NINDS 2009 Congressional Justification

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
National Institute of Neurological Disorders and Stroke
2009 Fiscal Year Budget
Congressional Justification

Organization Chart

Organization chart for NINDS. The chart shows 5 boxes, the Director box at the top with 4 beneath. The Director of NINDS is Dr. Story C. Landis. The director's 4 direct reports are: Deputy Director Dr. Walter Koroshetz, Executive Officer Ms. Joellen M. Austin, Division of Extramural Activities Dr. Robert Finkelstein, and Division of Intramural Research Dr. Alan Koretsky.


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Appropriation Language

For carrying out section 301 and title IV of the Public Health Services Act with respect to neurological disorders and stroke, $1,571,353,000 $1,545,397,000 (Department of Health and Human Services Appropriation Act, 2008)


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Amounts Available for Obligation 1/

Amounts Available for Obligation
Source of Funding F Y 2007 Actual F Y 2008 Enacted F Y 2009 Estimate
Appropriation $1,534,757,000 $1,571,353,000 $1,545,397,000
Pay cost add-on 78,000 0 0
Rescission 0 -27,452,000 0
Subtotal, adjusted appropriation 1,535,545,000 1,543,901,000 1,545,397,000
Real transfer under Director's one-percent transfer authority (GEI) -2,557,000 0 0
Real transfer to the Global Fund to fight HIV/AIDS, Malaria and Tuberculosis 0 0 0
Real transfer to the Office of Public Health Emergency Preparedness 0 0 0
Comparative transfer to NIBIB -71,000 0 0
Comparative transfer to OD -32,000 0 0
Comparative transfer to NCRR -535,000 0 0
Comparative transfers to the Office of the Assistant Secretary for Admin. and Mgmt. and to the Office of the Assistant Secretary for Public Affairs -3,000 0 0
Comparative transfer to (specify) 0 0 0
Comparative transfer under Director's one-percent transfer authority (GEI) 2,557,000 0 0
Comparative transfer to the Global Fund to fight HIV/AIDS, Malaria and Tuberculosis 0 0 0
Comparative transfer from DHHS 0 0  
Comparative transfer to DHHS for PHS historian 0 0  
Subtotal, adjusted budget authority 1,534,904,000 1,543,901,000 1,545,397,000
Unobligated balance, start of year 0 0 0
Unobligated balance, end of year 0 0 0
Subtotal, adjusted budget authority 1,534,904,000 1,543,901,000 1,545,397,000
Unobligated balance lapsing -11,000 0 0
Total obligations 1,534,893,000 1,543,901,000 1,545,397,000

1/ Excludes the following amounts for reimbursable activities carried out by this account: FY 2007 - $8,352,799 FY 2008 - $12,125,000 FY 2009 - $12,125,000 Excludes $411,103 in FY 2008 and $417,972 in FY 2009 for royalties.


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Budget mechanism table

(Dollars in Thousands)
Budget Mechanism - Total
MECHANISM FY 2007
Actual
FY 2008
Enacted
FY 2009
Estimate
Change
Research Grants: Number Amount Number Amount Number Amount Number Amount
Research Projects:
  Noncompeting 2,050 $796,537 1,894 $757,760 1,949 $765,307 55 $7,547
  Administrative supplements (104) 6,485 (104) 6,485 (104) 6,485 (0) 0
  Competing:
    Renewal 174 85,439 200 99,332 193 95,891 (7) -3,441
    New 473 143,420 545 166,740 526 160,965 (19) -5,775
    Supplements 1 75 1 87 1 84 0 -3
      Subtotal, competing 648 228,934 746 266,159 720 256,940 (26) -9,219
      Subtotal, RPGs 2,698 1,031,956 2,640 1,030,404 2,669 1,028,732 29 -1,672

SBIR/STTR
99 37,675 97 36,701 97 36,653 0 -48
      Subtotal, RPGs 2,797 1,069,631 2,737 1,067,105 2,766 1,065,385 29 -1,720

Research Centers:
  Specialized/comprehensive 69 87,552 70 88,544 70 88,544 0 0
  Clinical research 0 0 0 0 0 0 0 0
  Biotechnology 0 0 0 0 0 0 0 0
  Comparative medicine 0 0 0 0 0 0 0 0
  Research Centers in Minority Institutions 0 0 0 0 0 0 0 0
      Subtotal, Centers 69 87,552 70 88,544 70 88,544 0 0

Other Research:
   Research careers 296 47,354 320 49,061 320 49,061 0 0
   Cancer education 0 0 0 0 0 0 0 0
   Cooperative clinical research 63 5951 64 6,018 64 6,018 0 0
   Biomedical research support 0 0 0 0 0 0 0 0
   Minority biomedical research support 4 1,202 4 1,202 4 1.202 0 0
   Other 66 15,202 67 15,374 67 15,374 0 0
      Subtotal, Other Research 429 69,696 455 71,655 455 71,655 0 0
   Total Research Grants 3,295 1,226,879 3,262 1,227,304 3,291 1,225,584 29 -1,720

Research Training:

F T T P's
 
F T T P's
 
F T T P's
     
   Individual awards 411 15,390 411 15,390 411 15,513 0 123
   Institutional awards 346 17,050 346 17,050 346 17,169 0 119
   Total, Training 757 32,440 757 32,440 757 32,682 0

Research & development contracts
85 81,223 103 85,908 103 85,908 0 0
           (SBIR/STTR) (0) (69) (0) (69) (0) (69) (0) (0)

F T E's   F T E's   F T E's   F T E's  
Intramural research 364 142,139 364 144,982 370 147,157 6 2,175
Research management and support 153 52,223 153 53,267 155 54,066 2 799
Construction 0 0 0 0 0 0 0 0
Buildings and Facilities 0 0 0 0 0 0 0 0
Total, NINDS 517 1,534,904 517 1,543,901 525 1,545,397 8 1,496

Includes FTEs which are reimbursed from the NIH Roadmap for Medical Research


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Budget Authority by Program

BA by Program
(Dollars in Thousands)
  FY 2005
Actual
FY 2006
Actual
FY 2007
Actual
FY 2007
Comparable
FY 2008
Enacted
FY 2009
Estimated

Change
Extramural Research
Detail:
FTEs Amount FTEs Amount FTEs Amount FTEs Amount FTEs Amount FTEs Amount FTEs Amount
Channels, Synapses & Circuits   $230,197   $223,197   $193,083   $193,375   $194,112   $193,899   -$213
Neural Environment   338,930   333,020   330,855   331,354   332,617   332,252   -365
Neurodegeneration   197,778   186,827   192,755   193,046   193,782   193,569   -213
Neurogenetics   218,562   205,461   211,039   211,358   212,164   211,931   -233
Repair & Plasticity   136,052   141,135   154,237   154,470   155,059   154,889   -170
Neuroscience   195,378   189,691   191,996   192,286   193,019   192,807   -212
Technology Development,
Infrastructure & Resources
  41,937   60,709   64,555   64,653   64,899   64,827   -72


Subtotal, Extramural
  1,358,834   1,339,970   1,338,520   1,340,542   1,345,652   1,344,174   -1,478

Intramural research
385 134,617 374 142,648 364 142,234 364 142,139 364 144,982 370 147,157 6 2,175

Res. management & support
146 45,997 152 51,085 153 52,234 153 52,223 153 53,267 155 54,066 2 799

TOTAL
531 1,539,448 526 1,533,703 517 1,532,988 517 1,534,904 517 1,543,901 525 1,545,397 8 1,496

Includes FTEs which are reimbursed from the NIH Roadmap for Medical Research


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Major Changes in the Fiscal Year 2009 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 2009 budget request for NINDS, which is $1.496 million more than the FY 2008 Enacted, for a total of $1,545.397 million.

Research Project Grants (-1.672 million, total $1,028.7 million) NINDS will support a total of 2,669 Research Project Grant (RPG) awards in FY 2009.  Noncompeting RPGs will increase by 55 awards and increase by $7.547 million.  Competing RPGs will decrease by 26 awards and decrease by $9.219 million.  The NIH Budget policy for RPGs in FY 2009 does not include inflationary increases in noncompeting awards or increases in average costs for competing grants. 

Intramural Research - Neurogenetics Branch (+$2 million; total $8.3 million): NINDS will expand the intramural Neurogenetics Branch with the addition of two tenure track investigators to pursue exceptional opportunities that are emerging for progress toward therapies for neurogenetic disorders.

Intramural Research - Neuronal Cell Biology (+$1 million; total $1 million):  NINDS will expand the intramural program in cell biology, a rapidly advancing area of research that has implications for many neurological diseases.

NINDS Clinical Research Consortium (CRC)  (+$2 million; total $2 million):  Based on early experience, NINDS is revamping the CRC to more effectively meet its goals of increasing patient access to and recruitment to clinical trials through involvement of community neurologists.


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Summary of changes

Summary of Changes
(Dollars in Thousands)
F Y 2008 enacted $1,543,901,000
F Y 2009 estimated budget authority 1,545,397,000
Net change 1,496,000
  2008 Current
Enacted Base
Change from Base
  Budget Budget
CHANGES F T E's Authority F T E's Authority
 A.  Built-in:
    1.  Intramural research:
       
        a.  Annualization of January
             2008 pay increase
  $51,307,000   $576,000
        b.  January F Y 2009 pay increase   51,307,000   1,116,000
        c.  One less day of pay   51,307,000   (204,000)
        d.  Payment for centrally furnished services   26,129,000   392,000
        e.  Increased cost of laboratory supplies,
             materials, and other expenses
  67,546,000   1,206,000
        Subtotal       3,086,000

    2.  Research management and support:
       
        a.  Annualization of January  
             2008 pay increase
  $20,517   $230,000
        b.  January F Y 2009 pay increase   20,517   446,000
        c.  One less day of pay   20,517   (82,000)
        d.  Payment for centrally furnished services   11,411   171,000
        e.  Increased cost of laboratory supplies,
             materials, and other expenses
  21,339   399,000
        Subtotal       1,164,000

        Subtotal, Built-in
      4,250,000
Summary of Changes, continued
(Dollars in Thousands)
  2008 Current
  Enacted Base Change from Base
CHANGES No. Amount No. Amount
B.  Program:        
    1.  Research project grants:        
        a.  Noncompeting 1,894 $764,245,000 55 $7,547,000
        b.  Competing  746 266,159,000 (26) (9,219,000)
        c.  SBIR/STTR 97 36,701,000 0 (48,000)
                Total 2,737 1,067,105,000 29 (1,720,000)
    2.  Research centers 70 88,544,000 0 0
    3.  Other research 455 71,655,000 0 0
    4.  Research training 757 32,440,000 0 242,000
    5.  Research and development contracts 103 85,908,000 0 0
         Subtotal, extramural        (1,478,000)
  F T E's   F T E's  
    6.  Intramural research                                    364 144,982,000 6 (911,000)
    7.  Research management and support 153 53,267,000 2 (365,000)
    8.  Construction   0   0
    9.  Buildings and Facilities   0   0
        Subtotal, program   1,543,901,000   (2,754,000)
          Total changes 517   8 1,496,000


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Budget Graphs

History of Budget Authority and FTE's:

Funding Levels by Fiscal Year. Bar chart indicating funding levels (in thousands) for NINDS from 2005 through 2009. 2005, $1529.6 - 2006, $1533.0 - 2007, $1534.9 - 2008, $1543.9 - 2009, $1545.4 Bar chart indicating FTE's by Fiscal Year from 2005 through 2009. 2005, 563 - 2006, 526 - 2007, 517 - 2008, 517 - 2009, 525

Distribution by Mechanism:

FY 2009 Budget Mechanism (Dollars in Thousands) Pie chart indicating funding for fiscal year 2009 by budget mechanism. The pie has 7 slices. From largest to smallest the amounts are: Research Project Grants, $1,065,385 - 68%; Intramural Research, $147,157 - 10%; Research Centers, $88,544 - 6%; R&D Contracts, $85,908 - 6%; Other Research, $71,655 - 5%; RMS, $54,066 - 3%; Research Training, $32,662 - 2%

Change by Selected Mechanisms:

FY 2009 Estimate. Percent Change from FY 2008 Mechanism. Bar chart showing percent change by mechanism. There are 7 bars. From top to bottom they are: Research Project Grants, -0.2; Research Centers, 0.0; Other Research, 0.0; Research Training, 0.7; R&D Contracts, 0.0; Intramural Research, 1.5; Resource Management and Support, 1.5


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Justification

Authorizing Legislation: Section 301 and Title IV of the Public Health Service Act, as amended.
Budget Authority:
FY 2007
Actual
FY 2008
Enacted
FY 2009
Estimated

Increase or
Decrease
F T E's B A F T E's B A F T E's B A F T E's B A
517 1,532,988,000 517 $1,532,901,000 525 $1,545,397,000 8 $1,496,000

This document provides justification for the Fiscal Year (FY) 2009 activities of the National Institute of Neurological Disorders and Stroke (NINDS), including NIH/AIDS activities. Details of the FY 2009 HIV/AIDS activities are in the "Office of AIDS Research (OAR)" Section of the Overview. Details on the Common Fund are located in the Overview, Volume One. Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

Director's Overview

NINDS has launched a strategic planning process that will examine how the institute can better carry out its mission. The process will include all stakeholders in discussions of basic, translational, and clinical research across the spectrum of neurological disorders. To set the vision that will frame these pragmatic discussions, NINDS began by asking stakeholders to suggest "blue sky" goals to which NINDS should aspire.

In considering the future, it is useful to look at the past. Because of progress over the last 15 to 20 years, hundreds of thousands of strokes are prevented each year, the first effective emergency treatment can improve the outcome for people who do have a stroke, and science-based stroke rehabilitation is emerging. According to the Centers for Disease Control and Prevention, the age adjusted stroke death rate is continuing to decline, from 65.3 per 100,000 population in 1990 to 46.6 in 2005. Progress is also apparent for other neurological disorders; better drugs and surgical treatments now help people who have chronic pain, epilepsy, migraine, multiple sclerosis, neuropathies, Parkinson's disease, and many other diseases. Advances in brain imaging and in genetic testing have transformed diagnosis and treatment of many neurological diseases. Although the challenges remain formidable, we have entered an era in which neurologists and neurosurgeons can prevent and treat, in addition to diagnosing, many disorders.

The prospects for the future are also encouraging. With the discovery of gene defects that cause hundreds of inherited disorders, scientists can now work to understand what goes wrong in the brain, generate animal models that mimic human disease, and rationally develop therapies. Researchers have also begun to identify how genes contribute to the susceptibility and progression of common diseases, including stoke, multiple sclerosis, and Parkinson's disease, and are working to understand how genes and environment together cause disease. Building on basic research advances, NIH and private sector research teams are developing drugs that precisely target critical steps in the disease process, stem cell and regenerative therapies that repair damage, devices that adjust malfunctioning brain circuits, therapies that silence or replace defective genes, and behavioral interventions that encourage the "plasticity" of the brain and spinal cord to compensate for damage. In the future, insights from neuroscience will not only treat disease after it occurs, but also help people avoid disease and maintain healthy brains throughout their lifespan.

To continue progress, NINDS Intramural investigators conduct research on the NIH campus in Bethesda, Maryland, and the extramural program supports researchers at universities, medical centers, and small businesses throughout the U.S. Although the Institute targeted initiatives to specific problems when appropriate, NINDS emphasizes investigator-initiated research, which is especially suited to the diversity of challenges that nervous system diseases present. Investigators respond to institute priorities, because it engages the research community in identifying needs and opportunities. In 2007, for example, a major conference assessed progress since the 2000 conference that launched the Epilepsy Benchmarks planning process, and the research and patient community are working with NINDS to update the benchmarks. Other recent scientific workshops focused on ataxia-telangiectasia, frontotemporal dementia, gene therapy, hydrocephalus, mucopolysaccharidoses, muscular dystrophies, neonatal seizures, pain, Parkinson's disease, peripheral neuropathies including Charcot Marie Tooth disorder, spinocerebellar ataxias, stroke, and traumatic brain injury, among other topics. Ongoing NINDS extramural programs encourage the scientific community to seek out and exploit opportunities for basic, translational, and clinical research on all neurological disorders, and provide many ways for researchers to collaborate toward common goals.

NIH training of researchers, like NIH basic research, enhances progress in both the public and private sectors. NINDS has extended the payline for new investigators and supported the NIH Pathway to Independence Awards. The Institute continues its programs to promote diversity. Innovation is also crucial. The Institute supports NIH Pioneer Awardees and in 2008 began participation in the new EUREKA (Exceptional, Unconventional Research Enabling Knowledge Acceleration) program, which complements the NIH-wide Pioneer and New Innovator Award programs. In 2009, NINDS will continue to balance investigator-initiated research with initiatives that target opportunities that emerge from the strategic and disease planning efforts. New and continuing initiatives planned for 2009 will focus on:

  • Renewal of the Cooperative Program in Translational Research, which supports teams of researchers to develop therapies toward readiness for clinical testing. This program is showing encouraging progress, with projects moving towards clinical trials.
  • Research on axon (nerve fiber) damage in multiple sclerosis and on how immune cells contribute, in beneficial and harmful ways, to many nervous system disorders, including multiple sclerosis.
  • The NINDS Neural Prosthesis Program, which for more than three decades has pioneered the development of devices that restore or supplement nervous system functions lost by disease or damage.
  • Brain mechanisms of functional recovery after stroke. Stroke rehabilitation based on understanding of brain plasticity is showing encouraging results in clinical trials.
  • The CAPTR (Collaborative Activities to Promote Translational Research) administrative supplement program, which encourages investigators to develop new interdisciplinary collaborations that lead to therapy development.
  • The next phase of the ImPACT (Immediate Practice Altering Clinical Trials) program. ImPACT is developing a computer model to estimate the cost-benefits of proposed clinical trials and will test the validity and usefulness of the model within the Institute's strategic planning process.
  • Solicitations also continue in 2009 on ataxia telangiectasia, autism, bioengineering, deep brain stimulation, developmental pharmacology, dystonias, HIV infection in the central nervous system, migraine, neuroimaging, sarcoidosis, and women's health, among other topics. Many are cooperative efforts among NIH institutes and centers.

The NINDS participates in the support of the Translational Research Core Service Support and the Assay Technology Development initiatives funded through the NIH Common Fund.


FY2009 Justification by Activity Detail

Overall Budget Policy:

The NINDS continues to place high priority on supporting investigator-initiated research projects, new investigator research, and career development. NINDS maintains a balance between funding made available to support investigator-initiated projects and targeted solicitations issued to the extramural community in areas that need stimulation. The Institute carefully evaluates the mission relevance of requests to submit applications for all large investigator-initiated projects and of all Institute initiatives. Beginning in 2007, NINDS has set a maximum of 10 years duration for all unsolicited program project grants. Intramural Research and Research Management and Support receive modest increases to help offset the cost of pay and other increases. NINDS will continue to support new investigators and to maintain an adequate number of competing RPGs.

Program Descriptions and Accomplishments

Channels, Synapses, and Circuits

Ion channels, synapses, and neural circuits are fundamental elements of the nervous system. NINDS supports research on how these elements operate in the healthy nervous system in the adult and developing brain and on diseases in which they play a central role, including epilepsy. In March 2007, NINDS, working closely with non-governmental organizations, held a major conference "Curing Epilepsy II." The conference assessed progress against the Epilepsy Benchmarks that arose from the first "Curing Epilepsy" conference in 2000. Progress has been encouraging and the Institute is working with the epilepsy research and patient communities to update those benchmarks to reflect new goals that will guide future research.

Budget Policy: The 2009 budget estimate of $193,899,000 for Channels, Synapses, and Circuits represents a decrease of $213,000 from the 2008 enacted. In 2009, NINDS will continue to balance investigator-initiated and solicited research, including projects funded through the Institute's broad translational research and clinical trials programs. The NINDS is participating in an NIH program announcement, active through 2009, on the structural biology of membrane proteins, which include ion channels, neurotransmitter receptors, and other proteins that are critical in epilepsy and other neurological disorders.

Neural Environment

Fewer than 1 of 10 cells in the human brain are nerve cells. The non-neuronal cells maintain the local environment in the brain that surrounds nerve cells, fight infections, control which molecules in the blood circulation get into the brain, and serve the healthy and diseased brain in many other ways. These cells play a central role in several diseases that affect children and adults, including stroke, multiple sclerosis, brain tumors, neurofibromatosis, tuberous sclerosis, transmissible spongiform encephalopathies, neuroAIDs, and other infectious diseases. NINDS supports a wide spectrum of research on non-neuronal cells in the healthy and diseased brain and on translating scientific knowledge into better diagnosis, prevention, and treatment, including drug delivery to the brain. In 2007, the Stroke Progress Review Group (PRG) reported a major mid-course review of stroke research. The detailed reports will help guide the extensive NINDS stroke research programs. Program announcements continuing in 2008 focus on understanding and treating tuberous sclerosis complex and on transmissible spongiform encephalopathies, including Creutzfeldt-Jakob disease.

Budget Policy: The 2009 budget estimate of$322,252,000 for Neural Environment represents a decrease of $365,000 from the 2008 enacted. NINDS will continue to rely on a balance of solicited and investigator-initiated research, including research through the Institute's broad translational research and clinical trials programs. New NINDS solicitations in 2009 will focus on understanding and treating axon (nerve fiber) damage in multiple sclerosis, on the trafficking of immune cells into the brain and spinal cord, and on brain mechanisms that lead to functional recovery after stroke. In 2009, NINDS is also participating in a National Cancer Institute led initiative on adult brain tumor and in NIH initiatives begun in previous years that focus on HIV in the central nervous system, on sarcoidosis, and on sleep disorders.

Neurodegeneration

Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementias, Huntington's disease, and Parkinson's disease are among the neurodegenerative diseases that affect adults. For many neurodegenerative disorders, risk increases with age. So, these diseases present an increasing challenge to the U.S. as our population distribution ages. NINDS neurodegeneration research priorities include understanding how genes and the environment cause neurodegeneration and translating those insights into treatment and prevention. Among program activities in 2007, an independent review confirmed the value of the Morris K. Udall Parkinson's Disease Centers of Excellence and provided guidance that will be valuable for improving the continuing program; the NIH Exploratory Trials in Parkinson's Disease (NET-PD) program launched its first large multi-site clinical trial of a drug to slow the progression of Parkinson's disease; a scientific workshop examined the current status of research and opportunities for frontotemportal dementia; and a solicitation on the cognitive problems of Parkinson's disease is active through 2008.

Budget Policy: The 2009 budge