NINDS 2021 Congressional Budget Justification

¹ Excludes the following amounts (in thousands) for reimbursable activities carried out by this account:
FY 2019 - $18,957     FY 2020 - $19,700    FY 2021 - $19,560

² Of which $57.5 million in FY 2019, $70.0 million in FY 2020, and $50.0 million in FY 2021 is derived by transfer from the NIH Innovation Account under the 21st Century Cures Act.

³ Reflects 21st Century Cures Act funding not obligated in FY 2019, and carried over into FY 2020.

Budget Mechanism - Total ¹,²

(Dollars in Thousands)

¹ All items in italics and brackets are non-add entries.

² Of which $57.5 million in FY 2019, $70.0 million in FY 2020, and $50.0 million in FY 2021 is derived by transfer from the NIH Innovation Account under the 21^st Century Cures Act.

³ Includes $2.8 million of 21st Century Cures Act funding not obligated in FY 2019 and carried over into FY 2020.
 

Major Changes in the Fiscal Year 2020 President's Budget Request

Major changes by budget mechanism and/or budget activity detail are briefly described below. Note that there may be overlap between budget mechanism and activity detail, and these highlights will not sum to the total change for the FY 2021 President’s Budget request for the National Institute of Neurological Disorders and Stroke (NINDS), which is $2,245.1 million, a decrease of $201.5 million from the FY 2020 Enacted level. The FY 2021 President's Budget reflects the Administration's fiscal policy goals for the Federal Government. Within that framework, NINDS will pursue its highest research priorities through strategic investments and careful stewardship of appropriated funds.

Research Project Grants (RPGs) (-$165.6 million; total $1,627.1 million):

The NINDS budget mechanism table reflects a decrease in $165.6 million in the Institute’s Research Project Grants portfolio. NINDS plans a reduction of 7.0 percent in the cost of individual noncompeting awards relative to their committed level. Competing RPGs are expected to decrease by 362 grants in FY 2021 compared to the FY 2020 enacted level of awards.

Other Research (-$5.2 million; total $122.5 million):

NINDS plans to reduce its regular portfolio of Other Research. This mechanism also reflects an increase in Other Research grants funded from Opioid funding and from the BRAIN Initiative under the 21^{st> Century Cures Act.}

Intramural Research (-$13.9 million; total $205.7 million):

The intramural budget mechanism reflects a 6.3 percent decrease from the funding level of FY 2020.

Summary of Changes

(Dollars in Thousands)

Fiscal Year 2020 Budget Graphs

History of Budget Authority and FTE's:

 

 

Distribution of Mechanism:

 

Change by Selected Mechanism:

 

Budget Authority by Activity¹

(Dollars in Thousands)

¹ Includes F T Es whose payroll obligations are supported by the NIH Common Fund.

² Total for Opioid/Pain Research including IR and RMS is (in thousands) $240,843 in FY 2019, $$266,321 in FY 2020, and $266,321 in FY 2021.

 

Authorizing Legislation

Appropriations History

¹ Budget Estimates to Congress includes mandatory financing.

² Includes funds derived by transfer from the NIH Innovation Account under the 21st Century Cures Act.

Justification of Budget Request
National Institute of Neurological Disorders and Stroke

Authorizing Legislation: Section 301 and Title IV of the Public Health Service Act, as amended.

Budget Authority (BA):

Director's Overview

The National Institute of Neurological Disorders and Stroke (NINDS) supports research that advances the diagnosis, prevention, and treatment of neurological disorders; that is, diseases of the brain, spinal cord, and nerves of the body. Basic research to understand the brain in health and disease, the wellspring of public and private sector progress, is at the core of this mission.

Chronic pain, dementias, stroke, traumatic brain injury (TBI), epilepsy, Parkinson’s disease, multiple sclerosis, cerebral palsy, and other common neurological disorders affect millions of Americans of all ages. Hundreds of rare diseases collectively add to the enormous impact. Increasing the urgency for progress, brain disorders are becoming more common with the aging of our population, and the high prevalence of chronic pain is a major driver of the opioid crisis.

The multiplicity of neurological diseases, the complexity of the brain, and its sensitivity to disruption present formidable challenges to medical science. To confront this challenge, NINDS supports essential research that the private sector does not–basic studies to understand the brain and its diseases, innovations with long time horizons or high risk of failure, and preventive interventions that pay off in lives saved. Despite the challenges, each year research improves the lives of many people with neurological disorders, building on decades of NINDS and NIH investment. For example: In the 1960s fundamental studies of how nerve cells communicate led to drug therapy with L-DOPA, still the mainstay of Parkinson’s treatment. In the 1970s, NIH investment and advances in physics and engineering launched the revolution in brain imaging, transforming diagnosis and treatment of many brain diseases. In the 1980s, the first enzyme replacement therapy for an inherited metabolic disorder, Gaucher disease, showed the value of a sustained bench-to-bedside research program and provided an early boost to the biotechnology industry, and a pioneering NINDS technology development program moved “neuroprosthetic” devices from science fiction to reality, with the first cochlear implants for the hearing impaired. In the 1990s, research on the immune system and multiple sclerosis led to the first drugs that slow the disease; research on how normal and Parkinson’s disease affected brains control movement guided effective deep brain stimulation (DBS) therapy; and a targeted NINDS development plan, from the laboratory to human trials, developed the first emergency treatment for stroke, with the clot-busting drug tPA, after the private sector had abandoned stroke emergency treatment as too risky for investment.

Since 2000, NINDS research has continued to catalyze private sector therapy development, with several new drugs for multiple sclerosis, epilepsy, insomnia, migraine, and other disorders, and use of DBS to treat epilepsy, dystonia, and other diseases. Advances in genetics, driven by the Human Genome Project, are transforming the outlook for many previously intractable brain diseases. First, better diagnostics eliminated the years’ long diagnostic odysseys for many families confronting rare diseases. More recently, neurogenetics has led to the first wave of drugs and gene therapy, with recent successes for spinal muscular atrophy (SMA), muscular dystrophy, and Batten disease. In a few fortuitous examples, genome sequencing, which is now feasible for individual patients, has led to immediate improvements in care for children with rare forms of dystonia, epilepsy and other disorders. Treatments arising from genetic studies for Huntington’s disease, inherited amyotrophic lateral sclerosis (ALS), Parkinson’s disease, tuberous sclerosis, and several other disorders are now in clinical testing. And, though breakthroughs like gene technologies capture the public’s attention, sustained, incremental improvements in clinical medicine and prevention from dozens of clinical trials and epidemiological studies collectively drove reduction in stroke incidence by 32 percent from 1987 to 2017 for people aged 65 years and older.¹

NINDS’s highest priority is investigator-initiated research, because of its long record of driving progress. In addition to traditional NIH grant programs, the Javits Awards to scientists who have exceptional talent, imagination, and achievement, and the highly competitive Research Program Awards, which are available to all but the newest investigators, provide funding for ambitious, creative, or longer-term research projects. Neuroscientists are also remarkably well represented in the NIH-wide Pioneer Awards, Transformative R01, and New Innovator Awards, reflecting the dynamism of the field. For many years, NINDS policies have favored early career investigators. Thus, nearly one third of all NINDS investigators are in their first five years of independent NIH funding, and early-stage investigators receive more NINDS funding than any other cohort. NINDS diversity programs seek to tap the full wealth of the nation’s talent pool to confront the extraordinary challenges that neurological disorders present.

To complement investigator-initiated research, NINDS targets programs to critical public health needs of the present and extraordinary opportunities for the future. The Institute’s intensive engagement in the NIH Helping End Addiction Long-term (HEAL) and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiatives illustrate, respectively, these two types of priorities. The trans-NIH section of the separate Overview volume of the NIH Congressional Justification describes the HEAL and BRAIN programs. Here, the focus is on how, from the perspective of the NINDS mission, BRAIN and HEAL each build on past success and advance the Institute’s mission into the future.

More than 25 million Americans suffer from daily chronic pain.² The lack of effective, non-addictive treatment for many of these people is a major factor in the opioid crisis. As the largest supporter of pain research, NINDS leads several HEAL initiative programs that are developing non-addictive pain treatments to displace addictive drugs or be effective when opioids are not. HEAL initiatives to identify and validate targets for new pain interventions build on investments in basic pain research and on lessons from how basic research catalyzed private sector development of drugs for SMA, Parkinson’s disease, migraine, and other diseases. HEAL investments in biomarkers leverage NINDS biomarkers programs and recognition that NIH biomarker research stimulates progress. For example, the remarkable new therapies that use clot retrieval devices to directly clear blocked blood vessels in severe strokes when tPA does not restore blood flow rely on a brain imaging biomarker to determine who will benefit. HEAL screening of candidate non-addictive pain drugs follows the model of the NINDS Epilepsy Therapy Screening Program, which has energized the development of anti-seizure drugs by providing to academia and industry a rigorous, independent, standardized evaluation of drug candidates in a series of animal models. HEAL is also adopting the NINDS milestone-gated, preclinical translational research programs, which provide funding, resources, and expertise to basic researchers who identify promising opportunities but lack the resources and expertise for drug development. The HEAL Early Phase Pain Investigational Clinical Network, like pioneering NINDS clinical trials networks, employs innovations such as common institutional review boards that improve the speed and quality of clinical trials.

Rather than responding to a crisis, the BRAIN Initiative is shaping the future, a future in which we understand how dysfunctional brain circuits cause neurological, psychiatric, and substance misuse disorders and how to correct the problems. A convergence of opportunities from many fields of science and engineering launched the initiative, which is, in turn, empowering research across all of neuroscience and brain diseases. More than 40 years ago NINDS pioneered the then science-fiction field of devices that interface with the brain. Now BRAIN is developing ambitious brain computer interfaces that can reconstruct speech from brain signals or restore vision, and DBS methods that self-adjust by monitoring brain activity. Nobel Prize winning NIH research in the 1990s paved the way for optical methods to monitor the activity of neurons. Hundreds of investigators across NIH programs are applying advanced optical methods from the BRAIN Initiative to monitor and modulate brain cells to understand healthy and diseased brain circuits. NIH investment in genomics technologies laid the groundwork for the BRAIN Initiative Cell Census Networks. These methods are now identifying which cell types are affected by dementia, autism, and many other diseases and paving the way toward treatments that precisely target these cells. Beyond neuroscience, the private sector is already investing heavily to improve artificial intelligence (AI), human-computer interfaces, and computer hardware architecture based on understanding of the brain. As remarkable as many of these advances are, history teaches us that the most valuable insights from the BRAIN Initiative, like all basic research, are those that we cannot yet even imagine.

Overall Budget Policy: The FY 2021 President’s Budget Request for NINDS is $2,245.1 million, a decrease of $201.5 million or 8.2 percent compared with the FY 2020 Enacted level. Within this funding level, amounts allocated to the HEAL Initiative are held flat relative to the FY 2020 level, and other funding for opioid and pain research is likewise included at no less than the FY 2020 level.

Program Descriptions and Accomplishments:

Division of Neuroscience (DON)

As the largest part of the NINDS extramural program, DON supports research on the normal brain, spinal cord, and nerves of the body; the mechanisms of neurological disorders; and the early development of diagnostics and treatments. Investigator-initiated research is the foundation for all components of the DON portfolio. Targeted programs, as in the examples below, focus on specific research topics and public health priorities that are not adequately addressed through investigator-initiated programs. DON programs also support research resources, core facilities, and scientific conferences. Program areas include:

• Basic neuroscience research: Gaps in understanding how the nervous system normally develops and functions can form roadblocks to understanding what goes wrong in disease or after injury. Filling those gaps is a critical piece of the NINDS mission and an area unlikely to receive sustained support through the private sector. Because basic research benefits from the freedom to follow scientific opportunity, investigator-initiated, peer-reviewed research is the foundation of the NINDS basic research program. NINDS also promotes basic research through a targeted initiative with set-aside funding. In neuroscience as in other research fields, new research tools drive new discoveries. NINDS supports the development and application of new tools and technologies for neuroscience research, and this is also a major focus of the NIH BRAIN initiative, in which NINDS is a leading partner.
• Epilepsy: Since 2000, NINDS has worked with the scientific community and disease advocates to establish a statement of shared research priorities called the NINDS Benchmarks for Epilepsy Research. The NINDS Centers without Walls program for epilepsy research (CWOW) was designed to address these priorities and has supported Epi4K, a study of genetic causes of epilepsy in over 4,000 people that catalyzed further international collaboration; a center on sudden unexpected death in epilepsy (SUDEP); and the Epilepsy Bioinformatics Study for Antiepileptogenic Therapy, to find strategies to prevent epilepsy after traumatic brain injury. The newest CWOW investigates how specific gene variants cause epilepsy, which will inform precision diagnostics and treatments. An update to the Benchmarks in 2020 will guide future NINDS epilepsy research.
• Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): Researchers do not yet understand the causes of ME/CFS, and diagnostic tests and treatments are not available. Along with the National Institute of Allergy and Infectious Diseases (NIAID) and other NIH Institutes and Centers, NINDS supports ME/CFSnet, a network of collaborative research centers that are applying innovative approaches to study disease mechanisms and engaging the ME/CFS patient and advocacy community in their programs. NINDS will support new funding opportunities for ME/CFS research, and a working group of the National Advisory Neurological Disorders and Stroke (NANDS) Council has outlined additional opportunities to expand research on this complex disease.
• Rare diseases: Many individually rare diseases have neurological components. Research on these conditions often yields broader insights into understanding and treating common diseases that share biological mechanisms. NINDS supports investigator-initiated and targeted research on rare diseases and is a leading collaborator in the NIH Rare Disease Clinical Research Network. NINDS-funded research has enabled innovative new treatments for rare neurological disorders, including the first disease-modifying therapies for spinal muscular atrophy and the first enzyme replacement therapy for direct brain delivery. NINDS will continue to support an initiative for studies that fill gaps in clinical trial readiness for rare neurological and neuromuscular diseases with candidate therapies on the horizon.
• Parkinson’s disease (PD): NINDS support has led to progress in understanding the causes and mechanisms of PD and in developing treatments. Current programs include the Morris K. Udall Centers of Excellence for Parkinson’s Disease Research, supporting collaborative research on the causes of PD; the NINDS Parkinson’s Disease Biomarkers Program (PDBP) to identify biomarkers for PD and Lewy Body dementia that will improve clinical trials and facilitate earlier diagnosis; and the Accelerating Medicines Partnership for Parkinson’s Disease (AMP-PD), a public-private partnership leveraging existing patient cohorts and resources from PDBP and other programs for large-scale analyses designed to find biomarkers and new therapeutic targets. AMP-PD data and analyses will be shared broadly among partners and the biomedical community.
• Traumatic Brain Injury (TBI): NINDS supports research across the range of TBI severity, with studies on injury mechanisms, recovery processes, diagnosis and treatment. Transforming Research and Clinical Knowledge in TBI (TRACK TBI), an observational study of more than 3,000 adults and children with TBI, created a database, analytic tools, and resources to establish precise diagnostic methods, improve outcome assessment, and compare the effectiveness and costs of tests, treatments, and services. The Pediatric Guideline Adherence and Outcomes (PEGASUS) program aims to improve clinical guideline adherence and improve outcomes for pediatric TBI. NINDS and the Department of Defense promote data sharing and research coordination through the Federal Interagency TBI Research (FITBIR) informatics system.
• Other neurological disorders: DON research includes studies on many more neurological disorders and on mechanisms shared across diseases. Recent NINDS-supported advances suggest new paths to treatments for ALS, frontotemporal dementia (FTD), glioblastoma, and spinal cord injury. In 2019, NINDS convened a workshop and sought researcher and public input to identify priorities for spinal cord injury research, including ways to move promising regenerative therapies forward. Building on progress toward protecting the brain after stroke, the Stroke Preclinical Assessment Network will rigorously test potential neuroprotective therapies in rodent models of acute ischemic stroke. Because neuroscience spans scientific disciplines, NINDS will continue to work closely with other NIH Institutes and Centers in areas of complementary interest, including research on pain, Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD), neuroimmune conditions such as multiple sclerosis and infections of the nervous system, and genetic and neurodevelopmental disorders such as cerebral palsy, autism, muscular dystrophies, and Down syndrome.

Budget Policy:  The FY 2021 President’s Budget request for the Division of Neuroscience is $1,384.8 million, a decrease of $149.3 million, or 9.7 percent, from the FY 2020 Enacted level.