[Senate Hearing 118-]
[From the U.S. Government Publishing Office]


 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2024

                              ----------                              


                         THURSDAY, MAY 4, 2023

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met, at 10 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Tammy Baldwin (chairwoman) 
presiding.
    Present: Senators Baldwin, Murray, Durbin, Shaheen, Schatz, 
Capito, Moran, Kennedy, Boozman, Britt, and Collins.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF DR. LAWRENCE TABAK, ACTING DIRECTOR
ACCOMPANIED BY:
        DR. DOUGLAS LOWY, PRINCIPAL DEPUTY DIRECTOR, NATIONAL CANCER 
            INSTITUTE
        DR. JOSHUA GORDON, DIRECTOR, NATIONAL INSTITUTES OF MENTAL 
            HEALTH
        DR. RICHARD HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
        DR. NORA VOLKOW, DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE


               opening statement of senator tammy baldwin


    Senator Baldwin. Good morning. I want to welcome everyone 
to the Senate Appropriations Subcommittee on Labor, Health, and 
Human Services, Education, and Related Agencies hearing on 
fiscal year 2024 budget request for the National Institutes of 
Health, and today I am happy to welcome Acting Director Tabak 
and his colleagues and I will introduce you all before the 
testimony begins.
    These hearings are essential for our subcommittee to assess 
our country's needs for the coming year. For NIH (National 
Institutes of Health), this means providing our scientists with 
what they need to conduct cutting edge research, to discover 
and develop treatments to help patients fighting disease.
    As I happen to be the granddaughter of an NIH-funded 
scientist, my grandparents raised me and I understand what an 
important role biomedical research plays not just in treating 
and curing disease but also in bolstering our economic growth 
and ensuring that America is a global leader in innovation.
    We cannot afford to have NIH's potential limited or even 
worse have its legs cut out from under it. Yet that is 
precisely what the House Republicans have proposed to do with 
their fiscal year 2024 budget caps in the bill that they passed 
last week.
    Cutting spending as they have proposed would mean slashing 
approximately 22 percent from programs next year that support a 
range of programs, including supporting our veterans, keeping 
our communities safe and healthy, and doing vital research to 
find cures for illnesses and diseases.
    It would mean a cut of over $10 billion in fiscal year 2024 
alone for life-saving medical research at NIH. An extreme cut 
like that would mean NIH could fund 5,000 fewer grants and 
would shutter hundreds of labs across the country. It would 
stall training for the next generation of researchers and 
result in fewer drugs being developed for cancer, Alzheimer's 
disease, diabetes, serious mental illness, and other 
devastating conditions.
    This would slow progress to find treatments for disease and 
weaken America's competitiveness, particularly against China, 
and increase our reliance on foreign countries for clinical 
trials and drug development.
    Fortunately, here in the Senate, Ranking Member Capito and 
I are focused on writing a bipartisan Labor/HHS (Health and 
Human Services) spending bill to move our country forward. We 
are committed to working together to find compromise.
    Our communities are depending on us to continue providing 
the support needed to combat the opioid epidemic, the mental 
health crisis, and so many other challenges.
    Every day across Wisconsin researchers at world-class 
institutions, like Marquette University, the Medical College of 
Wisconsin, and the University of Wisconsin System, are working 
around the clock and making ground-breaking discoveries.
    I'm pleased to say this subcommittee has a proven track 
record of recognizing the tremendous importance of supporting 
our Nation's biomedical research community.
    Acting Director Tabak, I'm pleased to see that the 
Administration's budget request for NIH would increase funding 
for the Cancer Moonshot and Mental Health Research, and I look 
forward to learning about the agency's plans to deliver new 
cancer treatments with fewer side effects and develop a 
precision psychiatric initiative, but I'm disappointed to see 
programs that aim to address maternal mortality, the opioid 
epidemic, Alzheimer's disease, and health disparities and 
develop a universal flu vaccine to name just a few, that those 
programs remain flat or are actually cut in the proposal.
    I look forward to working with my colleagues to ensure NIH 
has the resources it needs across its 27 institutes and centers 
to continue the progress of recent years.
    I have been glad to see NIH working to examine barriers to 
diversity among its researchers and within its clinical trials 
and increased career opportunities for groups that are 
underrepresented in biomedical research, but there is still a 
long way to go, and in the meantime, these remain real problems 
with real consequences for research.
    Finally, before I turn it over to Senator Capito, I want to 
mention an article published last week in Science revealing 
NIH's failure to discipline an investigator with a known 
documented history of sexual harassment.
    In March of 2022, after years of urging NIH to take 
decisive action, this subcommittee wrote policy into law 
requiring institutions to inform NIH of disciplinary actions 
taken against harassers to ensure accountability.Yet, following 
a far-reaching investigation at Florida State University that 
resulted in a 131-page report detailing years of severe 
pervasive sexual harassment, NIH approved the transfer of an 
investigator from FSU (Florida State University) to San Diego 
Biomedical Research Institute and awarded him a new $2.5 
million grant. Unsurprisingly, the abuse continued, driving at 
least one trainee out of the institution.
    It is outrageous that NIH is complicit in this case of pass 
the harasser and I want to know what you're doing to hold the 
researcher and institutions accountable and how you will 
prevent incidents like this from happening again in the future.
    So, Acting Director Tabak, I look forward to your testimony 
and appreciate your being here today.
    In a moment, I will turn it over to Ranking Member Capito 
for her opening remarks. Following Senator Capito's opening 
statement, we will hear from Acting Director Tabak and after 
that Senators will each have 5 minutes for the first round of 
questions.
    Senator Capito.


               statement of senator shelley moore capito


    Senator Capito. Thank you. Thank you, Madam Chair, and I 
agree with you. We need to do this together, work together. We 
have the Vice Chair here. So, she's riding hard on all of us as 
she is with the Chair. So, we are hopeful that we have a 
successful result.
    Dr. Tabak, thank you for being here and for your role in 
performing the functions as NIH Director, really appreciate 
this. You've done it since December 2021 and have helped steer 
NIH through some interesting times. Maybe you'll write a book 
or something.
    Dr. Volkow, thank you. Dr. Hodes, thank you. Dr. Gordon and 
Dr. Lowy, thank you for being here today to discuss some of the 
biggest health issues facing our Nation.
    This is an important opportunity for us to hear about the 
NIH budget proposal and better understand the priorities for 
fiscal year 2024.
    I've mentioned before that our jobs will be more 
challenging this year given the debt ceiling and fiscal 
challenges that face our Nation. Supported funding for 
biomedical research at NIH has long been a bicameral, 
bipartisan priority.
    The budget proposes $48.8 billion in discretionary spending 
for NIH, including 21st Century cures and ARPA-H (Advanced 
Research Project Agency for Health). NIH funding has seen 
almost a 60 percent increase for the last 8 years and these 
investments are for good reasons since NIH research affects 
every American in every way.
    As I look through the dais, I think of all the people that 
I know in my home State who are affected by your different 
disciplines.
    In West Virginia, NIH supports 952 jobs and a $142 million 
in economic activity during 2022 alone through the $49 million 
that were received in grants and contracts.
    This year we need to prioritize areas of agreement, such as 
funding to find cures and treatment for cancer, including 
childhood cancer, and funding for our academic research 
institutions.
    For example, in the fiscal year 2023 Omnibus, we 
reauthorized the Childhood Cancer Star Act, which I led with 
Senator Jack Reed and included in there $30 million to continue 
to implement it.
    The Cancer Star Act directs the National Cancer Institute 
to advance childhood cancer research to better understand and 
track the disease and enhance support for survivors and those 
affected by childhood cancer. Childhood cancers are different 
than adults and this specialized research is very important.
    West Virginia ranks above the national average both in new 
cancer diagnoses and deaths. So, I'm pleased that the budget 
devotes increases to the Cancer Moonshot and significant 
resources to the Advanced Research Project Agency for Health or 
ARPA-H to focus on finding cures and treatments for cancer.
    Another area I greatly support is for the NIH Institutional 
Development Award or the IDEA Program. There have been few 
programs as impactful to my State as the IDEA Program and I'm 
disappointed that these awards are flat funded in the 
President's budget.
    West Virginia University is one of 17 research institutions 
nationwide to participate in an IDEA, an Echo Program that was 
started in 2016. The collaboration between WVU (West Virginia 
University) establishes pediatric clinical trials throughout 
the entire State of West Virginia so that doctors and patients 
have access to the same treatments that are available at WVU's 
hospital in Morgantown.
    WVU is also a leader in NIH COVID research. Dr. Sally 
Hotter with WVU is co-leading an IEDEA States Consortium 
Initiative to better understand the long-term effects of COVID.
    The research capabilities at West Virginia University 
continue to prove that our West Virginia institutions can 
compete with any other institution in the country.
    I'm disappointed in some of the overall funding levels in 
the NIH proposed budget. First, there are no new resources 
specifically for Alzheimer's research at NIH which Dr. Hodes 
knows is a great passion of mine. An estimated 6.7 million 
people 65 or older are currently living with Alzheimer's in our 
country and the national cost of caring for those Alzheimer's 
and other dementias is estimated to reach $345 billion, not to 
mention the emotional cost on our families and care-givers.
    There's a lot of exciting research going on in this area. 
Alzheimer's and dementia-related research must remain a 
national priority.
    Also, substance abuse challenges facing the Nation 
basically are receiving just lip service in this budget as the 
National Institute on Drug Abuse is receiving flat funding.
    In 2021, fatal overdoses claimed nearly a 107,000 
Americans. Dr. Volkow has visited my State and has seen 
firsthand how we are in the crosshairs of the opioid and 
addiction crisis.
    Dr. Hodes, I know we are anxious to have you back in West 
Virginia and, frankly, I'd welcome all of you to visit West 
Virginia not just to see and learn but also to enjoy the State, 
as well, and meet the dedicated professionals.
    I know we're dealing with a tight budget year this year, 
but investments in biomedical research are so important for the 
future of our country.
    Listen. I want to thank all of you for what you do. I 
should have started with that because you're in an exciting 
time for research and exciting time for break-throughs, and we 
want to support you as well as we can.
    So, thank you.
    Senator Baldwin. Thank you, Senator Capito, and I will now 
introduce our witnesses.
    Dr. Lawrence Tabak is the Acting Director of the National 
Institutes of Health.
    Dr. Joshua Gordon is the Director of the National Institute 
of Mental Health.
    Dr. Richard Hodes is the Director of the National Institute 
on Aging.
    Dr. Douglas Lowy is the Principal Deputy Director of the 
National Cancer Institute.
    Dr. Nora Volkow is the Director of the National Institute 
on Drug Abuse.
    I want to thank you all for joining us and underscore what 
Senator Capito just said. Thank you for what you do and how you 
have devoted your careers.
    Acting Director Tabak, you may deliver your opening 
remarks.


                summary statement of dr. lawrence tabak


    Dr. Tabak. Thank you, Chair Baldwin, Ranking Member Capito, 
and Distinguished Subcommittee Members.
    I'm honored to be here today representing the National 
Institutes of Health.
    Our mission at NIH is to seek fundamental knowledge about 
the nature and behavior of living systems and to apply that 
knowledge to save lives and improve health. Fundamental, 
translational, and clinical research are critical components of 
the biomedical research enterprise.
    However, fundamental or basic research rarely makes 
headlines. Understanding how proteins fold or how gene activity 
is controlled doesn't often improve human health immediately, 
but fundamental research is essential to making breakthrough 
discoveries that lead to treatments and cures.
    A paper published last Friday in the Journal of the 
American Medical Association indicated that NIH funding 
contributed to the development of 354 out of 356 new drugs 
approved by the U.S. FDA (Food and Drug Administration) from 
2010 to 2019.
    NIH supported the foundational evidence that pharmaceutical 
companies leveraged to develop life-saving drugs and many 
thousands of patents.
    I've spoken to this subcommittee previously about how 
fundamental research from NIH supported scientists and 
collaborators positioned the United States to develop COVID-19 
vaccines on an unprecedented timeline, but there are many other 
examples of how fundamental research has led to improvements in 
the health of Americans.
    One such case is the breakthrough stroke treatment tissue 
plasminagen activator or TPA that resulted from decades of work 
conducted across biological disciplines. Researchers first 
found the enzyme on cells that line blood vessels in 1946. 
Three decades later, certain cancer cells were found to secrete 
TPA in large quantities and once purified the purifying enzyme 
dissolved clots in animal models.
    A decade after that, using recombinant DNA technology NIH-
supported clinical trials led to the approval of TPA to treat 
heart attacks and then in the 1990s TPA transformed the 
treatment of stroke, allowing most patients who are treated 
within 3 hours to make a full recovery with far reduced health 
costs.
    Many of our most important advances have come when we were 
not even thinking about a direct application. Decades ago, NIH-
funded research on how bacteria protect themselves from 
viruses, for example. No one involved could have predicted that 
this research would lead to tools that have revolutionized all 
of medicine.
    Because of research on recombinant DNA in the 1960s, it 
became possible to produce drugs like human insulin and TPA for 
widespread use starting in the 1980s.
    Continued investments led to the transformative approaches 
for gene editing, such as CRISPR. This highly-versatile 
technology has revolutionized how basic research is conducted 
and how diseases may be treated, including such things as 
sickle cell and antibiotic resistant urinary tract infections.
    Discoveries build upon each other in ways that we cannot 
necessarily predict. Sustained public investment in fundamental 
research is essential to the discovery and development of new 
medical treatments.
    To foster the application of fundamental research, NIH 
continues to support translational research studies and 
collaborate with industry to advance crucial interventions for 
the public.
    As most of you know, Naloxone is a life-saving treatment 
that can quickly restore normal breathing when somebody 
overdoses on opioids. This drug is an essential tool in the 
fight against the opioid overdose crisis which claims 188 lives 
in the U.S. every day.
    Injectable Naloxone was used for years but an easier 
intervention was needed. In 2013, scientists from the National 
Institute on Drug Abuse created a stable formulation of 
concentrated Naloxone for use in a nasal spray injector 
developed by an industry partner. Working together, they 
conducted clinical trials to evaluate the nasal spray 
formulation, providing the pivotal data to support FDA approval 
of Narcan in 2015, and just a few weeks ago the FDA approved 
Narcan for use without a prescription.
    NIH-supported discoveries have affected nearly all of our 
lives from research studies that lay the foundation for future 
advances to clinical trials that evaluate potentially life-
saving interventions.
    Your continued support of our mission to help people live 
longer and healthier lives is crucial.
    I thank you for your time and I welcome your questions.
    [The statement follows:]
         Prepared Statement of Lawrence A. Tabak, D.D.S., Ph.D.
    Good morning, Chair Baldwin, Ranking Member Capito, and 
distinguished Members of the Subcommittee. I am Lawrence A. Tabak, 
D.D.S., Ph.D., privileged to be Performing the Duties of the Director 
of the National Institutes of Health (NIH). Thank you for the 
invitation to appear before you today so that I may provide you with 
information about our efforts in pandemic preparedness and our Fiscal 
Year (FY) 2024 budget request.
    I truly appreciate the Committee's ongoing bipartisan support for 
NIH. As a result of this support, scientific advances have been made 
that reach people of all ages across the United States. From improving 
treatment options for substance use disorders to developing vaccines to 
prevent infectious diseases to discovering novel cancer treatments, the 
investment Congress continues to make in NIH improves the health of 
your communities.
    The FY 2024 President's Budget builds on the Committee's investment 
in numerous public health challenges including maternal health, mental 
health, and health disparities research. In addition, it builds on the 
Reignited Cancer Moonshot,\SM\ continues efforts to develop a universal 
influenza vaccine, increases focus on substance use disorders, and 
prioritizes innovative nutrition research to reduce diet-related 
diseases.
                  steady progress on pandemic response
    The COVID-19 global pandemic demonstrated how fundamental research, 
and early-stage discovery, design, and development of vaccines and 
therapeutics can yield impactful results in a short amount of time. As 
we continue to address the effect of the pandemic on the public's 
health, a sustained investment in biomedical research is necessary to 
ensure our momentum on current vaccine and treatment options against 
future emerging infectious agents.
    NIH was able to respond efficiently to the COVID-19 pandemic by 
capitalizing on decades of basic and applied research to facilitate the 
rapid development of vaccines, therapeutics, and diagnostics. These 
continue to be important tools to reduce the threat of disease. Over 
the past 3 years, NIH established networks and initiatives that are 
cornerstones in the study of and response to pandemic threats. This 
includes the Antiviral Program for Pandemics, the Rapid Acceleration of 
Diagnostics (RADx) initiative, and the Accelerating COVID-19 
Therapeutic Interventions and Vaccines (ACTIV) public-private 
partnership.
    We are also grappling with a new public health challenge as we 
begin to understand the long-term effects of the COVID-19 pandemic, 
including Post-Acute Sequelae of SARS-CoV-2 Infection (PASC, also 
commonly known as ``Long COVID'') and the mental health effects of the 
pandemic. Furthermore, NIH continues to apply lessons learned during 
the COVID-19 pandemic to address other public health issues, including 
the recent mpox Public Health Emergency, and to help prepare for future 
pandemics.
        capitalizing on vaccine research for universal influenza
    Influenza viruses are deadly and costly pathogens that place a 
substantial health and economic burden on the United States and across 
the world each year. In the United States, the CDC estimates that the 
disease burden of influenza has resulted in between 9.2 million and 
35.6 million illnesses, between 140,000 and 710,000 hospitalizations, 
and between 12,000 and 56,000 deaths annually since 2010, all of which 
results in an estimated $27 billion in health costs. Pandemic 
influenza--which occurs when a new, non-human flu virus emerges from an 
animal source with the capacity to spread readily from person to 
person--can pose an even greater threat. Current influenza vaccination 
strategies rely on the development of an annual vaccine targeting the 
circulating strains that are anticipated to spread in the United 
States. However, this approach does not always yield high levels of 
protection against seasonal strains and offers little to no protection 
against pandemic influenza viruses.
    NIH seeks to develop a universal influenza vaccine that would 
generate robust, long-lasting protection against multiple subtypes of 
influenza, eliminating the need to update the vaccine each year and 
protect against newly emerging strains with pandemic potential. In 
2022, a Phase 1 clinical trial began enrolling healthy volunteers at 
the NIH Clinical Center to assess the safety and efficacy of a novel 
universal flu vaccine candidate.\1\ Building upon the success of mRNA 
vaccines developed during the COVID-19 pandemic, NIH is working to 
apply this platform to the universal influenza vaccine development. 
Additionally, NIH-supported researchers are actively identifying and 
developing novel adjuvants for influenza vaccines to increase their 
immunogenicity and effectiveness. Continued investment in this research 
will enable the development of more broadly protective and longer-
lasting influenza vaccines. The FY 2024 budget request includes $270.0 
million for universal influenza vaccine research, the same as the FY 
2023 Enacted level.
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    \1\ www.nih.gov/news-events/news-releases/trial-potential-
universal-flu-vaccine-opens-nih-clinical-center.
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                    a reinvigorated cancer moonshot
    In FY 2024, the President's Reignited Cancer Moonshot Initiative 
\2\ will support priority investments to advance the goals of the 
Reignited Cancer Moonshot which includes cutting America's cancer death 
rate by 50 percent over the next 25 years. Since its establishment in 
2016, the Beau Biden Cancer Moonshot has supported over 250 research 
projects that pushed the boundaries of discovery and collaboration on 
behalf of cancer patients. The President's Budget includes an increase 
of $500.0 million for the Cancer Moonshot from the FY 2023 Enacted 
level, for a total of $716.0 million, with further increases proposed 
in FY 2025 and FY 2026 using mandatory funding.
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    \2\ www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative.
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    Clinical trials play a prominent role in evaluating new cancer 
prevention, screening, and treatment approaches. NIH National Cancer 
Institute (NCI) funding will focus on doubling the number and 
increasing the diversity of people who enter NCI-sponsored clinical 
trials to develop new prevention, diagnostic, and therapeutic 
approaches at a more rapid pace. Funding will also support continued 
work towards increasing the pipeline of new cancer drugs. Additionally, 
the resources will fund a major trial to evaluate multi-center 
detection tests, the Cancer Moonshot Scholars program, and the NCI 
Telehealth Research Centers of Excellence, allowing the agency to 
sustain progress towards meeting the President's goal to end cancer as 
we know it. The FY 2024 proposal fully aligns with the following seven 
pillars of the Reignited Cancer Moonshot, which include diagnosing 
cancer sooner; preventing cancer; addressing inequities; targeting the 
right treatments to the right patients; accelerating progress against 
the most deadly and rare cancers, including childhood cancers; 
supporting patients, caregivers, and survivors; and learning from all 
patients.
             enhancing nutrition research and food security
    The Office of Nutrition Research (ONR), within the NIH Office of 
the Director, focuses on advancing nutrition science to promote health, 
and to reduce the burden of diet-related diseases and nutrition health 
disparities. The budget includes an increase of $120 million to support 
nutrition research, including investments that will advance the goals 
of the White House National Strategy on Hunger, Nutrition, and Health. 
Resources will expand the efforts of the NIH Common Fund Community 
Partnerships to Advance Science for Society, and help to ensure 
diversity and inclusion in nutrition, health, and food security 
research. Funding will also allow NIH to focus on expanding and 
diversifying the nutrition science workforce and investing in creative 
new approaches to advance research regarding the prevention and 
treatment of diet-related diseases, including the Food is Medicine 
initiative and an Artificial Intelligence for Precision Nutrition 
program.
    ONR is also collaborating with the NIH Institutes and Centers on a 
transformative research program examining the role of diet, food 
environment and related environmental exposures on the Developmental 
Origins of Health and Diseases. There is increasing concern that food 
environment, life stress, traumas, medications, health and nutritional 
status, microbiome ecology, and related environmental exposures are 
responsible for future diet-related disease risk. This discovery 
science program will also include a comprehensive study of human milk 
composition, dietary intake, and nutritional status measures and 
outcomes, answer mechanistic questions about the developmental origins 
of disease, and ultimately, lead to an optimized diet for the health of 
the mother and child.
         revolutionizing mental health with precision medicine
    With the FY 2024 President's Budget Request, NIH intends to direct 
increased attention towards mental health across all ages. Mental 
illnesses are the fifth leading cause of disability in the United 
States, accounting for 6.6 percent of all disability-adjusted life 
years in 2019. Exacerbated by the pandemic, suicide rates for youth 
have risen over the past 2 decades in the United States; in 2020, an 
estimated 6,643 youth ages 10 to 24 died by suicide.\3\ Despite 
advances in the treatment of depression and other serious mental 
illnesses, there remain few evidence-based interventions that rapidly 
reduce suicide risk within healthcare settings. Finding the right 
treatment for a specific individual required a trial-and-error process 
that can lead to unacceptable delays in receiving effective treatment. 
The President's Budget includes efforts to apply the concepts of 
precision medicine to the field of psychiatry through the Precision 
Psychiatry Initiative. This initiative includes two component parts: 
(1) an innovation funnel to rapidly identify and assess biomarkers for 
the treatment for depression with the intent to lead to large-scale 
clinical trials; and (2) a data-driven refinement of precision 
diagnostics to study patterns of clinical trajectories and treatment 
response across large cohorts over time.
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    \3\ wisqars.cdc.gov/data/explore-data/explore.
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    Serious Mental Illness (SMI) is a major, albeit less known, risk 
factor for COVID-19,\4\ and people with SMI are more prone to SARS-CoV-
2 infection and are more likely to require hospitalization and die from 
severe COVID-19. NIH supports research on many facets of mental health 
including rapid interventions to reduce severe suicide risk, funding 
adaptive interventions to optimize adolescent mental health treatments, 
and aggregating data to address mental health disparities research 
gaps. In response to the pandemic, NIH launched a project to support 
research focused on the social, behavioral, and economic impacts of 
COVID-19. The project supports research on the secondary effects of the 
pandemic, such as financial hardship, reduced access to healthcare, and 
school closures.\5\ This initiative includes NIMH-supported research 
on: the impact of COVID-19 mitigation efforts on socioeconomic 
disparities in mental health and healthcare utilization; the 
effectiveness of digital health apps like Headspace as a just-in-time 
approach to immediate, personalized behavioral healthcare; the 
effectiveness of a digital platform on depression/anxiety symptoms of 
healthcare workers during the COVID-19 pandemic; and effectiveness, 
barriers, and facilitators to the implementation of a gold standard 
exposure treatment for post-traumatic stress disorder in healthcare 
system employee assistance programs serving frontline healthcare 
workers.
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    \4\ nimh.nih.gov/health/statistics/mental-illness.
    \5\ covid19.nih.gov/news-and-stories/covid19-ripple-effects.
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    making progress on health disparities and inequities in research
    Building on investments made by this committee over the past 
several years, NIH hopes to continue the agency-wide effort to reduce 
health disparities across racial and ethnic minority, rural, low-
income, and other underrepresented and marginalized populations. The 
President's Budget requests $95 million to sustain health disparities 
research across the Institutes and Centers that are developing and 
testing interventions appropriately tailored to the breadth of clinical 
and community services found in diverse settings and contexts.
    UNITE, launched in February 2021, is an NIH-wide, collaborative 
effort comprised of five workstreams with distinct but coordinated 
objectives to tackle the problem of racial and ethnic equity in science 
while developing data-driven methods to promote diversity, equity, and 
inclusion across the biomedical and behavioral enterprise. To 
thoroughly address structural racism that may exist within the 
enterprise, UNITE works across three domains--Health Disparities and 
Minority Health Research, the internal NIH workforce, and the external 
biomedical and behavioral research workforce. Data gathering and 
analysis are central to all activities, and therefore evidence drives 
the work of UNITE. UNITE goals and charges are aligned with fundamental 
tenets of the NIH-Wide Strategic Plan for 2021--2025,\6\ the NIH 
Minority Health and Health Disparities Strategic Plan 2021--2025,\7\ 
and the NIH-Wide DEIA Strategic Plan for 2022--2026, released in March 
2023.\8\
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    \6\ www.nih.gov/sites/default/files/about-nih/strategic-plan-
fy2021-2025-508.pdf.
    \7\ www.nimhd.nih.gov/docs/nimhd-strategic-plan-2021-2025.pdf.
    \8\ diversity.nih.gov/about-us/strategic-plan.
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                   combatting overdose and addiction
    Opioid misuse, addiction, and overdose are among several widespread 
public health crises that were exacerbated by the pandemic. Since the 
pandemic, studies have found increases in the use of illicit drugs 
including fentanyl, cocaine, heroin, methamphetamine, cannabis,\9\ and 
most recently xylazine. Founded in 2018, the Helping to End Addiction 
Long-term (HEAL) initiative strives to address opioid addiction by 
developing new treatments and strategies to address both pain and 
opioid use disorder as well as advance healthy equity by acknowledging 
the environmental factors that contribute to drug use and chronic pain. 
In FY 2024, HEAL will focus on the health effects of taking multiple 
drugs together, find tailored treatment approaches, such as combination 
therapies, for different environments, and continue research on health 
disparities in treatment for opioid use disorder, neonatal opioid 
exposure and maternal health, and integrated pain and mental health 
treatments.
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    \9\ https://nida.nih.gov/research-topics/comorbidity/covid-19-
substance-use.
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    Opioid use is not the only alarming trend in addiction and 
overdose. The misuse of stimulants, such as methamphetamine, is also 
increasing, as are deaths attributed to combining opioids and 
stimulants. Improved prevention and treatment strategies are needed for 
both opioid use disorder and co-occurring conditions such as mental 
health conditions and polysubstance use for a range of at-risk 
populations and in various settings. Recently launched HEAL programs 
aim to develop safe and effective treatments, as well as define 
approaches to improve treatment access and retention in various 
settings.
              preventing maternal morbidity and mortality
    Even during a global pandemic, NIH continued to focus on other 
long-standing yet urgent public health needs. The CDC estimates 1,200 
women die each year in the United States of maternal causes, 80 percent 
of which are preventable, and thousands more experience severe 
pregnancy-related morbidity.\10,11\
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    \10\ www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-
mortality-rates-2021.htm.
    \11\ www.cdc.gov/reproductivehealth/maternal-mortality/erase-mm/
data-mmrc.html.
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    To address this alarming trend, NIH established an agency-wide 
collaboration called the Implementing a Maternal health and Pregnancy 
Outcomes Vision for Everyone (IMPROVE) Initiative \12\ which is an 
evidence-based approach to reduce preventable maternal and pregnancy-
related deaths and associated health disparities for women at all 
stages of pregnancy. To build on the momentum made by the committee's 
previous investments, the FY 2024 President's Budget requests $30 
million to continue the IMPROVE Initiative. In addition, the request 
also includes $3 million for the Eunice Kennedy Shriver National 
Institute of Child Health and Human Development to support research on 
mitigating the effects of COVID-19 on pregnancies, lactation, and post-
partum health with a focus on individuals from racial and ethnic 
minority groups.
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    \12\ www.nih.gov/research-training/medical-research-initiatives/
improve-initiative.
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    In summer 2023, IMPROVE will implement a national network of 
Maternal Health Research Centers of Excellence to support research 
projects that build on previous research and take innovative, community 
tailored approaches to address health disparities and risk factors for 
maternal morbidity and mortality. This research supports the 
development of earlier interventions to decrease or prevent negative 
maternal outcomes and promote maternal health equity.
                      nih buildings and facilities
    Facilities must co-evolve with science for NIH to achieve its full 
potential. A major component of the NIH Building and Facilities (B&F) 
program is the Repair & Improvement (R&I) program, which enables NIH to 
maintain and improve the performance of existing facilities throughout 
their life cycle. A key aspect of NIH's strategy is to sustain the 
condition of existing facilities to prevent premature deterioration and 
the curtailment of research. These investments help reduce the 
likelihood and consequences of building emergencies associated with 
NIH's Backlog of Maintenance and Repairs (BMAR) of nearly $3.8 billion 
across all campuses as of the end of FY 2022. NIH requests a funding 
level for B&F of $350.0 million, maintaining the FY 2023 Enacted level. 
This level is designed to address the pressing campus-wide 
infrastructure needs identified in the independent review of the 
facility needs of NIH's main campus in 2019 by the National Academies 
of Sciences, Engineering, and Medicine (NASEM). In addition to the B&F 
appropriation, NIH has received support for critical infrastructure 
projects in recent years from targeted allocations from the 
Nonrecurring Expenses Fund (NEF). In FY 2024, NIH is requesting a total 
of $120.1 million in NEF funding for five critical infrastructure 
projects on the Bethesda campus.
    NIH plans to execute various modernization and repair projects to 
NIH's research hospital, replace research animal facilities with a 
centralized and more efficient facility, improve facilities that 
advance computational and data science, replace temporary and obsolete 
administrative support facilities with permanent buildings, improve the 
energy and water efficiency of buildings, and support the co-evolution 
of science and buildings.
                               conclusion
    Turning discovery into health remains the central goal and mission 
of NIH. Improving health across the lifespan is essential to 
maintaining our country's greatest asset: its people. The NIH research 
community is fervently working on all fronts--from individualized 
medicine to societal level pandemic response--to foster new discoveries 
and catalyze breakthroughs in research. With the support of this 
Committee, NIH looks forward to tackling timely public health 
challenges through rigorous and innovative science in FY 2024. I look 
forward to answering your questions.

    Senator Baldwin. Thank you, Dr. Tabak.
    We will now begin our round, first round of questions. I 
have several questions that I want to get to, but first, as I 
noted in my opening statement, the House Republicans last week 
passed a bill that would have devastating impacts on biomedical 
research.

                           HOUSE BUDGET CUTS

    What they have proposed would require deep cuts to the NIH 
and would lock in those cuts over the next decade. I outlined a 
list of impacts I believed it might have on NIH.
    Very briefly, is there anything that you would like to add 
about what a more than $10 billion cut would mean for NIH 
research, including if those cuts were sustained over the next 
decade?
    Dr. Tabak. In addition to the numbers that you provided, 
Chair Baldwin, it would be a chilling effect on the entire 
biomedical research enterprise. It'll decrease interest in 
research careers and, as you well know in times of fiscal 
stress, disproportionately young investigators are the ones who 
suffer the most.
    It really bodes poorly for the future of biomedical 
science.
    Senator Baldwin. Thank you.

                          BIOSAFETY INCIDENTS

    Dr. Tabak, research that involves enhanced potential 
pandemic pathogens must be accompanied by safeguards and 
conducted under strict biosafety and biosecurity measures.
    There have been two biosafety incidents involving the H5N1 
virus at the University of Wisconsin, Madison, campus. The CDC 
(Centers for Disease Control and Prevention) considered a 2013 
incident a serious exposure that required a researcher to 
quarantine for a week, which they ended up doing at home rather 
than at a dedicated quarantine facility.
    NIH officials didn't find out about an incident in 2019 
until 10 days after a trainee had been exposed. In March, the 
National Science Advisory Board for Biosecurity published a 
report recommending the U.S. expand the scope and impose 
stricter oversight of federally-funded research on dangerous 
pathogens. This includes NIH-funded studies overseas.
    Dr. Tabak, how will the NIH increase its oversight of this 
research and ensure institutions are held accountable when 
incidents happen?
    Dr. Tabak. So, as you know, the NSABB (National Science 
Advisory Board for Biosecurity) recently provided its report to 
HHS and this is informing ongoing discussions across the USG.
    I can't presume what those discussions will yield but I can 
speak to what NIH is doing in the meantime.
    First, we are considering how best to elevate the 
transparency and oversight of the decision process that we use 
at NIH that feeds into the HHS oversight function.
    We are also developing approaches to partner more 
effectively with our applicant organizations by developing new 
materials which will clarify both institutional and NIH 
responsibilities in the process.
    We're also performing a comprehensive review to our 
resisting recombinant DNA and synthetic molecules policies to 
ensure that we capture biosafety considerations related to 
emerging technologies, like CRISPR.
    Senator Baldwin. I appreciate your answer.
    I just want to comment also that when we look at this 
oversight, we want to make sure that we don't prompt scientists 
to move their experiments to countries where there are less 
stringent requirements. It's a balance that we must reach.
    Dr. Volkow, I'm concerned that this budget request leaves 
opioid research flat footed. Our communities continue to 
struggle with an opioid crisis and fentanyl is making it so 
much worse.
    Fentanyl is 50 times stronger than heroin and a hundred 
times stronger than morphine and it has become the leading 
cause of death for people 18 to 45. In my home State of 
Wisconsin, synthetic opioids, primarily fentanyl, were 
identified in 91 percent of opioid overdose deaths from 2021 to 
2022.
    I've heard from families across Wisconsin of lost loved 
ones to fentanyl poisonings and overdoses. We have to utilize 
every tool in our toolbox, from stopping it from coming into 
our country to preventing its use to bringing an end to this 
national crisis.
    Last October, the Wisconsin Department of Health Services 
distributed a 120,600 fentanyl test strips to organizations 
across the State to help prevent drug overdose deaths.
    Doctor, what does research show about how effective 
fentanyl test strips are in a real-world setting?
    Dr. Volkow. The data is actually showing that they are 
effective in changing the practices of people that are 
intending to use drugs when these come back negative and 
research is ongoing to actually strengthen the guidelines that 
can then inform the users on how to take these drugs in a more 
safe way and how to test them.
    Senator Baldwin. Thank you.
    I see my time has ended. I'm going to turn it to Senator 
Capito.
    Senator Capito. Thank you.

                            CHILDHOOD CANCER

    Dr. Lowy, I wanted to talk a little bit about the childhood 
cancer that I spoke about in my opening statement. I talked 
about the Star Act, but I guess what I would ask you is where 
are you seeing the most promising advances in terms of being 
able to make advances in this pediatric cancer space and what 
are some of the differences or the top challenges that you 
have?
    Dr. Lowy. Senator Capito, I really want to thank you and 
Senator Reed for the initial passage of the Star Act and its 
reauthorization this year and as you know, we are able as a 
result to support areas for cancer survivors, for improving our 
biospecimens, and then for collaborating with the Childhood 
Cancer Initiative to develop molecular characterization in more 
detail.
    We hope that these and other advances will be able to 
improve the lives of children who develop cancer, both with 
improved treatment as well as with less toxicity. There have 
been several FDA approvals over the last few years but it's not 
enough.
    Children who get cancer, as you know, terrible. Children 
who die from cancer, even worse. We are working hard at the NCI 
(National Cancer Institute) to support research that is 
specifically targeted to molecules that are able to interfere 
with specific abnormalities in a wide range of childhood 
cancers.
    As you said in your opening statement, childhood cancers 
are not adult cancers in children but they are qualitatively 
different and we take advantage of that.
    Thank you very much.
    Senator Capito. Thank you. Thank you.

                  ALZHEIMER'S AND PARKINSON'S RESEARCH

    Dr. Hodes, I want to ask you about the flat funding in 
Alzheimer's which makes absolutely no sense to me when we see 
the raging numbers. We know there have been a lot of 
breakthroughs recently, but I also wanted to ask you about 
Parkinson's disease because I think--I don't know that it's 
related to Alzheimer's, but it's a neurodegenerative disease.
    Senator Murphy and I have just put a bill in that's leading 
legislation, National Plan to End Parkinson's Act, which would 
coordinate the research across the Federal Government and other 
ways.
    So can you first talk about Alzheimer's and then the 
Parkinson's issue, on the Alzheimer's, the budgeting issue and 
then on the Parkinson's, what breakthrough kind of things are 
you anticipating, are you seeing within your research?
    Dr. Hodes. In terms of Alzheimer's disease research, we're 
clearly at a very exciting juncture, as many of you all have 
seen in the news, which, to be perfectly clear, the outcome of 
congressional support and NIH-funded research has led from 
translation of basic practice into clinical trials which are 
now showing effects for the first time.
    The necessary funds to continue research in this area are 
important as we recognize it from the brains in people with 
Alzheimer's is really a very diverse disease. No one treatment 
is likely to be sufficient for all and promising reflection of 
what we have been able to accomplish, for example, are now some 
59 early stage Phase 1 and Phase 2 clinical trials, only eight 
of which are targeted to amyloid. The other 51 are towards 
other diverse targets, such as inflammation, protein folding, 
and ultimately it's going to be the ability to personalize 
which of these is most effective for individuals.
    So your question about budget and momentum reflects on the 
fact that if there were a limit in resources, we'd, of course, 
do our best to ration them appropriately but it would mean a 
slowing of this whole and very successful pipeline from basic 
discovery for clinical trials research.
    I'd also add that as we are seeing a time when clinical 
trial results are going to be translated into common practice 
in the communities, we are going to have to look very carefully 
at what happens when treatment reaches the community. Which 
individuals profit most? Who is most at risk for side effects? 
This is going to mean monitoring these outcomes in a way that 
we haven't done before.
    To touch briefly perhaps on Parkinson's disease, the 
potential for a national plan equivalent to what has happened 
in Alzheimer's disease, I can only project could be as 
extraordinarily valuable as it has been for Alzheimer's 
disease.
    I think you may be referring in fact to one particular 
discovery of a new sensitive means for a biomarker 
accomplishment in Parkinson's that shows the promise of 
detecting disease even before clinical symptoms and biomarkers 
as they have been in Alzheimer's disease are very critical to 
identification early to monitor the effects of clinical trials 
and to making the appropriate interventions available to the 
broadest diverse populations.
    Senator Capito. Well, thank you. Just as a comment, thank 
you very much. I would agree now is not the time for us to take 
the foot off the pedal when we're starting to see these early 
breakthroughs that affect so many families across the country. 
Thank you.
    Senator Baldwin. Chair Murray.
    Senator Murray. Well, thank you very much, Chair Baldwin, 
and Ranking Member Capito.
    As Senator Collins and I have said from the start of these 
hearings, we are very determined to get back to regular order 
and make sure we pass the funding necessary to keep our 
families safe and healthy and keep our Nation competitive and 
that simply has to include providing robust funding for the 
National Institutes of Health.
    If we want to continue to lead on the world stage, we have 
to continue our global dominance in biomedical research. Our 
Nation is the leading light here. I should know. I come from 
Washington State. We have many world-class institutions, and I 
couldn't disagree more with the House Republicans whose 
proposal to slash NIH funding would mean we will fall behind 
and fail to keep investing in these breakthroughs that have 
truly made a world of difference for patients across our 
country and across the globe.
    We've got to build on that critical progress we've been 
making and ensure that our investments keep pace, not slash 
them as House Republicans voted to do.
    You know, after a global pandemic that brought the world 
economy to a grinding halt and cost more than one million 
American lives, House Republicans are seriously suggesting that 
we slash funding for life-saving research.
    So if we truly care about protecting families, we need to 
understand that this funding is just as critical as the 
investments we make in our military and we cannot forget the 
millions of families who are fighting cancer and Alzheimer's, 
substance use disorders, long COVID, and so much more.
    We have to make sure that our investments reflect the 
reality that illness is one of our Nation's deadliest 
adversaries and biggest economic and national security threats.
    As I mentioned, we saw that all too clearly during the 
COVID pandemic, but we also saw the incredible pace of 
discovery with COVID vaccines. It was no accident. It was made 
possible by our investments in research into mRNA vaccines in 
response to Ebola and other viruses and by a premier biomedical 
research enterprise that we have strategically built over 
decades and in the bipartisan pandemic response bill that I got 
signed into law last Congress, I'm glad that we were able to 
establish ARPA-H to continue strengthening our capacity for 
cutting edge research.
    So I look forward to hearing from the witnesses today about 
the resources we need across NIH to continue supporting this 
life-saving work because at the end of the day, what we get for 
these investments are really important discoveries that keep 
our Nation competitive, that prepare us for pandemics and other 
health crises, and give families more time with their loved 
ones, and give patients hope for the future. That's not just 
worth the cost, it is priceless.
    So I hope we all remember that as House Republicans have 
now voted for deeply serious and deeply dangerous cuts to 
cutting edge life-saving research, in the Senate we need to 
make sure that we are continuing to fund these important and 
critical investments.
    So I'm glad to be here today and speak to our witnesses 
and, Dr. Tabak, I am a huge supporter of NIH but I have to ask 
you a tough question today.

                               HARASSMENT

    I have been pressing NIH for years about how to ensure that 
Federal dollars are not flowing to researchers who harass or 
bully or retaliate against or even create a hostile environment 
for their colleagues and for their students and how to ensure 
NIH workers themselves are not continuing to experience 
harassment.
    So I have to say I am really appalled by recent reporting 
that an NIH-funded scientist who faced institutional 
disciplinary action because he was found to have sexually 
harassed colleagues was simply able to transfer his award from 
one university to another research institute where he then 
harassed a trainee in his new lab and, even worse, NIH awarded 
him a new $2.5 million grant.
    That happened despite the fact that Congress directed NIH 
to make it mandatory for institutions to inform NIH when 
scientists or key staff are removed or otherwise disciplined 
due to harassment, bullying, retaliation, or hostile working 
conditions.
    Despite NIH posting publicly that you require notification 
from all of your award recipients, despite NIH's knowledge of 
the investigation's finding, and I just have to say it is 
completely unacceptable.
    So I need to ask you today what is NIH doing to fully 
implement the requirement under last year's law that such 
actions must be reported to the agency and how are you using 
that requirement to enforce workplace protections against 
harassment?
    Dr. Tabak. Chair Murray, I want to assure you that we take 
this issue very, very seriously. We've handled over 650 
allegations of harassment, discrimination, and hostile work 
environments. We have dedicated staff addressing these 
allegations and about 30 percent of those allegations have been 
substantiated and in dozens of cases principal investigators 
were removed from grants.
    The issue that you point out this morning of so-called pass 
the harasser problem, we, of course, are well aware of that and 
the specific case. Unfortunately, the original institution was 
not completely forthcoming about the extent of the 
investigator's behavior and it was only after the individual's 
grant was allowed to transfer to the second institution that we 
became aware of the greater severity of what the issues were.
    We are now working with the second institution to 
understand what the most recent allegations are and I can 
assure you that if these allegations are sustained, we will 
take immediate action as required.
    Senator Murray. Okay. Well, I want to follow up with you. 
I'm out of time, but I want to find out how you are making 
clear to these institutions and your grantees that these 
behaviors are not being accepted and what you're doing to make 
sure that our NIH workers themselves are not experiencing 
harassment because at the end of the day, innovation isn't just 
driven by programs, it is driven by people, and we need the 
best and the brightest, and if this is what they see around 
them, we are going to lose them. So this is critical.
    Thank you.
    Senator Baldwin. Vice Chair Collins.
    Senator Collins. Thank you very much, Chair Baldwin.
    Before I turn to my questions, I'm going to make a few 
comments.
    First, I want to thank each of you for your extraordinary 
work. In my judgment, there is no investment that pays greater 
dividends to American families than our investment in 
biomedical research and that is why I've been such a strong 
supporter of NIH and I will continue to be one.
    I think we're very fortunate that all of those who are on 
this committee share that view, including the Chair and the 
Vice Chair of this subcommittee.

                          ALZHEIMER'S FUNDING

    That is why I am puzzled at the flat funding for 
Alzheimer's research. We have made real investments to help the 
6.7 million Americans aged 65 and older who are currently 
living with Alzheimer's and those who care for them and we know 
that this number is on a trajectory to double by 2060.
    Alzheimer's is also one of our Nation's most costly 
diseases and it's one of the leading causes of death among 
seniors. As the Senator representing the oldest State in the 
Nation, this is of particular concern to me and as a person who 
lost her father, her grandfather, and two uncles to this 
devastating disease, I know personally what this means to 
American families. So I hope that we can correct the flat 
funding and continue the trajectory that we have been on.
    Now let me turn to my questions. First, Dr. Hodes, I want 
to commend the National Institute of Aging. You have been 
essential in your institute in sustaining the progress that we 
have been making and we've seen an exciting new class of 
treatments, one announced just yesterday that is similar to 
another that has been approved under the accelerated process of 
FDA that could delay or slow the onset of Alzheimer symptoms.
    In a statement last year following the release of Phase 3 
lecanemab data, NIH said, ``Although NIH did not fund this 
study, our decades of research paved the way for this 
Alzheimer's trial that notably met its primary and secondary 
endpoints.'' I agree.
    That's why I'm so frustrated that these new therapies based 
on sound science approved by the FDA are not reaching patients 
because of CMS's (Centers for Medicare and Medicaid Services) 
inexplicable determination that they are not reasonable and 
necessary for seniors and here's my real concern.
    While this is being finally sorted out, it is so sad 
because these treatments are most effective when they're given 
early when people are in the early stages of Alzheimer's. So 
the patients who would benefit the most are not receiving 
access to this medication.
    Dr. Hodes, in your view, what would broader access now to 
these disease-modifying therapies mean for patients?
    Dr. Hodes. Well, thank you for the question, and, of 
course, the FDA and CMS have the regulatory authorities that 
are distinct from NIH, but from an NIH perspective, as you 
said, the therapies that have become available now are the 
clear outcome result of research supported by NIH.
    In fact, lecanemab, one of the drugs, is now being studied 
in three trials directly funded by NIA (National Institute on 
Aging), one of which, for example, is treating individuals 
before any symptoms, so an even earlier stage than before a so-
called secondary prevention trial.
    Through these, we're trying to work for exposure to more 
diverse populations and in terms of what this could mean to the 
public, we are preparing for when final FDA approvals and CMS 
coverage occurs so we can monitor and ensure that we understand 
in populations that are diverse, rural, urban, racial, ethnic, 
which are likely to differ and just which treatment, what time 
is best, that we have the infrastructure and the trials in 
place to optimize their impact on society.
    This is the next stage, having first found successful 
interventions to learn from these first leads and to optimize 
them. So I agree with you the impact on the broad population 
can be huge and it's our research commitment to make sure that 
we are prepared to assess this.
    Senator Collins. Thank you.

                          EFFECTS OF CANNABIS

    Dr. Volkow, I am very concerned about the widespread use of 
extremely potent cannabis by our young people whose brains are 
still developing.
    NIH research has sought to better understand the 
relationship between marijuana use and psychiatric disorders. 
Given recent trends in recreational cannabis use and increased 
potency, is more research needed to better understand the 
short- and long-term effects of cannabis use on mental health 
and is NIH or its grantees investigating cannabis-induced 
psychosis?
    Dr. Volkow. Thanks very much for that question.
    Yes, indeed, we are very concerned about the increased use 
of cannabis with very high content of THC (Delta-9-
tetrahydrocannabinol) and also by the increased in regular use. 
So what we are seeing in the United States is an increase in 
the number of people that are using cannabis regularly at very 
high doses. This is particularly important because it is the 
high doses that are associated with psychosis.
    It's a very important area of research to try to understand 
under what conditions the use of marijuana can result in 
psychosis and importantly chronic psychosis. So, yes, we are 
prioritizing this as an area of research to try to 
unequivocally determine if there's a causal link between the 
use of cannabis and psychosis.
    Researchers are also investigating the potential role that 
cannabis use can have in suicidal behavior. So we need to 
understand what may be consequence or not of the use of 
cannabis, but from what we know, we should be concerned and 
certainly be monitoring the trends.
    Senator Collins. Thank you.
    Senator Baldwin. Senator Durbin.
    Senator Durbin. Thank you, Madam Chair. It's an honor to be 
here and want to thank all of you for your work.

                   BREACHING THE BRAIN BLOOD BARRIER

    I would like to address an announcement this week in 
Chicago from Northwestern University. It was a breakthrough in 
their research related to the brain and it has a personal 
element to it. We lost two of the pillars of the United States 
Senate to glioblastoma, brain cancer, Senator McCain and 
Senator Kennedy.
    I understand the treatment of this terrible disease is 
limited by and large to surgical intervention because of the 
blood-brain barrier.
    Now I'm going to stop trying to sound like I've ever 
attended medical school or even got close to one, but in 
reading the news account of this Northwestern University 
breakthrough, it appears that they have now opened the blood-
brain barrier to allow drugs to pass through to the brain, 
meaning that unusable chemotherapy drugs can now reach brain 
tumors. So there's an option beyond surgery or could be soon.
    The process they created is known as Sonication and I won't 
go any further to try to describe it, but it also said in the 
article that this could have an application on Parkinson's as 
well as Alzheimer's.
    Would someone please comment as to whether this was an NIH-
funded research project and what the prospects may be?
    Dr. Tabak. Senator, I don't know the answer to that and 
will have to get back to you for the record.
    Senator Durbin. Well,----
    Dr. Tabak. It certainly is a breakthrough and unless one of 
my colleagues knows specifically. No. We'll get back to you for 
the record, sir.

                         MENTAL HEALTH FUNDING

    Senator Durbin. Second point I'd like to raise is a number 
of people said to me if you ever get NIH in front of you, ask 
them why they aren't putting more money into mental health 
research.
    I noticed in your opening statement, you talk about 
precision medicine, but when we look at the scourge of mental 
illness in this country, particularly as it affects young 
people now in extraordinary numbers and percentages, could you 
give me some kind of point of reference as to how much is being 
invested in mental health or mental illness as opposed to 
physical illness?
    Dr. Tabak. Dr. Josh Gordon could answer that question, sir.
    Dr. Gordon. When we're talking strictly dollars here, we're 
talking that the National Institute of Mental Health's budget 
is about two billion. There's a couple billion dollars more in 
NIDA (National Institute on Drug Abuse) and NIAAA (National 
Institute on Alcohol Abuse and Alcoholism).
    But, of course, the crisis isn't about dollars, it's about 
people. We are in the midst of a national mental health crisis 
and we have to respond.
    You noted in particular two priorities that we are 
highlighting in our research response and are highlighted by 
the President's agenda: precision psychiatry and youth mental 
health.
    On the precision psychiatry space, we know that we need to 
do a better job in psychiatry in matching patients with 
treatments and we also know that we're on the cusp of being 
able to do for mental health, at least for some parts of mental 
health, like depression and schizophrenia, what the NIA has 
done for Alzheimer's, that is, develop and prove biomarkers can 
work and can be used in the clinic to help guide clinical 
decisionmaking and to innovate treatments and so we are 
spearheading--in the President's budget, we are proposing two 
large initiatives in precision psychiatry, one aimed more 
generally at mental health and one aimed at depression.
    On the youth mental health space, again we know from a lot 
of different studies what to do, but we need to do a better job 
of figuring out how to implement things like suicide prevention 
programs and mental health prevention programs and early 
detection and early prevention treatments for psychosis in 
youth, in schools, and through digital health and through other 
settings that we know can reach children. So those are two of 
our priorities in those areas.
    Senator Durbin. Many any of the cities across America face 
what Chicago faces with gun violence, particularly from young 
people. I went to the Cook County Juvenile Facility where 
teenagers are being held waiting for trial, many of them 
accused of murder. They spend 1 to 3 years in this building. 
They've created a high school in the building for these 
teenagers. It looks like a regular high school inside, 
gymnasium, cafeteria, classrooms, and such, and when I asked 
the counselors what do you find when you sit down and talk to 
these young people who are on trial for murder and accused of 
gun violence, they said, well, we find the full menu of mental 
illness, but the one recurring theme is trauma. They've been 
exposed to trauma in their lives and it's really changed the 
way they look at the world.
    Senator Capito and I have a bill on this issue looking at 
trauma, ACEs (Adverse Childhood Experiences). It just seems to 
me that when we talk about youth mental illness, this is the 
most obvious frontline challenge that we face.
    What should we be doing now that we're not doing when it 
comes to trauma exposure?
    Dr. Gordon. You're a hundred percent correct that trauma is 
at the root of much mental illness not only in childhood but in 
adulthood, as well.
    We know we need to do a better job of building resilience 
to trauma. One of the earliest findings in trauma research was 
that successful navigation of trauma in childhood can lead to 
resilience to a range of mental health consequences later in 
life.
    So that's really been the focus of much research at NIMH 
(National Institute of Mental Health) and really needs to be 
the focus of implementation moving forward.
    Senator Durbin. I would just say in closing that I've been 
proud of this subcommittee and what it's achieved in terms of 
funding for NIH research. The 2 percent figure sent to us by 
the Administration is a true disappointment. I mean to tell the 
President as much.
    The idea that the Republicans have suggested in the House 
of a 20-25 percent cut in NIH funding is scandalous.
    Thank you, Madam Chair.
    Senator Baldwin. Thank you.
    Senator Moran.
    Senator Moran. Chairman, thank you. I wish you and the 
Ranking Member well and will pledge to be a good member of this 
subcommittee to see that we achieve good results for NIH and 
other things.
    Impact of Increased Funding
    One of the examples of not in every instance if you spend 
money do you necessarily get a better result, but there is 
plenty of evidence that at NIH that does occur.
    Dr. Hodes, I would highlight particularly the increasing 
total amount of money.
    Dr. Tabak, I highlight that to you and what has happened, 
but in the area of Alzheimer's, I think we've seen significant 
difference and perhaps you could tie it to the additional 
resources that this subcommittee, this Congress has provided to 
NIH. I would be happy if you'd like to confirm that more 
resources do make a difference, Dr. Hodes.
    Dr. Hodes. I'd be happy to confirm that they have made a 
difference. The enormous progress we've seen could not have 
happened at this pace without the increased support and 
investment in research and similarly we'll do our best to 
continue the momentum of this with whatever resources are 
available.
    Senator Moran. Could you put that in personal terms what it 
might mean for a family or an individual who has been diagnosed 
with Alzheimer's?
    Dr. Hodes. Well, I think with the reduction and limitation 
in resources, we do our best, of course, to be good stewards of 
what resources we have, but inevitably it would slow the 
progression from most basic discovery to the identification of 
new diagnostic, therapeutic, and preventive measures. We 
haven't spoken as much about prevention as we have treatment 
but that's another one of the very high priorities in which 
we've made great progress, the continuation of which is going 
to be dependent upon resources.
    Senator Moran. Thank you for the reminder about prevention.

                            DOWN'S SYNDROME

    I chair the Down Syndrome Caucus in the Senate and one of 
the things that I appreciate is the opportunity. We have one of 
the institutes that have a role to play in that research. The 
relationship between Down Syndrome and Alzheimer's is still 
being developed and understood and hopefully providing 
information and a path forward.
    Anything that I ought to know maybe, Dr. Tabak, about 
what's going on in the realm of Down Syndrome and how our 
caucus and my colleagues and I can be helpful in not only the 
research that's going on but in assistance to individuals and 
families?
    Dr. Tabak. Well, with the continued leadership and support 
of the Congress, we have expanded our work with individuals 
with Down Syndrome. For example, the INCLUDE Initiative, which 
stands for Investigation of Co-Occurring Conditions.
    As you know, people with Down Syndrome are more susceptible 
to certain types of disease and are less susceptible to others 
and so there's something to be learned for the general 
population as well as those with Down Syndrome.
    We are in particular trying to enroll more people with Down 
Syndrome in typical clinical trials so that we have a better 
understanding of what interventions that we use for the general 
population would have on individuals with Down Syndrome.
    We've already alluded to the intersection between Down 
Syndrome and Alzheimer's disease and, of course, Dr. Hodes is 
best prepared to speak to that specific point if you are 
interested.
    Senator Moran. Dr. Tabak, let me suggest to you that if NIH 
would provide me with information about how to encourage 
additional individuals with Down Syndrome to participate, we'd 
be glad to take that on as a project in educating our 
constituents. It's beneficial to them and beneficial to NIH.
    Dr. Tabak. Thank you. We really appreciate that.
    Senator Moran. And we may suggest that we have a Down 
Syndrome Caucus meeting in which we pursue that and other 
issues that are going on.
    Dr. Tabak. Thank you.

                             CANCER FUNDING

    Senator Moran. Dr. Lowy, I raised this issue a year ago 
with Dr. Tabak and I want to highlight this again.
    I'm concerned about the competition that will occur for 
cancer research funding. So we have funding at the Advanced 
Research Project Agency, ARPAA, and I want to make sure that it 
doesn't come at the expense of basic clinical research at NCI.
    We also have ARPA-H and the Cancer Moonshot Initiative, and 
I'm looking for a commitment by you and by NIH that there will 
be a prioritization that NCI competitive cancer grants will be 
funded in fiscal year 2024.
    Dr. Lowy. Senator Moran, thanks to you and the committee 
and the long-term strong support, we were able in fiscal year 
2023 to increase the pay line for our large awards from the 
11th percentile to the 12th percentile. This will mean more 
than a hundred additional grants than we were able to do in 
2022.
    It is still not enough. As you know, there has been 
tremendous opportunities for cancer research and so researchers 
are flocking to the NCI in large numbers, larger than in other 
areas, and therefore although we're supporting many more 
investigators than we did previously, our pay lines or success 
rates are not where they should be.
    Turning to your specific question about these other 
entities, I can assure you that we interact regularly with 
them. For example, with ARPA-H, Dr. Bertagnolli and Dr. 
Wegrzyn, who is the head of ARPA-H, meet regularly, but we also 
are communicating directly with various possibilities of 
research that could be conducted by ARPA-H versus research that 
will be more appropriate for NCI and to work collaboratively 
and together to make this a reality.
    Senator Moran. Thank you.
    Chairman, I wish that Dr. Collins was here to hear Dr. Lowy 
say that researchers are flocking, flocking to the NCI and I 
would look at that photograph of this young lady whose grant 
wasn't adopted and she was ending her career in research. It 
was something that captured me a long time ago on this topic 
about individuals that we lose when the money's not there.
    Thank you.
    Senator Baldwin. Senator Shaheen.
    Senator Shaheen. Thank you, Madam Chair and Senator Capito, 
for holding this hearing, and thank you to all of you for your 
work every day and for being here.

                            OPIOID EPIDEMIC

    Dr. Volkow, you've been to New Hampshire. You know what a 
challenge we've had in my State of dealing with the opioid 
epidemic. 2022 was the worst year for overdose deaths since 
2017 in our State, and I understand that in your testimony you 
discussed the important work of the Heal Initiative.
    Can you talk about what's being done to address vaccinating 
individuals against substance use disorders and what other 
promising medications you're seeing?
    Dr. Volkow. Yes, thank you very much, and, indeed, the 
funds from the Heal Initiative have enabled us one thing. For 
example, to expand very much the medication development 
pipeline and that includes development and research on vaccines 
and monoclonal antibodies.
    So there is ongoing research on different strategies to 
develop vaccines that are targeting fentanyl, oxycodone, 
heroin, or multiple drugs at the same time. In parallel, we are 
investing also significant amount of resources to get 
monoclonal antibodies because those will be able to deliver 
higher titers.
    These interventions are targeted to monoclonals to help 
prevent and reverse overdoses from fentanyl as well as with 
other drugs.
    In terms of investments, we have a whole pipeline that goes 
from repurposing of medications that may be useful to result in 
better outcomes for the treatment of opioid disease disorders 
as well as completely novel targets that will be able to help 
people that are addicted not just to opioids but to multiple 
substances. That is a goal at the basis of the molecular 
mechanisms linked with addiction.
    Also, an area that I think extraordinarily exciting is the 
utilization of narrow modelization by which we can actually 
strengthen or weaken certain sequence or hobs in the brain that 
are found to be associated with addictive behaviors and there 
many of the developments that have enabled us to go 
increasingly more precisely are part of the Brain Initiative 
which is another brain fundamental.

                            METHAMPHETAMINES

    Senator Shaheen. How about methamphetamines?
    Dr. Volkow. Methamphetamines, we don't have any medications 
that have been approved by the FDA. So it is a major priority 
for us. It can be very exciting.
    Currently, we are doing clinical trials Phase 1 and Phase 4 
monoclonal antibodies against methamphetamines because we don't 
have anything to reverse an overdose, but we're also working on 
vaccines for methamphetamines.
    We are also doing research in terms of clinical trials 
taking advantage of medications that when combined have already 
shown to be beneficial in reducing craving and withdrawal. So 
this is an area that requires again investment of research and 
partnerships with industry so that we can bring these 
developments and translate them into the clinic.
    Senator Shaheen. And are we talking about 5 years, 10 
years, beyond that in terms of having something that we think 
is going to actually be marketable?
    Dr. Volkow. I would actually like to say that there are so 
many lower hanging fruit, like the repurposing of medications. 
What I would hope that we could have them in the clinic if the 
FDA approves the indications, say, within 5 years.
    For the issue of monoclonal antibodies or vaccines, this is 
a completely new adventure and there is no antecedent of 
approval by the FDA of vaccines or monoclonals which is likely 
again to result in a longer trajectory to get them from the 
research. Now they are in humans, some of these toys, into the 
clinic, but I predict this is going to be longer-lasting, but 
there's also an area where we are investing and that is the use 
of devices and that enables us to translate problems much 
faster because the level of safety that the FDA requires is 
much lower.
    So we are investing on multiple roads to get more rapid and 
then also in the long term things that can be transformative.
    Senator Shaheen. Well, thank you, very much appreciate your 
work.

                                DIABETES

    Dr. Tabak, I'd like to switch to another illness. Senator 
Collins and I have been--we chair the Diabetes Caucus in the 
Senate and we've been looking at how we can continue to support 
the research to address diabetes, and I understand that right 
now we have beta cell- and stem cell-derived islet replacement 
therapies that are actually showing promise for cures.
    My daughter told me she had been to a conference where she 
met a man who had benefited from that therapy. He had been 
diabetes-free for 3 years.
    Can you talk about what NIH is doing to support that and 
any challenges? I understand also that FDA has been an obstacle 
in getting approvals. Can you speak to that and what we need to 
see from FDA in order to see this research actually bear fruit?
    Dr. Tabak. We don't view them as being an obstacle, but 
it's certainly----
    Senator Shaheen. That's my term. You don't----
    Dr. Tabak. But certainly, we need to partner with them.
    Senator Shaheen. Thank you.
    Dr. Tabak. The challenges are to protect the newly-
transplanted islet cells, regardless of what their origins 
were, from attack from the human immune system, and so we're 
using different approaches.
    For example, we're encapsulating them as a barrier. We're 
also trying to genetically engineer the islet cells so that 
they're not recognized as being foreign. These are the types of 
approaches that will take things to the next level, but as you 
point out, the findings are very, very promising.
    Senator Shaheen. So that we could actually see a cure in 
the foreseeable future for diabetes?
    Dr. Tabak. The results are very promising.
    Senator Shaheen. That's okay. You don't have to repeat 
that. I can use that. Thank you.
    Thank you, Madam Chair.
    Senator Baldwin. Thank you.
    Senator Schatz.
    Senator Schatz. Scientists and their hedging. Thank you 
very much, all of you, for being here.
    Social Media Use
    Dr. Gordon, I don't have to tell you that we're facing a 
youth mental health crisis. The Surgeon General has called out 
a link between this crisis and social media use and said that 
13-year-olds are too young to join social media.
    Last week I introduced a bipartisan bill with Senators 
Cotton and Britt and Murphy to empower parents and protect kids 
on social media.
    NIH has recognized these risks, too, and you are requesting 
an additional $20 million to continue to study the impact of 
social media on children.
    Dr. Gordon, I know that correlation and causation are not 
the same thing, but does a spike in mental health challenges in 
kids correspond with increased social media use?
    Dr. Gordon. First, there has been a spike. I actually 
wouldn't call it a spike. I would call it a mountain with a 
slope that really started 5 years ago or more increased rates 
of suicide deaths in children, increases rates of depression 
and anxiety.
    So it's there, no question, and certainly the COVID 
pandemic has played a role, and there is evidence to suggest 
that social media can be a harm for children's mental health. 
There's been a number of studies funded by NIH, including NIDA, 
NIMH, and the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, which have shown some of 
these negative impacts. Adolescents, for example, who discussed 
self-injurious behaviors through social media were more likely 
to have a suicide attempt, adolescents who place higher levels 
of importance on social media use and self-image report higher 
levels of depression symptoms. The list of findings goes on and 
on.
    It is important to recognize, though, that social media can 
also be leveraged for positive impacts on mental health. For 
example, customized moderated social media platforms have been 
used to effectively deliver a wide variety of social supports 
and mental health treatments.
    Senator Schatz. Because my time is limited, first of all, I 
agree with everything you said and thank you for that.
    I'm going to reduce one question for the record, which is 
how you're going to use the $20 million in the President's 
budget.
    But I'd just point out that, yes, there are plenty of 
beneficial uses of social media, especially for kids who are 
feeling alienated, but there are, in my view, no beneficial 
uses of the predictive algorithm that boosts content into 
people's brains, especially children's forming brains, and 
let's just take one moment to understand the business model.
    The business model is engagement equals revenue and the 
algorithm has discovered that the way to get engagement is to 
upset kids.
    So publicly-traded companies have a fiduciary obligation to 
run an algorithm that is systematically upsetting generations 
of children and so we shouldn't wonder why this is happening. 
This is happening. It is true that kids can find affinity 
groups and learn things and, you know, my kids certainly learn 
to do arts and crafts and fix bikes and there's all kinds of 
cool stuff on social media but none of that is coming from the 
predictive algorithm. All of that is coming from the search 
function. So I just wanted to make that kind of technical 
point.
    Dr. Tabak, one of your priorities is to reduce health 
disparities and to build a diverse workforce. I was 
disappointed to see that the budget request makes no mention of 
the Native Hawaiian community, even as Native Hawaiians face 14 
fewer years of healthy life than other groups.
    What can NIH do to increase the representation of Native 
Hawaiians as investigators in community-based research?
    Dr. Tabak. Well, one of the approaches, of course, is to 
launch studies that seek to understand the nature of these 
disparities in the health communities.
    We recently announced a funding opportunity announcement 
for Native Hawaiians, Pacific Islanders, that collaboration, to 
support a population-based study to look at the key health gaps 
and we're committing about $44 million over the next several 
years.
    Getting studies of this type into the communities often 
will attract people from those communities to participate and 
that's sort of an on-ramp, if you will, into health-based 
careers. So that's one approach.
    Senator Schatz. Thank you. Thank you.

                          PSYCHEDELIC THERAPY

    Dr. Volkow, 60 years ago the United States was producing 
research on psychedelics as therapy for addiction, chronic 
pain, and mental illness. This, as you know, research was cut 
off as a matter of public policy as part of the War on Drugs, 
and I know that there has been a pivot to sort of relook at 
these not to make an assumption that any of these things are 
medicines.
    There's a process for that determination, but I think all 
of your agencies are now starting to relook at the potential 
therapeutic benefits of some of these pharmaceutical substances 
that have now been made contraband and used almost exclusively, 
you know, as very illegal recreational drugs.
    Can you provide us an update on where we are on 
psychedelics research?
    Dr. Volkow. Yes, thanks very much for this question on 
psychedelic research effectivity halted for many years, and as 
the evidence is starting to emerge that shows significant 
potential in terms of therapeutics for certain conditions, like 
severe depression or post-traumatic stress disorder and also 
preliminary research showing benefits for the treatment of 
addiction, we're actually engaging the scientific community to 
try to understand how basically psychedelic drugs can be 
potentially utilized for the treatment, how they affect the 
brain, and also how to deploy them in ways that are going to be 
safe and very effective.
    So this is an area of great interest. Both NIMH and NIDA 
are partnering and trying to expand and accelerate.
    Senator Schatz. Thank you.
    Senator Baldwin. Senator Boozman.
    Senator Boozman. Thank you, Madam Chair and Senator Capito, 
for this really important hearing, and thank all of you all for 
being here and just the great work that you do and the 
remarkable careers that you've had through the years.

                      NCI DESIGNATED CANCER CENTER

    Dr. Lowy, the University of Arkansas for Medical Sciences, 
UMS, in Little Rock has been doing incredible work expanding 
its Cancer Institute and working towards applying for NCI 
designation.
    As you know, there are 71 NCI-designated cancer centers in 
36 States across the country with the closest to Arkansas being 
in Memphis, pediatrics only, Dallas, and Oklahoma City.
    NCI-designated centers receive the large majority of the 
available NCI funding for research in clinical trials, giving 
them a unique advantage over non-designated centers. It's 
critical for all areas of the country to have access to quality 
cancer research and clinical trials.
    What are the NCI's plans for supporting NCI-designated 
cancer centers in areas in the country where there are none, 
such as Arkansas?
    Dr. Lowy. Senator Boozman, thank you very much for this 
question.
    As you point out, there are 14 States that do not yet have 
NCI-designated cancer centers. To some degree, this is 
compensated for by some of the NCI-designated cancer centers 
having outreach beyond their States. For example, the 
University of Utah and Wyoming just as an example, but Arkansas 
is one area where it would be wonderful if the University of 
Arkansas Cancer Center were able to meet the requirements that 
NCI has for NCI designation and our Office of Cancer Centers 
has interacted with the Cancer Center as recently as a couple 
of months ago to--we would really welcome the possibility of 
the Arkansas Cancer Center coming in for this important area.
    While waiting for that, it's important to recognize that 
NCI supports other parts of the cancer research enterprise, 
such as the Community Oncology Research Program, which has more 
than 2,000 areas or places where people can enter clinical 
trials, including in Arkansas.
    Thank you.
    Senator Boozman. We appreciate that and we do appreciate 
your help and you all have been really good in helping in 
getting us where we need to go.

                       CLINICAL TRIALS ENROLLMENT

    One of the problems that we've got is with the finding 
enrollment for clinical trials. Arkansas, 41 percent of the 
population is rural and so that makes it just that much more 
difficult.
    The budget request includes a $500 million increase for the 
Cancer Moonshot with one of the goals of the funding being to 
boost recruitment in clinical trials that NCI sponsors and/or 
supports.
    What can we do to do a better job of accessing cancer 
trials in Rural America? How can we help you?
    Dr. Lowy. Senator Boozman, this is a very important issue 
because there are so many parts of the United States, not just 
Arkansas, where rural populations are even at higher risk of 
developing cancer and unfortunately over the last 20 years, 
although mortality rates for cancer has gone down for people in 
rural areas as well as in urban, the rate of decrease now is 
slower for people in rural areas compared with urban.
    NCI has had a number of meetings. In the very near future 
we are going to be providing research awards for areas of 
chronic poverty which are one of the potentially rural areas 
which have particular high incidence of mortality from cancer.
    One of the good news, one of the few areas of good news for 
the pandemic has been the expansion of telemedicine and also 
the streamlining of clinical trials to make it easier for 
people in rural areas to enter and participate in those trials.
    Thank you, sir.
    Senator Boozman. Well, thank you, and we do appreciate 
those efforts, and anything we can do to help you, we would be 
pleased to do. So we look forward to visiting with you.
    Thank you all again very much. Thank you, Madam Chair.
    Senator Baldwin. Thank you.
    Senator Kennedy.
    Senator Kennedy. Thank you, Madam Chair.
    Dr. Tabak, nice seeing you.
    Dr. Tabak. That's fine. Thank you, sir. Tabak.
    Senator Kennedy. By the way, I think the NIH is an 
extraordinary institution. You and your colleagues, your work 
is breathtaking.

                        DIVERSITY AND INCLUSION

    But I want to ask you about one of your programs, Doctor. 
In 2020, you created a program called The Faculty Institutional 
Recruitment for Sustainable Transformation, and basically under 
the program, you gave 12 institutions $241 million, a lot of 
jack in anybody's book, and you directed the grant applicants 
to use the money to demonstrate a strong commitment to 
promoting diversity and inclusive excellence when you hire 
people. Okay?
    Two of the institutions to which you gave money, one was 
University of South Carolina to hire faculty members and public 
health and nursing and the other one was University of New 
Mexico to hire faculty members in neuro-science and data 
science, two great institutions.
    South Carolina and New Mexico issued rules to administer 
the money that you gave them and they both said that we are 
going to punish candidates who apply for jobs with us with this 
money that you gave them who espouse ``race neutrality.''
    In other words, both of those institutions said we're going 
to give a very low score for anyone who states, ``An intention 
to ignore the varying backgrounds of their students and treat 
everyone the same.''
    So they took your money and they said we're hiring faculty 
members and any applicant who says we don't believe in racial 
prejudice. We think everybody ought to be treated the same gets 
an F.
    Did you know that?
    Dr. Tabak. I'm not familiar with the specifics like you are 
mentioning, Senator.
    Senator Kennedy. Would you look into it?
    Dr. Tabak. I certainly will. This program is an important 
effort by NIH to create a more highly diverse workforce.
    Senator Kennedy. I agree with that. It's a good idea. Do 
you know anybody against diversity?
    Dr. Tabak. Well, unfortunately, sir,----
    Senator Kennedy. I don't.
    Dr. Tabak [continuing]. I have run across a few over the 
years, but----
    Senator Kennedy. I'm sure there's some out there, but I 
think most fair-minded people agree with diversity.
    Dr. Tabak [continuing]. Our effort is to create an 
environment where people from all backgrounds in every 
different dimension will be safe and welcomed to conduct high-
quality biomedical research.
    Senator Kennedy. And I agree with that, but here's what I'm 
getting at. Do you think it's fair for the University of New 
Mexico and the University of South Carolina, two extraordinary 
schools, to say to an applicant who's borrowed hundreds of 
thousands of dollars to get her Ph.D. and who comes forward and 
they say how do you feel about race and they say I believe in 
racial equality, I believe everybody should be treated the 
same. They get an F. They're dismissed summarily. Do you think 
that's fair to do that with your money, with taxpayer money?
    Dr. Tabak. Again, sir, I can't speak to the specifics of 
these institutions. I will look into it.
    Senator Kennedy. Well, would you--if it's true, do you 
support that?
    Dr. Tabak. Again, I'd have to see what exactly it is----
    Senator Kennedy. But if it's true, do you support it?
    Dr. Tabak. What we are trying to do, sir, is create 
inclusive environments because unfortunately far too often 
certain individuals do not succeed in obtaining faculty level 
positions at universities.
    Senator Kennedy. But if I hire somebody--suppose--can I as 
an American legally, constitutionally, morally say I'm only 
going to hire Asian Americans? Anybody else of any different 
ethnic background need not apply. Is that moral? Is that 
constitutional?
    Dr. Tabak. Well, God knows I'm not a lawyer, but, sir,----
    Senator Kennedy. Well, but you're a human being.
    Dr. Tabak. [continuing.] To get to a faculty level position 
is a multistep process and very often highly-qualified 
candidates are never even considered because of where they 
train, where they're from, or what they look like.
    Senator Kennedy. Yes. But do you think----
    Dr. Tabak. And none of that is fair.
    Senator Kennedy. Do you think--I don't think you're 
answering my question. Do you think it's right for an 
institution using money that you gave them to say if you 
believe in racial equality and you say you want to treat 
everybody the same, say a big old hook comes out around their 
neck and pulls them off the stage and they say I'm not going to 
be hired? Do you think that's right?
    Dr. Tabak. I just don't--I would need to understand the 
context, sir, and I really don't know what these institutions 
are saying to candidates and I will certainly find out.
    Senator Kennedy. Well, I'm going to follow up. I want to 
know.
    Dr. Tabak. Fair enough.
    Senator Kennedy. I mean, that's how they spent taxpayer 
money that you gave them and I'm going to follow up and I wish 
you would, too. This disturbs me.
    Because I don't think that's lawful.
    Dr. Tabak. We will certainly get back to you, sir, with 
what we find.
    Senator Baldwin. Thank you, Senator Kennedy.
    Senator Britt.
    Senator Britt. Thank you, Madam Chairman.

                  DIGITAL PLATFORMS AND MENTAL HEALTH

    I wanted to talk today obviously about the crisis in this 
Nation with regards to mental health.
    Mr. Tabak, when you look at what is happening, it's clear 
that NIH has also identified this crisis as being one that is 
plaguing communities across this great Nation.
    The White House in 2023, the Mental Health Research 
Priorities, those even showed they speak to digital platforms 
in terms of their effectiveness to treat mental and behavioral 
health outcomes.
    However, there are plenty of NIH studies that show how 
social media and screen time likely have a negative effect on 
mental health, particularly youth mental health.
    Now let me tell you something. As a momma of a 13- and a 
14-year-old, this is something that is particularly important 
to me. I look at how young people are having to grow up right 
now. I know as someone who went through middle school and high 
school as a young woman that it's tough. I can't even imagine 
the additional pressures that they feel given having a screen 
at their fingertips all of the time.
    I think the reports are shocking and I don't think the 
numbers lie. Last year, one in three high school girls said 
that they seriously considered suicide and actually one in nine 
or almost nine percent, one in 10 high school students reported 
actually attempting suicide in the last 12 months.
    Folks, I ran for the Senate as a momma on a mission. I said 
that my children and other people's children and grandchildren 
should be able to achieve the American dream. If we do not take 
a hold of what is happening right now with social media and our 
youth, it is going to be so far gone we cannot get it back.
    My question to you is what is the NIH doing to address the 
damage of social media and what effect it is having on our 
children and our children's mental health?
    Dr. Tabak. So, Senator, on a personal level, I have a 
grandson who's the same age as your children. So I completely 
understand.
    Senator Britt. Thank you.
    Dr. Tabak. If I may turn this to Dr. Josh Gordon, who's the 
Director of NIMH, to answer you specifically.
    Senator Britt. Absolutely. Thank you.
    Dr. Gordon. To add to that personal, I have children who 
are 20 and 25 who grew up with social media. I saw them wrestle 
with it and the challenges they are in, and I can absolutely 
from that personal perspective understand the situation.
    Senator Britt. And I think if you look at the correlation, 
so from 2011 to 2019 the CDC says that depression amongst our 
children, our high school kids more than doubled. It is no 
coincidence that that actually coincides with the exact time 
where we had a rise in social media.
    Dr. Gordon. For that matter, not just depression but 
suicide deaths have been dramatically increasing in children 
and children who are even younger than used to typically die. 
So we're seeing dramatic increases in the rates in pre-teens 
which is incredibly disturbing.
    So what are we doing about social media and mental health? 
We and the National Institute of Child Health and Human 
Development both have programs in understanding the impacts of 
social media and, importantly, looking specifically at what 
aspects of social media use correspond with negative outcomes 
from the mental health perspective and trying to figure out how 
we might intervene and especially trying to support families 
and parents in working with children to figure out how to avoid 
the negative consequences of social media and how to regulate 
social media use at the family level.
    So we have a range of different programs in this research 
that we've been supporting with specific dollars appropriated 
by this subcommittee in the past and we will continue to 
support that work.
    Senator Britt. I hope that you will all continue to work on 
this, to pay close attention. Our children are counting on us.
    I want to follow up on what Senator Schatz said earlier. We 
have introduced a piece of legislation along with Senator 
Cotton and Senator Murphy to help with this. It's bipartisan. 
It prohibits children from under the age of 13 from using 
social media, which is consistent with what social media 
companies say that they already do. It requires a parent or 
guardian's permission for children ages 13 to 17 to create an 
account, so very simple, and the last thing is it requires 
social media companies to verify that quickly but it also does 
not allow them to utilize algorithms against our children.
    So between 13 and 17, when they're on social media, they 
would not be able to be targeted by algorithms pushing them 
into what we know to be so many deep dark holes and so I am 
hopeful that this body will act. I am hopeful that we will come 
together and actually do something to put parents back in the 
driver's seat and to protect our children. I will tell you they 
are counting on us.
    Thank you. I yield my time.
    Senator Baldwin. Thank you.
    We will begin a second round, hopefully quick and painless.

                                XYLAZINE

    So I wanted to start where I left off with you, Dr. Volkow. 
In March, the Drug Enforcement Agency announced it had detected 
a drug called Xylazine in nearly a quarter of all confiscated 
fentanyl in 48 States.
    The combination of these drugs have proven to be very 
deadly, but the tools that we have to combat fentanyl 
overdoses, like the test strips we were talking about and 
Naloxone, may not help us in this situation.
    So I wonder if you could talk about the impact that 
Xylazine has on the medicines that we use for overdose reversal 
and how NIH research is adapting to new and deadly ingredients 
that are being added to opioids.
    It seems like, you know, every other day we hear about a 
new challenge with regard to other additives or things that are 
harmful in different ways.
    Can you talk a little bit about Xylazine and how you're 
adapting your research?
    Dr. Volkow. It's very important problem that has grown 
actually very, very fast. I would say in the past 3 or 4 years. 
So the first thing that we needed to understand is why more and 
more of the drugs, particularly fentanyl and heroin, were sold 
mixed with Xylazine, and what appears to be happening is that 
Xylazine basically expands the duration of the effects of 
fentanyl or heroin.
    So it allows the dealers to actually basically create the 
product that has the characteristic that may be more 
reinforcing and therefore greater value.
    It's become very challenging because whereas Naloxone 
serves to reverse an overdose from fentanyl, the response when 
you combine these two drugs are not the same. So current 
research is ongoing to try to determine both in animals and 
animal models and in humans what should be the optimal target 
to try to prevent the deaths associated with the combination of 
fentanyl and Xylazine.
    They act by very different mechanisms. Fentanyl inhibits 
respiration and breathing, so you don't have oxygen in your 
blood, but Xylazine also by a different mechanism that doesn't 
engage the same receptors is decreasing oxygenation.
    So you have when you combine these two mechanisms that are 
exacerbating the outcomes which is why in some instances when 
you use Naloxone, Narcan, to reverse the overdoses, you don't 
get adequate responses and research is ongoing to develop 
therapeutics that can actually help in those overdoses.
    Senator Baldwin. Thank you.

                      NEXT GENERATION RESEARCHERS

    Dr. Tabak, I was proud to author the Next Generation 
Researchers Act with Senator Collins to improve NIH 
opportunities for new and early stage researchers.
    Since this bill was signed into law as part of the 21st 
Century CURES Act, NIH has increased funding for early stage 
investigators by 63 percent, and I'm proud of this progress but 
there's still a long way to go.
    The average age of the first-time RO1-funded investigators 
remains 42 years old. Today, more than twice as many RO1 grants 
are awarded to investigators over 65 than to those under 36 
years old. In the 1990s, those figures were reversed.
    So we all know that diversity in the biomedical workforce 
leads to research innovation, higher quality work, and more 
participation in clinical trials by people from 
underrepresented groups. Yet inequities persist, and a study 
published in February shows that whenever there's an uptick in 
NIH funding, it creates more inequity.
    Women and people of color face increased barriers and an 
uneven playing field to obtain funding.
    So, Dr. Tabak, tell me how NIH is working to support more 
early stage investigators, including women and those from 
diverse backgrounds.
    Dr. Tabak. Well, thank you for your leadership in this area 
and certainly we have made some progress, but as you point out, 
we have a ways to go.
    Our target has been a minimum of 1,100 new early stage 
investigators each year. Last year we were able to fund over 
1,600 which is the good news. But you're quite right. Those who 
already have support have advantage. It's just that simple and 
so we have set up some additional programs which we hope will 
level the playing field.
    For example, there is the Katz Award where no preliminary 
data is required for the application. That may seem 
counterintuitive, but, in fact, what it does is it liberates 
the applicant from the work of their former mentor, their 
former Ph.D. advisor or postdoc advisor so that they can come 
with their best ideas and don't need to have enormous resources 
to create the preliminary data that's needed to really just 
support things for a great new idea.
    We have the NIH Pathway to Independence Award. It's the 
Skip the Postdoc Award. You go right from graduate school into 
a faculty level position. It's not for everybody but there are 
talented people out there for whom this is just an ideal 
circumstance.
    We are also looking at the NIH Director's New Innovative 
Award Program where, of course, we are trying to incentivize 
young people with great ideas to come into our system and this 
is gradually bringing in people from outside of the traditional 
biomedical research disciplines.
    The good news about this pool of early career investigators 
is they are enriched for both women and people of color. There 
are more young people of color. There are more women in this 
early stage cohort than in the general cohort, and so if we 
keep pushing to fund more and more of these early career 
investigators, we are going to see a shift in that right 
direction that we all hope to achieve.
    Senator Baldwin. Thank you.
    Senator Capito.
    Senator Capito. Thank you.

                                 ARPA-H

    I wanted to ask about ARPA-H. In the fiscal year 2023 
Omnibus there was $1.5 billion for ARPA-H and moved them under 
the NIH umbrella and then this new budget is asking for an 
additional billion dollars.
    I'm a supporter of the goals of ARPA-H to be high-risk/
high-reward, partnering with the private sector, but I don't 
really understand why ARPA-H is going up a billion and yet most 
of the other biomedical research being done at NIH is pretty 
flat funding.
    Dr. Tabak, can you describe how NIH and ARPA-H can 
complement one another and your perception of this and where is 
ARPA-H fitting into the overall organization?
    Dr. Tabak. So ARPA-H is an independent entity within the 
NIH superstructure. They have taken advantage of a number of 
our administrative systems so that they don't have to 
reduplicate, you know, sort of basic business systems and 
things of this nature.
    The inaugural director, Dr. Wegrzyn, has been putting 
together her team. They've been onboarding over a hundred folks 
now. The key to their business model, if you will, is the 
recruitment of program managers who come with them unique ideas 
for bold and creative projects that they would like to see 
supported.
    They have been sorting through some 250 candidates thus 
far. They have hired a few to begin with. They've just recently 
released a broad agency announcement for research to improve 
health outcomes across patient populations, communities, 
diseases, and health conditions.
    The ARPA-H leadership has been engaging with the rest of 
the NIH leadership on a regular basis. We certainly want to 
avoid duplication----
    Senator Capito. Right.
    Dr. Tabak [continuing]. Or we want to incentivize shared 
engagement with one entity doing one aspect of a problem and 
the other entity doing another and so, you know, this is a bold 
new idea about how to fund biomedical research which we think 
will complement what we do at NIH and we're looking forward to 
continuing to work with Dr. Wegrzyn and her colleagues.
    Senator Capito. Well, I would hope, you know, the 
complementary aspect of it certainly and we see all the 
expertise on the panel and all the folks behind the expertise 
that we see here seated today certainly makes sense.
    So we'll watch that as it fully develops and thank you for 
that explanation.
    Last week the Republicans on Energy and Commerce launched 
an investigation into the NIH use of public relations 
communications services worth about a billion dollars since 
2018 contracts to 10 public relations companies.
    As I was reading this, I was thinking wow, that's a lot of 
money, a lot of money, and, you know, for 10 companies that's a 
lot of money, but then when I started thinking about the years 
and the fact that it had initial funding of $500 million and 
then was doubled to a billion under COVID, the COVID pandemic, 
and you and I talked about this on the phone, you know. There's 
a lot of people who have moved through COVID confused as to the 
best way to have achieved this, the best way to cope with it, 
you know. You're seeing all second guesses. Should we have 
closed the schools, should we not have closed the schools? Is 
it contagious? Can I get it from touching this? All the 
different things that we went through during that period.

                     NIH PUBLIC RELATIONS SPENDING

    So I guess I have a two-fold question. First of all, I 
don't think we got our bang for the buck for NIH spending this 
much money in public relations because I think the confusion is 
partially owned by NIH and other health--you know, we could 
look at who else owns part of this.
    We've never really been through this. You know, we don't 
really know. It was a hundred years ago, the influenza of 1918, 
you know, might have had some similarities.
    But we can't sit here and say this is never going to happen 
again or could never happen again. So I guess my question is, 
as you look--first of all, will you keep us here at the Senate, 
at the subcommittee in the loop as to what that investigation 
uncovers with the vast amounts of dollars there? So I would 
like a yes. Thank you.
    The other thing I would say is what is NIH doing to do a 
look-back in this area--I'm not talking about vaccine 
development or anything like that--of communicating to the 
American people how you could improve that part of the reaction 
to COVID and it's going to play into long COVID and everything 
else as we move forward.
    So are you all doing a full analysis of what your reactions 
were? Are you going to make that public? When can we expect to 
see that?
    Dr. Tabak. So as you well know, our mission is to translate 
and communicate research findings in a way that's 
understandable to all of our stakeholders, patients, families, 
healthcare providers, and again it's all done with the goal of 
improving health and so we are taking a look back to see how--
--
    Senator Capito. In a formal way are you making----
    Dr. Tabak. Well, I think it will become more formal, but 
initially we're sort of doing a landscape because--and again 
not to make excuses because we have to own, how it came out, 
okay, and I accept that.
    But, of course, we were dealing with something that was 
ever-evolving and as you know, as you learn more and more, your 
message can be more and more precise and so we are looking back 
to try and figure out how things might have been done better 
with an eye towards what happens the next time because you're 
right, there will be a next time about something.
    Senator Capito. There will be, and like if we look at like 
Dr. Volkow's area of expertise, it was thought initially, oh, 
well, if people can do telemedicine in this area with their--
and then you saw the numbers go up. So maybe that wasn't true, 
you know. So it had a whole different dynamic.
    If you look at mental health, huge issues there, and so I 
think we've got to do a really deep down analysis, but I think 
where we really need to--and you all are doctors and thank 
goodness you are, but sometimes we need to communicate in plain 
language what is actually going on and what you need to do and 
you can play a big role here with all the research.
    Thank you all very much.
    Dr. Tabak. Be happy to do that, yes.
    Senator Capito. Thank you.
    Dr. Tabak. Thank you.
    Senator Baldwin. So this will end our hearing today. I want 
to thank all of our committee members who attended for their 
thoughtful questions and thank you to all of you, Dr. Tabak, 
Dr. Gordon, Dr. Lowy, Dr. Hodes, and Dr. Volkow all for being 
here and sharing your expertise with us today.

                     ADDITIONAL COMMITTEE QUESTIONS

    For any Senators who wish to ask additional questions, 
questions for the record will be due on May 12 by 5 p.m., and 
the hearing record will also remain open until then for members 
who wish to submit additional materials 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. Lawrence Tabak
              Questions Submitted by Senator Tammy Baldwin
Dr. Lawrence Tabak, Acting Director, National Institutes of Health 
        (NIH)
    Question. Swine are an optimal model species for investigation of a 
large number of human diseases and have made valuable contributions to 
almost every field of human medicine. Swine share anatomic and 
physiologic characteristics with humans that make them ideal models for 
research. In addition the anatomy and physiology make pig organs likely 
candidates for xenotransplantation. The NIH-funded National Swine 
Resource and Research Center was established in 2003 to develop the 
infrastructure to ensure that biomedical investigators across a variety 
of disciplines have access to critically needed swine models of human 
health and disease.
    Can you provide an explanation of the benefits of designating a 
second NIH-funded national swine research center? Specifically, please 
share what the benefits would be of partnering with an academic 
institution that has existing medical imaging platforms dedicated for 
swine research use.
    Answer. The National Institutes of Health (NIH) has long 
acknowledged the value of and invested in swine as a model organism for 
biomedical research. The NIH Office of Research Infrastructure Programs 
(ORIP) within the Office of the NIH Director (OD), in partnership with 
the National Institute of Allergy and Infectious Diseases (NIAID) and 
the National Heart, Lung, and Blood Institute (NHLBI), has supported 
the National Swine Resource and Research Center (NSRRC) at the 
University of Missouri since its creation in 2003. The NSRRC serves 
researchers across the nation by supporting swine-based research across 
multiple disciplines, providing valuable services to the research 
community and creating new genetically-engineered swine models in 
collaboration with investigators. The NSRRC has facilities and 
laboratories with advanced biosecurity to ensure animals remain 
pathogen-free from 14 specific pathogens. In addition, the NSRRC serves 
as a central repository by importing, maintaining, preserving, and 
distributing swine models and wildtype animals, cells, tissues, and 
organs to investigators throughout the country while ensuring the 
highest possible level of animal care and model quality. The NSRRC also 
serves as a source of information and training related to the use of 
these animals in biomedical research as models of human health and 
disease for the broader research community. The NSRRC performs its own 
cutting-edge research to advance technology in this area. Its inventory 
of live animals includes more than 20 genetic backgrounds.
    The establishment of a second center would require substantial 
upfront financial and resource investment in equipment, infrastructure, 
animal care, maintenance, and ongoing research support. The existing 
NSRRC serves as a valuable resource for researchers, and it is at the 
forefront of providing swine models to the biomedical research 
community. The NSRRC's activities have been significantly expanded 
since its inception, including an $8 million NIH C06 Construction grant 
in FY 2022 to expand animal housing. This expansion has allowed more 
efficient use of the existing space and will permit the NSRRC to widen 
its exploration of applications of new swine models in various research 
fields and extend its training activity on the use of swine models. The 
enhanced capacity will also allow the interdisciplinary team of 
scientists that operate the NSRRC to enhance establishment and 
characterization, including phenotyping, of existing and newly 
developed swine models. The NSRRC partnering with an academic 
institution that possesses the necessary imaging equipment and 
expertise would be more cost-effective compared to establishing and 
maintaining imaging capabilities independently. Partnering with an 
academic institution would also foster interdisciplinary collaboration 
by bringing together experts from different fields such as imaging, 
veterinary and comparative medicine, and swine research. We believe 
that a partnership between an academic institution and the current 
NSRRC would be of greater benefit with less upfront costs than 
establishment of a second center.
    Question. The Subcommittee's Joint Explanatory Statement (JES) for 
fiscal year 2023 included explicit recommendations on the 
implementation of funding for the Clinical and Translational Science 
Awards (CTSA) program. The JES expressed concerns about disaggregation 
of the CTSA Hubs and stated the agreement's support for maintaining the 
size, scope, and historic mission of the CTSA program. The agreement 
also maintained that no funded CTSA Hub should receive less than 95% of 
the funding it received in previous awards.
    How will the National Center for Advancing Translational Sciences 
(NCATS) implement the explicit instructions in the FY 2023 JES?
    Answer. NCATS leadership reached out in writing to House and Senate 
Appropriations Staff within 30 days of budget enactment, per the report 
language. Then on Monday, February 6, 2023, NCATS leadership, along 
with the NIH Budget Officer, met with House and Senate Appropriations 
Staff to provide an update on the Clinical and Translational Science 
Awards (CTSA) program as requested. Based on the discussion and outcome 
of the briefing, NCATS will continue with its existing funding 
opportunity announcements and will keep Appropriations Staff apprised 
of funding plans and any updates to the program, as previously 
requested. NCATS also encouraged the Appropriations Staff to reach out 
at any time to discuss the program.
    Question. Geroscience offers exciting potential to address a wide 
range of aging-related diseases and conditions--including Alzheimer's, 
cancer, cardiovascular diseases, osteoporosis, and many others. Several 
NIH Institutes and Centers (ICs), as well as the Cellular Senescence 
Network within the Common Fund, recognize the promise of this approach 
by supporting research in this field. The comprehensive nature of the 
research, the number of ICs involved, and the possible applications to 
many diseases and conditions make it especially critical to track how 
much funding NIH is allocating for geroscience and for which purposes. 
This is why Congress asked NIH to submit a report on geroscience to the 
House and Senate Appropriations Committees within 180 days of enactment 
of the fiscal year 2023 appropriations bill, which will occur next 
month. Congress also encouraged NIH to consider launching a trans-NIH 
initiative that would guide and enhance future research on geroscience.
    Please provide an update on the report and plans for such an 
initiative.
    Answer. The required report on geroscience activities across NIH is 
under review and will be transmitted to Congress in the coming weeks. 
Geroscience research is a priority across NIH, with more than 20 
institutes and centers (ICs) actively involved in this area of 
research. These ICs participate in an NIH-wide Geroscience Interest 
Group, which meets monthly to discuss updates from researchers in the 
field, discuss potential research initiatives, plan future geroscience 
events, and explore gaps and opportunities in the field.\1\ In April 
2023, the group hosted the fourth Geroscience Summit, which brought 
together researchers and clinicians interested in geroscience and aging 
to explore the state of the science, including identification of 
research gaps and opportunities.\2\
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    \1\ www.nia.nih.gov/gsig.
    \2\ www.nia.nih.gov/2023-fourth-geroscience-summit.
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    Question. Urinary incontinence associated with lower urinary tract 
symptoms affects millions of women. Research to date has shown that the 
efficacy of treatment for the different types of urinary incontinence 
associated with lower urinary tract symptoms varies widely depending on 
individual patient characteristics and symptoms, and that a 
personalized treatment plan for these conditions has been found to be 
most effective. There are knowledge gaps around the etiology of these 
symptoms which are impeding the development of effective treatments and 
successful utilization of precision medicine for patients with lower 
urinary tract symptoms.
    What needs to be done to advance scientific knowledge of the 
etiology of lower urinary tract symptoms to enable a personalized 
precision medicine approach for the treatment of these conditions and 
how will the NIH and NIDDK accomplish this?
    Answer. NIH is dedicated to furthering an understanding of the 
various causes and manifestations of lower urinary tract symptoms 
(LUTS) with the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) as the lead institute for research in this area. NIDDK 
funds the Symptoms of Lower Urinary Tract Dysfunction Research Network 
(LURN), comprised of an interdisciplinary team of researchers, study 
coordinators, and medical facilities at six United States clinical 
sites and a data coordinating center. LURN aims to increase 
understanding of LUTS to inform strategies to better measure and manage 
the condition and improve patients' lives. Through development and use 
of detailed questionnaires, LURN aims to measure patient experiences, 
assess the wide range of symptoms, and characterize different subtypes 
of men and women with LUTS as a first step to developing precision 
medicine approaches. Through the NIH-funded Multidisciplinary Approach 
to the Study of Chronic Pelvic Pain (MAPP) Research Network, NIDDK 
hopes to provide a better understanding of the underlying causes and 
distinct symptom profiles of urological chronic pelvic pain syndrome 
(UCPPS), which is characterized by chronic pain and diverse LUTS in men 
and women. Understanding that bladder health is an important aspect in 
the development of LUTS, NIDDK also supports the Prevention of Lower 
Urinary Tract Symptoms (PLUS) Research Consortium, to develop tools and 
strategies to measure and promote bladder health in women. This 
knowledgebase will inform individualized strategies for the prevention 
of LUTS in women. Additionally, NIDDK supports basic, translational, 
and clinical research into LUTS through funding of various other 
programs, centers, and investigator-initiated research projects. For 
example, the O'Brien Urology Centers are studying the pathophysiology 
of urologic diseases and conditions, and the Stimulating Urology 
Interdisciplinary Team Opportunity Research program supports 
investigator-initiated projects, some of which are studying how 
neurologic dysfunctions may impact various types of incontinence.
    These activities are ongoing, and NIDDK continues to welcome 
investigator-initiated research in these areas. The knowledge gained 
from these studies will provide insight that can lead to more precise 
diagnoses and more effective, personalized treatment of LUTS.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
Dr. Lawrence Tabak, Acting Director, National Institutes of Health 
        (NIH)
    Question. Pulmonary fibrosis, or PF, means scarring in the lungs 
that, over time, can destroy the normal lung and make it hard for 
oxygen to get into the blood. There are over 250,000 Americans 
currently living with the illness. PF affects 1 out of 200 adults over 
the age of 70 in the United States. The prevalence of PF is on the rise 
with more than 50,000 new cases diagnosed annually and around 40,000 
people dying each year from PF. There is currently no cure for PF. The 
average life expectancy for someone diagnosed with idiopathic pulmonary 
fibrosis, the most common form of PF, is just three to 5 years.
    The National Heart, Lung, and Blood Institute (NHLBI) provides 
funds that are crucial to advancing pulmonary fibrosis research. In 
November 2022, the NHLBI brought together stakeholders to identify 
directions for research in PF. This meeting established the need for 
funding in several areas: improved research models, tools for earlier 
diagnosis, streamlined clinical trials, and enhanced focus on the 
genetics of PF, to name just a few.
    A report on the outcomes of the Summit is currently being drafted.
    I was pleased to learn that the National Heart, Lung, and Blood 
Institute (NHLBI) cosponsored a ``Pulmonary Fibrosis Stakeholder 
Summit'' last November that brought together leading PF researchers and 
patients to discuss a research blueprint for this devastating disease 
for the next 5 years. Can you or Dr. Gary Gibbons, Director of the 
NHLBI, comment on some of the key outcomes of this meeting and what you 
see as next steps in implementing strategies and approaches that were 
discussed?
    Answer. On November 8 and 9, 2022, NHLBI, in co-sponsorship with 
the Three Lakes Foundation and Pulmonary Fibrosis Foundation, hosted a 
workshop entitled ``The Pulmonary Fibrosis Stakeholder Summit.'' This 
workshop sought to identify scientific gaps and future basic and 
clinical research directions related to pulmonary fibrosis (PF) by 
providing a platform for investigators, sponsors, physicians, and 
patients to share innovative ideas for synergizing research efforts and 
ultimately improving patient outcomes for PF. Some key research gaps 
and opportunities that were identified during this workshop include:
  --Development of Novel Models and Research Tools to Better Study PF 
        and Uncover New Therapies
    --Development of models that recapitulate the evolution of PF from 
            injury to fibrogenesis to the point where the disease no 
            longer progresses, and to test drug candidates during the 
            established fibrotic phase of disease in these models.
    --Expanding the practice of collecting fresh tissue and live cells 
            at the time of routine clinical procedures and using 
            standardized collection protocols to establish a central 
            repository for research use of biospecimens across the 
            fibrotic lung disease spectrum.
  --Identification of Early Disease Risk Factors and Methods to Improve 
        PF Diagnosis
    --Development of integrated molecular-, imaging-, and AI/ML-based 
            diagnostic tools to predict individual risk factors and 
            mechanistic drivers of disease progression from preclinical 
            to advanced disease and convert those to optimal strategies 
            for screening and surveillance of high-risk populations.
    --Increase diverse race and ethnicity representation in studies of 
            genetic risk for PF onset and progression, and use that 
            information to define guidelines for incorporating genetic 
            testing into clinical practice for individuals with or at 
            risk of PF.
  --Advance Innovative Approaches to PF Clinical Trial Design
    --Development and validation of additional patient-centered 
            endpoints for use in PF clinical trials to more 
            comprehensively assess the success or failure of novel 
            interventions to modify disease and/or improve patient 
            quality of life.
    -- Leverage more innovative statistical analysis approaches and 
            clinical trial designs, including pragmatic, adaptive, 
            umbrella, basket, and platform designs, to optimize 
            participation in and enhance the output of PF clinical 
            trials.
    A workshop report is being prepared by the participants for 
submission to a scientific journal, with the hopes of disseminating 
this information to the broader community and stimulating new research 
in these areas to ultimately improve the diagnosis, care, and quality 
of life for patients living with PF.
    Question. NIH recently has faced criticism surrounding research 
integrity from OIG reports that NIH had lax controls on its grants with 
EcoHealth and the sub-awards to eight subrecipients, including the 
Wuhan Institute of Virology.
    The OIG found several deficiencies in the oversight of the awards. 
Some of these deficiencies include: EcoHealth's inability to obtain 
scientific documentation from WIV; and EcoHealth's improper use of 
grant funds, resulting in $89,171 in unallowable costs.
    NIH resumed grant funding for EcoHealth despite OIG reported 
failures by EcoHealth surrounding previous NIH grant funding. Can you 
explain the decision process in determining resumed grant funding to 
EcoHealth?
    What corrective actions have EcoHealth and NIH taken to date to 
address deficiencies identified by the OIG?
    Answer. NIH takes its stewardship over the Nation's investment in 
biomedical research very seriously and routinely considers processes 
and measures for strengthening its oversight of Federal funds. NIH has 
implemented additional oversight measures regarding grants awarded to 
EcoHealth Alliance (EHA) to ensure that EHA's documented efforts to 
strengthen administrative processes meet NIH's requirements. NIH 
continues to actively monitor EHA's progress and is taking these 
further actions to ensure NIH meets its collective goal of supporting 
rigorous science to improve human health.
    As background, awards to EHA aimed to advance our understanding of 
how pathogens can emerge from wildlife and spillover to cause disease 
in people. This includes research important for understanding how bat 
coronaviruses evolve naturally in the environment to become 
transmissible to the human population. This type of research is 
critical for the U.S. to prepare for how to respond if these pathogens 
do enter the human population. All awards were reviewed through NIH's 
two-stage review process and were determined to be scientifically 
meritorious during external peer review. Prior to funding, all awards 
were rigorously assessed by NIH to determine if any additional 
biosafety or biosecurity measures would be necessary.
    After a detailed administrative review of EHA's management of these 
awards, NIH notified EHA of the need to implement a corrective action 
plan to ensure robust oversight and accountability to NIH. A summary of 
these communications and actions are as follows:
  --On January 6, 2022, NIH provided Congress with a status update 
        regarding an ongoing NIH Office of Extramural Research (OER) 
        administrative review of EHA. At that time, NIH determined that 
        EHA needed to improve specific areas of its administrative 
        policies and practices representing shortcomings identified by 
        the OER administrative review. Therefore, NIH placed immediate 
        specific award conditions (SACs) on EHA's active awards while 
        the grant recipient worked on developing a requested Corrective 
        Action Plan (CAP) to address the identified issues.
  --On August 19, 2022, NIH provided Congress with an update on EHA's 
        implementation of the CAP. At that time, NIH determined that 
        EHA had demonstrated it was working toward correction of the 
        administrative and financial problems with a full 
        implementation plan laid out in the CAP.
  --NIH also identified one area of non-compliance under the grant 
        R01AI110964 (R01) that could not be remedied with SACs. NIH had 
        requested EHA provide NIH the laboratory notebooks and original 
        electronic files from the research conducted at WIV. Since EHA 
        failed to provide these records and WIV was unable to fulfill 
        its duties for the subaward, NIH notified EHA on August 19, 
        2022, that it would be terminating the WIV subaward for failure 
        to meet award terms and conditions.
  --To maintain a higher level of oversight, NIH imposed additional 
        SACs for all EHA awards for a minimum of 3 years. These SACs 
        included doubling the frequency of the required scientific 
        progress and financial reports EHA is required to submit to 
        NIH. In addition, EHA is required to conduct onsite inspections 
        of all its subawardees every 6 months to confirm that all terms 
        of subaward agreements are being fully and appropriately 
        executed.
    NIH acknowledges prior cooperation and substantial improvement in 
EHA processes and recognizes EHA is still working on implementing 
corrective actions. However, given the seriousness of these challenges, 
NIH will provide additional oversight of EHA's management of its grant 
awards while EHA addresses the material deficiencies related to 
financial reporting and subrecipient monitoring. Accordingly, in 2023, 
NIH imposed four additional SACs on NIH awards to EHA. These include 
requiring EHA to develop or improve written policies to comply with the 
NIH Grants Policy Statement (GPS) and requiring EHA to receive prior 
approval of subaward written agreements from NIH to ensure EHA complies 
with all requirements in the NIH GPS.
    In addition, NIH is removing EHA's eligibility for unrestricted 
advance drawdowns of funds--which means NIH is converting EHA from an 
advance payment method to a reimbursement method. This will require EHA 
to submit monthly reimbursement requests with a detailed list of actual 
expenses incurred and supporting documentation. The reimbursement 
method will provide NIH with stronger oversight of EHA's accounting and 
spending practices. Lastly, NIH is requiring EHA to obtain an 
independent third-party audit to conduct a comprehensive review of 
EHA's accounting practices and financial responsibilities under the 
terms and conditions of the NIH awards.
    NIH believes these additional monitoring mechanisms will allow NIH 
stronger oversight of EHA to ensure that the grant recipient meets the 
responsibilities required to receive Federal funding.
    EcoHealth Alliance is not suspended or debarred at this time. The 
HHS Assistant Secretary for Financial Resources' office makes 
discretionary suspension and debarment decisions, not NIH. Any 
suspensions or proposed debarments are subject to the Office of 
Management and Budget guidelines to agencies under the Nonprocurement 
Common Rule in 2 CFR 180 for nonprocurement transactions (as further 
implemented by HHS at 2 CFR Part 376) or the Federal Acquisition 
Regulation 48 CFR Subparts 9.406--9.407 for procurement transactions 
(as further supplemented by HHS at 48 CFR Subpart 309.4).\3\
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    \3\ www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180.
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    Question. Prion disease, which is caused by misfolded proteins in 
the brain is similar in some respects to Alzheimer's and related 
dementias. Creutzfeldt-Jakob disease (CJD) is a rare, 100% fatal, 
degenerative brain disease that causes rapidly progressive dementia.
    Is NIH doing any specific research on CJD?
    Answer. NIH supports dozens of studies on Creutzfeldt-Jakob disease 
(CJD) and other prion diseases such as transmissible spongiform 
encephalopathy, which are fatal brain diseases that occur in sporadic, 
infectious, and inherited forms, and are caused by misfolded cellular 
prion protein that propagates rapidly throughout the brain leading to 
widespread neuronal death. NIH-funded scientists are investigating the 
normal function of cellular prion protein, what triggers them to 
misfold and aggregate in neurons, how misfolded prion protein spreads 
throughout the brain, the mechanisms by which misfolded prion protein 
contributes to cell death, and how inflammation contributes to the 
disease process. NIH-funded researchers are also conducting preclinical 
studies in animal models of prion disease to investigate potential 
treatment strategies that prevent or attenuate prion misfolding, 
aggregation, and/or propagation; thereby slowing or stopping disease 
progression.
    Question. Are there areas of research in the ADRD space that can 
help inform treatments or cures for CJD
    Answer. Several neurodegenerative disorders, for example 
Alzheimer's disease, Alzheimer's disease- related dementias (e.g., 
Frontotemporal dementia, Lewy body dementias), and Parkinson's disease, 
share a core disease mechanism with CJD. Although the specific proteins 
vary between diseases, in all cases, proteins misfold and aggregate and 
spread throughout the brain, thereby initiating a cascade of cellular 
events that contribute to wide-spread cell death in the brain.
    Ongoing research to understand the mechanisms by which proteins 
misfold, aggregate, and contribute to cell death as well as research to 
identify therapeutic agents that could prevent or attenuate prion 
misfolding, aggregation, and/or propagation could advance research on 
CJD, as well as other neurodegenerative diseases. Similar to 
understanding and intervening in prion misfolding, researchers are 
intently studying misfolding of beta-amyloid and tau (two proteins that 
are the cellular hallmark of Alzheimer's), as well as misfolding of the 
protein alpha-synuclein in the context of Lewy body dementia and 
Parkinson's. It is hoped that advances in any one of these specific 
areas could help inform treatments for CJD, and vice versa. In fact, 
research on prion disease has already facilitated major advances in 
other neurodegenerative diseases. Building upon an assay originally 
developed by the NIH Rocky Mountain Laboratories for prion disease, 
scientists have developed a test to detect the abnormal form of alpha-
synuclein in the fluid that surrounds the brain of people with 
Parkinson's. The test requires greater validation, but current data 
suggests it has good accuracy in diagnosing a particular form of 
Parkinson's, even years before motor symptoms begin. Currently the test 
requires a spinal tap, but NINDS-supported scientists are working to 
modify the test so that it can be used with skin or saliva samples. 
NIH-funded researchers are developing similar tests for beta-amyloid 
and tau and are using these same technologies to develop a skin test 
for prion protein in people with sporadic CJD, which could enable early 
detection and early intervention.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
Dr. Lawrence Tabak, Acting Director, National Institutes of Health 
        (NIH)
    Question. Dr. Tabak, at the end of 2020, Congress provided $1.15 
billion for research on long COVID. Using this funding, NIH started the 
RECOVER program, which over the life of the program has received a lot 
of criticism. Concerns have been raised about NIH's lack of urgency and 
whether it is focused too much on open-ended research questions as 
opposed to testing treatments and moving therapeutics to clinical 
trials.
    How significantly are you working with private industry to research 
and test treatments?
    Answer. NIH is moving with deliberate speed to understand and 
clinically define this new post-viral condition, elucidate the 
underlying biologic mechanisms, and launch clinical trials testing 
treatment strategies. Recognizing the important role that the private 
sector plays in development and commercial availability of medical 
treatments, NIH has met with numerous industry representatives, 
including industry partners participating in the ACTIV public-private 
partnership, to review the RECOVER clinical trial program and invite 
interested groups to discuss potential public-private collaborations.
    Question. How many contracts or grants do you have with industry on 
treatments?
    Answer. We have executed confidentiality disclosure agreements with 
approximately twenty companies/industries to explore possible 
collaborations. In addition, as of May 4, 2023, there were five 
agreements under development with industry/private sector to support 
collaborations and provision of candidate interventions such as 
antiviral, neuro-stimulatory, and immune modulating interventions.
    Question. How much funding has been obligated for public-private 
collaborations on treatments?
    Answer. Four of the five RECOVER clinical trials involve public-
private collaborations. As of May 4, 2023, NIH anticipates an 
approximate investment of $95 million for the conduct of these trials 
(exclusive of infrastructure costs and subject to adjustment in 
response to clinical protocol requirements). NIH support of exploratory 
Phase II studies to provide proof-of-concept and assess safety of 
candidate interventions across a broad range of interventions (e.g., 
immune modulators, antivirals, and neurostimulants) and patient 
populations provides the foundation for larger scale private sector 
studies.
    Question. How many clinical trials are funded by NIH that are 
testing treatments for long COVID?
    Answer. There are five clinical domains that make up the RECOVER 
clinical trials. These are: a) viral persistence and immune 
dysregulation; b) neurologic/cognitive dysfunction; c) autonomic 
dysfunction; d) sleep disorders; e) cardiopulmonary/exercise 
intolerance/fatigue. These domains were informed by data coming out of 
RECOVER cohort studies, input from clinicians, and questionnaires that 
identified some the most burdensome symptoms reported by patients.
    Although there are five domains, that does not mean that there will 
only be five interventions tested. Rather, multiple interventions will 
be assessed in each clinical domain pending the availability of funds. 
In addition, trials in the five symptom areas will be run in parallel, 
which means we will not wait for one set to be complete before starting 
another one.
    RECOVER clinical trials will utilize an adaptive platform trial 
design. This unique design will allow researchers to easily add 
different therapies to be tested and to stop interventions if these are 
proven ineffective. The trials are designed so that they will inform 
one another. This advanced methodology will enable the best treatments 
to get to patients on a quicker timeline compared to traditional 
clinical studies.
    Question. How many of these trials are phase I, II, and III?
    Answer. Currently the clinical trial portfolio comprises five Phase 
II trials, including exploratory trials as well as trials designed to 
pave the way to pivotal Phase III studies.
    Question. How much funding has been obligated or committed for 
clinical trials?
    Answer. As of May 4, 2023, NIH RECOVER obligated $171.5 million 
(inclusive of infrastructure) to launch a suite of clinical trials 
through the Clinical Trials Data Coordinating Center (DCC) at Duke 
Clinical Research Institute.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
Dr. Lawrence Tabak, Acting Director, National Institutes of Health 
        (NIH)
    Question. As our understanding of Alzheimer's and related dementias 
expands, we now have a better understanding that many of these 
neurological diseases have similar underlying mechanisms. For example, 
there are many similarities between Alzheimer's Disease (AD)/
Alzheimer's Disease Related Dementias (AD/ADRD) and prion disease, 
which is caused by misfolded proteins in the brain. Alzheimer's Disease 
has already benefited from prion disease research, specifically 
research for Creutzfeldt-Jakob disease (CJD) a rare, 100% fatal, 
degenerative brain disease that causes rapidly progressive dementia. 
The specialized protein amplification techniques developed to study CJD 
are now being applied to Alzheimer's and contributing greatly to our 
understanding of that disease.
    Will NIH consider prion disease, specifically CJD, as a research 
priority within AD/ADRD? If not, please provide a detailed explanation 
as to why not.
    Will NIH intentionally expand the research the agency funds through 
the National Institute of Aging (NIA) to include prion disease, 
specifically CJD?
    How does NIH consider updates to what the agency considers to be 
AD/ADRD to reflect the most current state of scientific understanding 
of these diseases and their underlying mechanisms?
    Answer. The National Plan to Address Alzheimer's Disease and 
Related Dementias defines the specific diseases and conditions that are 
considered to be Alzheimer's or a related dementia.\4\ Under the 
implementation approach that NIH uses to identify AD/ADRD research 
projects, any proposals that explore prion disease that also make a 
strong and clear scientific connection to AD/ADRD (e.g., disease 
mechanisms, etiology, health outcomes) are able to be considered for 
AD/ADRD funding. Currently, NIH uses AD/ADRD funds to support several 
studies that are exploring direct mechanisms of prion-related 
neurodegeneration. In FY 2023, NINDS released a funding opportunity 
announcement (FOA) inviting projects on Cellular and Molecular 
Mechanisms of Prion-Like Aggregate Seeding, Propagation, and 
Neurotoxicity in AD/ADRD (PAR-23-023).\5\
---------------------------------------------------------------------------
    \4\ aspe.hhs.gov/collaborations-committees-advisory-groups/napa/
napa-documents/napa-national-plan.
    \5\ grants.nih.gov/grants/guide/pa-files/PAR-23-023.html.
---------------------------------------------------------------------------
    The National Plan to Address Alzheimer's Disease and Related 
Dementias (NAPA) defines the specific diseases and conditions that are 
considered to be Alzheimer's or a related dementia\6\ NIH's AD/ADRD 
portfolio is wholly inclusive of these National Plan-defined 
conditions. In addition, other scientifically valid and closely related 
research conditions may also be eligible for AD/ADRD funding. NIA/NIH 
considers any meritorious grant application that is relevant to 
Alzheimer's and related dementias for AD/ADRD funding. NIH already uses 
AD/ADRD funds to support several studies that explore prion diseases, 
including CJD, in the context of dementia-related research themes.
---------------------------------------------------------------------------
    \6\ aspe.hhs.gov/collaborations-committees-advisory-groups/napa/
napa-documents/napa-national-plan.
---------------------------------------------------------------------------
    The National Plan to Address Alzheimer's Disease and Related 
Dementias defines the specific diseases and conditions that are 
considered to be Alzheimer's or a related dementia.[1] As stated in the 
National Plan, ``In addition to AD, this National Plan addresses 
Alzheimer's disease-related dementias (ADRD) consistent with the 
approach Congress used in NAPA. These ADRDs include frontotemporal 
dementia (FTD), Lewy body dementias (LBD--which include dementia with 
Lewy bodies and Parkinson's disease dementia), vascular contributions 
to cognitive impairment and dementia (VCID), and mixed dementias--
especially AD mixed with cerebrovascular disease or Lewy bodies.'' 
While NIH's AD/ADRD portfolio is wholly inclusive of these National 
Plan-defined conditions, this does not exclude other scientifically 
valid and closely related research conditions from eligibility for AD/
ADRD funding. As mentioned above, any proposals that make a strong and 
clear scientific connection to AD/ADRD (e.g., disease mechanisms, 
etiology, health outcomes) are able to be considered for AD/ADRD 
funding. Therefore, AD/ADRD appropriations are being used to support 
projects that explore AD/ADRD-related mechanisms or themes in 
conditions beyond those that are formally defined in the National Plan, 
for example in prion diseases, ALS, post-traumatic brain injury 
dementia, and Down syndrome.
                                 ______
                                 
                Questions Submitted to Dr. Douglas Lowy
              Questions Submitted by Senator Tammy Baldwin
Dr. Douglas Lowy, Principal Deputy Director, National Cancer Institute 
        (NCI)
    Question. Clinical trials are essential for determining whether new 
treatments work against cancer. But often there aren't enough staff who 
are qualified to support and administer these trials. This is 
especially true for trials that are testing complicated new 
technologies. In some cases, the staffing shortage is forcing trial 
sponsors to delay cancer trials or even abandon them. The FY 2024 
President's Budget proposes a $500 million increase for NCI to expand 
and modernize cancer clinical trials to more quickly produce 
prevention, detection, and treatment measures. These investments are 
expected to double the participation of patients in NCI clinical 
trials, but we can't expand clinical trials without the staff to run 
them.
    What is NCI doing to address staffing shortages for clinical 
trials?
    Answer. The shortage of clinical research staff (e.g., research 
nurses, research coordinators, and regulatory staff), as well as 
healthcare workers, has diminished the capacity of the cancer clinical 
trials workforce. This is a major concern of the National Cancer 
Institute (NCI), as this deficit could lead to long-term consequences 
for the speed of NCI's clinical research programs. In November 2021, 
NCI directed a survey of NCI-Designated Cancer Centers to assess the 
ongoing impact of the COVID-19 pandemic on the capacity of Cancer 
Centers to conduct treatment trials. The results indicated that the 
pandemic has taken a toll on clinical trial resources and put even 
greater strain on the workforce who support clinical trials, causing 
many staff to leave their positions in academic or community research 
settings for higher pay, career advancement, and/or for the ability to 
work remotely.
    NCI is taking steps to improve cancer clinical trials and to create 
flexibility for clinical trial sites. NCI has determined that it is 
possible to develop flexible, faster, simpler, less expensive, and 
higher impact clinical trials by focusing on four key areas: 
streamlining processes for trial design and execution, focusing on 
essential endpoints, setting up trials in a way that broadens rather 
than limits participant access, and increasing efficiency of data 
collection, which would help to alleviate demands on the clinical 
trials workforce.
    These recommendations came from a report released by the Strategic 
Planning Working Group of NCI's Clinical Trials and Translational 
Research Advisory Committee (CTAC).\7\ In alignment with these 
recommendations, in fall 2023, NCI plans to launch elements of a 
Virtual Clinical Trials Office (VCTO) supporting NCI trials conducted 
at NCI-Designated Cancer Centers and NCI Community Oncology Research 
Program (NCORP) sites to alleviate the strain on the cancer clinical 
trial workforce. VCTO personnel would work remotely to support local 
research site health professional staff. Initial services under 
consideration include eligibility screening, study coordination, and 
promoting enrollment of patients who are medically underserved. VCTOs 
may also assist with questions about informed consent and the 
enrollment process; regulatory support; and adverse event reporting. 
NCI recently solicited feedback from NCI-Designated Cancer Centers and 
received universally positive feedback from small and large centers and 
is collecting additional input regarding specific needs and conditions 
from individual sites. NCI has already supported the hiring of VCTO 
personnel and aims to identify up to six Cancer Centers and six NCORP 
sites to begin the pilot program in fall 2023, based on need, 
activation time, and accrual of underserved populations.
---------------------------------------------------------------------------
    \7\ www.cancer.gov/about-nci/organization/ccct/ctac.
---------------------------------------------------------------------------
    Question. According to the NCI FY 2024 budget justification, NCI 
has invested nearly $1.4 billion of the $1.8 billion in available Cures 
Act Cancer Moonshot funding to support over 240 research projects 
across more than 70 cancer science initiatives.
    Given NCI received the largest proposed boost of all NIH ICs--
nearly 7 percent--how is NCI prioritizing the proposed increase and 
what Cancer Moonshot initiatives will continue or end as a result of 
the drawdown in Cures Act Cancer Moonshot funds?
    Answer. While Cures Act Innovation Funds for the Cancer Moonshot 
conclude in FY 2023, several Cancer Moonshot projects have timelines 
that extend beyond FY 2023. Flexibility to carry over funds allows NCI 
to support each project on the appropriate timeline. At the same time, 
NCI continues to plan for additional research to pursue new Moonshot 
goals in FY 2024 and beyond, as described in the FY 2024 Congressional 
Justification, and pending the availability of new appropriations.
    Because Congress provided multi-year budget authority for 
Innovation Funds under the Cures Act, NCI will be able to continue to 
support certain Moonshot programs beyond the end of FY 2023. This 
important flexibility enables NCI to conclude certain Moonshot programs 
that have met initial goals, avoid any abrupt endings to ongoing 
projects, and maximize the gains these programs have made--including 
through the development of new programs to build upon progress made to 
date.
    Approximately 90 percent of the funds appropriated for the Cancer 
Moonshot from FY 2017 through FY 2023 will be obligated by the end of 
FY 2023 to support continuing Cancer Moonshot programs including the 
Cancer Immune Monitoring and Analysis Centers-Cancer Immunologic Data 
Commons (CIMAC-CIDC) Network \8\ and the Human Tumor Atlas Network.\9\ 
NCI plans to deploy an additional $220 million after the close of FY 
2023 to minimize any disruptions in the progress of Moonshot projects, 
including the Participant Engagement and Cancer Genome Sequencing (PE-
CGS) Network,\10\ projects focused on cancer survivorship transitions 
of care,\11\ and research efforts aimed at developing new approaches to 
identify and care for individuals with inherited cancer syndromes.\12\
---------------------------------------------------------------------------
    \8\ www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative/implementation/adult-immunotherapy-network#cancer-immune-
monitoring-and-analysis-centers-cimacs-and-the-cancer-immunologic-data-
commons-cidc.
    \9\ www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative/implementation/human-tumor-atlas.
    \10\ epi.grants.cancer.gov/events/pe-cgs/.
    \11\ grants.nih.gov/grants/guide/rfa-files/RFA-CA-19-035.html.
    \12\ grants.nih.gov/grants/guide/rfa-files/rfa-ca-19-017.html.
---------------------------------------------------------------------------
    Other programs initially supported through the Cancer Moonshot 
include the Immuno-Oncology Translational Network (IOTN),\13\ 
established to improve immunotherapy outcomes across the spectrum of 
adult cancers and to prevent cancers before they occur, and a related 
follow-on project, the Cancer Immunoprevention Network (CIP-Net),\14\ 
which aims for a deeper understanding of immunoprevention and fostering 
a community of cancer immunoprevention researchers. Additional examples 
include the Fusion Oncoprotein Childhood Cancer Consortium 
(FusOnC2),\15\ a collaborative group of transdisciplinary researchers 
focused on the molecular drivers of childhood cancer, and a 
subsequently-developed network to support projects to better understand 
fusion-drive cancers, identifying new drug targets and agents to 
disrupt fusion oncoprotein drivers for high-risk solid tumors and brain 
cancers. The projects noted above will be transitioned from Moonshot 
funding to regular funding mechanisms, pending availability of 
appropriations.
---------------------------------------------------------------------------
    \13\ www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative/implementation/adult-immunotherapy-network.
    \14\ prevention.cancer.gov/major-programs/cancer-immunoprevention-
network-cip-net.
    \15\ www.cancer.gov/research/key-initiatives/moonshot-cancer-
initiative/implementation/childhood-cancer-research.
---------------------------------------------------------------------------
    As described in the FY 2024 Congressional Justification, top 
priorities for NCI and the Cancer Moonshot in reaching the goal of 
reducing cancer mortality rates by 50 percent over 25 years include a 
significant modernization and expansion of NCI-supported clinical 
trials networks to support doubling patient enrollment and 
democratizing enrollment in clinical trials. Additionally, modernizing 
clinical trials infrastructure includes building a National Cancer 
Research Data Ecosystem to collect, integrate, and share data from 
clinical trials and a broad range of research studies--while protecting 
patient privacy.
    With the proposed FY 2024 Moonshot funding, NCI would continue 
successful Moonshot programs that support these FY 2024 priorities to 
accelerate progress, while also funding new initiatives to leverage 
progress made so far. Examples of continuing Moonshot programs include 
the Telehealth Research Centers of Excellence,\16\ Acquired Resistance 
to Therapy Network,\17\ and Cancer Moonshot Scholars.\18\ These 
programs will make important contributions to expanding the scope of 
and access to NCI-supported clinical trials, provide new insights to 
overcome drug resistance, and fortify the cancer research workforce. 
The proposed Cancer Moonshot increase will provide critical resources 
to continue these and other programs and make progress toward a 
doubling of clinical trials enrollment, and toward the Cancer Moonshot 
mortality reduction goal.
---------------------------------------------------------------------------
    \16\ healthcaredelivery.cancer.gov/telehealth/trace.html.
    \17\ www.cancer.gov/about-nci/organization/dcb/research-programs/
artnet.
    \18\ www.cancer.gov/about-nci/organization/crchd/diversity-
training/cancer-moonshot-scholars-diversity-program.
---------------------------------------------------------------------------
    The proposed Cancer Moonshot increase in FY 2024 aims to both 
support continuation of successful research initiatives launched with 
Cures Act funds and to launch the new efforts. These new initiatives 
and necessary expansions will help more people with cancer and at risk 
of cancer participate in NCI-supported clinical trials and will ensure 
data generated through these trials and through other NCI-supported 
research efforts is available to inform future discoveries.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
Dr. Douglas Lowy, Principal Deputy Director, National Cancer Institute 
        (NCI)
    Question. We know that the most important way to combat cancer is 
early detection, however in most rural areas its difficult to access 
healthcare, let alone cancer screenings. West Virginia has a high 
cancer rate than the national average, and in particular has high rates 
of late stage cancer--such as colon cancer and lung cancer.
    Dr. Lowy, what can be done to increase cancer screenings in rural 
America?
    Answer. Increasing uptake of cancer screening is an important 
priority across the National Cancer Institute (NCI). NCI supports 
several key programs, partnerships, and individual research grants that 
aim to increase screening access and uptake. The ``Accelerating 
Colorectal Cancer Screening and Follow-up through Implementation 
Science (ACCSIS)'' Program is a Cancer Moonshot Initiative that 
supports research to improve colorectal cancer screening, follow-up, 
and referral for care among populations that have low colorectal cancer 
screening rates. The ACCSIS program focuses on underserved groups, 
including underserved racial and ethnic minority populations and people 
living in rural or difficult-to-reach areas. The program includes 
research centers in Appalachia (Kentucky and Ohio), Arizona, California 
(San Diego), Illinois (Chicago), New Mexico, North Carolina, Oklahoma, 
and Oregon.\19\
---------------------------------------------------------------------------
    \19\ healthcaredelivery.cancer.gov/accsis/.
---------------------------------------------------------------------------
    NCI is also supporting several research efforts to reduce barriers 
and increase uptake of cervical cancer screening, including in rural 
areas. Over half of new cervical cancer cases are diagnosed among women 
who have never been screened or are infrequently screened, reflecting 
barriers presented by socioeconomic disparities and geographic 
inaccessibility, among other factors.
    NCI's Cervical Cancer `Last Mile' Initiative is a public-private 
partnership that will help inform the accuracy and clinical 
effectiveness of self-sampling-based human papillomavirus (HPV) testing 
for primary cervical cancer screening. As part of the `Last Mile' 
Initiative, NCI is supporting the ``Self-sampling for HPV testing to 
Improve Cervical Cancer Prevention (`SHIP')'' trial, which will include 
participants representing a wide diversity of socioeconomic and racial/
ethnic groups and geographic regions, including both urban and rural 
populations across the U.S.\20\ NCI is also supporting the ``Multilevel 
HPV Self-Testing Intervention for the Increase of Cervical Cancer 
Screening Among Women in Appalachia'' clinical trial, which studies how 
well an HPV self-testing intervention works for increasing cervical 
cancer screening among women in four Appalachia states (Ohio, Kentucky, 
West Virginia, and Virginia).\21\ NCI and several Federal agencies have 
partnered to form the Federal Cervical Cancer Collaborative (FCCC), a 
Cancer Moonshot Initiative focused on reducing the persistent 
disparities in cervical cancer through more equitable cervical cancer 
vaccination, screening, and management among geographically isolated 
and economically and medically vulnerable populations. The FCCC aims to 
bring cervical cancer prevention and management guidelines into safety-
net settings of care more swiftly.\22\
---------------------------------------------------------------------------
    \20\ prevention.cancer.gov/major-programs/nci-cervical-cancer-last-
mile-initiative.
    \21\ www.clinicaltrials.gov/ct2/show/NCT04411849.
    \22\ dceg.cancer.gov/news-events/news/2022/Federal-cervical-cancer-
collaborative.
---------------------------------------------------------------------------
    Activities to increase cancer screening in rural regions are also 
part of NCI-Designated Cancer Centers' Community Outreach and 
Engagement efforts.\23\ For example, the University of Kentucky Markey 
Comprehensive Cancer Center, in partnership with community-based 
hospitals, is engaging in statewide collaborative efforts \24\ to 
increase lung cancer screening and survivorship care, which has helped 
Kentucky achieve the second highest lung cancer screening rate in the 
country, leading to a 19 percent reduction in the diagnosis of late-
stage lung cancers in the state. The Markey Cancer Center also includes 
a Patient-Oriented and Population Sciences Shared Resource 
Facility,\25\ which supports an initiative to refine and assist with 
dissemination of materials designed to increase uptake of cervical 
cancer prevention among high-risk populations in primary care practices 
in Ohio, Kentucky, Virginia, and West Virginia.
---------------------------------------------------------------------------
    \23\ cancercontrol.cancer.gov/research-emphasis/supplement/coe.
    \24\ ukhealthcare.uky.edu/markey-cancer-center/community/learning-
opportunities/lung-screening.
    \25\ ukhealthcare.uky.edu/markey-cancer-center/research/srf/popsrf.
---------------------------------------------------------------------------
    Another NCI-Designated Cancer Center undertaking efforts to improve 
screening in rural populations is the University of Virginia Cancer 
Center (UVACC), which serves 87 contiguous counties across northwestern 
Virginia and West Virginia, where 30 percent of the population is 
rural.\26\ Among the screening programs developed by UVACC are a Mobile 
Prevention Coach to provide free/reduced-cost mammograms, Pap tests, 
and HPV self-sampling tests to low-access communities; a Telehealth 
Lung Cancer screening program to provide radiology consults to rural 
hospitals, leading to a sustainable pathway to screening; and a CRC 
navigator program to enable a pathway to colonoscopy and increase the 
utilization of stool-based CRC screening.
---------------------------------------------------------------------------
    \26\ med.virginia.edu/community-outreach-engagement/discover-the-
community-we-serve/.
---------------------------------------------------------------------------
    NCI is also supporting the discovery, testing, and validation of 
new tests that may detect cancer more accurately and potentially reduce 
barriers to screening. The NCI Division of Cancer Prevention is in the 
process of creating a network to carry out widespread evaluation of 
cancer detection tests across populations. The Cancer Screening 
Research Network \27\ is on track to begin in 2024, with sites 
representing different regions and populations across the country.
---------------------------------------------------------------------------
    \27\ prevention.cancer.gov/major-programs/cancer-screening-
research-network-csrn.
---------------------------------------------------------------------------
                                 ______
                                 
                Questions Submitted to Dr. Joshua Gordon
              Questions Submitted by Senator Tammy Baldwin
Dr. Joshua Gordon, Director, National Institute of Mental Health (NIMH)
    Question. A recent CDC survey found that teenage girls and LGBTQ 
youth are grappling with a mental health crisis. Suicide is the second 
leading cause of death in youth and young adults aged 10-24. Data show 
that almost 45 percent of LGBTQ youth seriously considered suicide in 
the past year, and that suicide rates for Black youth are on the rise. 
The FY 2024 President's Budget proposes at $200 million increase for 
mental health research. This funding would support a Precision 
Psychiatry Initiative focused on developing biomarkers for major 
depression and identifying diagnostics to better predict patient 
prognosis and optimize treatment.
    How would identifying new biomarkers for depression deliver better, 
faster treatments to patients? And how could these investments help 
reduce suicide?
    Answer. Effective treatments for depression exist; however, 
identifying the best treatment for a specific person experiencing 
depression remains a significant challenge. Treatments are often 
selected by trial and error, with providers and patients sometimes 
waiting months to see if a treatment is effective. As part of the 
Precision Psychiatry Initiative, the National Institute of Mental 
Health (NIMH) aims to support research to uncover why people with 
depression respond differently to different treatments and identify 
biomarkers--objective, measurable characteristics that indicate health 
or disease states--to define depression subtypes, which could greatly 
improve treatment selection. Using biomarkers, mental healthcare 
providers may be able to predict a patient's response to different 
treatment options, which will decrease the time-consuming trial and 
error process and provide people with a working treatment sooner. Since 
depression is one of the main risk factors for suicide, advancements in 
biomarker development to optimize depression treatment may help 
considerably reduce suicide deaths.
                                 ______
                                 
              Questions Submitted by Senator John Boozman
Dr. Joshua Gordon, Director, National Institutes of Mental Health 
        (NIMH)
    Question. According to the CDC, rates of suicide among farmers are 
1.5 times higher than the national average.
    Farming communities are essential in Arkansas with almost 50,000 
farms across the state.
    I appreciate Congress and the Administration's support for 
expanding access to mental healthcare. However, I fear that farmers are 
often left out of the conversation.
    How does the NIMH intend to tailor its mental health research to 
ALL Americans, especially the farmers that are core to our nation's 
agricultural mission?
    Answer. The National Institute of Mental Health (NIMH) recognizes 
that farmers and others who live or work in underserved rural and 
frontier areas may experience mental health disparities--that is, 
increased risk for mental illnesses and suicide, as well as limited 
access to evidence-based mental health treatments and services. NIMH 
aims to address this serious and growing concern by supporting research 
to understand how mental health disparities arise and improve the 
delivery of mental health services and interventions in rural areas and 
other under-resourced communities. For example, in September 2023, the 
NIMH Office for Disparities Research and Workforce Diversity will 
sponsor a webinar titled ``Coming Face to Face with Suicide in American 
Farming,'' with the goal of identifying knowledge gaps in this area. 
Also, NIMH recently published a set of priorities for mental health 
disparities research, which identified reducing suicide and suicidal 
behavior among rural populations as a top priority area. The NIMH 
Office of Rural Mental Health Research collaborates with others in the 
Department of Health and Human Services to coordinate and support 
mental health research activities focusing on the unique strengths, 
challenges, and needs of individuals who live in rural and other 
underserved areas. Through these efforts, NIMH remains committed to 
advancing the goal of mental health equity and ensuring that NIMH-
supported research benefits all Americans.
                                 ______
                                 
                Questions Submitted to Dr. Richard Hodes
          Questions Submitted by Senator Shelley Moore Capito
Dr. Richard Hodes, Director, National Institute on Aging (NIA)
    Question. Precision medicine-based approaches are being used in 
many fields. Some NIH Institutes, such as the National Cancer 
Institute, have embraced it significantly.
    Can you comment on how precision medicine can be advanced for 
Alzheimer's Disease and other neurodegenerative diseases?
    Answer. NIH is working to advance precision medicine for people 
living with Alzheimer's and other neurodegenerative diseases, including 
those living with mixed dementia, a condition in which more than one 
dementia pathology is observed to occur simultaneously in the brain. 
Essential to precision medicine is a dedication to ensuring research--
from basic science through clinical trials--is inclusive so that 
findings are applicable to all populations, especially those most at 
risk for dementia. NIH funds several efforts to meet the need for 
therapeutics informed by precision medicine. As one example, NIH 
recently launched the second iteration of the Accelerating Medicines 
Partnership Program for Alzheimer's Disease (AMP AD) program in 
collaboration with the Foundation for the National Institutes of 
Health. In its first phase, this partnership involving government, 
industry, and not-for-profit organizations yielded the identification 
of more than 600 new potential disease mechanisms and risk factors 
(e.g., genes and proteins). This helps inform the development of a 
range of precision medicine treatment approaches by providing 
additional targets for drug discovery. The second phase builds on this 
success by collecting and analyzing additional data and samples from 
populations most at risk for Alzheimer's. Researchers in the program 
are using cutting-edge approaches to bring new medicines and support to 
patients by enhancing validation of novel, clinically relevant 
therapeutic targets and biomarkers.
    NIH is also funding several projects at institutions around the 
country to accelerate the development of precision medicine approaches 
for Alzheimer's and other neurodegenerative diseases, including a 
recent funding opportunity to build infrastructure for precision 
medicine research on minority health and disparities in Alzheimer's and 
related dementias.\28\ This effort is complemented by several workshops 
and research summits focused on identifying key gaps and opportunities 
for advancing precision medicine for Alzheimer's and related 
dementias.\29\ These efforts are reflected in the broad range of drug 
candidates being tested in NIA-funded clinical trials. As a result of 
the substantial research progress achieved over the last several years 
in understanding how Alzheimer's and related dementias develop and 
worsen, the drug development pipeline has never been more diverse. Drug 
candidates now in NIA-funded clinical studies target multiple aspects 
of the disease process, from inflammation in the brain to disrupted 
sleep patterns to changes in hormone levels and more.
---------------------------------------------------------------------------
    \28\ grants.nih.gov/grants/guide/rfa-files/RFA-AG-23-020.html.
    \29\ Examples include: 2021 NIH Alzheimer's Research Summit: Path 
to Precision Medicine for Treatment and Prevention; NIA-AA Symposium: 
Enabling Precision Medicine for Alzheimer's Disease Through Open 
Science; Microphysiological Systems to Advance Precision Medicine for 
AD/ADRD Treatment Virtual Workshop.
---------------------------------------------------------------------------
    Question. How we can tap into dramatic advances in genomics in the 
past few years towards this?
    Answer. Several NIH efforts are aimed at harnessing advances in 
genomics in broader, more diverse populations to enable a precision 
medicine approach to preventing and treating these diseases. Ten years 
ago, we knew of only 10 genes associated with Alzheimer's. Thanks to 
efforts like the NIH-funded Alzheimer's Disease Sequencing Project,\30\ 
we now know of and are researching more than 70 related genetic 
variants, which offer a broad range of new targets for intervention, 
such as those involved in inflammation or metabolism or that are 
associated with growth factors and hormones. The Alzheimer's Disease 
Sequencing Project continues to identify new genes and gene variants 
that contribute to increased risk for or protection against the 
disease. This project also includes the Diverse Population Initiative--
a targeted effort to sequence the entire genome of individuals from 
diverse communities to help identify shared and novel genetic 
riskfactors for Alzheimer's and related dementias across populations. 
Genomics data from this and other efforts are made available, with 
appropriate privacy and security safeguards, to the research community 
via a centralized data repository. These important genomics data can 
help advance precision medicine for dementia and other 
neurodegenerative diseases.
---------------------------------------------------------------------------
    \30\ www.nia.nih.gov/research/dn/alzheimers-disease-sequencing-
project-consortia.
---------------------------------------------------------------------------
    Question. The Labor-HHS Committee Report in the last two 
appropriations cycles contained language expressing concern about a 
correlation found between medications that are commonly prescribed for 
overactive bladder and the development of cognitive impairment and 
Alzheimer's Disease and Related Dementia (ADRD). The report language 
urged NIA to study these medications and other treatments for 
overactive bladder to determine their safety and efficacy, as well as 
their potential risks related to ADRD.
    Has NIA initiated research on adverse neurocognitive effects of 
overactive bladder medications?
    If research on these medications has not been initiated, what are 
the NIA's plans for studying the safety of the medications that are 
being prescribed to millions of Americans for treatment of overactive 
bladder?
    Answer. NIA has supported and continues to support studies on the 
safety of drugs used to treat overactive bladder, including research 
investigating the adverse neurocognitive effects of these medications. 
As one example, NIA is funding research using a novel model to 
investigate dementia induced by a specific class of medications meant 
to treat overactive bladder.\31\ NIA is also funding research 
evaluating the cognitive effects of overactive bladder medications in 
older women with incontinence.\32\ Because these drugs may increase the 
risk of developing dementia, they may be important targets for 
deprescribing, a process meant to safely reduce or stop medication to 
minimize or prevent harmful side effects. Along with other research 
initiatives,
---------------------------------------------------------------------------
    \31\ reporter.nih.gov/search/0lm26jQsukuQXix5r_QvGw/project-
details/10258975.
    \32\ reporter.nih.gov/search/0lm26jQsukuQXix5r_QvGw/project-
details/10343015.
---------------------------------------------------------------------------
    NIA is funding a clinical trial testing whether discontinuing use 
of anticholinergics, a class of drugs used to treat overactive bladder, 
improves cognition and lowers the risk of dementia, as well as other 
research on the impact of deprescribing on dementia risk.\33\ NIA also 
funds the United States Deprescribing Network, an effort to enhance 
research on possible ways to deprescribe potentially risky medications 
and improve medication use among older adults. The Deprescribing 
Network itself provides funding for several pilot and exploratory 
studies, grant planning activities, and small collaboration grants.
---------------------------------------------------------------------------
    \33\ reporter.nih.gov/search/Shaj-qYerkm0U6DRn1S6tg/project-
details/10129872.
---------------------------------------------------------------------------
    NIH also funds studies of non-drug therapeutic approaches to treat 
overactive bladder. One NIA-funded research study is assessing brief 
mindfulness and non-invasive brain stimulation to reduce symptoms of 
urgency incontinence in women.\34\ NIA also recently supported a study 
testing a novel, non-invasive nerve stimulation device for in-home 
treatment of overactive bladder.\35\
---------------------------------------------------------------------------
    \34\ reporter.nih.gov/search/PWzY007ysEW1d1WslGSukQ/project-
details/10259722.
    \35\ reporter.nih.gov/search/rmFNoL91xkamsqkkLW-QEQ/project-
details/10219001.
---------------------------------------------------------------------------
    In addition, NIA has several broad funding opportunities available 
to fund meritorious applications proposing additional such research. 
Some of the current projects on dementia and overactive bladder are 
funded via these opportunities, which include support for:
  --basic and clinical research
  --small businesses (such as those developing non-drug therapies for 
        overactive bladder)
  --training and career development awards for the next generation of 
        clinicians and researchers working in this area
    NIA has funded and continues to fund studies on the safety of drugs 
used to treat overactive bladder, including those described above.
                                 ______
                                 
                 Questions Submitted to Dr. Nora Volkow
             Questions Submitted by Senator Jeanne Shaheen
Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA)
    Question. Xylazine, a sedative only authorized in the US for 
veterinary use, has been detected in a growing number of overdose 
deaths and illicit drug combinations. It is commonly encountered in 
combination with fentanyl but has also been detected in mixtures 
containing cocaine, heroin and a variety of other drugs. From 2020 to 
2021, the Drug Enforcement Agency found a more than 60% increase in 
xylazine-positive heroin tested at DEA labs in the Northeast, and 
xylazine-related overdose deaths also doubled in the Northeast over 
that same time period. As NIDA is aware, common opioid overdose 
reversal drugs such as naloxone are ineffective against xylazine, as 
xylazine is not an opioid.
    Could NIDA please detail what research the agency is funding to 
find overdose reversal drugs, similar to naloxone, for xylazine?
    Answer. Given the rapid recent spread of xylazine across the United 
States, NIDA has been quickly growing its research efforts to 
understand xylazine toxicity and to develop xylazine overdose reversal 
agents. Xylazine is a sedating agent that targets alpha-2 adrenergic 
receptors (A2R) in the brain and is approved by the United States Food 
and Drug Administration (FDA) for use as an animal tranquilizer. While 
not approved for human use, it is increasingly mixed with illicit 
opioids in the United States and has become implicated in a growing 
number of opioid-related overdose deaths. Case studies show that 
xylazine alone can cause slowed breathing and heart rate, loss of 
consciousness, and coma. Given that opioid misuse can cause similar 
symptoms, there is concern that xylazine and opioids may be an 
especially dangerous combination. While the opioid reversal agent 
naloxone should always be administered in cases of overdose involving 
xylazine laced opioids, effects specific to xylazine do not respond to 
naloxone.
    The mechanisms of xylazine overdose in humans, alone or in 
combination with opioids, are not fully understood. In veterinary 
practice, xylazine sedation is reversed using A2R antagonists such as 
yohimbine. These antagonists may hold promise for reversing overdose in 
people exposed to xylazine; however, some of them lack specificity for 
A2R and can trigger adverse reactions, including paradoxically deeper 
sedation, observed in veterinary settings.\36\ There is also concern 
that rapid, simultaneous reversal of xylazine and opioid overdose could 
trigger severe withdrawal symptoms. NIDA is supporting preclinical 
studies to characterize these mechanisms and identify safe, effective 
reversal agents for xylazine overdose. For example, NIDA intramural 
investigators are testing the effects of xylazine, with and without 
opioids, in a rodent model that they originally developed to identify 
stronger opioid overdose reversal agents.\37\ Once these investigators 
establish the baseline effects of xylazine and xylazine-plus-opioids in 
this model, they will test the potential therapeutic effects of A2R 
antagonists, with and without naloxone.
---------------------------------------------------------------------------
    \36\ pubmed.ncbi.nlm.nih.gov/30372437.
    \37\ pubmed.ncbi.nlm.nih.gov/36828628.
---------------------------------------------------------------------------
    To gain further insight into xylazine overdose and approaches to 
treatment, NIDA-funded investigators have been gathering data from 
people who have been exposed to xylazine. In a recent study of patients 
who presented to the emergency department with opioid overdose or 
toxicity, those who also tested positive for xylazine had lower rates 
of cardiac arrest and coma than those positive for opioids alone.\38\ 
In addition, the two groups did not differ significantly in their 
length of stay in the ED, hospital admission, or mortality. Other 
studies have found that people heavily sedated or unconscious from 
xylazine are at high risk of being in environments where they are 
victims of violent assaults; so, xylazine sedation alone, without 
effects on heart or lung function, can incur serious health and safety 
risks.\39\ Overall, these studies suggest that overdose and other 
outcomes associated with xylazine toxicity are more complex than 
anticipated based on xylazine's known pharmacology, and that it will be 
important to fully understand the full array of these outcomes as we 
work toward appropriate therapies, including overdose reversal agents. 
To that end, NIDA is prioritizing new research on the prevalence and 
outcomes of xylazine use and treatment of xylazine overdose in 
combination with other drugs.
---------------------------------------------------------------------------
    \38\ pubmed.ncbi.nlm.nih.gov/37014353.
    \39\ pubmed.ncbi.nlm.nih.gov/36846574.
---------------------------------------------------------------------------
    Question. Could NIDA please detail the timeline the agency expects 
for those reversal drugs to be available for commercial use?
    Answer. Research on potential xylazine overdose reversal agents has 
begun but is not yet at a stage in which a timeline to market 
availability can be predicted. As noted above, preclinical studies are 
underway to address whether A2R antagonists can also reverse xylazine 
overdose, alone and in combination with opioids. NIDA intramural 
investigators estimate that these studies will be complete in 6 months. 
If these studies show promise, there is potential to further accelerate 
the development of xylazine overdose reversal agents by repurposing the 
veterinary medicines already available, as opposed to starting over 
with new drug discovery and synthesis. We expect that forthcoming 
research will help further accelerate progress in developing treatments 
for xylazine use and overdose, including xylazine overdose reversal 
agents.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA)
    Question. Recent estimates show more than 106,000 Americans, and 
more than 1,500 West Virginians, died from drug-related overdoses in 
the last year. West Virginia continues to have the highest rate of 
overdose deaths in the country with 90 deaths per 100,000 people, which 
is almost triple the national average of 31.5 deaths per 100,000 
people. To combat this ongoing epidemic, the Administration released 
its National Drug Control Strategy. The Strategy highlights the need to 
expand the science behind recovery and directs the Office of National 
Drug Control Policy to partner with the National Institute on Drug 
Abuse, among others, to develop, prioritize and implement a Federal 
recovery agenda.
    What are other ways that we can better expand access to substance 
use disorder treatment in rural America, particularly in West Virginia, 
where the overdose rates are the highest in the nation?
    Answer. NIDA acknowledges the vital need to ensure rural access to 
evidence-based interventions and supports substance use research in 
rural communities. Through the Rural Opioid Initiative, a collaboration 
with the Appalachian Regional Commission, the Substance Abuse and 
Mental Health Services Administration, and the Centers for Disease 
Control and Prevention, NIDA has funded several projects aimed at 
assisting rural communities with comprehensive approaches to addressing 
drug use. Ongoing studies address opioid, stimulant, and tobacco use, 
spanning diverse approaches such as novel peer-delivered and 
technology-supported interventions, harm reduction approaches, and 
strategies that address social determinants of health and reduce 
stigma. The Kentucky Viral Hepatitis Treatment (KeY Treat) Study 
underway at the University of Kentucky, for example, is working toward 
reducing the health burden of hepatitis C infection associated with 
drug use in rural Kentucky.\40\
---------------------------------------------------------------------------
    \40\ www.ncbi.nlm.nih.gov/pmc/articles/PMC8258565/.
---------------------------------------------------------------------------
    With funding from the NIH Helping to End Addiction Long-term 
Initiative (HEAL), NIDA supports large research programs with rural 
components, conducted in real-world settings and in collaboration with 
a diverse range of stakeholders to ensure that the strategies being 
studied are sustainable and scalable. NIDA's Clinical Trials Network 
expanded its multi-site network for developing and testing treatment 
effectiveness with new nodes and protocols to expand the use of 
medications for opioid use disorder (MOUD) in rural settings and 
emergency departments, implement evidence-based models to optimize the 
delivery of MOUD, and prevent opioid use disorder (OUD) or progression 
to more severe OUD. Specifically, the CTN added the Appalachian 
Node,\41\ representing a collaboration among the University of 
Pittsburgh, West Virginia University, and Pennsylvania State 
University. NIDA's HEALing Communities Study is testing evidence-based 
strategies to reduce opioid-related overdose deaths, increase MOUD 
treatment, and reduce risky opioid prescribing in 67 communities within 
4 states, including in rural areas highly affected by the overdose 
crisis. The recently launched Harm Reduction Research Network also aims 
to test and improve the effectiveness, implementation, and impact of 
harm reduction strategies in rural areas and other communities. 
Finally, through the Integrative Management of chronic Pain and OUD for 
Whole Recovery program (IMPOWR), a NIDA-led study aims to develop 
effective, equitable, and sustainable interventions for chronic pain 
and OUD to meet the needs of people in rural and Black communities. 
Findings from these studies will provide valuable insights into how 
specific rural communities can increase access to interventions for OUD 
through tailored approaches that meet individual and community needs.
---------------------------------------------------------------------------
    \41\ www.ctn.pitt.edu/.
---------------------------------------------------------------------------
    Question. Far too many West Virginians are familiar with substance 
use and the impact it can have on loved ones, families and communities. 
However, the driving force behind the record numbers of overdose deaths 
we are seeing is illicit fentanyl. In the last year illicit fentanyl 
became the number one cause of death among Americans 18 to 45, 
surpassing deaths from COVID-19, suicide and car accidents.
    We must act now to better understand substance use and ensure that 
we do not lose future generations to overdose. West Virginia may lead 
the nation in drug overdoses, but there are some very smart people 
leading innovative research projects to find treatments for substance 
use disorder.
    Dr. Volkow, you have been to West Virginia, visited the West 
Virginia University's Rockefeller Neuroscience Institute, and have seen 
first-hand the work being done to study and find treatments for 
substance use disorder.
    Dr. Volkow, how can NIDA continue to support research institutions 
that are studying the science of substance use disorder and working on 
treatments for substance use disorder?
    Answer. Through a variety of NIH funding mechanisms, NIDA continues 
to fund meritorious applications submitted by researchers from diverse 
institutions to maximize its support of research. Notably, there are 
multiple NIH funding mechanisms geared toward increasing research 
infrastructure.
    For example, the congressionally mandated Institutional Development 
Award (IDeA) program builds research capacity at institutions in states 
with historically low levels of NIH funding.\42\ Similarly, 
Institutional Research Training Grants support institution 
infrastructure to enable the recruitment and training of graduate 
students and postdoctoral candidates.\43\
---------------------------------------------------------------------------
    \42\ www.nigms.nih.gov/Research/DRCB/IDeA/Pages/default.aspx.
    \43\ researchtraining.nih.gov/programs/training-grants/T32-a.
---------------------------------------------------------------------------
    NIDA also uses novel approaches to bring a variety of institutions 
into the research enterprise. For example, with funding from the NIH 
HEAL Initiative, NIDA expanded its Clinical Trials Network, adding five 
new research nodes and supporting the development of new protocols to 
develop and test substance use interventions. In addition, through 
NIDA's Racial Equity Initiative, the Institute issued two notices of 
funding opportunity (NOFO) specific to Minority Serving Institutes 
(MSIs) which are underrepresented in substance use research, with 
companion notices for other research institutions. One opportunity 
focused on novel research to understand how structural racism impacts 
substance use and another aims to support visionary applications to 
study the intersection of substance use and racial equity. Applications 
submitted in response to these NOFOs are being reviewed and will be 
funded in FY 2023. NIDA is also currently participating in two novel 
NIH funding opportunities to further promote the diversity, breadth, 
and geographic locations of research programs.\44,45\ Together, these 
efforts aim to encourage diversity and, in doing so, increase the 
scientific value and impact of research.
---------------------------------------------------------------------------
    \44\ grants.nih.gov/grants/guide/pa-files/PAR-23-122.html.
    \45\ grants.nih.gov/grants/guide/pa-files/PAR-23-144.html.
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                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA)
    Question. Last year, you [Dr. Volkow] wrote about the financial 
sense in investing in prevention. You said that ``You can't put a 
dollar value on the losses American families have suffered due to the 
addiction and overdose crisis,'' but that certain prevention and 
treatment strategies can save costs for the healthcare system in the 
long run.
    Can you tell us about the cost savings associated with drugs use 
prevention and addiction treatment?
    Answer. Research has demonstrated that substance use prevention and 
treatment strategies are a good investment and reduce burden across 
many sectors of society, including healthcare, public safety and the 
criminal legal system, behavioral health, and education. These 
strategies are relatively inexpensive compared to the high costs 
incurred if substance use disorders develop and are left untreated.
    NIDA-funded researchers have found that higher-risk adolescent 
behaviors, including substance use, accounted for more than 10 percent 
of all hospital charges to healthcare payors in North Carolina, 
suggesting there is significant potential for cost savings if barriers 
to preventative and treatment services are addressed.\46\ Another 
analysis from researchers funded by NIDA showed that implementation of 
a structured prevention approach called Communities That Care had a 
sustained impact on reducing risky health behaviors and a continued 
positive cost benefit, with an approximately $602 investment in each 
child yielding an estimated $7,754 in savings by the time participants 
were age 23--a $12.88 return for each dollar invested. The return was 
over twice as great when the downstream economic benefits of completing 
college was included.\47\ Other research studies have shown that 
addiction treatment is associated with a net positive cost savings, 
with one study showing greater than 7:1 ratio of benefits to costs, 
estimating substance use treatment costs at $1,583 while being 
associated with a monetary benefit to society of $11,487.\48\ The 
primary drivers of these benefits are reduced costs associated with the 
criminal legal system and increased employment earnings.\49\
---------------------------------------------------------------------------
    \46\ Ridenour et al., 2022 www.ncbi.nlm.nih.gov/pmc/articles/
PMC8554188/.
    \47\ Kuklinski et al., 2021 pubmed.ncbi.nlm.nih.gov/33837890/.
    \48\ Ettner et al., 2006 pubmed.ncbi.nlm.nih.gov/16430607/.
    \49\ Koenig et al., 2005 pubmed.ncbi.nlm.nih.gov/15797638/.
---------------------------------------------------------------------------
    It should also be noted that NIH, with leadership from NIDA, is 
supporting two national studies--Healthy Brain and Child Development 
(HBCD) study and Adolescent Brain Cognitive Development SM Study (ABCD 
Study)--that aim to provide research which can inform prevention 
service delivery. Specifically, HBCD identifies human brain, cognitive, 
behavioral, social, and emotional development beginning prenatally 
through childhood (e.g., age 9-10). The study will help predict and 
prevent some of the known impacts of pre/postnatal exposure to drugs or 
adverse environments, including risk for future substance misuse, 
mental disorders, and other behavioral and developmental problems.\50\ 
The ABCD Study will determine how childhood experiences (such as 
sports, videogames, social media, unhealthy sleep patterns, and 
smoking) interact with each other to affect brain development, 
academic, health, and other outcomes. The results of the ABCD Study 
will provide a broad array of stakeholders including, families, 
schools, health professionals; and policymakers with information to 
promote the health, well-being, and success of children, which can lead 
to cost savings.\51\
---------------------------------------------------------------------------
    \50\ heal.nih.gov/news/stories/healthy-brain-child-development-
hbcd-study.
    \51\ nida.nih.gov/research-topics/adolescent-brain/longitudinal-
study-adolescent-brain-cognitive-development-abcd-study.
---------------------------------------------------------------------------
    Question. From February 2020 to June 2021, substance use caused a 
9-26% decline in prime-age labor force participation. This is an issue 
that affects not only the workforce in my state of West Virginia, but 
working adults across the country.
    Can you tell us about the potential effects that addiction 
treatment can have on employment and workforce readiness?
    Answer. While NIH is not the United States government lead on labor 
force participation, we work closely with other Departments and 
Agencies to address health issues affecting the Nation. Work from other 
government entities has been summarize below.
    According to the United States Bureau of Labor Statistics, the 
labor force participation rates (LFPR) of workers aged 25-54 declined 
substantially (around 3 percentage points) during the COVID pandemic. 
Recovery has been slow: As of January 2022, the rate was still about 1 
percentage point below pre-pandemic levels, however, according to data 
for April 2023 \52\ the LFPR has fully recovered. A May 2022 study from 
the Federal Reserve Bank of Atlanta \53\ had suggested that up to about 
one quarter of the post pandemic drop could be accounted for by 
increased problematic substance use in the workforce, highlighting the 
importance of maximizing access to substance use treatment in the 
workplace.
---------------------------------------------------------------------------
    \52\ fred.stlouisfed.org/series/LNS11300060.
    \53\ www.atlantafed.org/-/media/documents/research/publications/
policy-hub/2022/05/09/05--did-substance-abuse-during-pandemic-reduce-
labor-force-participation.pdf.
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    The implementation of effective and comprehensive addiction 
treatments could have transformational effects on workforce readiness, 
as employment is one of the most widely acknowledged social 
determinants of health and well-being among the general population. At 
the same time, it must be acknowledged that the relationship between 
problematic substance use and employment is complex. For example, that 
relationship is bidirectional: substance use can impact labor market 
outcomes and the experience of work can similarly influence substance 
use patterns.\54\ Another important aspect in need of further research 
is the effects of remote working on mental health symptoms and 
substance use patterns in members of the workforce with psychiatric 
vulnerabilities.\55\ Finally, research has shown that the type and rate 
of substance use varies quite dramatically by occupation and 
industry.\56\
---------------------------------------------------------------------------
    \54\ Addiction, employment, and the return to work. 
pen.library.ubc.ca/media/stream/pdf/52383/1.0347521/5.
    \55\ Cohen and Bloomberg. Fortune Magazine May 2023 fortune.com/
2023/05/13/remote-workers-substance-use-disorders-return-to-office-
mandates/.
    \56\ SAMHSA 2015. www.samhsa.gov/data/sites/default/files/
report_1959/ShortReport-1959. html.
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                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA)
    Question. Insomnia impacts approximately 25 million Americans, with 
one-third to one-half of servicemembers and veterans impacted. Insomnia 
is a significant societal problem with a considerable disease burden--
including comorbidities of PTSD, anxiety, depression, and drug abuse. 
Currently, one of the most common insomnia prescriptions is 
benzodiazepines and z drugs (zopiclone/zolpidem)--that are recommended 
for short-term use, but are commonly used long-term, resulting in 
daytime impairments and lead to abuse. Treatment options exist that 
address chronic insomnia without dependence issues and decrease the 
likelihood of drug abuse--DORA class. Dual Orexin Receptor Antagonists 
(DORAs) work by blocking signals in the brain that stimulate 
wakefulness. DORAs have an excellent safety profile that does not 
suggest habit-forming behavior. Various research agencies are currently 
studying DORAs to help with insomnia-associated conditions (DoD for 
PTSD, NIH/NIDA for Sleep).
    Currently, DORAs are schedule IV on the DEA Controlled Substance 
Schedule. Idorsia filed a Citizens Petition asking the DEA 
Administrator to initiate a rulemaking process to remove the DORA class 
medications from scheduling under the Controlled Substances Act (CSA) 
based on 8 years of real-world evidence that shows the class has an 
insignificant abuse profile and potential for abuse. The first step in 
the process for DEA to consider de-scheduling DORAs is for FDA to 
review the Citizen Petition and, if they concur with the scientific 
evidence, to then recommend to DEA that it begin the rule making 
process to propose de-scheduling the DORA class of treatments (which 
currently includes three products from three separate manufacturers).
    The DORA class of drugs are also already available on the market in 
Europe without any of the restrictions or potential stigma that exist 
in the U.S. market.
    Dr. Volkow, I know that NIDA has focused on finding non-addictive 
treatments for insomnia. This is particularly an issue for our 
servicemembers and veterans, who are significantly impacted by insomnia 
and may be prescribed drugs that can become addictive. Can you discuss 
the research NIDA has either already done or has planned in this space, 
particularly with the DORA class of drugs? Has NIDA identified 
priorities around finding the best treatments, at the lowest risk, for 
insomnia?
    I also understand that NIDA is interested in research into the DORA 
class of drugs as a potential treatment for opioid use disorder. What 
relevant research do you have underway or planned on this topic?
    Answer. Dual orexin receptor antagonist (DORA) medications block 
the activity of both versions of the brain's receptors for the 
signaling peptide orexin, which helps regulate sleep stages and 
wakefulness. NIDA research on DORA medications is not specific to 
veteran populations, though NIDA research does address this priority 
more broadly in the context of addiction, a field where the 
identification of pharmacotherapies (e.g., for pain and sleep 
disorders) with less potential for misuse constitutes a strategic 
research area. DORAs are a good example in this context as the orexin 
system plays a prominent role in health (e.g., sleep and appetitive 
behaviors) and disease (e.g., Parkinson's, depression/anxiety, and 
addiction). NIDA's significant investments in investigating potential 
applications for DORAs (in the broad context of addiction) illustrates 
this interest. Relevant projects in this space include studies to:
  --Identify potential mechanisms of sleep disruption induced by 
        methamphetamine use via investigations of the orexin system and 
        the therapeutic potential of DORAs. The results of this project 
        may lead to new and more broadly effective medications that 
        will target both methamphetamine abuse and related insomnia; 
        \57\
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    \57\ reporter.nih.gov/search/A6Z2dnBww0SwLArh0G3z8A/project-
details/10631661.
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  --Investigate the clinical potential of a potent and selective orexin 
        1 receptor (OX1R) antagonist (a medication that blocks the 
        activity of only the orexin 1 receptor) (AZD4041/BPN-19302), 
        which studies in rodents and non-human primates have shown can 
        reduce the addiction-like behaviors that are relevant to those 
        commonly found in opioid use disorder patients; \58\
---------------------------------------------------------------------------
    \58\ reporter.nih.gov/search/TqdUrvtOv0GD2jHNie_YgQ/project-
details/10469590.
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  --Evaluate the potential of the FDA approved orexin antagonist 
        suvorexant to alleviate the adverse effects of opioid and 
        methamphetamine co-use, including the sleep disturbances 
        characteristic of this condition; \59\
---------------------------------------------------------------------------
    \59\ reporter.nih.gov/search/A6Z2dnBww0SwLArh0G3z8A/project-
details/10577909.
---------------------------------------------------------------------------
  --Identify new compounds to alleviate opioid withdrawal dependent 
        sleep disruption in an animal model of oxycodone dependence; 
        \60\
---------------------------------------------------------------------------
    \60\ reporter.nih.gov/search/TqdUrvtOv0GD2jHNie_YgQ/project-
details/10516885.
---------------------------------------------------------------------------
  --Develop novel OX1R antagonists for the treatment of cocaine use 
        disorder without the sleep-inducing liabilities seen with 
        existing DORAs; \61\ and
---------------------------------------------------------------------------
    \61\ reporter.nih.gov/search/A6Z2dnBww0SwLArh0G3z8A/project-
details/10400321.
---------------------------------------------------------------------------
  --Translate positive preclinical findings showing orexin antagonism 
        has substantial promise for treating addiction into the 
        clinical domain by administering suvorexant to people who smoke 
        cigarettes with a tobacco use disorder as a means to facilitate 
        smoking cessation.\62\
---------------------------------------------------------------------------
    \62\ reporter.nih.gov/search/A6Z2dnBww0SwLArh0G3z8A/project-
details/9979831.
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    In addition, the NIH's National Center on Sleep Disorders Research 
(NCSDR), located within the National Heart, Lung, and Blood Institute 
(NHLBI), is currently supporting several clinical studies and clinical 
trials for the treatment of insomnia. As insomnia is commonly 
associated with, and exacerbates, other medical and psychiatric 
disorders, it is of critical importance to find effective therapies for 
this disorder. Currently, cognitive-behavioral therapy for insomnia 
(CBT-I) is the recommended first-line treatment for this disorder; 
however, research supported by NIH has shown that there are different 
``types'' of insomnia. Depending on the type an individual may have, 
treatment can be personalized.
    In summer 2023, NHLBI will launch its largest randomized clinical 
trial, with sites in the United States and Canada, to test both 
medication and behavioral interventions in individuals that have the 
different types of insomnia. NHLBI is also supporting a new hybrid 
effectiveness-implementation trial to use brief behavioral treatment of 
insomnia in socioeconomically disadvantaged adults in primary care.\63\
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    \63\ reporter.nih.gov/search/zBDt0NIqqESUbopRoK8FzQ/project-
details/10507411.
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                          SUBCOMMITTEE RECESS

    Senator Baldwin. The committee will next meet in this room, 
Dirksen 192, on Thursday, May 11, at 10 a.m., for a hearing on 
the Biden Administration's Budget Request for the Department of 
Education.
    Until then, this committee stands adjourned.
    [Whereupon, at 11:40 a.m., Thursday, May 4, the 
subcommittee was recessed, to reconvene at 10 a.m., Thursday, 
May 11.]