--given 
how hard we were hit by this pandemic, I think it is really 
important to understand where we will be with that. Data 
suggest from SARS, not SARS-CoV-2, but from SARS, that is 
similar to coronavirus, that people have waning immunity over 
time.
    And if you looked at what happened in the SARS outbreak 
several years ago, you saw that people were eligible for 
reinfection. So there is biologic plausibility that there would 
be waning immunity after you were infected. And we just don't 
know when that will be.
    One of the concerns has been that if we first vaccinated 
our very most vulnerable, our people in nursing homes, that 
they may not have had as robust a response, and that they might 
be the first to--they would be a first who would need a booster 
anyway, because they were vaccinated first. But in fact that 
they may not have had a robust response is in----
    Senator Blunt. If we spend $7.9 billion, which I guess we 
did decide to do on May the 2nd, do we think those vaccines 
last for some time?
    Dr. Walensky. I am not under the impression those are being 
made right now. I think part of the issue is what do they need 
to look like? Are we going to boost with the exact same mRNA 
structure as we do now? Or might we want to boost with a 
variant structure? And I think those are all conversations that 
are happening.
    Senator Blunt. Yes. Well, I think that is a pretty big 
spending decision to make based on the information we have. But 
we can talk about that more, later. If we do go forward with 
booster vaccines, are you all working to see if in an adult 
immunization program, we would try to combine more things with 
that booster? A flu shot, or whatever other shot that an adult 
might need at this point?
    Dr. Walensky. I think it is pretty clear that we have had 
an immunization program for adults that was not prepared for 
what we needed in this, in this structure.
    Senator Blunt. Right.
    Dr. Walensky. And yes, I think it would be advantageous. 
Currently, we don't have data as to whether you can co-
administer vaccines, those data we are looking for. And in 
fact, the ACIP (Advisory Committee on Immunization Practices) 
just opined on this last week, because we are so behind on 
childhood immunizations, 11 million behind on childhood 
immunizations. So those are all the data that we are looking 
for, because I think it would be really great to be able to 
leverage what we are doing for COVID for influenza as well, and 
vice versa.

                           DATA MODERNIZATION

    Senator Blunt. Exactly. And I hope you will keep us posted 
on that as that happens. On data, that was actually where I was 
going next. You know, the data, we obviously had a data 
shortage, a shortage and some confusion about what data to 
input, which was not as helpful as it might have been.
    Now, the committee, in what was then a fairly controversial 
decision, even among our colleagues, we decided, before COVID, 
to invest $50 million in base funding over the last 2 years for 
data. When COVID occurred, you know, and the numbers we were 
suddenly looking at and dealing with, we did another $500 
million.
    Dr. Schuchat, tell me where you think we are on better data 
preparation in the future? Or being better ready in the future 
to have data, and the tracking that comes with data? Where are 
we, and where would you think--that had CDC in the next fiscal 
year, for instance?
    Dr. Schuchat. This is essential. The $50 million base 
appropriations were vital, but you saw how behind we were. This 
is critical. We are so far behind, even with the increased 
resources. This is a long-term need; we are better, but we are 
not where we need to be. We have made huge progress this past 
year with electronic lab reporting of enormous numbers in terms 
of how many people were being tested, and getting us daily 
data. But the data were not necessarily complete, and as you 
heard the race/ethnicity data often missing.
    We have a need to move to the cloud for many of our 
systems. We have a need to become--have a workforce that can 
handle the data at the local level, at the State level, that 
can use these sophisticated tools and not just react, but 
predict. So we still have a long way to go, but COVID, we have 
made a lot of progress on. We need to make that progress across 
the spectrum of public health issues.
    Senator Blunt. Well data, and tracking, and other things I 
think are an important part of the future of health. And we 
want to be helpful. And I would hope that the $550 million, 
collectively, in the last couple of years has made a 
substantial difference in where we are headed.
    Thank you, Chair.
    Senator Murray. Senator Blunt. Thank you.
    I have one additional question for you. The CDC faced 
unexpected difficulties, as we all remember during those 
opening phases of the pandemic, especially around testing, and 
delays in establishing a large-scale testing, likely allowed 
the virus to spread undetected, as we know, one of the several 
factors that really hampered our efforts to contain that 
outbreak.

                         EARLIEST COVID LESSONS

    Dr. Walensky, I just wanted to ask you today, what lessons 
has CDC learned from the experience in those first few weeks?
    Dr. Walensky. There has been a lot of research going into 
what we could have done better during that period of time. My 
responsibility is to own that and to make sure that we are 
better. Among the challenges were quality--assurance quality 
control programs that were not in place the way they should 
have been. And in fact, among the things that we are doing is 
to ensure that all labs, research and diagnostic labs are fully 
accredited.
    So we are learning those lessons. Those were hard lessons 
to learn. I do also think that we need to recognize that among 
CDC's responsibilities is that when we have a new infectious 
pathogen, we are responsible for creating the diagnostics for 
that pathogen. Once we have done so, we need interagency 
collaboration with ASPER, with FDA to make--with the private 
sector to ensure that we can bring it to scale.
    We are now at 1.1--we did one million tests yesterday, we 
are testing one to two million a day. That scale up has to be 
interagency. And so, yes, we have a lot of lessons that we can 
learn from what occurred, and we are learning them and taking 
resources that have been provided to us so that we can, not 
just take a line--a line item and improve X-lab, but we can 
improve all of the labs and through this accreditation process, 
for example, but then also to be able to scale at the national 
level.
    Senator Murray. Okay. Thank you. Thank you very much. That 
will end our hearing today.
    But I do want to thank both Director Walensky, and 
Principal Deputy Director Schuchat for joining us.
    Thank you to all of our colleagues on the committee who 
participated as well.

                     ADDITIONAL COMMITTEE QUESTIONS

    For any Senators who wish to ask additional questions, 
questions for the record will be due one week after the 
President's budget is delivered at 5:00 p.m. The hearing record 
will also remain open until then for members who wish to submit 
additional material for the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
              Questions Submitted to Dr. Rochelle Walensky
              Questions Submitted by Senator Patty Murray
    Question. Researchers in the United States continue to discover new 
variants of the coronavirus that are spreading throughout the country. 
Congress provided $1.75 billion in the American Rescue Plan for CDC to 
increase genomic sequencing of SARS-CoV2 to identify emerging variants. 
President Biden's fiscal year 2022 budget proposal includes $8.7 
billion for the CDC, a $1.6 billion increase from fiscal year 2021's 
budget.
    How will the CDC's budget be used to help state and local public 
health offices expand their surveillance capabilities to keep pace with 
new and emerging variants?
    Answer. In May 2021, CDC awarded $240 million in American Rescue 
Plan (ARP) funds to state and local health jurisdictions to build 
sequencing and analytic capacity for all pathogens of interest, 
including SARS-CoV-2. CDC plans to fund these state and local labs for 
additional years, with ARP funds, to continue and to build on these 
activities, including funding support for equipment, supplies, and 
staffing. These activities build on expertise gained through the 
Advanced Molecular Detection (AMD) program. In addition, CDC is 
currently soliciting proposals for construction and renovation costs 
necessary to modernize the sequencing units of the nation's public 
health labs, which will also be funded through ARP funds. All of these 
labs are currently sequencing bacterial foodborne pathogens, and at 
last count, more than 60 labs were sequencing SARS-CoV-2. A subset of 
these labs are sequencing other pathogens, such as antimicrobial-
resistant bacteria and fungi, influenza virus, and the agents of 
tuberculosis and Legionnaire's disease. The number of labs sequencing 
these pathogens, as well as the number of pathogens they are 
sequencing, is expected to increase with the availability of these 
funds. CDC is also providing technical assistance, as well as support 
in planning and administration.
    Question. How long will it take to revitalize all state and local 
jurisdictions so they are equally equipped to help stop the spread of 
COVID-19 and other future disease outbreaks?
    Answer. All state public health laboratories, and an increasing 
number of county/local public health laboratories, have the potential 
to perform next-generation sequencing. At the beginning of the 
pandemic, the main limiting factors were (1) limited staffing; (2) the 
large number of competing priorities in responding to the pandemic; (3) 
a lack of bioinformatics capacity; and (4) limited experience and 
knowledge among epidemiologic staff in how to use genomic data as part 
of the response. With the long-term investments to strengthen public 
health infrastructure as proposed in the fiscal year 2022 Budget, 
including public health laboratories, we will be in a better position 
to respond and control future outbreaks. With experience from COVID-19, 
these organizations are already in a better position to apply genomic 
epidemiology during the next public health emergency. But over the next 
three to 5 years, with both the investments above as well as 
investments in the sequencing Centers of Excellence (also supported by 
the ARP funds) and large increases in training, state and local 
jurisdictions will be in a much better position to apply genomics to 
intervene at the start of a public health emergency.
    Question. Thus far, the available COVID-19 vaccines protect against 
most of the variants currently circulating. A group of biostatisticians 
at Fred Hutchinson Cancer Research Center, based in Seattle, WA, are 
studying breakthrough infections of COVID-19 following full vaccination 
to determine which variants are able to evade the body's immune 
response. By understanding the correlation between needed level of 
protection and infection prevention, they hope to simplify the process 
of booster shots or vaccines against new variants.
    What other research or studies would the CDC conduct to make sure 
the United States can quickly and proactively protect people from new, 
and potentially more dangerous, variants?
    Answer. CDC has monitored for variant viruses since the beginning 
of the pandemic and continues to monitor for variants nationwide, in 
support of ongoing efforts by the SARS-CoV-2 Interagency Group. We use 
genomic information in combination with hospitalization and other case 
and outcomes data to identify the spread of, and potential consequences 
of, variants of concern.
    CDC leads the National SARS-CoV-2 Strain Surveillance (NS3) 
program, which identifies new and emerging SARS-CoV-2 variants to 
determine implications for COVID-19 diagnostics, treatments, and 
vaccines authorized for use in the United States. Genomic sequencing 
allows scientists to identify SARS-CoV-2 and monitor how it changes 
over time into new variants, understand how these changes affect the 
characteristics of the virus, and use this information to better 
understand how it might impact health. A notable strength of NS3 is the 
regular collection of specimens from across the United States to 
support variant characterization efforts, which provides important data 
to inform public health decision-making.
    Since January 2021, CDC has significantly increased domestic 
genomic surveillance platforms to monitor circulating viruses. NS3 was 
scaled up to process 750 specimens per week from public health 
laboratories across the U.S. CDC also is contracting with large 
commercial diagnostic laboratories to sequence samples. CDC has 
commitments from these laboratories to sequence more than 20,000 
samples per week, pending the availability of SARS-CoV-2 positive 
specimens, with the capacity to scale up in response to the nation's 
needs.
    Since 2014, CDC's Advanced Molecular Detection Program has been 
integrating next-generation sequencing and bioinformatics capabilities 
into the U.S. public health system. Many state and local health 
departments have been applying these resources as part of their 
response to COVID-19. Public health departments support local 
investigations, conduct studies, and make genomic data available to 
public databases. To further support these efforts, on December 18, 
2020, CDC released $15 million from COVID supplemental funds through 
the Epidemiology and Laboratory Capacity Program.
    In May 2021, CDC made available $240 million in American Rescue 
Plan funds to state and local health jurisdictions through the 
Epidemiology and Laboratory Capacity for Prevention and Control of 
Emerging Infectious Diseases (ELC) cooperative agreement. These funds 
are to be used over 3 years to build sequencing and analytic capacity 
for all pathogens of interest, including SARS-CoV-2. In addition, CDC 
plans to fund these state and local labs for at least an additional 3 
years, with ARP funds, to continue and to build on these activities, 
including funding support for equipment, supplies, and staffing. These 
activities build on expertise gained by the Advanced Molecular 
Detection (AMD) program since 2014 in the application of pathogen 
genomics to public health.
    Furthermore, we have issued 29 awards, totaling approximately $37 
million, as part of the SARS-CoV-2 Sequencing for Public Health 
Emergency Response, Epidemiology, and Surveillance (SPHERES) 
Initiative. These awards are intended to fill knowledge gaps and 
promote innovation in the U.S. response to the COVID-19 pandemic and 
will help integrate next-generation genomic sequencing technologies 
with bioinformatics and epidemiology expertise across the US public 
health system.
    As CDC and our public health partners sequence more SARS-CoV-2 
genomes, we will continually improve our understanding of which 
variants are circulating in the US, how quickly variants emerge, and 
which variants are of most concern to public health, and thus the most 
important to characterize and track.
    Question. Is the CDC continuing to monitor other public health 
concerns such as influenza?
    Answer. Yes, CDC has continued to maintain and strengthen its 
surveillance systems during the COVID-19 pandemic. For example, in 
preparation for the 2021-2022 influenza season, CDC made several 
enhancements to influenza surveillance systems, which improve detection 
of influenza circulation and illness, to differentiate influenza from 
COVID-19, and support COVID-19 surveillance. Data enhancements include 
adding more than 1,000 emergency departments to the U.S. Outpatient 
Influenza-like Illness Surveillance Network (ILINet), adding new data 
sources from the National Long Term Care Facility Surveillance system 
that reports data from approximately 15,400 facilities weekly, and 
integrating HHS Protect hospital data from approximately 6,000 
hospitals. Differentiation between influenza and COVID-19 is supported 
by the CDC-developed multiplex assay for use by CDC-supported public 
health laboratories, which simultaneously tests for type A and B 
seasonal influenza viruses and SARS-CoV-2. These and other updates have 
further strengthened the U.S. influenza surveillance system.
    Question. I am alarmed by increasing antimicrobial resistance, and 
the fact that high levels of antibiotic use during the COVID-19 
pandemic have likely driven the development of new resistance threats 
that have not yet been identified. The 2020-2025 National Action Plan 
for Combating Antibiotic Resistant Bacteria calls for expanded efforts 
that will only be possible with significant new Federal resources. 
Addressing AMR is central to preparedness, as resistant secondary 
infections complicate public health emergencies.
    How does the President's Budget Proposal support the CDC Antibiotic 
Resistance Solutions Initiative in fiscal year 2022 to expand efforts 
to preserve the effectiveness of antibiotics, reduce inappropriate 
antibiotic use, increase surveillance and ensure that we are prepared 
to address this public health threat, as outlined in the 2020-2025 
National Action Plan for Combating Antibiotic Resistant Bacteria?
    Answer. The fiscal year 2022 President's Budget has $172 million 
for the Antibiotic Resistance Solution Initiative, consistent with the 
fiscal year 2021 appropriation. CDC is working to effectively leverage 
resources and invest in key prevention strategies, such as early 
detection and containment, infection prevention, and ensuring the 
appropriate use of antibiotics. The availability of safe, effective, 
and quality-assured antibiotics underlies much of modern medicine, and 
the emergence and spread of AR threatens to undo this progress at 
enormous human and economic cost.
    COVID-19 has potentially created a perfect storm for antibiotic 
resistance (AR) infections in healthcare settings, with longer lengths 
of stay, crowding, severely ill patients, antibiotics frequently 
prescribed upon admission, and infection control challenges like PPE 
shortages. CDC supports a robust domestic infrastructure through its AR 
Solutions Initiative to respond to emerging threats wherever they occur 
across healthcare, the community, and the environment while building 
key capacity to address AR internationally. CDC continues to use a One 
Health approach to tackle AR and to gain a better understanding of AR 
transmission, interactions, and impact between humans, animals, and the 
environment.
    CDC has also proposed ambitious plans to strengthen international 
public health infrastructure as outlined in the 2020-2025 National 
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). Over 
the next 5 years of the plan, it proposes that CDC would establish two 
networks--the Global Action in Healthcare Network and Global 
Antimicrobial Resistance Laboratory & Response Network, which would 
expand CDC's surveillance efforts globally.
    Working together, these new global networks would enhance detection 
and response to infectious disease threats internationally, and 
implement prevention and containment strategies at local, national, and 
regional levels. CDC also has proposed plans to expand surveillance of 
AR threats in the environment, domestically and globally. These 
activities would help to better understand resistance in the 
environment, the connections between resistance in healthcare, 
agriculture, and environmental settings, and its impact on human 
health. CDC is piloting investments in these activities in fiscal year 
2021.
    Question. The COVID-19 pandemic laid bare the gaps resulting from 
decades-long erosion of support for the public health workforce, which 
did not have the people or resources needed to surge to meet the 
demands of the emergency response. Strategic investments in a diverse, 
robust, well-trained public health workforce at the community level are 
critical to ensure that we are able to tackle local public health 
challenges and be prepared for the next infectious disease outbreak. 
President Biden's fiscal year 2022 budget proposal includes a request 
for $106 million, a $50 million increase above fiscal year 2021, to 
develop the next generation of essential public health workers.
    How does CDC envision this proposed investment in fellowship and 
training programs will translate in rebuilding the public health 
workforce of epidemiologists, contact tracers, lab scientists, 
community health workers, data analysts, behavioral scientists, and 
communicators?
    Answer. The COVID-19 response shone a stark light on deficiencies 
in the nation's investment in its public health workforce, which did 
not have the people or resources to surge to meet the demands of a 
pandemic emergency response. Strategic investments in a diverse, well-
trained public health workforce are needed. CDC's fellowships and 
training programs continue to supply a competent and sustainable 
workforce capable of surging in response to imminent public health 
threats.
    CDC hosts approximately 300 fellows across seven fellowship 
programs each year in 45 U.S. states and five territories. In fiscal 
year 2021, all 137 EIS officers and Laboratory Leadership Services 
(LLS) fellows contributed to the COVID-19 response, leading COVID-19 
responses in their assigned states and publishing key findings in the 
MMWR leading to actionable recommendations around mitigating the spread 
of disease. CDC designs its fellowships and curricula to meet the 
evolving needs of the public health workforce. A survey of human 
resources directors identified the highest priority workforce needs as 
epidemiologists, laboratory scientists, and public health informatics 
specialists. CDC's fellowships are a pathway for training the next 
generation of public health leaders.
    Actions taken now to invest in developing the next generation of 
essential public health workers will better position our communities 
and the nation to respond to the current pandemic and to build back a 
better workforce to safeguard Americans' health. With the fiscal year 
2022 request of $106,000,000 for Public Health Workforce, CDC will 
rebuild the workforce of epidemiologists, contact tracers, lab 
scientists, community health workers, data analysts, behavioral 
scientists, and communicators who can help protect America's health.
    While health departments are the frontlines of emergency response, 
Federal investment in workforce development is essential to a 
coordinated national health workforce strategy. In fiscal year 2022 CDC 
will:
  --Expand the pathway of critical public health workers through 
        fellowship programs; assisting state, tribal, and local health 
        departments to conduct barrier assessments and implement best 
        practices for recruitment, hiring, and retention, and 
        publishing training materials for state, tribal, and local use 
        and STEM resources highlighting pathways to careers in public 
        health.
  --Modernize workforce development information technology systems.
  --Increase participants in CDC fellowship programs and place them in 
        areas of critical need.
    CDC will invest in understanding barriers and facilitating 
solutions around matching graduates in critical discipline areas with 
positions serving local, tribal, and state communities. Developing 
robust pathways to attract graduates to public health is essential to 
future health security of the United States.
    CDC will expand fellowship opportunities, from the Public Health 
Associate Program to Epidemic Intelligence Officers. CDC will enhance 
recruitment efforts and pave pathways for careers in public health at 
the Federal, state, tribal, and local levels. Increasing the cohort of 
EIS officers will provide critical applied learning and pathways for 
the next generation of public health leaders. CDC will increase the 
number of fellows in the field that provide essential assistance and 
expertise to CDC and state, local, territorial, and tribal health 
departments.
    CDC will also strengthen the laboratory workforce to support 
clinical and public health laboratory practice. Of the 800,000 
laboratory professionals who work across 295,000 CLIA-certified 
laboratories, less than 10 percent of the nation's clinical laboratory 
professionals currently access CDC training and workforce development 
resources. CDC will:
  --Expand the reach of CDC's training and workforce development 
        resources beyond the public health laboratory community into 
        the broad clinical laboratory community, including those who 
        perform point-of-care testing, building critical bridges 
        between healthcare and public health.
  --Continue data-driven development, promotion, and dissemination of 
        laboratory capacity- building initiatives and resources that 
        enhance the laboratory community's ability to combat emerging 
        threats, learn evolving practices, and stay current with the 
        newest standards and technologies
  --Formalize partnerships to expand its reach and accessibility of its 
        training products and resources to the laboratory community 
        through its learning course syndication system.
  --Expand development of its virtual reality training portfolio to 
        meet the evolving needs of laboratory professionals.
    Question. How will state and local health departments benefit from 
an expansion of these training programs?
    Answer. With investment in CDC's fellowship and training programs, 
CDC will rebuild the workforce of epidemiologists, contact tracers, lab 
scientists, community health workers, data analysts, behavioral 
scientists, and communicators who can help protect America's health. 
These investments are essential to build a competent and empowered 
public health workforce prepared to respond to future public health 
emergencies. CDC will work with state, tribal, local, and territorial 
health departments to rebuild the workforce and support these partners 
to assist in hiring and recruitment; identify and address barriers to 
hiring at the state and local levels; address workforce gaps; and build 
capacity to respond to current and future public health threats. These 
funds will support recruitment and training of public health leaders 
through Epidemic Intelligence Services (EIS), Laboratory Leadership 
Service fellowship programs, and Public Health Associate Program 
(PHAP). They will complement other initiatives including:
  --Public Health AmeriCorps, a new public health workforce program in 
        partnership with AmeriCorp, supported by investment from the 
        American Rescue Plan, will deploy a nationwide cohort of 
        workers, who will receive applied learning training and a 
        stipend in non-Federal term positions.
  --Modernization of the public health workforce in which CDC will work 
        with public health leaders across Federal, state, local, and 
        territorial jurisdictions to create a new grant program to 
        provide under-resourced health departments with the support 
        they need to hire staff and build a public health workforce for 
        the future.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
    Question. Given that diabetes is one of the co-morbid conditions 
that puts patients with COVID-19 at highest risk, I was pleased to see 
CDC guidance that recommended prioritization of both Type 1 and Type 2 
diabetes patients for vaccination. With 34 million Americans currently 
living with diabetes, the economic cost of the condition now exceeds 
$300 billion per year. Now more than ever, we need to do more to help 
prevent Type 2 diabetes where possible and help people with diabetes 
improve their management of the condition, so that we can see improved 
outcomes.
    How is CDC approaching the rapid growth in diabetes prevalence in 
this country and what can we do in Congress to help?
    Answer. CDC established the National Diabetes Prevention Program 
(National DPP) to address the growing epidemic of type 2 diabetes. The 
National DPP lifestyle change program is led by trained coaches who 
facilitate participants' strategies for eating a healthy diet, 
increasing physical activity, and developing coping skills. The 
Diabetes Prevention Program clinical trial showed that participants who 
engage in these lifestyle changes through a structured program can lose 
five to 7 percent of their body weight and reduce development of type 2 
diabetes by as much as 58 percent (71 percent for those 60 years of age 
and older).
    CDC supports state health departments and other stakeholder 
organizations in expanding access to the National DPP for populations 
at greatest risk for type 2 diabetes. Achieving insurance coverage is a 
critical step for increasing access to this highly effective program. 
Based on recipient reported data from September 30, 2018 to June 30, 
2019, state health departments and other partners have secured health 
insurance coverage for the National DPP for more than 1 million public 
employees and their dependents in 24 states. In addition, the National 
DPP lifestyle change program is currently a covered benefit for more 
than 2.2 million private sector employees and their dependents across 
21 states, a 61 percent increase from 2018. More than 1.4 million 
Medicaid beneficiaries have the National DPP lifestyle change program 
as a covered benefit, which includes participation from 30 states.
    In March 2016, the Centers for Medicare & Medicaid Services (CMS) 
certified the expansion of the National DPP into the Medicare program. 
This was the first preventive service model from the CMS Innovation 
Center to become eligible for expansion into the Medicare program--a 
landmark for public health. The future of the MDPP as a covered service 
will be determined by the outcome of the CMS Innovation Center's 
expanded model evaluation. However, based on findings from the original 
DPP research trial, subsequent translation studies demonstrating the 
program's effectiveness in non-clinical settings, and the 15-year 
results of the DPP Outcomes Study, this intervention has been studied 
extensively and already has substantial evidence supporting its 
effectiveness across settings and populations.
    Question. Can you provide an update on CDC's investments in the 
Division of Diabetes Translation (DDT) and the National Diabetes 
Prevention Program (NDPP)? How is CDC measuring success for those 
programs?
    Answer. More than 550,000 people at high risk for developing type 2 
diabetes have participated in the National DPP lifestyle change program 
across the U.S. Evaluated participants have lost an average of 5.5 
percent of their body weight. To date, there are almost 1,900 CDC-
recognized organizations offering the program in-person, virtual and 
through distance learning. CDC aims to enroll 1 million participants 
into the National DPP lifestyle change program by 2025.
    Since the onset of the COVID-19 pandemic, a majority of the CDC-
recognized organizations are offering virtual (telehealth) options for 
the National DPP lifestyle change program, an especially critical 
feature to ensure participant safety. A 2017 study (Vadheim, L.M, et 
al., 2017) found that participants who received the National DPP 
lifestyle change program through telehealth videoconferencing (distance 
learning) had similar rates of participation and achieved similar 
weight loss as participants who attended the program in-person.
    Through implementation of the National DPP, CDC aims to reduce the 
number of adults newly diagnosed with type 2 diabetes. The national 
rate of diabetes incidence (6.4 new cases per 1,000 adults in 2018) has 
successfully moved below the Healthy People 2020 target (7.2 new cases 
per 1,000 adults). The continued growth of the diabetes burden in terms 
of absolute prevalence, lifetime risk, years spent with diabetes, and 
the incidence rate remaining considerably higher than it was in the 
1990s, are all contributing factors indicating a need for continued 
prevention efforts like the National DPP.
    Question. The COVID-19 pandemic has exacerbated challenges in our 
response to the substance use disorder epidemic. As you know, the 2020 
state-level CDC data on opioid overdose deaths will also dictate the 
distribution of Federal opioid response dollars through the State 
Opioid Response (SOR) grant program administered by the Substance Abuse 
and Mental Health Services Administration (SAMHSA).
    When does CDC expect to publish state-level data for 2020 on drug 
poisoning deaths per capita? When CDC does publish the data, please 
keep my office informed.
    Answer. The National Center for Health Statistics provides 
provisional drug overdose death data by state: Products--Vital 
Statistics Rapid Release--Provisional Drug Overdose Data (cdc.gov). 
Provisional data currently provides information on drug overdose deaths 
occurring through October 2020. Final drug overdose death data for 2020 
will be available in late 2021.
    Question. Often there are discrepancies in state rankings on opioid 
overdose deaths per capita compared to overall drug poisoning deaths 
per capita. For instance, in examining CDC's WONDER data on 2018 opioid 
overdose deaths per capita, as reported by the National Institute on 
Drug Abuse (NIDA), compared to CDC's publication of 2018 overall drug 
poisoning deaths per capita, New Hampshire ranks third in opioid 
overdose deaths per capita and sixth in overall drug poisoning deaths 
per capita. Will CDC publish data on opioid specific overdose deaths 
per capita by state for 2020, as a supplement to its publication of 
overall state-by-state drug poisoning deaths per capita in 2020?
    Answer. Yes. In addition to drug overdose death data (including 
deaths attributed to opioids) CDC provides analyses on final drug 
overdose death data, including deaths related to prescription opioids, 
heroin, synthetics opioids, and psychostimulants. CDC will update the 
data once final 2020 overdose data are available.
    CDC currently funds 47 states and the District of Columbia to 
improve the timeliness and comprehensiveness of unintentional/
undetermined drug overdose mortality data. The State Unintentional Drug 
Overdose Reporting System (SUDORS) captures detailed information on 
toxicology, death scene investigations, route of administration, and 
other risk factors that may be associated with a fatal overdose from 
funded recipients. CDC continues to release analyses of data received 
through this program. For example, CDC published a report describing 
decedent demographic characteristics and circumstances surrounding 
overdose deaths during January--June 2019 among 25 jurisdictions 
participating in SUDORS, and it highlights the involvement of opioids 
and stimulants, separately and in combination.
    Question. I was pleased to see that the administration's budget 
proposal calls for a continued commitment to efforts to defeat HIV in 
this country. At the same time, we are also seeing significant 
increases in the spread of sexually-transmitted diseases, including a 
heartbreaking 40 percent increase in congenital syphilis passed from 
mother to child during pregnancy in recent years. I have been concerned 
that we have underfunded state and local STD prevention efforts for a 
long time, which may impede our abilities to stop the spread of STDs.
    Can you discuss how CDC is addressing growing rates of STD 
infections, and congenital syphilis infections in particular?
    Answer. CDC provides national leadership, research, policy 
assessment, and scientific information about STDs to the medical 
community and the public. CDC coordinates and publishes national STI 
Treatment Guidelines and Recommendations, which translates research 
into practice and serves as the gold standard for STI care in the 
United States. Further, CDC supports health departments in all 50 
states, Washington, D.C., and select cities and territories to conduct 
core and essential STD prevention work through our flagship STD 
prevention program, totaling $95.5million in 2020. CDC also has seventy 
field staff embedded in state and local STD programs around the 
country, who provide technical assistance and capacity building in 
disease investigation to support communities and public health 
partners, including investigating STDs in the community through field 
testing, public health detailing, outbreak response, and contact 
tracing.
    COVID-19 mitigation necessitated innovative approaches to 
delivering STD care that may prove to be valuable investments into the 
infrastructure for STD care in the U.S. for years to come, including 
(but not limited to):
  --STD express clinics, which provide walk-in testing & treatment 
        without a full clinical exam
  --Partnerships with pharmacies & retail health clinics, which can 
        provide new access points for STD services (e.g., on-site 
        testing and treatment)
  --Telehealth/telemedicine, which can close gaps in testing and 
        treatment, ensure access to healthcare providers, support self-
        testing or patient-collected specimens, and is especially 
        critical in rural areas
    These strategies and more are outlined in HHS's first ever STI 
Federal Action Plan, which provides a roadmap to develop, enhance, and 
expand prevention and care programs at the national, state, tribal and 
local levels over the next 5 years to reverse the course of the STD 
epidemic.
    Further, through its flagship STD prevention program, CDC supports 
state and local public health departments to prioritize and strengthen 
their efforts to eliminate congenital syphilis by matching syphilis 
surveillance data with birth and mortality data and strengthening 
congenital syphilis morbidity and mortality case review boards. On July 
13, CDC funded four state STD programs, working in cooperation with the 
state epidemiologist, to ensure that the implementation of congenital 
syphilis projects prioritize sustainable system level or policy level 
interventions in alignment with local epidemiology.
    Finally, CDC is working diligently to support the Disease 
Intervention Specialists (DIS) Workforce with funding from the American 
Rescue Plan. For many years, DIS have provided invaluable support to 
prevent and control STDs, tuberculosis, HIV, and other infectious 
diseases. More recently, DIS were called to support the COVID-19 
response, conducting case investigation and contact tracing in a 
variety of community settings. CDC is making a $1.13 billion investment 
over a five-year period to continue supporting the COVID-19 response 
and other infectious disease prevention and response, by:
    1. Expanding and enhancing frontline public health staff
    2. Conducting DIS workforce training and skills building
    3. Building organizational capacity for outbreak response
    4. Evaluating and improving recruitment, training, and outbreak 
response efforts
    In addition to helping to contain and prevent COVID-19, we expect 
that this cadre of culturally competent and experienced DIS will be 
able to address STDs, such as congenital syphilis, as well as other 
infectious diseases.
    Question. In 2016, the New Hampshire Department of Health & Human 
Services requested that the CDC's Agency for Toxic Substances and 
Disease Registry (ATSDR) conduct health consultations for the public 
water systems and private wells in the Merrimack-area of southern New 
Hampshire after the discovery of per- and polyfluoroalkyl substances 
(PFAS) contamination in drinking water. It is my understanding that 
these health consultations remain ongoing, and I am concerned that 
residents are still waiting and wondering about their exposure risks.
    Can you provide an update on the status of these health 
consultations and when you expect they will be concluded and released?
    Answer. ATSDR continues to work on the private well and public 
water health consultations. ATSDR received comments on the private well 
health consultation from the state environmental department through our 
data validation review process and is working to address those 
comments. After the comments are addressed the document is reviewed 
through CDC's clearance process, it will be released for public 
comment.
    In addition, ATSDR is currently completing a draft of the public 
water health consultation and preparing for internal review and 
clearance.
    Question. The last thing firefighters should have to worry about is 
the safety of the equipment they wear while in the line of duty. Yet 
many active and retired firefighters are deeply concerned about 
exposure to harmful PFAS chemicals from their protective gear. I was 
proud to include my bipartisan Guaranteeing Equipment Safety for 
Firefighters Act provisions in the fiscal year 2021 National Defense 
Authorization Act (NDAA), which as you know, includes collaborative 
efforts at the National Institute of Standards and Technology (NIST) 
and National Institute for Occupational Safety & Health (NIOSH) to 
study of the personal protective equipment worn by firefighters. I have 
also worked through the Appropriations process to kick start this 
research at NIST.
    Can you discuss the CDC's current collaboration with NIST as they 
work to identify a firefighter's relative risk of exposure to PFAS 
released from their protective gear? How will NIST's study inform the 
CDC's work--within both ATSDR and NIOSH--to better understand the 
health effects of PFAS exposure?
    Answer. CDC's collaborates with NIST, sharing information, 
presentations, and collaborating on research activities such as 
characterizing PFAS in turnout gear textiles. In 2021, NIST and NIOSH 
provide overviews of PFAS activities and identified three topics for 
further discussion, analytical and collection methodologies, selection 
of and access to turnout gear textiles, and PFAS toxicity testing. 
Meetings on these topics were conducted with smaller groups to help 
facilitate targeted discussions.
    NIST's research into PFAS in firefighter turnout gear is 
anticipated to provide valuable information on potential exposures for 
firefighters by identifying PFAS present in textiles and the conditions 
contributing to the release of PFAS from said material. The analytical 
methods included in NIST's study comprise a larger panel of PFAS than 
is currently used in many studies of human exposure. Results from this 
expanded panel will help guide future PFAS analyses of serum collected 
from this occupationally exposed population as well as inform future in 
vivo and in vitro studies of toxicity. When paired with studies of 
dermal absorption and exposure assessments of firehouse air or dust, 
NIST's research will also provide insight into the contribution of PFAS 
from gear to a firefighter's total exposure, providing a more complete 
understanding of the relevant pathways and routes of exposure in this 
population.
    NIOSH's National Personal Protective Technology Laboratory (NPPTL) 
has been collaborating with NIST to determine which PFAS compounds are 
on firefighter turnout gear and if they are released through 
laundering. NPPTL collaborated with NIST, providing 20 different 
textile swatches laundered using current fire service protocols. These 
samples will undergo additional aging and stressing techniques to 
measure PFAS release from textiles by NIST researchers.
    NPPTL's comprehensive laundry study to identify and quantify the 
individual PFAS compounds on firefighter textiles and to measure their 
release through a series of washings, supplements the ongoing NIST work 
. Additional NPPTL research studies the ability of PFAS compounds to 
migrate through the 3-layered garment to be in direct contact with a 
wearer's skin.
    The NIST-NIOSH research collaboration will provide valuable 
information regarding possible PFAS exposures related to firefighter 
PPE and will yield time and monetary cost savings to both institutes.
    Question. The Firefighter Cancer Registry Act, which was passed by 
Congress and signed by the President in 2018, directed the CDC to 
establish and maintain a voluntary National Firefighter Registry to 
better understand the link between on-the-job exposure to toxic 
substances and cancer in firefighters. The National Firefighter 
Registry will be used to track and analyze cancer trends and risk 
factors among firefighters. I have heard from firefighters in my state 
interested in volunteering to participate. It is my understanding that 
at this time, however, enrollment for the National Firefighter Registry 
is not yet open.
    Can you provide an update on the work being done to establish the 
registry and a timeline of when it will be open for enrollment? When 
the registry is opened for enrollment, will you work with my office to 
provide information to active and retired firefighters about how to 
participate if they so choose?
    Answer. The National Firefighter Registry (NFR) has made 
substantial progress in developing a rigorous scientific protocol, 
enrollment questionnaire, and consent form. These documents have been 
posted publicly at www.cdc.gov/niosh/bsc/nfrs. The enrollment 
questionnaire has been submitted to OMB for review under the Paperwork 
Reduction Act. The NFR program has also drafted an Assurance of 
Confidentiality (AoC), which provides additional protection for 
identifying information.
    The NFR program has also made progress on the online NFR 
Registration System. However, any public-facing data collection portal 
must meet numerous Federal data security regulations and requirements--
some of which are relatively new and costly. NIOSH is working closely 
with our IT and security specialists to ensure that the NFR 
Registration System is compliant with these requirements. This has 
extended the original timeline for the launching of the NFR. NIOSH also 
recognizes that the registration system not only needs to be highly 
secure, but also needs to be relatively easy for firefighters to 
complete in order to maximize voluntary participation across the United 
States.
    The NFR team has been working closely with key scientific and fire 
service stakeholders to determine the optimal design of the NFR 
Registration System and what data must be collected. Launching of the 
NFR Registration System is one step in many that will be needed over 
the next several years to ensure the success of the program and meet 
the requirements under the Firefighter Cancer Registry Act of 2018.
    Once the NFR opens for registration, NIOSH will work with numerous 
fire service organizations and other stakeholder groups to encourage 
firefighters throughout the country, including career and volunteer, 
active and retired, and firefighters with and without cancer, to enroll 
in the NFR. The NFR team has developed a robust communications plan and 
strong connections to fire service organizations such as the 
International Association of Fire Fighters (IAFF) and National 
Volunteer Fire Council (NVFC), which are the two largest organizations 
representing career and volunteer firefighters, respectively. We 
welcome opportunities to work with congressional offices to reach 
firefighters within your state or district.
    Question. Can you discuss how you expect this epidemiological 
information and analysis will help public safety officials, 
researchers, scientists and medical professionals find better ways to 
protect those in the fire service?
    Answer. The enrollment questionnaire will serve as the primary data 
collection instrument when firefighters initially register collecting 
information about work history (including large or unusual responses), 
implementation of control measures, family history of cancer, and 
healthy behaviors. The questionnaire will also ask for identifying 
information, such as name and date of birth, which can be used to make 
linkages to state cancer registries. Collecting identifying information 
will allow NIOSH to periodically link to existing cancer diagnosis 
databases to detect new cases of cancer long-term that may not have 
been reported.
    Additional follow up questionnaires will allow for analysis of 
specific workplace factors as well as topics of special interest to the 
public safety community. The NFR program also plans to work with fire 
departments to capture fire and incident information to build an 
exposure profile for the NFR participants. Over time and with broad 
participation, all this data can be used to better understand the 
amount and types of cancer among firefighters; the prevalence of cancer 
risk factors and healthy behaviors among firefighters; and the 
relationship between firefighter cancer and workplace characteristics, 
exposures, and practices. We will explore cancer risk among 
understudied firefighter groups including women, minorities, 
volunteers, and firefighters in sub-specialty assignments like wildland 
firefighters or fire-cause investigators. We will also evaluate how the 
adoption of certain control measures, like routine laundering of 
turnout gear, affects cancer risk. These analyses will help scientists 
at CDC/NIOSH identify the most important factors associated with 
firefighters' risk of specific types of cancer, including rare forms of 
cancer. Results can then be used by public safety officials to 
implement new evidence-based policies or procedures to reduce 
firefighters' cancer risk. Medical professionals will also have more 
knowledge about the types of cancer that are most elevated among the 
different groups of firefighters, which could assist them in providing 
advanced screening and healthcare for firefighters.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
    Question. The Food and Drug Administration reports that nearly 40 
percent of finished drugs and roughly 80 percent of active 
pharmaceutical ingredients are manufactured abroad. During the COVID-19 
pandemic we saw factories shut down in order to prevent spread of the 
virus, drug supply chains disrupted, and drug shortages increase. As a 
result American's access to essential medicines was put into jeopardy. 
To avoid future shortages of essential medicines, domestic 
manufacturing is key to shoring up our supply chain.
    How important is a strong domestic supply chain for essential 
medicines?
    Answer. Ensuring a safe and consistent public health supply chain 
for medical materials, ingredients, and supplies is critical for any 
national response to public health emergencies.
    Question. How can we ensure we don't experience future drug 
shortages when global supply chains are disrupted?
    Answer:
  --Investments in securing the industrial base and domestic supply 
        chain require dedicated and persistent management and 
        engagement.
  --Throughout the COVID-19 response, ASPR has leveraged the 
        authorities delegated to the Secretary under the Defense 
        Production Act (DPA) to issue 62 priority ratings for United 
        States Government (USG) contracts for health resources, eight 
        priority ratings for USG contracts for industrial expansion, 
        three priority ratings for non-USG contracts to support the 
        production of resins for both diagnostics and infusion pumps, 
        and the manufacture of closed suction catheters for treatment 
        of patients with COVID-19--all to ensure private sector 
        partners making life-saving products are able to acquire the 
        raw materials, components, and products requisite to deliver 
        for the response.
  --Also under the DPA, ASPR is strengthening the industrial base to 
        secure and develop domestic capacity, retool and expand 
        industry machinery, scale production facilities, train 
        workforces, and ultimately infuse the supply chain and 
        marketplace with products the US needs to contain further 
        pandemic waves. ASPR continues to invest in critical funding in 
        expanding domestic manufacturing including investments of: $250 
        million in manufacturing PPE; $268 million in manufacturing of 
        testing consumables; $14.8M in vaccine raw material 
        manufacturing; $160 million in fill finish capacity; $65 
        million in vaccine vial manufacturing; $168 million in 
        manufacturing capacity for at home and point of care tests; 
        and, $53.8M in testing raw materials. Each of these domestic 
        manufacturing initiatives meets current, as well as future 
        COVID-19 needs, and seeks to create or sustain high-value 
        domestic jobs.
    Question. Last week, the CDC announced $7.4 billion from the 
American Rescue Plan to support the public health workforce and the 
response to the COVID pandemic. This funding included $2 billion for 
state health departments. This will go a long way to shoring up our 
public health workforce as you outlined, in particular the requirement 
for at least 40 percent of the funding to support local hiring through 
local health departments or community-based organizations. West 
Virginia led the country in vaccination rates in large part due to our 
local health departments and health centers across the state 
establishing Local Leadership Planning teams to roll out vaccination 
plans in all 55 counties. These teams are multisector, 
multidisciplinary local health leaders. They know their communities, 
and have stepped up to respond to this virus.
    In addition to this funding, what is CDC doing to support local 
initiatives like West Virginia's Local Leadership Planning teams?
    Answer. Partnerships and trusted community members have been 
critical to reaching communities disproportionately affected by the 
pandemic. Community health workers (CHW) are frontline public health 
workers who have a trusted relationship with the community and are able 
to facilitate access to a variety of services and resources for 
community members. Scaling up and sustaining a nationwide program of 
CHWs who support populations hit hardest by COVID-19 is critical. In 
addition to the $7.4 billion to support the public health workforce 
awarded from the American Rescue Plan, CDC also plans to provide $300 
million to jurisdictions for CHW services to support COVID-19 
prevention and control. CDC plans to provide an additional $32 million 
for training, technical assistance, and evaluation. CDC expects to 
award funds to approximately 75 organizations through the ``Community 
Health Workers for COVID Response and Resilient Communities.'' Notices 
of awards will be issued in the summer, with the amount each 
jurisdiction receives determined by population size, poverty rates, and 
COVID-19 statistics.
    CDC also provided funding with specific guidance to focus on 
reaching disproportionately affected communities, including:
  --$3 billion to strengthen vaccine confidence (awarded early April 
        2021): Funding focuses on reaching 64 communities hit hardest 
        by the pandemic, including those in rural areas, to ensure 
        greater equity and access to vaccine and expand COVID-19 
        vaccine programs. To ensure health equity and expanded access 
        to vaccines, 75 percent of funding must focus on specific 
        programs and initiatives intended to increase vaccine access, 
        acceptance, and uptake among racial and ethnic minority 
        communities, and 60 percent must go to support local health 
        departments, community-based organizations, and community 
        health centers.
  --$3 billion in cooperative agreements to support broad-based 
        distribution, access, and vaccine coverage (awarded Jan. 2021): 
        A minimum of 10 percent to jurisdictions must be allocated for 
        high-risk and underserved populations, including rural 
        communities.
    --75 percent of the total funding must focus on specific programs 
            and initiatives intended to increase vaccine access, 
            acceptance, and uptake among racial and ethnic minority 
            communities; and,
    --60 percent must go to support local health departments, 
            community-based organizations, and community health 
            centers.
  --$2.25 billion in grant funding to states and localities 
        (anticipated to be awarded June 2021) to address COVID-19 in 
        high-risk and underserved communities, including rural 
        communities and communities with large populations of racial 
        and ethnic minorities. Recipients are strongly encouraged to 
        collaborate with and provide funding and resources to reach 
        organizations such as community-based and civic organizations, 
        faith-based organizations, non-governmental organizations, and 
        state offices of rural health or their equivalent such as state 
        rural health associations.
    Question. How can we maintain local efforts like these to ensure 
they continue to operate after the public health emergency?
    Answer. CDC must build on initial investments and lessons learned 
from COVID-19 with sustained, flexible investments in the nation's 
public health infrastructure as proposed in the fiscal year 2022 
Budget. This work must include public health workforce development, as 
well as public health data modernization and epidemiology and 
laboratory capacities, so that we can address the broader public health 
consequences of the pandemic such as opioids, injuries, violence, 
immunization, and chronic disease control. It will also help us prepare 
for the future, because there are and will be more public health 
threats.
    Question. Just last week the CDC updated its guidelines in regards 
to people who have been fully vaccinated. One guideline has caused 
confusion in my state, specifically in regards to reporting and the 
quarantining of people who have been vaccinated with a known exposure 
to COVID. Currently, the guidelines require a fully vaccinated person 
to quarantine for 10 days only if they develop symptoms. However, there 
does not appear to be a clear reporting requirement for persons who 
have been exposed and develop minor symptoms. Nor is there flexibility 
for a fully vaccinated person to quarantine for a shorter period of 
time if their symptoms disappear. Tracking these breakthrough cases is 
important to ensure we know if and when a booster may be needed to 
ensure protection for our population, and tracking potentially 
problematic COVID variants.
    How does the CDC plan to effectively monitor breakthrough cases?
    Answer. The goal of national surveillance for COVID-19 vaccine 
breakthrough infections is to identify unusual patterns, such as trends 
in age or sex, the vaccines involved, underlying health conditions, or 
which of the SARS-CoV-2 variants made people sick. To date, CDC's 
monitoring of breakthrough cases shows there are no unusual patterns in 
cases that have been detected in the data CDC has received. Despite the 
high level of vaccine efficacy, it is expected that a small percentage 
of fully vaccinated persons will develop symptomatic or asymptomatic 
infections (i.e. breakthrough infections) with SARS-CoV-2, the virus 
that causes COVID-19.
    Vaccine breakthrough surveillance focuses on those cases resulting 
in hospitalization or death. CDC coordinates with state and local 
health departments to investigate vaccine breakthrough cases and 
identify patterns or trends. Health departments report breakthrough 
cases to CDC on a voluntary basis. However, it is important to note 
that tracking and publicly reporting vaccine breakthrough via national 
surveillance is just one way CDC measures vaccine effectiveness. CDC is 
leading multiple vaccine effectiveness studies, some of which include 
information on vaccine breakthrough infections, to ensure COVID-19 
vaccines are working as expected. Through these studies in various 
populations, locations, and settings, CDC can obtain more 
representative, scientifically valid, and complete information about 
these types of infections.
    CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track 
and analyze breakthrough infections. This population-based surveillance 
system includes data on laboratory-confirmed COVID-19- associated 
hospitalizations in 99 counties in 14 states, representing 
approximately 10 percent of the U.S. population. COVID-NET cases are 
hospitalizations occurring in residents of a designated COVID-NET 
catchment area who are admitted within 14 days of a positive SARS-CoV-2 
test. COVID-NET personnel collect COVID-19 vaccination status (doses, 
dates administered and product) from state Immunization information 
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also 
include information on clinical outcome. Some sites have expanded 
collection of vaccination status to non-sampled cases, which were 
included for analysis if all cases in a single month had vaccination 
status available.
    Question. Is the CDC considering reducing the required isolation 
period for fully vaccinated persons after their symptoms disappear?
    Answer. CDC data indicates that vaccinated people are less likely 
to contract COVID-19 and are much safer from having serious outcomes if 
they do contract it. If they become infected, they can spread the virus 
to others. Moreover, if the infection is caused by the Delta variant, 
based on what we know at this time, they can likely spread it as easily 
as unvaccinated people who are infected, at least initially. As 
infection progresses, vaccinated persons with COVID-19, including 
COVID-19 caused by the Delta variant, appear to be infectious for a 
shorter period of time than infected unvaccinated people.
    CDC is reviewing all the emerging evidence and will continue to 
monitor the data on duration of infectiousness for breakthrough cases. 
Throughout the pandemic, CDC has updated guidance to reflect the latest 
available information about COVID-19 and would consider changing 
recommendations for isolation periods for vaccinated people who have 
breakthrough infections if the accumulating science indicates such a 
change were both safe and reasonable.
    Question. As you are aware we are facing an epidemic within a 
pandemic. West Virginia is ground zero for the drug epidemic, with the 
highest rate of drug overdose deaths in the country. To make matters 
worse, 2020 was the worst year for drug overdoses, with over 90,000 
deaths. West Virginia saw at least a 47 percent increase in overdose 
deaths last year. The drug epidemic has led to a sharp increase in 
opioid-related infectious diseases, including HIV and viral hepatitis. 
This has stretched the resources of our public health departments and 
health providers even further.
    What resources is the CDC providing to states to combat this 
epidemic?
    Answer. CDC is providing resources to states through Overdose Data 
to Action (OD2A), a cooperative agreement that began in September 2019. 
It combines strategies from previous surveillance and prevention 
funding agreements to address the complex and changing nature of the 
drug overdose epidemic. Through OD2A, 47 states, Washington D.C., 16 
localities, and two territories are receiving almost $300 million in 
funding.
    CDC is also addressing the infectious disease consequences of the 
opioid epidemic. Nearly $13 million of combined fiscal year 2019 and 
fiscal year 2020 funding was awarded through the Infectious Disease and 
the Opioid Epidemic initiative to state and local health departments 
and national organizations to address the infectious disease 
consequences of drug use.
    In light of the COVID-19 pandemic, CDC has worked to provide 
flexibilities to the 66 grantees by extending the funding for an 
additional year and providing additional guidance and assistance as 
needed. We have also engaged grantees to identify innovative ways to 
respond during the pandemic. We are also using COVID-19 funding to:
  --Understand how substance use patterns and attitudes among youth 
        have changed due to COVID-19 and disseminate tailored public 
        health messaging and interventions to help address increased 
        substance use during this period of time and prevent 
        detrimental long-term consequences.
  --Identify innovative harm reduction practices to assess the extent 
        to which these strategies can be sustained and scaled. CDC 
        plans to summarize these strategies and disseminate them to 
        state, local, and Federal partners.
    In addition, CDC is Combating Opioid Overdose Through Community-
level Intervention Initiatives (COOCLI). CDC, through its Opioid 
Response Strategy partnership, provided funding to the Office of 
National Drug Control Policy to create public health/public safety 
interventions at the local level. COOCLI sub-awards funded pilot 
programs to implement innovative, evidence- based, community-level 
interventions.
    Question. Is the CDC working on helping increase testing for viral 
hepatitis and HIV as well as linking patients to care?
    How can CDC help improve testing and surveillance of opioid-related 
infectious diseases with our current substance use treatment programs 
and recovery facilities?
    Answer. Our nation has seen steady increases in infectious 
diseases--including viral hepatitis and HIV--among people who use drugs 
since the start of the opioid crisis over a decade ago. Making testing 
for viral hepatitis and HIV accessible, convenient, and routine is 
critical, especially in populations disproportionately affected by 
these diseases, including people who inject drugs (PWID). CDC developed 
programs to increase infectious disease testing among PWID and 
continues to invest in these programs through state and local health 
departments and through community-based organizations. Specifically, 
CDC is focusing investments on scaling up HIV self-testing--like the 
Take Me Home self-testing program that provides free HIV self-tests--
making HIV screening a regular part of healthcare, and delivering viral 
hepatitis and HIV testing in non- traditional settings, such as 
correctional facilities and syringe services programs (SSPs).
    As viral hepatitis, HIV, and substance use disorders continue to 
impact communities throughout the United States, CDC is not only 
increasing support for testing, but also diagnosis, linkage to care, 
and treatment. CDC is also improving implementation of and access to 
high-quality SSPs across the country, where legal, through 
dissemination of best practices and providing technical assistance. 
CDC's core Integrated HIV Surveillance and Prevention for Health 
Departments program (PS18-1802) supports the implementation of 
comprehensive SSPs as part of a key community-level HIV prevention 
strategy. In addition, CDC's National HIV Behavioral Surveillance 
system collects important data among persons at high risk for HIV 
infection, including persons who inject drugs. These programs work to 
ensure the provision of high-quality, comprehensive harm reduction 
services, which include testing for infectious diseases, linking 
patients to opioid use disorder treatment, and providing infectious 
disease care for clients of syringe services programs.
    In addition to testing and treatment for infectious diseases, CDC 
works to increase linkage to substance use disorder treatment within 
SSPs and during healthcare encounters for PWID.
    Question. The COVID-19 pandemic has revealed public health data 
infrastructure shortcomings within both our Federal and state 
institutions. West Virginia's response to the COVID-19 pandemic, 
however, shows our ability to adapt in times of crisis. In addition to 
the strong leadership of our National Guard, our local health 
information exchange stepped up to track important health data, such as 
hospitalization and vaccination rates, demographic data, and much more. 
Most importantly, our health information exchange helped us build out 
systems so that West Virginia health providers were able to fully 
utilize the CDC's Vaccine Administration Management System (VAMS). As 
outlined in President Biden's national strategy, we need improved 
systems for public health data exchange and surveillance. This will 
allow us to better track outbreaks, testing, vaccination rates and much 
more.
    How will you ensure Federal investments into public health data 
will support data sharing between public health and healthcare 
delivery, such as the West Virginia's health information exchange?
    Answer. The success of CDC's Data Modernization Initiative (DMI) is 
critical for our nation's response to COVID-19 and beyond. Improving 
data sharing between public health and healthcare delivery is key to 
realizing the full potential of public health data modernization. 
Monitoring and evaluation are how we make sure we are delivering on the 
promise of data to protect America's health. The need for modernization 
never stops. Within DMI, we are monitoring progress on a growing suite 
of modernization projects. These investments touch nearly every part of 
the public health data ecosystem.
    All of CDC's data modernization investments are guided by a Roadmap 
of Activities and Expected Outcomes that guides all current and future 
investments in data modernization. This strategic roadmap lays out our 
priorities and keeps our end goals in front of us. It ensures work 
going on through any given stream ties into and benefits the others--
and that we are moving toward the same definition of success. The 
roadmap is the basis for our DMI monitoring and evaluation framework. 
Robust monitoring and evaluation will maximize our impact on public 
health. This is where we track our progress consistently and 
scientifically to see what our investments have produced. We can also 
see which solutions are working well and which may need additional 
support to reach their goals.
    Electronic case reporting (eCR) has demonstrated success in 
improving data sharing between public health and healthcare. eCR is the 
automated, real-time exchange of case report information between 
electronic health records (EHRs) and public health agencies for review 
and action. It moves data quickly, securely, and seamlessly from EHRs 
in healthcare facilities to state or local health departments. All 50 
states, D.C., and 11 large local jurisdictions are now capable of 
receiving COVID-19 electronic case reports, up from only a handful of 
jurisdictions in late 2019. As of May 15, more than 8.1 million COVID-
19 reports have been sent to 61 public health agencies and more than 
7,900 healthcare facilities in all 50 states can send COVID-19 
electronic case reports. There are currently 236 facilities in West 
Virginia actively using eCR, including West Virginia University.
    CDC is actively working to expand the number of healthcare 
organizations implementing eCR and support public health agencies to 
fully use the case reports within their data ecosystem. This includes 
collaboration with healthcare systems, EHR vendors, and with the Office 
of the National Coordinator for Health Information Technology (ONC) to 
improve exchange of health information.
    Question. Will you work with state partners like WVU Health 
Sciences to continue to improve data analytics?
    Answer. Support and engagement with partners to improve data and 
analytics is an important component of the CDC Data Modernization 
Initiative (DMI). Data modernization requires an ongoing commitment and 
partnership across the public health sector--and especially with our 
state, tribal, local, and territorial partners. CDC will continue to 
support and engage with partners to improve data collection, 
interoperability and data analytics. CDC is working closely with public 
health partners to provide technical assistance focused on:
  --Developing interoperable data systems to reduce the burden on 
        healthcare systems, facilities and laboratories that report 
        critical data to jurisdictions
  --Increasing the overall efficiency of public health data systems at 
        the state level
    CDC also supports public health partners like the Association of 
Public Health Laboratories (APHL) and the Council of State and 
Territorial Epidemiologists (CSTE). These partners are providing 
technical assistance to jurisdictions focused on improving data 
sharing, accelerating use of shared decision support services, data 
science upskilling of the public health workforce, and developing and 
increasing use of standards to improve quality and timeliness of 
reported data.
                                 ______
                                 
                Questions Submitted by Senator Roy Blunt
    Question. Dr. Walensky, several of the COVID-19 vaccine developers 
have indicated we may need a vaccine booster. To that end, BARDA 
notified an intent to purchase 400 million doses of COVID-19 vaccine 
from Moderna and Pfizer for $7.9 billion on May 2nd as booster shots.
    Was that the right decision? Because many public health experts 
indicate, including former CDC Director Tom Frieden, that there is 
growing evidence that a first round of global vaccinations may offer 
enduring protection. What is your opinion here? What I think could be 
very dangerous is if vaccine companies, rather than public health 
experts, are setting the public's expectations around COVID-19 
boosters.
    Answer. CDC will update its recommendations on re-vaccination or 
additional doses of COVID-19 vaccines when additional information is 
available. CDC is closely collaborating with Federal partners and the 
global science and public health community to determine next steps on 
COVID-19 vaccine boosters. Currently, there is not enough data to 
support recommending boosters.
    Question. Adult immunization programs are not typically done well 
in the U.S.
    Should we face the prospect of COVID-19 boosters next year, what is 
CDC doing now to plan for that possibility?
    Answer. CDC will update its recommendations on re-vaccination or 
additional doses of COVID-19 vaccines when additional information is 
available. CDC is closely collaborating with Federal partners and the 
global science and public health community to determine next steps on 
COVID-19 vaccine boosters. CDC works continuously with our state and 
local immunization programs to strengthen their capacity to deliver 
vaccines, monitor their safety and effectiveness and address identified 
gaps.
    The fiscal year 2022 budget request includes nearly a $100 million 
increase to expand existing efforts to enhance the adult immunization 
infrastructure to increase routine vaccination rates, detect and 
respond to outbreaks of VPDs, and address vaccine hesitancy. Adult 
immunization program funding will build on recent investments in the 
COVID-19 vaccine program to support essential activities aimed at 
strengthening the safety net for uninsured adults, addressing 
disparities in adult vaccine coverage, and supporting vaccine efforts 
across the lifespan.
    Question. Will you try to team other adult vaccinations with the 
COVID vaccination?
    Answer. COVID-19 vaccines were previously recommended to be 
administered alone, with a minimum interval of 14 days before or after 
administration of any other vaccines. This was out of an abundance of 
caution and not due to any known safety or immunogenicity concerns. 
However, substantial data have now been collected regarding the safety 
of COVID-19 vaccine currently authorized by FDA for use under Emergency 
Use Authorization. Although data are not available for COVID-19 
vaccines administered simultaneously with other vaccines, extensive 
experience with non-COVID-19 vaccines has demonstrated that 
immunogenicity and adverse event profiles are generally similar when 
vaccines are administered simultaneously as when they are administered 
alone.
    COVID-19 vaccines and other vaccines may now be administered 
without regard to timing. This includes simultaneous administration of 
COVID-19 vaccine and other vaccines on the same day, as well as 
coadministration within 14 days. When deciding whether to co-administer 
vaccine(s) with COVID-19 vaccine, vaccination providers should consider 
whether the patient is behind or at risk of becoming behind on 
recommended vaccines, their risk of vaccine-preventable disease (e.g., 
during an outbreak or occupational exposures), and the reactogenicity 
profile of the vaccines.
    Question. There are reports, many of which the CDC has published, 
highlighting the toll this pandemic has had on our nation's public 
health. And there's an increasing number of reports that the overall 
health of Americans has suffered as a result of the pandemic. It is 
increasingly evident that in the coming months, as we emerge from under 
the shadow of this pandemic, existing and emerging public health 
challenges will have to be addressed.
    How are you planning to address these challenges and how does the 
fiscal year 2022 budget reflect those needs?
    Answer. CDC is committed to upgrading the public health system so 
the nation is ready for whatever may come next by building on 
investments and lessons learned during the pandemic. Key priorities 
include modernizing our public health data systems, supporting a 
diverse and skilled public health workforce, enhancing laboratory 
capacity, and promoting global health security. We now know that long-
term and flexible funding--as proposed in the fiscal year 2022 budget--
will be required to sustain improvements and address broader 
consequences of the pandemic and historical underinvestment in areas 
like health equity, opioid use and misuse, injuries and violence, 
immunization planning, and hypertension control.
    Question. What are the areas where this budget request may fall 
short--perhaps because we're only just beginning to understand the vast 
impact of the pandemic in areas such as chronic conditions, delayed 
care and immunizations, or reemerging infectious diseases, such as STDs 
and hepatitis?
    Answer. The nation's public health system has not recovered from 
the economic downturn in 2008, which resulted in significant reductions 
in public health staffing at the state and local level. Similarly, CDC 
has become increasingly reliant on infusions of supplemental funds to 
address specific health crises. Building back a robust public health 
infrastructure will take sustained investments over time to address 
both foundational needs like data, lab capacity and workforce as well 
as strategic investments to address health equity and social 
determinants of health. The fiscal year 2022 President's budget 
includes request for increased funding needed to address some of the 
consequences of the pandemic including mental health, opioids, and 
prevention of chronic and infectious diseases.
    Question. Conversely, our nation has made great strides these last 
several months against the COVID pandemic and we've gained a greater 
understanding as to what is needed for a robust public health system--
from the public health laboratories to health statisticians and 
academic researchers to private enterprise--advancements have been made 
across the board.
    How does the fiscal year 2022 budget request account for the 
lessons learned over the last year to improve our public health 
infrastructure?
    Answer. The ability to respond to a public health emergency 
requires a strong day-to-day public health system, supported by 
infrastructure that is not highly segmented by disease, condition, or 
activity. In addition to the COVID-19 pandemic, over the past 24 
months, CDC has also responded to diverse public health threats from E-
cigarette or Vaping Product Use-Associated Lung Injuries (EVALI), 
Ebola, complex multi-state food-borne disease outbreaks, wildfires, and 
hurricanes. Responding to the unique characteristics of each of these 
public health emergencies has required deep scientific expertise to 
deploy a specialized approach and called for a robust public health 
system with world-class infrastructure nationwide to stop disease at 
its source. Unfortunately, this recent history has revealed the effects 
of inadequate public health infrastructure. Ongoing health disparities 
made us as a nation more vulnerable to pandemics and large-scale public 
health emergencies, as well as burdening large segments of our 
population with chronic public health concerns. Additional investment 
in both domestic and global public health infrastructure is needed as 
requested in the fiscal year 2022 Budget.
    With investments requested in fiscal year 2022, CDC will begin to 
address mission-critical gaps in public health infrastructure and 
capacity nationwide. Transitioning from sporadic influxes of 
supplemental funding tied to a specific emergency to flexible funding 
that can prevent another crisis will strengthen the current public 
health system. Flexible, sustainable investments in infrastructure and 
capacity are critical for saving lives and averting economic losses 
caused by public health emergencies and chronic public health problems. 
In fiscal year 2022, CDC will prioritize funding to rebuild the most 
critical public health infrastructure needed to safeguard the nation's 
health and economic security.
    Question. The budget includes $400 million for Public Health 
Infrastructure Capacity.
    How does this request account for the flexibility needed to scale 
certain functions or respond in the future to a wholly different public 
health threat?
    Answer. CDC will expand its ability to leverage public health 
infrastructure to address emerging and longstanding issues by providing 
direct funding for capacity-building resources, guidance, and 
collaboration to states, localities, and territories. These resources 
will be disease-agnostic investments in core public health 
infrastructure and capacity to expand programs and systems that address 
long-standing public health issues and support public health response.
    Question. How, specifically, will this $400 million be divided 
between the different activities outlined in the budget?
    Answer. This investment must be flexible, stable, and keep pace 
with inflation and technological advancements in order for states, 
localities, and territories to address their most urgent needs, such 
as: a diverse, data-savvy workforce with secure funding that attracts 
the best talent to public health; robust technological infrastructure 
that is nimble and scalable; innovations and collaborations with 
multiple sectors; and programs that address disparities during and 
after the COVID-19 pandemic.
    Question. Unfortunately, there is no question that the pandemic has 
been challenging for many people--our nation has faced an unprecedented 
mental health crisis and a rise in overdoses. CDC's provisional data 
shows a 28 percent increase in overdose deaths in the 12-month period 
ending in October 2020. More than 88,000 lives were lost to an overdose 
during that period, the highest number of fatal overdoses ever recorded 
in the U.S. in a single year, three-quarters of which were opioid-
related. Throughout my time on this Subcommittee, I made it a priority 
to combat the opioid crisis and I'm concerned we have suffered a 
significant setback. We need to better understand the impact that the 
pandemic has had on overdoses and substance abuse.
    What can you say about these trends in fatal overdoses and what are 
some of the immediate needs to combat them?
    Answer. Provisional 2020 data reveal that over 93,000 people died 
of an overdose in 2020, a nearly 30 percent increase over 2019. The 
recent increase in drug overdose mortality began in 2019 and continued 
into 2020, prior to the declaration of the COVID-19 National Emergency 
in the United States in March.
    There are many factors that can be driving the increase in overdose 
deaths including:
  --The changing illicit drug marketplace and the wider availability of 
        illicitly manufactured fentanyl and fentanyl analogs,
  --Co-use of illicitly manufactured fentanyl with other drugs such as 
        cocaine and methamphetamine, and
  --Mixing of illicitly manufactured fentanyl into the drug supplies of 
        methamphetamine and cocaine
    CDC's Overdose Data to Action (OD2A) funds health departments in 47 
states, the District of Columbia, two territories, and 16 cities and 
counties to obtain high-quality, comprehensive, and timely data on 
fatal and nonfatal drug overdoses to inform prevention and response 
efforts. To help curb this epidemic, Overdose Data to Action strategies 
focus on enhancing linkage to and retention in substance use disorder 
treatment, improving prescription drug monitoring programs, 
implementing post-overdose protocols in emergency departments, 
including naloxone provision to patients who use opioids or other 
illicit drugs, and strengthening public health and public safety 
partnerships, enabling data sharing to help inform comprehensive 
interventions.
    The President's Budget for fiscal year 2022 includes a requested 
increase of $237.8 million for opioid overdose prevention and 
surveillance. Immediate needs to combat the acceleration in overdoses 
include:
  --Expanding the provision and use of naloxone and overdose prevention 
        education;
  --Expanding access to and provision of treatment for substance use 
        disorders;
  --Intervening early with individuals at the highest risk for 
        overdose; improving detection of overdose outbreaks due to 
        fentanyl, novel psychoactive substances (e.g., fentanyl 
        analogs), or other drugs to facilitate an effective response;
  --Continued partnerships with public safety to monitor trends in the 
        illicit drug supply, including educating the public that drug 
        products might be adulterated with fentanyl or fentanyl analogs 
        unbeknownst to users.
    A comprehensive and coordinated approach from clinicians, public 
health, public safety, community organizations, and the public must 
incorporate innovative and established prevention and response 
strategies, including those focused on polysubstance use.
    Question. The Labor/HHS bill provides funding for opioid-related 
programs at the CDC, and a particular area of focus addresses 
infectious diseases associated with the opioid epidemic. Those 
resources help strengthen our understanding of the full scope of the 
burden of infectious diseases associated with substance use disorders. 
As a result of the pandemic, many public health departments' staff that 
would normally work on surveillance and prevention of infectious 
diseases, such as hepatitis, have been detailed to work on the COVID 
response.
    What do we know about the impact of the pandemic on surveillance 
and prevention of infectious diseases associated with the opioid 
crisis?
    Answer. The COVID-19 pandemic has deepened the opioid crisis and is 
having a profound impact on the fight against infectious diseases 
associated with this epidemic. We don't yet know the full impact but we 
are concerned that the major disruptions in access to prevention 
services and deferral of healthcare services during the pandemic may 
result in more infections and lead to severe health consequences in the 
long run. Deferral of healthcare services ultimately delays diagnosis 
and treatment, leaving people living with Hepatitis C and/or HIV 
unaware of their status and vulnerable to disease progression while 
also increasing the risk of spreading the viruses. Available data from 
CDC's funded programs also indicates that 50 percent of syringe 
services programs (SSPs) have reduced operations and 25 percent have 
closed further impacting opportunities for hepatitis testing and 
linkage to care. The closures of these SSPs severely limited access to 
vital hepatitis C virus and HIV prevention services, including 
referrals to treatment services as well.
    In October 2020, CDC released a health advisory about the 
possibility of new injection-related HIV infections and outbreaks and 
noted how prevention efforts could be hindered because of the COVID-19 
pandemic. Many HIV and viral hepatitis program staff were reassigned to 
support the COVID-19 response which further hindered prevention 
efforts. In the context of the pandemic, ongoing delivery of core 
public health services to address the injection drug use crisis and the 
infectious diseases associated with this epidemic, like hepatitis C and 
HIV are essential. CDC is committed to helping states build capacity to 
combat both epidemics and will continue to provide guidance as we 
address new and evolving challenges.
    Question. In response to the COVID pandemic, states have received 
billions of dollars in aid, with the intent of giving them maximum 
flexibility to respond to their unique needs and challenges. Congress 
passed five bipartisan emergency supplemental funding bills last year, 
four of which included funding specifically for CDC activities totaling 
$16.25 billion for the agency. The vast majority of the funding, 
roughly 75 percent, is to support state and local public health 
preparedness and response, laboratory capacity, and surveillance. It is 
my understanding there is a sizable portion of unobligated funds 
remaining from the bipartisan emergency supplemental bills. And now 
there is even more funding provided as part of the American Rescue Plan 
reconciliation bill for the same purpose. While it is important to know 
how fast CDC is getting this funding into the hands of the frontline 
responders on the state level, it is just as important to know if 
they're spending the money.
    What are the spend rates that CDC is seeing at the state level?
    Answer. States have multiple funding sources, including 
disbursements from the treasury, that are used for public health 
purposes. The amounts and purposes vary greatly by state and it is not 
possible to generalize about spend rates. Recipient cash drawdowns are 
a lagging indicator of recipient performance because the recipient 
draws down cash to reimburse at the time of, or after, they pay their 
bills. In addition, as recipients have their own project plans and cash 
management processes, cash drawn totals provide a high-level picture 
for that recipient and are generally not comparable across a cohort of 
recipients in the same program.
    Question. What accountability do the States have to tell you how 
they have used the funds?
    Answer. Recipients regularly report on their use of funds and the 
outcomes they achieved per the terms of the funding agreement by which 
they are awarded the funds.
    Question. Given the unprecedented volume of funding going out from 
the CDC as a result of the partisan reconciliation bill--can you 
explain CDC's decisionmaking infrastructure, process, and planning 
mechanisms for deploying unprecedented sums of money in such a short 
period of time? How does CDC plan for states and the public health 
infrastructure to sustain these advancements when the supplemental and 
mandatory funding runs out?
    Answer. CDC is allocating funding to states based on the provisions 
included in the statute. CDC uses funding mechanisms available to fit 
the purpose outlined in the statute, and where needed, has developed 
new ones.
    The ability to respond to a public health emergency requires a 
strong day-to-day public health system, supported by infrastructure 
that is not highly segmented by disease, condition, or activity. In 
addition to the COVID-19 pandemic, over the past 24 months, CDC has 
also responded to diverse public health threats from E-cigarette or 
Vaping Product Use-Associated Lung Injuries (EVALI), Ebola, complex 
multi-state food-borne disease outbreaks, wildfires, and hurricanes. 
Responding to the unique characteristics of each of these public health 
emergencies has required deep scientific expertise to deploy a 
specialized approach and called for a robust public health system with 
world-class infrastructure nationwide to stop disease at its source. 
Unfortunately, this recent history has revealed the effects of 
inadequate public health infrastructure. Ongoing health disparities 
made us as a nation more vulnerable to pandemics and large-scale public 
health emergencies, as well as burdening large segments of our 
population with chronic public health concerns. Additional investment 
in both domestic and global public health infrastructure is needed as 
proposed in the fiscal year 2022 Budget.
    With investments requested in fiscal year 2022, CDC will begin to 
address mission-critical gaps in public health infrastructure and 
capacity nationwide. Transitioning from sporadic influxes of 
supplemental funding tied to a specific emergency to flexible funding 
that can prevent another crisis will strengthen the current public 
health system. Flexible, sustainable investments in infrastructure and 
capacity are critical for saving lives and averting economic losses 
caused by public health emergencies and chronic public health problems. 
In fiscal year 2022, CDC will prioritize funding to rebuild the most 
critical public health infrastructure needed to safeguard the nation's 
health and economic security.
    Question. The Administration has placed an emphasis on addressing 
health equity, especially as it relates to the pandemic response 
efforts.
    What trends are you seeing in rural communities right now with 
regard to the pandemic?
    Answer. Data continue to show the disproportionate impact of COVID-
19 on population groups, including people living in rural or frontier 
areas. CDC's publication examining disparities in COVID-19 vaccination 
coverage found COVID-19 vaccination was lower in rural counties (38.9 
percent) than in urban counties (45.7 percent). These data are 
available on the county tracker, which provides an integrated, county-
level view of key data for monitoring the COVID-19 pandemic in the 
United States. It allows for the exploration of standardized data 
across the country. The footnotes describe each data source and the 
methods used for calculating the metrics. For the most complete and up-
to-date data for any particular county or state, visit the relevant 
health department website.
    Question. How does the CDC's health equity work account for the 
needs of rural communities?
    Answer. Rural areas face unique challenges both during the COVID-19 
pandemic and when confronting ongoing public health challenges. The CDC 
COVID-19 Response Health Equity Strategy, developed under the 
leadership of the Chief Health Equity Officer Unit, affords a robust 
platform from which CDC and its partners are pursuing deeper 
engagements of diverse communities, stronger infrastructures to better 
support data-driven action, and culturally responsive approaches 
optimized for serving diverse, differentially impacted populations in 
different areas, including rural and frontier populations. CDC has 
provided historic funding to address health disparities, including 
support for rural areas, as follows:
  --$3.0 billion to strengthen vaccine confidence (awarded early April 
        2021): Funding will focus on reaching communities hit hardest 
        by the pandemic, including those in rural areas.
  --$3.0 billion to ensure broad-based distribution, access and vaccine 
        coverage (awarded Jan. 2021): A minimum of 10 percent to 
        jurisdictions must be allocated for high- risk and underserved 
        populations, including rural communities.
  --$2.25 billion to states and localities to address COVID-19 in 
        medically underserved communities including rural communities 
        and communities with large populations of racial and ethnic 
        minorities
    Additionally, the Federal Retail Pharmacy Program continues to be 
an important component in our commitment to address the 
disproportionate and severe impact of COVID-19 on communities of color 
and other underserved populations, including rural populations. From 
February 10 to May 19, 2021, 46,811,020 vaccine doses had been 
administered and reported by retail pharmacies across programs in the 
U.S. A total of 21 retail pharmacy partners are participating in the 
program, with more than 41,000 locations online and administering doses 
nationwide.
    CDC has numerous initiatives working to reduce disparities in rural 
populations. A few examples include:
  --Community Health Workers for Covid Response and Resilient 
        Communities (CCR) supports the training and deployment of 
        community health workers (CHWs) to response efforts and by 
        building and strengthening community resilience to fight COVID-
        19 through addressing existing health disparities. Priority 
        populations are those with increased prevalence of COVID-19 and 
        are disproportionately impacted by long-standing health 
        disparities. Recipients to be announced at the end of August 
        2021.
  --Racial and Ethnic Approaches to Community Health (REACH) program 
        works to reduce racial and ethnic health disparities, including 
        those found in rural communities. Interventions focus on proper 
        nutrition, physical activity, tobacco use and exposure, and 
        chronic disease prevention, risk reduction, and management.
  --The Healthy Tribes Program funds tribal communities across the 
        country to strengthen connections to culture to promote healthy 
        lifestyles and reduce risk factors for chronic diseases. These 
        programs together support community-developed strategies that 
        work in rural settings to address the unique challenges that 
        contribute to health disparities for these communities.
  --Scaling the National Diabetes Prevention Program in Underserved 
        Areas funds 10 national organizations to expand the reach of 
        the National Diabetes Prevention Program lifestyle change 
        program to underserved areas and populations, including hard-
        to-reach rural regions of the US with fewer resources to 
        address health disparities. Priority populations include 
        Hispanic/Latino, African American, American Indian/Alaska 
        Native, and Asian American persons; Pacific Islanders; and 
        noninstitutionalized people with visual impairments or physical 
        disabilities.
    Question. Dr. Walensky, as more Americans are vaccinated, there are 
certainly going to be more ``breakthrough'' cases--individuals who test 
positive for COVID-19 even after being fully vaccinated. This is to be 
expected since no vaccine is 100 percent effective. What concerns me is 
that while we're seeing breakthrough cases, for example the New York 
Yankees reported a staggering number of breakthrough cases in the 
spring, the CDC announced it will no longer track all breakthrough 
cases.
    Are we letting down our guard--should all COVID-19 cases continue 
to be counted?
    Answer. Despite the high level of vaccine efficacy, a small 
percentage of fully vaccinated persons will develop symptomatic or 
asymptomatic infections (i.e. breakthrough infections) with SARS-CoV-2, 
the virus that causes COVID-19. The goal of national surveillance for 
COVID-19 vaccine breakthrough infections is to identify unusual 
patterns, such as trends in age or sex, the vaccines involved, 
underlying health conditions, or which of the SARS-CoV-2 variants made 
these people sick. To date, no unusual patterns in cases have been 
detected in the data CDC has received.
    Question. Can you explain why the change was made and exactly what 
CDC is now tracking with regard to breakthrough cases?
    Answer. State and local health departments report COVID-19 vaccine 
breakthrough cases to CDC voluntarily. The number of COVID-19 vaccine 
breakthrough infections reported to CDC likely are an undercount of all 
SARS-CoV-2 infections among fully vaccinated persons. Reports may not 
be complete and because not all infected persons get tested, not all 
breakthrough cases will be identified. This is particularly true in 
instances of asymptomatic or mild illness. The shift to focus on 
hospitalized or fatal cases will help maximize the quality of the data 
collected on cases of greatest clinical and public health importance, 
while representative, scientifically valid data on vaccine 
effectiveness comes from studies CDC is leading across the country.
    Reporting vaccine breakthrough cases through national surveillance 
is only one of the ways CDC measures COVID-19 vaccine effectiveness. 
CDC continues to lead studies in multiple U.S. sites to evaluate 
vaccine effectiveness and to collect information on COVID-19 vaccine 
breakthrough infections from these sites regardless of clinical status. 
For example, CDC is working with Emerging Infection Program (EIP) sites 
in nine states to compare SARS-CoV-2 sequence data from vaccinated and 
unvaccinated cases, regardless of clinical severity. CDC also is 
working on more than 30 ongoing studies to assess vaccine 
effectiveness, some of which include information on vaccine 
breakthrough infections in patients with asymptomatic and milder 
illness. Through these studies in various populations, locations, and 
settings, CDC can obtain more representative, scientifically valid, and 
complete information about these types of infections.
    CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track 
and analyze breakthrough infections. This population-based surveillance 
system includes data on laboratory-confirmed COVID-19-associated 
hospitalizations in 99 counties in 14 states, representing 
approximately 10 percent of the U.S. population. COVID-NET cases are 
hospitalizations occurring in residents of a designated COVID-NET 
catchment area who are admitted within 14 days of a positive SARS-CoV-2 
test. COVID-NET personnel collect COVID-19 vaccination status (doses, 
dates administered and product) from state Immunization information 
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also 
include information on clinical outcome. Some sites have expanded 
collection of vaccination status to non-sampled cases, which were 
included for analysis if all cases in a single month had vaccination 
status available.
    This strategic, deliberative approach will yield better information 
on vaccine effectiveness and provide critical insight on cases of 
greatest concern.
    Question. Related, there is increasing concern about the public 
health impact of long-term symptoms weeks or months after an individual 
has had COVID-19.
    What monitoring or tracking is the CDC undertaking with regard to 
COVID ``long-haulers''?
    Answer. CDC is spearheading rapid and multi-year studies to further 
investigate post-COVID conditions (PCC), also known as ``long COVID'' 
or ``long-haul COVID.'' These studies will help us better understand 
post-COVID conditions and how to treat patients with these longer-term 
effects. For example, ongoing studies will follow patients for up to 3 
years and provide information on the percent of persons who develop 
post-COVID conditions, assess risk factors for development of post-
COVID conditions, and evaluate different virus strains and antibody 
responses.
    Question. How many long-haulers would you estimate are living with 
post-COVID related symptoms?
    Answer. At this time, we do not have a precise way to measure and 
capture the prevalence of persons living with post-COVID-19 related 
symptoms, but we know there are many people who are suffering from 
this.
    Currently, CDC and its Federal partners have proposed a new PCC 
ICD-10 code and are looking at all considerations on how this may 
impact the final version of this new code. The new ICD-code could 
potentially be used for a range of conditions, including subsequent 
chronic respiratory failure to help track and monitor people living 
with PCC. CDC's National Center for Health Statistics (NCHS) presented 
a proposal for public input to implement the code U09.9, post-COVID-19 
condition, based on a proposed international classification of 
diseases, tenth revision (ICD-10) code from the World Health 
Organization (WHO) last year. This proposal is expected to move forward 
after public input and may be implemented in October 2021 (as part of 
the regular ICD-10 code process/timelines) to allow clinical data 
systems and health insurers to adapt and fully implement it. We hope 
this will provide us with a better estimate of those who may be living 
with PCC.
    Question. How does CDC plan to continue to monitor and track the 
long-term impacts of COVID?
    Answer. CDC is using multiple de-identified electronic health 
record (EHR) databases to examine persistence of symptoms and incidence 
of post-COVID conditions. CDC has also partnered with health systems to 
perform in-depth medical record reviews, which can provide insight into 
the patterns of health effects that patients are experiencing.
    Question. Dr. Walensky, CDC has received a lot of criticism 
throughout the pandemic. A lot of it is justified. And most of it 
transcends political leadership at the agency. There are a lot of 
lessons to be learned from what we did right and what we did wrong. As 
I said in my opening statement, we did a lot right--so much so, in 
fact, that we have three FDA authorized vaccines that are getting into 
Americans' arms as we speak. But we also must recognize the missteps 
when they happen as well. That is how we learn and how we become better 
for the next public health emergency. Unfortunately, much of the 
criticism about our pandemic response, that continues to this day, 
revolves around the CDC. As Chair Murray and Senator Burr work on a 
pandemic reform bill in the health authorizing Committee, I think it 
would be a benefit to this Subcommittee to hear from you on these 
issues as well. Can you please respond to the comments below:
    Answer. First, CDC is risk adverse. I think that we have seen that 
in several cases, from mask mandates for campers to discouraging travel 
for the fully vaccinated.
    Question. Second, CDC guidelines are impractical. The agency simply 
doesn't issue guidelines that are clear and straightforward enough to 
be useful. What I continually heard is that Federal guidance needs to 
be practical for implementers on the ground or the American people to 
follow it.
    Answer. Since the early days of the pandemic, scientists at CDC 
have been using evidence from systematic reviews and expert judgement 
to develop guidance that informs various populations on how to slow the 
spread of COVID-19 and protect their health and their communities. The 
process and information communicated can be complex and evolves as our 
understanding of the virus increases. CDC's group of multidisciplinary 
stakeholders assesses the benefits and risks informed by data from the 
field and issues evidence-based guidelines. State and local health 
departments then decide how the research and guidance is implemented.
    Question. Third, CDC has an entrenched bureaucracy that is 
unwilling or unable to think big or implement on a large scale. The 
perfect, and befuddling, example is why CDC didn't engage with private 
sector partners like Abbott or Roche to commercialize their assay. 
Testing was one of the early failures. Was this the reason why?
    Further, at the outset, lab testing followed the flu model. 
Asymptomatic spread requires significant testing, but this was low-
balled and kept in-house which could only produce about 100,000 tests 
when what needed to happen was to engage the private sector labs to get 
1-2 million higher volume throughput.
    Answer. CDC aids and equips state and public health laboratories in 
diagnostic testing for novel pathogens. When a new virus emerges or a 
public health need for a new diagnostic tool arises, CDC may develop a 
new diagnostic tool and, in partnership with state and local public 
health partners and non-governmental organizations, strategize 
distribution. This process is intended to fulfill needs within the 
public health scope of outbreaks or new technologies. It is not 
currently intended to replace or fulfill testing that may need to be 
developed or distributed by commercial vendors to meet broader health 
sector needs.
    Furthermore, the EUA process for diagnostic (IVD) test development 
and analysis/validation follows a predetermined framework at CDC, as 
does deployment of the test after FDA authorization.
    Question. Lastly, the Center structure at CDC is stove piped and 
hampered the response. As a result, response efforts were locked into 
the flu center, which treated COVID-19 like the flu--which spreads 
symptomatically. Is this the reason we missed asymptotic spread? 
Because we didn't have the right experts in charge or a CDC-wide body 
responsible?
    Answer. On January 7, 2020, the Director of the National Center for 
Immunization and Respiratory Diseases (NCIRD) issued the directive 
authorizing a Center Level Response, Novel Coronavirus (nCoV) 2019 
Response, for the pneumonia outbreak in Wuhan, China in consultation 
with the CDC Director. This Directive was effective January 6, 2020. As 
the situation evolved, CDC escalated its response from the Center and 
activated its Emergency Operations Center facilitating a CDC-wide 
response on January 20, 2020.
    When reports of asymptomatic spread first emerged, CDC's guidance 
addressed the current circumstances. CDC proactively and aggressively 
investigated evidence from the field, and updated its guidance 
accordingly based on the best available data.
    Question. Dr. Walensky, the Influenza Hospitalization Surveillance 
Network (FluSurv-Net) is a population-based surveillance system that 
collects laboratory confirmed influenza associated hospitalizations 
from 14 states. The coverage area for FluSurv-Net is roughly 29 million 
people, or 9 percent of the U.S. population. There is no site in 
Missouri and the Midwest is not represented at all, except for Iowa.
    How can the CDC accurately track an influenza outbreak without 
real-time data from 36 states?
    Answer. CDC's influenza surveillance systems are a collaborative 
effort between CDC and its many partners in state, local, and 
territorial health departments, public health and clinical 
laboratories, vital statistics offices, healthcare providers, clinics, 
and emergency departments. The system consists of complementary 
components that capture virologic surveillance, outpatient illness 
surveillance, hospitalization surveillance, and mortality surveillance. 
This comprehensive surveillance infrastructure is used to identify when 
and where influenza activity is occurring, determine which influenza 
viruses are circulating, detect changes in influenza viruses, and 
measure the impact influenza is having on outpatient illness, 
hospitalizations, and deaths. Surveillance is performed continuously 
throughout the year and data are presented in FluView, a weekly 
influenza surveillance report, and FluView Interactive, an online 
application which allows for more in-depth exploration of influenza 
surveillance data, which are updated weekly.
    Additionally, the HHS Protect Hospital Data reporting system 
provides daily information on the number of patients hospitalized with 
influenza-related and COVID-related illnesses from over 6,000 hospitals 
in all 50 states and U.S. territories. This system provides situational 
awareness of severe respiratory illness and local hospitalization 
trends for influenza and COVID-19 on a daily basis that is beneficial 
for monitoring severe illness during an outbreak.
    Question. And how did the lack of real-time data stymy the response 
to COVID-19?
    Answer. COVID-19 highlighted the importance of real-time data 
needed to get ahead and stay ahead of the disease. CDC must build on 
initial investments and lessons learned from COVID-19 by investing in 
the nation's public health infrastructure. The ability to respond to a 
public health emergency requires a strong day-to-day public health 
system, including efficient data sharing, and supported by 
infrastructure that is not highly segmented by disease, condition, or 
activity. With investment in fiscal year 2022, CDC will begin to 
address mission-critical gaps in public health infrastructure and 
capacity nationwide. Transitioning from sporadic influxes of 
supplemental funding tied to a specific emergency to flexible funding 
that can prevent another crisis will strengthen the current public 
health system. Flexible, sustainable investments in infrastructure and 
capacity are critical for saving lives and averting economic losses 
caused by public health emergencies and chronic public health problems.
    Question. Reports are already speculating that the next flu season 
may be bad after a year of hardly any flu cases.
    How concerned should we be that many Americans are left without an 
immunity to flu--especially children--who may be more susceptible than 
any other recent year?
    Answer. A flu vaccine is the best way to protect children from flu. 
CDC recommends that everyone 6 months and older should get a flu 
vaccine every season. Annual vaccination is important to protect both 
yourself and to provide protection for those who are more vulnerable to 
serious flu illness, including children, older adults, and people with 
certain chronic health conditions.
    The flu can be dangerous for children. During the 2019--2020 
season, nearly 200 flu deaths in children were reported to CDC in the 
United States, which was the highest reported number of pediatric 
influenza deaths on record. About 80 percent of those children were not 
vaccinated. Last year, childhood influenza vaccination coverage is 
estimated to have dropped 4.1 percentage points from 62 percent during 
2019-2020 to 58 percent.
    CDC is working diligently to support the vaccination of as many 
Americans as possible during the upcoming influenza season. Vaccine 
manufacturers have projected that they will supply 188 to 200 million 
doses of influenza vaccine for the 2021-2022 season. CDC will continue 
to emphasize the importance of influenza vaccination through targeted 
communication outreach. CDC will build off its 2020-2021 communication 
campaign, which was estimated to have been seen more than 5 billion 
times. This year's media campaign will include population-wide outreach 
and will have a special emphasis on targeting disproportionately 
affected audiences, including people ages 40-64 with chronic medical 
conditions, African American and Hispanic persons, essential workers, 
pregnant women, and parents.
                                 ______
                                 
            Questions Submitted by Senator Richard C. Shelby
    Question. The Alabama Department of Public Health saw a delay in 
the reporting of vaccine distributions upon the initial allocation of 
vaccine allotments to states. Ultimately, there was not a delay in the 
distribution of the vaccine, but in the reporting of administered 
vaccines. In the last 15 months, Congress has appropriated $1.1 billion 
to the CDC for the purpose of public health data modernization and 
addressing public health data reporting issues that were experienced in 
Alabama. In 2019, CDC stakeholders requested $1 billion over a ten-year 
period to tackle public health data modernization, which CDC has 
indicated is needed and Congress has far surpassed to this point. $500 
million was appropriated through both the CARES Act and the American 
Rescue Plan Act of 2021, and $50 million was appropriated for both 
fiscal years 2020 and 2021 annual appropriations for the funding of 
public health data modernization through the CDC.
    Could you give a detailed description of how that $1.1 billion has 
been used to date, who that funding has gone to (e.g., through 
contracts, cooperative agreements, and grants), and for how much? 
Please also provide a detailed plan for the remaining funds.
    Answer:

                         ANNUAL APPROPRIATIONS

          Table 1. Budget Plan for Annual Appropriations \1,2\
------------------------------------------------------------------------
                                                    Fiscal Year
             Major Activity              -------------------------------
                                               2020            2021
------------------------------------------------------------------------
Partnering with State and Local Public            $32.5M          $32.5M
 Health, Partners, and Health Care
 Systems................................
Accelerating Public Health Data for               $15.5M          $15.5M
 Action.................................
Sustaining Innovation...................      $2 million      $2 million
    Total...............................     $50 million     $50 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
  activities.
\2\ Amounts per activity are based on current information and may
  require adjustment.

Data Modernization Base Funding
    Congress recognized the need to modernize CDC's data systems and 
provided funding in fiscal year 2020 dedicated specifically to data 
modernization. DMI base funding is focused on strengthening and 
sustaining the core foundational surveillance systems that state, local 
and territorial jurisdictions use every day. These systems benefit all 
of public health and serve as ``early warning signals'' for our biggest 
threats--systems that handle emergency room visits, case reporting, 
notifiable diseases, lab results, and death data. Investments to date 
have laid the groundwork and spurred real progress, but much work 
remains to be done.
    In fiscal year 2020, CDC focused on solutions for the timely, 
secure, and accurate flow of health data from electronic health 
records, laboratories, and other primary data sources to state and 
local jurisdictions and the multi-directional data flows between these 
jurisdictions and CDC. The focus of these efforts has been on the 
following:
  --Expanded use of eCR and connectivity to Electronic Health Records 
        (EHR)
  --Increasing the number of emergency departments and use of syndromic 
        and disease surveillance data through the NSSP
  --Enhancing automated electronic laboratory reporting (ELR) and 
        implementation of Electronic Test Orders and Results (ETOR) at 
        clinical and public health laboratories
  --Implementing improvements to birth and death reporting in NVSS
  --Modernization of disease reporting through NNDSS and of states' 
        National Electronic Disease Surveillance System (NEDSS) Base 
        System (NBS)
    CDC has continued to reimagine what its core surveillance systems 
could deliver in fiscal year 2021. CDC works closely with public health 
partners to reduce their reporting burden and make sure everyone has 
the capacity to connect with each other. The pandemic drove huge leaps 
in electronic case reporting (eCR), with thousands of healthcare 
facilities now exchanging automated, real-time health information. All 
50 states, D.C., and 11 large local jurisdictions are now capable of 
receiving COVID-19 electronic case reports, up from only a handful of 
jurisdictions in late 2019. The National Vital Statistics System (NVSS) 
expanded its modernization community and began delivering provisional 
COVID-19 death data and new data on excess deaths. Currently, 67 
percent of deaths are reported electronically in less than 10 days, up 
from 7 percent in 2010. CDC has dramatically improved the quality of 
laboratory report data received by public health through nationwide use 
of standardized messaging with Electronic Laboratory Reporting (ELR), 
with 56 jurisdictions reporting lab data directly to CDC, up from zero 
in 2019. Data from 70 percent of all U.S. emergency departments is 
reported to CDC through the National Syndromic Surveillance Program 
(NSSP), with 75 percent of emergency department data received in less 
than 24 hours of a visit. As a result, more early warning signals from 
systems that track emergency department visits and notifiable diseases 
were and are being captured.
    In fiscal year 2020, approximately $22.5 million was distributed 
through a cooperative agreement to 58 awardees, including states, 
cities, and territories, with an average award of $391,417. These funds 
supported specific strategies, activities, and outcomes to improve 
health information systems infrastructure, workforce development, and 
public health laboratories. States have used these funds to conduct 
needs assessments, strengthen technical and informatics skills, 
streamline changes to surveillance systems, and identify a lead person 
in each jurisdiction to support data modernization.
    CDC is continuing to improve core public health data systems, 
enhance data science and informatics workforce capabilities across the 
public health systems, improve interoperability and innovation through 
adoption of new standards and approaches for public health reporting 
such as Fast Healthcare Interoperability Resources (FHIR) standards, 
and support ongoing data modernization at CDC and with its partners.
    Our focus in fiscal year 2021 has been on providing technical 
assistance to state and local jurisdictions to leverage progress made 
at the Federal, state, and local levels on electronic case reporting 
(eCR) and Electronic Test Orders and Results (ETOR), as well as other 
core systems and processes for data exchange. Technical assistance is 
being provided by CDC and through a cooperative agreement with public 
health partners like the Association of Public Health Laboratories 
(APHL) and the Council of State and Territorial Epidemiologists (CSTE). 
These partners are providing technical assistance to jurisdictions 
focused on improving data sharing, accelerating use of shared decision 
support services, data science upskilling of the public health 
workforce, and developing and increasing use of standards to improve 
quality and timeliness of reported data. Focus on continuing to improve 
core public health data systems, enhance data science and informatics 
workforce capabilities across the public health systems, improve 
interoperability and innovation through adoption of new standards and 
approaches for public health reporting (such as FHIR standards) and 
support of ongoing data modernization at CDC and with its partners
    CDC also provided funding through a cooperative agreement to three 
tribal health entities to focus on three activity areas: augmenting 
workforce development and capacity, identifying and deploying specific 
enhancements in public health data and health information systems, and 
employing shared services to improve data quality, exchange, and 
management. CDC has provided funding to tribal entities in fiscal year 
2021 to focus on the improving access to data, modernizing 
infrastructure for data collection and analysis, and expanding 
workforce data skills.
    To keep CDC at the forefront of innovative, data-driven public 
health solutions, we are strengthening skills for a state-of-the-art 
data science workforce by supporting workforce development to assure 
capable data scientists and informatics-skilled staff are available to 
state, territorial, local, tribal, and Federal public health agencies. 
In fiscal year 2020, CDC completed a pilot cohort of team training 
through the Data Science Upskilling (DSU), which included 79 unique 
learners on 18 teams. DSU is a new model of team training using 
experiential learning tailored to agency priorities. Teams include both 
CDC staff and fellows from the Public Health Informatics Fellowship 
Program utilizing curated online courses and in-depth, boot-camp-style 
training on topics like machine learning. Team projects align with 
agency DMI priorities, CDC's winnable battles, or COVID-19 response. 
CDC also funded the Council of State and Territorial Epidemiologists 
(CSTE) to implement a similar program, Data Science Team Training 
(DSTT).
    DSTT was designed as a replica to CDC's Data Science Upskilling 
program, with modifications to better meet state, tribal, local, and 
territorial, needs. Training activities began in January 2021 with 20 
teams and 86 learners. There is representation from a mix of state, 
local, tribal, and territorial health departments.
                            cares act funds
    Together with base funding, the Coronavirus Aid, Relief, and 
Economic Security (CARES) Act extended and accelerated CDC's data 
modernization goals for the nation. CARES funding focuses on 
infrastructure, innovations, and connecting systems and data sources. 
Rather than discrete, one-off projects or a narrow focus on individual 
capacities, we have looked at the entire surveillance and data 
ecosystem and identified the areas most in need of investment and 
modernization. While COVID-19 is the priority, the end goal of DMI is 
to create lasting, adaptable solutions that will make public health 
more responsive and resilient in the future.
    CARES funding is being invested across three major areas:
  --Data Sharing across the Public Health Ecosystem
  --Modernizing critical tracking capabilities and core surveillance 
        systems
  --Extending data lakes and services that support electronic 
        laboratory reporting and immunization information
  --Expanding the type, variety, and quality of data available to CDC 
        programs and STLT
  --Automating the flow of data from electronic health records and 
        other sources
  --CDC Systems and Service Enhancements for Ongoing Data Modernization
  --Expanding enterprise cloud services to bring in and use large 
        datasets from partners in new ways
  --Expanding CDC's enterprise data hub, orchestration, warehouse, 
        lake, analytics, and visualization capacity
  --Building a state-of-the-art data science workforce
  --Ensuring open and accessible data while protecting privacy and 
        security
  --New Standards and Approaches for Public Health Reporting
  --Implementing new standards and approaches, such as FHIR across the 
        public health ecosystem
  --Assessing policy/legal barriers to sharing data, including STLT 
        data
    Our work focused on data sharing across the public health ecosystem 
includes modernizing critical tracking capabilities and surveillance 
systems, such as the National Healthcare Safety Network (NHSN), Public 
Health Environmental Tracking Network, the National Electronic Injury 
Surveillance System-All Injuries Program (NEISS-AIP), and the National 
Vital Statistics System (NVSS). We are also rapidly expanding 
electronic case reporting (eCR) from healthcare to public health. We 
have rapidly extended data lakes and services that support electronic 
laboratory reporting and immunization information, including the 
creation of a new immunization data lake that is now actively receiving 
and making available 3.1M administration records per day. Funding has 
also supported the creation of the Pan Respiratory Surveillance 
Initiative, informing our knowledge of molecular surveillance, viral 
evolution, and helping track trends in emerging variants.
    Enhancements to CDC systems and service enhancements for ongoing 
data modernization include deploying cloud-based technology to bring in 
and use large data sets from partners in new ways, while also providing 
highly scalable data analytic and visualization capabilities. This is 
already strengthening our data sharing capabilities. For example, we 
modernized data sharing with Homeland Security to ingest daily 
international passenger arrival contact tracing information, parse it, 
and provide it overnight to states through a secure, cloud-based file 
transport system for STLTs to ingest into their individual tracking 
systems. In the past year, the percentage of usable data has improved 
to over 95 percent and time to transmit to STLTs has decreased from 
days to overnight. Ongoing work to expand CDC's enterprise data hub, 
orchestration, warehouse, lake, analytics, and visualization capacity 
makes us better able to support modernization project needs across the 
agency. We have streamlined identity proofing and access management, 
use of enterprise code repositories, and enterprise security and code 
complexity scanning. The CDC Data Hub actively continues to ensure that 
analytics, including machine learning and artificial intelligence, are 
enabled in cloud-based data pipelines. At the same time, we have 
Initiated training opportunities to build a state-of-the-art data 
science workforce, including CDC's Data Academy, which has delivered 
more than 1000 hours of free training.
    Our modernization efforts include developing new standards and 
approaches for public health reporting. We are preparing CDC and our 
STLT and healthcare partners to implement technologies and standards 
that make systems interoperable and help these systems ``speak the same 
language.'' Federal policies and advancements in technologies are 
opening doors to make new connections for exchanging public health 
data, and a major focus is on implementing Fast Healthcare 
Interoperability Resources, or ``FHIR,'' across the public health 
ecosystem. FHIR application programming interfaces (APIs) can help 
public health to access detailed and timely data from EHRs while 
lowering burden on and delivering greater value to data providers. We 
are also working closely with jurisdictions and research partners to 
innovate toward FHIR-based interoperability at every level. This will 
give us more complete data and surveillance capabilities nationwide. 
Our goal is to take what works and scale nationwide, through pragmatism 
and collaboration to realize significant benefits to the way we use and 
share data across all of public health.

         Table 2. Budget Plan for CARES Act Appropriations \1,2\
------------------------------------------------------------------------
                                                         Funding Levels
                     Thematic Area                      for  Fiscal Year
                                                            2020-2021
------------------------------------------------------------------------
Data Sharing Across the Public Health Ecosystem.......          $140.55M
CDC Systems and Service Enhancements and Ongoing Data           $120.62M
 Modernization........................................
New Standards and Approaches for Public Health                   $13.83M
 Reporting............................................
Additional fiscal year 2020 funding for Emergency                $41.44M
 Operations Center public health surveillance
 activities...........................................
Future fiscal year 2022-2023 funding..................          $183.56M
    TOTAL.............................................      $500 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
  activities.
\2\ Amounts per activity are based on current information and may
  require adjustment.

                       american rescue plan funds
    CDC appreciates further appropriations in data modernization 
awarded through The American Rescue Plan Act. Where possible CDC is 
evaluating recent investments made in national data infrastructure and 
working with states to understand the gaps that still exist and 
barriers to modernizing to further drive the best practices for 
efficient and effective data modernization across the public health 
ecosystem. Planning is currently underway to apply ARP data 
modernization resources to drive a flexible, responsive, and modern, 
response- ready data infrastructure.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
    Question. In February, the CDC issued an order requiring face masks 
on conveyances and at transportation hubs. Last week, you updated your 
guidance for fully vaccinated individuals, saying they can stop wearing 
masks indoors and outdoors. However, the CDC has not taken any steps to 
update the February transportation order.
    When can we expect such an update?
    Answer. While those who are fully vaccinated may resume many 
activities without wearing a mask, the travel environment presents a 
unique set of circumstances based on the number and close interaction 
of travelers (both vaccinated and unvaccinated). Traveling on public 
transportation increases a person's risk of getting and spreading 
COVID-19 by bringing people in close contact with others, often for 
prolonged periods. Staying 6 feet away from others is often difficult 
on public transportation conveyances. People may not be able to 
distance themselves by the recommended minimum of 6 feet from other 
people seated nearby or from those standing in or passing through the 
aisles on airplanes or buses, for example.
    Correct and consistent use of masks on public transportation 
conveyances and at transportation hubs protects travelers and workers, 
enables safe and responsible travel during the pandemic, and helps to 
reduce the spread of coronavirus disease 2019 (COVID-19).
    CDC will update the Order and other recommendations as more people 
get vaccinated, as rates of COVID-19 change, and as additional 
scientific evidence becomes available.
    Question. Given the different risk levels of COVID transportation 
across the transportation network, for instance traveling on public 
transportation verses operating a freight locomotive, can we expect 
different guidance?
    Answer. CDC will continue to evaluate the requirements of its Order 
and determine whether other changes are warranted by examining 
characteristics like the transportation environment as well as indoor 
and outdoor locations. CDC will update the Order and other 
recommendations as more people get vaccinated, as rates of COVID-19 
change, and as additional scientific evidence becomes available.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. There are two FDA-approved buprenorphine products for the 
treatment of moderate to severe chronic pain. Both buprenorphine-based 
products have been classified by the U.S. Drug Enforcement 
Administration (DEA) as Schedule III meaning they have less abuse and 
addiction potential compared to Schedule II drugs like oxycodone, 
fentanyl, and oxymorphone. Furthermore, buprenorphine provides an 
important safety advantage as it is the only opioid with a demonstrated 
ceiling effect on respiratory depression, which is what typically leads 
to death in an opioid overdose. In addition, there are several 
buprenorphine-based products approved to treat opioid addiction. This 
means that one of the same drug compounds that help millions of 
Americans curb their addiction to illicit and prescription opioids can 
also be used effectively to treat chronic pain with a lower chance of 
addiction, abuse and overdose. However, it's my understanding that the 
CDC's Guideline for Prescribing Opioids for Chronic Pain, which was 
published in 2016, doesn't include any language about the benefits of 
Schedule III buprenorphine products, even though they have less 
potential for addiction and abuse, for the treatment of chronic pain. 
Instead, the Guideline recommends starting opioid therapy with 
immediate release Schedule II opioids, which have been shown to have 
higher rates of addiction, abuse and overdose.
    Do you know why the Guideline doesn't differentiate between 
Schedule II and Schedule III opioids and recommend the use of Schedule 
III opioids given their enhanced safety profile and lower risk of 
abuse, addiction and overdose?
    Answer. The evidence reviews informing the 2016 Guideline found 
evidence of increased risks from extended-release/long acting (ER/LA) 
full agonist opioids but did not identify other differences in safety 
or effectiveness by type of opioid, including by schedule. Therefore, 
there was no evidence on which to base recommendations to use different 
types of opioids (except recommendations on ER/LA vs. short-acting 
opioids).
    Question. Can you provide an update on the process and timing of 
the CDC's efforts to update the Guideline? Do you expect the updated 
Guideline to consider DEA scheduling and recommend prescribers begin 
opioid therapy with Schedule III drugs, when clinically appropriate, 
before advancing to a Schedule II Drug?
    Answer. CDC funded the Agency for Healthcare Research & Quality 
(AHRQ) to conduct systematic reviews of the scientific evidence that 
has been published since the Guideline's release in March 2016. These 
reviews are the following:
  --Noninvasive Nonpharmacological Treatment for Chronic Pain (An 
        Update)
  --Nonopioid Pharmacologic Treatments for Chronic Pain
  --Opioid Treatments for Chronic Pain
  --Treatments for Acute Pain: A Systematic Review
  --Acute Treatments for Episodic Migraine
    Based on AHRQ's completed reviews, CDC has determined that an 
update to the Guideline and an expansion of the Guideline to certain 
acute conditions is warranted.
    On December 4, 2019, the Board of Scientific Counselors of the 
National Center for Injury Prevention and Control (BSC/NCIPC) 
established the Opioid Workgroup (OWG). The OWG will report to the BSC/
NCIPC, a Federal advisory committee. The primary purpose of the OWG is 
to review the updated draft Guideline for opioid prescribing (as 
prepared by CDC) and to develop a report that will provide the 
workgroup's findings and observations about the draft GL to the BSC/
NCIPC.
    The OWG began reviewing a draft Guideline for opioid prescribing 
(as prepared by CDC) in March 2021. The OWG met for a total of 11 times 
since October 2020 and developed a report of findings and observations 
about the draft Guideline update (prepared by CDC). The OWG presented 
its findings at the July 2021 BSC/NCIPC meeting. The BSC/NCIPC will 
then review the OWG's report and provide recommendations for CDC to 
consider as part of the Guideline update process.
    It is anticipated that a revised Guideline will be posted in the 
Federal Register for a 60-day public comment in late 2021, which will 
provide a critical opportunity for diverse input from the public.
    Release of a final updated Guideline is anticipated to occur in 
late 2022.
    On opioid therapy--there are very limited clinical trial data 
comparing safety and efficacy of partial agonist buprenorphine with 
full agonist/schedule II opioids for chronic pain. In order to ensure 
that the updated guideline would be informed by available clinical 
evidence on types of opioids, CDC asked AHRQ to specifically address, 
in its evidence review on opioids for chronic pain to inform CDC's 
guideline update, the following questions on effectiveness and safety 
of opioids by type of opioid:
    ``Key Question 1. Effectiveness and Comparative Effectiveness . . . 
        . b. How does effectiveness vary depending on . . .  (4) the 
        type of opioids used (e.g., pure opioid agonists, partial 
        opioid agonists such as buprenorphine or drugs with mixed 
        opioid and nonopioid mechanisms of action such as tramadol or 
        tapentadol)?''
    ``Key Question 2. Harms and Adverse Events . . . . b. How do harms 
        vary depending on . . .  (5) the mechanism of action of opioids 
        used (e.g., are there differences between pure opioid agonists 
        and partial opioid agonists such as buprenorphine or drugs with 
        opioid and nonopioid mechanisms of action such as tramadol and 
        tapentadol) . . . ?''
    The AHRQ evidence review published in 2020 found very limited 
evidence on comparative safety or effectiveness of opioids for chronic 
pain by type of opioid. Please see the report for additional detail, 
which can be found at https://effectivehealthcare.ahrq.gov/sites/
default/files/pdf/opioids-chronic-pain.pdf.
    CDC is considering all findings from the AHRQ evidence reviews in 
developing updated recommendations.

                          SUBCOMMITTEE RECESS

    Senator Murray. The committee we will next meet in Dirksen 
562, Wednesday, May 26 at 10 a.m., for a hearing on the Biden 
Administration's Budget Request for the National Institutes of 
Health.
    Thank you very much.
    [Whereupon, at 11:50 a.m., Wednesday, May 19, the 
subcommittee was recessed, to reconvene at 10 a.m., Wednesday, 
May 26.]