Congressional Justification
FY 2016

February 2015

Organization Chart

Organization chart for the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The chart shows 7 boxes, the overarching box contains the names of the Director, Deputy Director and the Associate Director for Management and Operations. The Director of NIAMS is Stephen I. Katz, M.D., Ph.D., the Deputy Director is Robert H. Carter, M.D., the Associate Director for Management and Operations is W. Gahan Breithaupt, M.B.A. The top box subsumes 6 boxes beneath. The director's 6 direct reports are: Office of Administrative Management Director, W. Gahan Breithaupt, M.B.A., Office of Science Policy and Planning and Communications Director, Anita M. Linde, M.P.P., Intramural Research Program Scientific Director, John J. O'Shea, M.D., Division of Extramural Research Activities Director, Laura K. Moen, Ph.D., Division of Musculoskeletal Diseases Director, Joan A. McGowan, Ph.D., Division of Skin and Rheumatic Diseases Director, Susana Serrate-Sztein, M.D.

View a larger version of the organization chart.


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Appropriation Language

NATIONAL INSTITUTES OF HEALTH

National Institute of Arthritis and Musculoskeletal and Skin Diseases

For carrying out section 301 and title IV of the PHS Act with respect to arthritis and musculoskeletal and skin diseases, [$521,665,000]$533,232,000.


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Amounts Available for Obligation

Amounts Available for Obligation 1
(Dollars in Thousands)

Source of Funding

FY 2014
Actual

FY 2015
Enacted

FY 2016
President's Budget
Appropriation $520,053 $521,665 $533,232
Type 1 Diabetes 0 0 0
Rescission 0 0 0
Sequestration 0 0 0
FY 2014 First Secretary's Transfer - 1,305 0 0
FY 2014 Second Secretary's Transfer - 102 0 0

Subtotal, adjusted appropriation
$518,646 $521,665 $533,232
OAR HIV/AIDS Transfers 0 -137 0
National Children's Study Transfers 1,709 0 0

Subtotal, adjusted budget authority
$520,355 $521,528 $533,232
Unobligated balance, start of year 0 0 0
Unobligated balance, end of year 0 0 0

Subtotal, adjusted budget authority
$520,355 $521,528 $533,232
Unobligated balance lapsing - 41 0 0

     Total obligations
$520,314 $521,528 $533,232

1Excludes the following amounts for reimbursable activities carried out by this account:
FY 2014 - $2,811†    FY 2015 - $2,895     FY 2016 - $2,982


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Budget Mechanism Total

Budget Mechanism - Total¹
(Dollars in Thousands)
MECHANISM FY 2014
Actual
FY 2015
Enacted
FY 2016
President's Budget
FY 2016 +/-
FY 2015
No. Amount No. Amount No. Amount No. Amount
Research Projects
Noncompeting 698 $242,521 677 $237,668 722 $240,506 45 $2,838
Administrative
Supplements
(15) 771 (15) 1,090 (15) 1,090 (0) 0
Competing:
Renewal 45 18,744 55 17,642 66 18,608 11 966
New 237 65,556 257 70,225 263 74,069 6 3,844
Supplements 6 1,722 6 1,794 7 1,893 1 99
Subtotal, Competing 288 $86,021 318 $89,661 336 $94,570 18 $4,909
Subtotal,
RPGs
986 $329,312 995 $328,419 1,058 $336,166 63 $7,747
SBIR/STTR 43 13,832 45 14,452 48 15,507 3 1,055
Research Project Grants 1,029 $343,144 1,040 $342,871 1,106 $351,673 66 $8,802

Research Centers
Specialized/Comprehensive 42 $42,688 42 $41,560 44 $43,388 2 $1,828
Clinical Research 0 0 0 0 0 0 0 0
Biotechnology 0 0 0 0 0 0 0 0
Comparative Medicine 0 29 0 29 0 29 0 0
Research Centers in Minority
Institutions
0 0 0 0 0 0 0 0
Research Centers 42 $42,717 42 $41,589 44 $43,417 2 $1,828

Other Research
Research Careers 150 $18,923 156 $19,490 156 $19,491 0 $1
Cancer Education 0 0 0 0 0 0 0 0
Cooperative Clinical
Research
0 0 0 0 0 0 0 0
Biomedical Research Support 0 0 0 0 0 0 0 0
Minority Biomedical Research
Support
0 195 0 195 0 195 0 0
Other 25 3,197 36 3,183 36 3,183 0 0
Other Research 175 $22,315 192 $22,868 192 $22,869 0 $1
Total Research Grants 1,246 $408,176 1,274 $407,328 1,342 $417,959 68 $10,631
  
Ruth L. Kirschstein Training Awards
FTTPs FTTPs FTTPs FTTPs
Individual Awards 62 $2,998 61 $3,046 61 $3,095 0 $49
Institutional Awards 224 11,915 224 12,106 224 12,300 0 194
Total Research Training 286 $14,913 285 $15,152 285 $15,395 0 $243
Research & Development Contracts 37 $15,148 37 $16,109 37 $16,109 0 $0
SBIR/STTR (non-add) (0) (69) (0) (147) (0) (152) (0) (5)
Intramural Research 135 53,602 135 54,138 135 54,680 0 542
Research Management and Support 107 28,516 108 28,801 108 29,089 0 288
Research Management and Support (SBIR Admin) (0) (0) (0) (0) (0) (0) (0) (0)
Construction   0   0   0   0
Buildings and Facilities   0   0   0   0
Total, NIAMS 242 $520,355 243 $521,528 243 $533,232 0 $11,704

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


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Major Changes in the Fiscal Year 2016 Presidentís 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 2016 Presidentís Budget for NIAMS, which is $11.567 million more than the FY 2015 Enacted level, for a total of $533.232 million.

Research Project Grants (+$8.802 million; total $351.673 million): NIAMS will support a total of 1,106 Research Project Grant (RPG) awards in FY 2016. Noncompeting awards will increase by 45 awards and $2.838 million. Competing RPGs will increase by 18 awards and $4.909 million. NIAMS continues to place a priority on support to new investigators.

Research Centers (+$1.828 million; total $43.417 million): NIAMS will support a total of 44 Research Centers awards in FY 2016 which is an increase of 2 awards and $1.828 million to help support the Precision Medicine Cohort Initiative. NIH proposes to launch a national research cohort of one million or more Americans Ė to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing. Participants who voluntarily choose to join this effort will be able to share their genomic data, biological specimens, and behavioral data, and, if they choose, link it to their electronic health records (EHRs), taking advantage of the latest in social media and mobile applications, and with appropriate privacy protections in place. Bona fide researchers from across the country will have access to data voluntarily provided, thereby crowdsourcing rich data to the brightest minds in biomedical research. The cohort will be built largely by linking existing cohorts together taking advantage of infrastructure, data security and expertise already in place. NIH will help to connect these existing cohorts, but the current sponsors of the cohorts will maintain their ownership and management. Research on this scale promises to lead to new prevention strategies, novel therapeutics and medical devices, and improvements in how we prescribe drugs — on an individual and personalized basis.

Research Training (+$0.243 million; total $15.395 million): NIAMS will support 285 pre- and postdoctoral trainees in full-time training positions, the same as the number funded in FY 2015. Support for NRSA training mechanism will be increased by $0.243 million amount to cover the cost of increased stipends.


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Summary of Changes

Summary of Changes
(Dollars in Thousands)
FY 2015 Enacted $521,528
FY 2016 President's Budget $533,232
Net change $11,704
CHANGES 2016
President's Budget
Change from FY 2015
FTEs Budget
Authority
FTEs Budget
Authority
A. Built-in:
1. Intramural Research:
a. Annualization of January
2015 pay increase & benefits
  $19,203   $46
b. January FY 2016 pay increase
& benefits
  19,203   139
c. One more day of pay (n/a for 2015)   19,203   73
d. Differences attributable to
change in FTE
  19,203   0
e. Payment for centrally furnished
services
  9,637   235
f. Increased cost of laboratory supplies,
materials, other expenses, and
non-recurring costs
  25,840   366
Subtotal       $859

2. Research Management and Support:
a. Annualization of January 2015 pay
increase & benefits
  $16,185   $39
b. January FY 2016 pay increase
& benefits
  16,185   118
c. One more day of pay (n/a for 2015)   16,185   61
d. Differences attributable to
change in FTE
  16,185   0
e. Payment for centrally furnished
services
  3,765   92
f. Increased cost of laboratory supplies,
materials, other expenses, and
non-recurring costs
  9,138   84
Subtotal       $394

Subtotal, Built-in
      $1,253


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Summary of Changes
(Dollars in Thousands)
FY 2015 Enacted $521,528
FY 2016 President's Budget $533,232
Net change $11,704
  2016
President's Budget

Change from
FY2015
CHANGES FTEs Budget Authority FTEs Budget Authority
A. Built-in:
1. Intramural Research:
a. Annualization of January 2015 pay increase & benefits   $19,203   $46
b. January FY 2016 pay increase & benefits   19,203   139
c. One more day of pay (n/a for 2015)   19,203   73
  2016
President's Budget

Change from
FY2015
CHANGES No. Amount No. Amount
B. Program:
1. Research Project Grants:
a. Noncompeting 722 $241,596 45 $2,838
b. Competing 336 94,570 18 4,909
c. SBIR/STTR 48 15,507 3 1,055
Subtotal, RPGs 1,106 $351,673 66 $8,802
2. Research Centers 44 $43,417 2 $1,828
3. Other Research 192 22,869 0 1
4. Research Training 285 15,395 0 243
5. Research and development contracts 37 16,109 0 0
Subtotal, Extramural   $449,463   $10,874
  FTEs   FTEs  
6. Intramural Research 135 $54,680 0 -$317
7. Research Management and Support 108 29,089 0 -106
8. Construction   0   0
9. Buildings and Facilities   0   0
Subtotal, Program 243 $533,232 0 $10,451
Total changes       $11,704


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Fiscal Year 2016 Budget Graphs

History of Budget Authority and FTEs:

Bar chart indicating funding levels (dollars in millions) for NIAMS from 2012 through 2016. 2012, $534.8;  2013, $504.7; 2014, $520.4; 2015, $521.5, 2016 $533.2.

Bar chart indicating FTE's by Fiscal Year from 2012 through 2016. 2012, 239; 2013, 246; 2014, 242; 2015, 243; 2016, 243. Note: Fiscal Year 2012 are non-comparable for DEAS transfer

Distribution by Mechanism:

FY 2016 Budget Mechanism Pie chart indicating funding for fiscal year 2016 by budget mechanism. The dollars are in thousands. The pie has 7 slices. From largest to smallest the amounts are: Research Project Grants, 67% and $351,673; Intramural Research, 10% and $54,680; Research Centers, 8% and $43,417; R.M. and S, 5% and $29,089; Other Research, 4% and $22,869; R&D Contracts, 3% and $16,109; Research Training, 3% and $15,395.

Change by Selected Mechanisms:

Bar chart showing FY 2016 Estimate Percent Change from FY 2015 by Mechanism. There are 7 bars. From top to bottom they are: Research Project Grants, 2.57%; Research Centers, 4.40%; Other Research, 0.00%; Research Training, 1.60%; R&D Contracts, 0.00%; Intramural Research, 1.00%; Research Management and Support, 1.00%.


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Budget Authority by Activity

Budget Authority by Activity¹
(Dollars in Thousands)
  FY 2014
Actual
FY 2015
Enacted2
FY 2016
President's Budget
FY 2016 +/-
FY2015
Extramural Research
Detail:
FTEs Amount FTEs Amount FTEs Amount FTEs Amount
Arthritis and Rheumatic Diseases   $103,430   $103,514   $106,082   $2,568
Musculoskeletal Biology and Diseases   132,962   133,065   136,360   3,295
Bone Biology and Diseases   60,048   60,097   61,588   1,491
Muscle Biology and Diseases   68,786   68,842   70,550   1,708
Skin Biology and Diseases   73,011   73,071   74,883   1,812


Subtotal,
Extramural
  $438,237   $438,589   $449,463   $10,874

Intramural Research
135 $53,602 135 $54,138 135 $54,680 0 $542

Research Management & Support
107 $28,516 108 $28,801 108 $29,089 0 $288

TOTAL
242 $520,355 243 $521,528 243 $533,232 0 $11,704

1/ Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

1/ Items in italics are "non-adds"; for reference only (NIH Director's Challenge Fund amounts are already included in OD Operations budget.)

2/ The amounts in the FY 2014 column take into account funding reallocations, and therefore may not add to the total budget authority reflected herein.


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Authorizing Legislation

Authorizing Legislation
  PHS Act/
Other Citation
U.S. Code
Citation
2015 Amount
Authorized
FY 2015
Enacted
2016 Amount
Authorized
FY 2016
President's Budget
Research and Investigation Section 301 42§241 Indefinite $521,528,000 Indefinite $533,232,000
National Institute of
Arthritis and Musculoskeletal and Skin Diseases
Section 401(a) 42§281 Indefinite Indefinite
Total, Budget Authority       $521,528,000   $533,232,000


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Appropriations History

Appropriations History
Fiscal
Year
Budget Estimate
to Congress
House
Allowance
Senate
Allowance
Appropriation
2006 $513,063,000 $513,063,000 $525,578,000 $513,063,000
Rescission       ($5,131,000)
2007 $504,533,000 $504,533,000 $508,585,000 $508,240,000
Rescission       $0
2008 $508,082,000 $516,044,000 $519,810,000 $517,629,000
Rescission       ($9,043,000)
Supplemental       $2,075,000
2009 $509,080,000 $526,583,000 $523,246,000 $524,872,000
Rescission       $0
2010 $530,825,000 $543,621,000 $533,831,000 $539,082,000
Rescission       $0
2011 $555,715,000   $554,846,000 $539,082,000
Rescission       ($4,733,461)
2012 $547,891,000 $547,891,000 $528,332,000 $536,801,000
Rescission       ($1,014,454)
2013 $535,610,000   $537,233,000 $535,786,446
Rescission       ($1,071,573)
Sequestration       ($26,892,795)
2014 $540,993,000   $537,398,000 $520,053,000
Rescission       $0
2015 $520,189,000     $521,665,000
Rescission       $0
2016 $533,232,000      


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Justification of Budget Request

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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

Budget Authority (BA):

  FY 2014 Actual FY 2015
Enacted
FY 2016
Presidentís
Budget
FY 2016 +/-
FY 2015
BA $520,355,189 $521,528,000 $533,232,000 +$11,704,000
FTE 242 243 243 +0

Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

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DIRECTOR'S OVERVIEW

As the primary Federal agency for supporting medical research on diseases of the bones, joints, muscles, and skin, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) touches the lives of nearly every American. Arthritis limits the activities of approximately 21 million adults in the United States each year; medical care and lost wages attributable to musculoskeletal conditions cost Americans an estimated $950 billion annually; and skin conditions such as eczema and psoriasis affect more than 12 percent of people worldwide.1 NIAMS is working to enhance health, lengthen life, and reduce illness and disability by supporting basic and translational research that will impact clinical practice, training the next generation of bone, joint, muscle, and skin scientists, and disseminating the findings and related health information from the studies it supports to all Americans. The activities described below highlight the Instituteís many efforts to advance public health.

Investigator-initiated basic research is one of NIAMSí highest priorities. NIAMS-supported efforts to understand the basic mechanisms of disease provide a foundation for the development of new therapies and suggest new uses for existing drugs. For example, identification of the immune cells and signaling molecules responsible for destroying hair follicles in people with alopecia areata—a common autoimmune disease that causes disfiguring hair loss—led to a small clinical trial of a Food and Drug Administration-approved drug that targets similar pathways in other conditions. Each of three patients regrew their hair within five months of starting treatment; investigators are continuing the study to determine the drugís long-term success and safety.

1 Cheng YJ, et al. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitationóUnited States, 2007Ė2009. MMWR 2010;59(39):1261Ė1265
U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Medical Expenditures Panel Survey, 1996 Ė 2006. Data analyzed and modeled by Edward H. Yelin, PhD, Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA, as cited in www.boneandjointburden.org/highlights/FactsinBrief.pdf, accessed October 3, 2014
Vos T, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. PMID: 23245607

In the NIAMS Intramural Research Program (IRP), investigators are finding treatments for children who have rare diseases, while learning how the body maintains a delicate balance between protective and destructive responses. They recently treated a seven-year-old girl who appeared to have a rare disease called macrophage activation syndrome (MAS). When the childís lab tests indicated that an unknown mechanism was triggering her life-threatening inflammation, the researchers used sophisticated genome sequencing tools to identify the mutation responsible for her illness. Not only did their finding reveal that the child would benefit from an existing drug, which reduced many of her symptoms, it pointed to an additional molecule that could be the target of future, better treatments for MAS and other conditions.

In addition to supporting basic research into disease mechanisms, NIAMS leads several projects with industry and non-profit partners to develop resources for translating discoveries into treatments, diagnostic approaches, and prevention strategies. In FY 2014, NIAMS, the National Institute of Allergy and Infectious Diseases (NIAID), the Foundation for NIH, six pharmaceutical companies, and five patient advocacy and professional societies established the Accelerating Medicines Partnership in Rheumatoid Arthritis and Lupus (AMP RA/Lupus) Network. Over five years, the Network will examine molecules and pathways involved in RA and lupus at the single-cell level, and will identify differences and similarities between people with and without disease, and among those at various disease stages. Identification of shared and disease-specific pathways is expected to reveal targets for drug development at an overall lower cost, and in less time, than could be done through individual studies. The Institute also continues to participate in other public-private partnerships, such as the Osteoarthritis Initiative and the Biomarkers Consortiumís Bone Quality Initiative and Osteoarthritis Biomarkers Project, which are developing tools to improve the efficiency of future clinical studies.

As NIAMS looks to FY 2016, the Institute is planning to reissue a series of initiatives that will help investigators ask and answer the most important clinical questions facing health care providers and patients today. Building on discussions at the Instituteís FY 2014 scientific planning retreat, NIAMS is considering strategies to encourage research ideas that challenge existing paradigms or uncover new directions related to the diagnosis, treatment, or prevention of diseases within the NIAMS mission.

Genome-wide association studies (GWAS) have led to significant advances in understanding complex musculoskeletal, rheumatic, and skin disorders by facilitating identification of common genetic variants that influence disease risk. A growing body of data generated through efforts such as the Encyclopedia of DNA Elements (ENCODE) Project and the NIH Epigenomics Program has enabled researchers to extend results of GWAS studies through genome-wide analysis of transcription, chromatin organization, and epigenetic markers. The Instituteís activities for FY 2016 include continuing to consider ways in which bone, joint, muscle, and skin researchers can leverage these data for studies that will lead to better diagnostic, preventive, and treatment strategies. NIAMS also will continue its participation in trans-NIH activities to support the nationís biomedical, behavioral, and clinical research needs in Big Data Science.

NIAMS is committed to ensuring that a sufficient number of well-trained basic scientists and clinical researchers are prepared to conduct cutting-edge studies related to musculoskeletal, skin, and rheumatic diseases. The Institute funds a combination of institutional training grants and individual fellowships for this purpose. Building on a successful effort to encourage clinician scientists as they transition from mentored research to full independence, NIAMS began meeting with clinical and patient-oriented research career development awardees in both the first and third years of their grants. These interactions identify challenges that the investigators face and ways to better support them and future awardees. In addition, NIAMS is participating in an NIH-wide effort to increase the number of grants made to investigators with meritorious ideas who previously have not had a substantial independent NIH award and is developing a program that would provide sustained support for scientists who have received their first competitive renewal, or type 2, research project grant. This Supplements to Advance Research (STAR) program focuses on a particularly vulnerable time when investigators no longer qualify for new-investigator status, but have not yet developed the robust research portfolio that places them on even ground with long-established faculty members. Other plans for FY 2016 include continuing a small grant program that supports new investigators as they generate the preliminary data necessary for a larger NIH research project grant.

Overall Budget Policy: The FY 2016 Presidentís Budget request for NIAMS is $533.232 million, an increase of $11.704 million or 2.2 percent above the FY 2015 Enacted level.


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Program Descriptions and Accomplishments

Arthritis and Rheumatic Diseases: This program advances high-quality basic, translational, and clinical biomedical and biopsychosocial research to treat, cure, and prevent arthritis and autoimmune diseases. It supports the application of new insights in the fields of genetics, genomics, proteomics, immunology, and imaging to understand how the immune system interacts with various tissues in normal and pathological conditions, and to ensure a continuous supply of new targets on which therapies can be based. Many of the diseases covered by this program vary with respect to the severity of the symptoms that patients experience and the damage done to tissues and organs. Where treatments exist, clinicians lack the ability to differentiate between patients who should be treated conservatively because their conditions are stable and those who might benefit from additional, more aggressive therapies. Numerous research teams are addressing this need by searching for predictive markers that could be easily measured as part of an office visit; some recently have made progress toward identifying molecules from patientsí blood samples that correlate with the severity of conditions including lupus and scleroderma. The program also managed the Patient-Reported Outcomes Measurement Information System (PROMIS®) initiative for the NIH Common Fund and continues to support the development and use of PROMIS technologies. NIAMS-funded researchers recently published a set of PROMIS questions that accurately evaluates patient function across a wider range of physical abilities. This expansion is compatible with the World Health Organizationís increased emphasis on health as a state of well-being rather than simply an absence of disease.

Budget Policy: The FY 2016 budget estimate for this program is $106.082 million, an increase of $2.568 million or 2.5 percent above the FY 2015 Enacted level. Program plans for FY 2016 include encouraging investigators to explore the signaling pathways within and between immune cells and their target tissues, with the goal of identifying potential drug targets or diagnostic strategies for autoimmune diseases. In addition, as lead of the Lupus Federal Working Group, NIAMS will continue to facilitate collaborations among the NIH Institutes and Centers, other Federal agencies, voluntary and professional organizations, and pharmaceutical companies with an interest in lupus.

Musculoskeletal Biology and Diseases: This program focuses on understanding the fundamental biology of tissues that constitute the musculoskeletal system and on translating and applying this knowledge to a variety of diseases and conditions, including osteoarthritis (OA). One recent advance supported by this program comes from a research team that developed a mouse model of the disease pseudoachondroplasia (PSACH), a severe form of dwarfism that starts to manifest as children approach their second birthday; not only have the findings shed light on the pathology of the disease, the research identified a window during which treatments may be most effective. The program also supports the development of technologies such as bone and joint imaging, tissue engineering, and regenerative medicine to improve the diagnosis and treatment of skeletal disorders, or to facilitate repair of damage caused by trauma to otherwise healthy tissue. It oversees clinical research into the treatment and prevention of acute and chronic bone and joint injuries and orthopaedic conditions.

Program Portrait: The Spine Patient Outcomes Research Trial (SPORT) for Low Back Pain

FY 2015 level: $0.828 million
FY 2016 level: $0.775 million
Change:-$0.053 million

World-wide, low back pain is the leading cause of disability, as measured by years lived with disability (YLDs), and it is the sixth greatest source of disease burden as measured in disability-adjusted life years (DALYs).2 Although clinicians quickly can identify some of their patients who require surgery for their low back pain — and others who will recover without it — guidance about how best to care for patients who are not at either extreme would be beneficial.

For the past decade, NIH-funded researchers have been monitoring the health of people who have low back pain due to one of three specific diagnoses: intervertebral disc herniation, lumbar spinal stenosis, or degenerative spondylolisthesis. Early findings from the study, called SPORT, showed that, in general, otherwise healthy people who have surgery for one of these three conditions are likely to fare better than those who receive non-operative care. However, people who are reluctant to have surgery may also recover with non-operative treatments if their conditions are not progressing and their pain is tolerable. And, importantly, delaying or avoiding surgery does not cause additional damage in most cases.

Benefits from surgical intervention occurred for all conditions at four years and for disc herniation at eight years. Eight-year results for the other two conditions are pending. Continued follow-up of SPORT participants has created a rich database of traits that are associated with a surgeryís success. Although the current NIAMS commitment to the SPORT trial runs through FY 2015, program plans for FY 2016 and beyond include supporting an effort to incorporate the findings into a decision tool that will inform patients and their health care teams about likely improvements in physical activity, pain, and overall health after surgical or non-surgical treatment for low back pain.

 

Budget Policy: The FY 2016 budget estimate for this program is $136.360 million, an increase of $3.295 million or 2.5 percent above the FY 2015 Enacted level. Program plans for FY 2016 include continuing an effort, begun in FY 2013, to promote the use of data and images collected as part of the Osteoarthritis Initiative in studies of the epidemiology and natural history of OA and its risk factors. NIAMS also will continue to encourage identification of molecular and cellular mechanisms underlying progressive deterioration of joint structure and function in OA. The goal is to accelerate the development of strategies to predict who will experience OA, how OA can be prevented, and how it can be treated once joint degeneration has begun.

Bone Biology and Diseases: This program covers a broad spectrum of research designed to better understand genetic and cellular mechanisms involved in the build-up and breakdown of bone. It supports studies of the regulation of bone remodeling; bone formation, bone resorption, and mineralization; and the effects of hormones, growth factors, and other signals on bone cells. One project, supported in a partnership with the National Aeronautics and Space Administration and the Center for the Advancement of Science in Space on board the International Space Station, is exploring how bone cells respond to the absence of gravity and how those changes relate to the bone loss that millions of people experience each year because of illness or injury. The program also supports several large epidemiologic cohorts for characterization of the natural history of osteoporosis and for identification of genetic and environmental risk factors that contribute to bone disease. Building on the knowledge that bone adapts to exercise by getting bigger, heavier and stronger, and that bones respond best during childhood and adolescence, many NIAMS-funded research teams are studying bone health in pediatric populations. One group recently demonstrated that bone-building activities during youth provide benefits that last a lifetime. Another identified characteristics of childhood fractures that are associated with underlying bone health problems; whereas children who break their arms after moderately forceful accidents (e.g., falling off a bicycle) likely have healthy bones, those who fracture following a mild trauma (e.g., a fall while running on a playground) might benefit from nutritional and exercise interventions to improve bone health.

Budget Policy: The FY 2016 budget estimate for this program is $61.588 million, an increase of $1.491 million or 2.5 percent above the FY 2015 Enacted level. Program plans for FY 2016 include encouraging investigators to study the cell and mineral changes that lead to atypical femoral fractures—breaks in the upper part of the leg bone that are thought to be a rare side-effect of long-term bisphosphonate treatment for osteoporosis. NIAMS also will promote collaborations and the exchange of information at the agency level through the Federal Working Group on Bone Diseases—an interagency committee led by the Institute.

Muscle Biology and Diseases: This program supports a wide range of basic, translational, and clinical research projects in skeletal muscle biology and diseases. It focuses on the fundamental biology of muscle development, physiology, and muscle imaging. The overarching objective is to advance the understanding of the role that muscle plays in musculoskeletal and whole body health and, ultimately, to treat or prevent skeletal muscle diseases and disorders, including the muscular dystrophies, inflammatory myopathies, muscle ion channel diseases, disuse atrophy, skeletal muscle injury, and loss of muscle mass associated with aging and diseases. For example, a team of researchers recently linked genetic mutations that alter muscle cellsí ability to process calcium with a common side effect of cholesterol-lowering drugs called statins. The connection between statin-induced muscle damage and these mutations, which also are associated with a potentially fatal condition called malignant hyperthermia, suggests health care providers should carefully monitor people known to have malignant hyperthermia who take statins for cholesterol control. The findings also could have implications for people with a history of statin-induced myopathy, as the condition may be a sign that they are harboring malignant hyperthermia mutations.

Budget Policy: The FY 2016 budget estimate for this program is $70.550 million, an increase of $1.708 million or 2.5 percent above the FY 2015 Enacted level. Plans include continued participation in the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers Program, collaborations with other NIH components and Federal agencies to advance research objectives in the new Action Plan for the Muscular Dystrophies, and efforts to encourage researchers to investigate the molecular processes by which skeletal muscle influences other organ systems.

2Brauer CA, et al. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. PMID: 19826027

Skin Biology and Diseases: This programís support for basic, translational, and clinical research includes work on the developmental and molecular biology of skin, the study of skin as an immune organ, and the genetics of skin diseases. One emerging area of research into skinís sensory functions focuses on understanding the biological basis of chronic itch, a symptom associated with many skin diseases and with responses to certain drugs. Chronic itch, which affects millions of Americans, can be difficult to treat and manage, potentially leading to severe deterioration of a personís quality of life. Although the underlying cellular and molecular mechanisms of itch are not well understood, a number of NIAMS-funded research teams recently identified cells, molecules, and pathways involved in chronic itch and have developed new tools to study the condition. The Skin Biology and Diseases program also supports research into ways to prevent skin damage due to ultraviolet (UV) light. Despite the well-known link between skin cancer and chronic UV light exposure from the sun or tanning beds, people have been slow to adopt measures that will protect their skin, and skin cancer incidence continues to rise. NIAMS-funded investigators recently demonstrated that UV exposure causes skin cells to produce molecules that resemble opioids; prolonged exposure leads to addiction-like responses that likely contribute to UV-seeking behavior and the increase in skin cancer cases reported each year.

Program Portrait: Studying Stem Cells to Help the Body Heal

FY 2015 Level: $71.286 million
FY 2016 Level: $72.855 million
Change: +$1.569 million

Dividing stem cells can take two paths; they can generate more stem cells or mature into other cell types. NIAMS-funded research into the signals that control stem cell behavior is answering several questions that have puzzled investigators for decades. For example, salamanders and newts are well known for their ability to regenerate lost limbs; but people can only regenerate the tips of fingers and toes, and only if part of the nail remains. In FY 2014, investigators discovered that a signaling pathway triggers fingertip regeneration by stimulating the formation of new nail from stem cells found at the base of the nail. The regenerating nail then draws nerve cells into the wound site. These nerve cells — by promoting the release of a growth factor — help form the other tissues that comprise the finger, such as bone, muscle, and tendons.

Other groups are exploring methods to grow new tissue from stem cells in the laboratory, with the goal of developing functional material that could replace tissue that was damaged by injury or disease. One group has found a way to isolate muscle stem cells from rats and turn them into an elongated bundle of muscle fibers that spontaneously twitch. When stimulated with electric pulses, the fibers contract like natural muscles. And, the tissue developed its own blood supply and continued to function when implanted into rats whose muscles had been injured. The next step is to see if the fibers can connect to the animalsí nervous system and work in tandem with the remaining healthy muscle tissue.

A third example of the healing power of stem cells comes from a team that showed how muscle stem cells can be turned into brown fat — an energy-burning type of fat. This entailed altering the amount of one of the many molecules that regulate genes. When tested in mice, the increased production of brown fat made the animals more resistant to diet-induced obesity and better able to process sugar. Four months later, they also burned more calories than their untreated counterparts. This finding could have implications for treating obesity and the health risks associated with it, such as Type 2 Diabetes, osteoarthritis, and other disorders.

 

Budget Policy: The FY 2016 budget estimate for this program is $74.883 million, an increase of $1.812 million or 2.5 percent above the FY 2015 Enacted level. Building on the significant gains in understanding itch sensation in recent years, NIAMS will continue to encourage basic and translational research that will lead to more discoveries about the mechanisms of itch sensation and the development of interventions to modulate and control itch in disease. Other FY 2016 activities include efforts to help the scientific community continue to expand its knowledge about how skin communicates with the brain and responds to changes in other organ systems. Ongoing programs that NIAMS will continue to support include a clinical trial of an antibody against a key signaling pathway in moderate and severe atopic dermatitis (a type of eczema).

Intramural Research Program: The mission of IRP is to conduct innovative basic, translational, and clinical research relevant to the health concerns of the Institute and to provide training for investigators who are interested in related research careers. IRP conducts basic scientific and clinical studies on the genetics, etiology, pathogenesis, and treatment of a variety of rheumatic, autoimmune, inflammatory, bone, skin, and muscle diseases. IRP consists of basic researchers and physician-scientists who have contributed many noteworthy discoveries. In addition to the MAS advance mentioned above, 2014 findings include the identification of a gene that underlies a very rare but devastating autoinflammatory condition, which the researchers named STING-associated vasculopathy with onset in infancy (SAVI). Several existing drugs have shown therapeutic potential in laboratory studies, and one is currently being studied in children with the disease. Because some of SAVIís characteristics appear in other diseases such as lupus, the work could lead to novel insights and new treatments that reach far beyond a single rare disease. As part of its commitment to providing a world-class training experience for future clinician scientists, NIAMS continued to participate in the NIH IRP Medical Research Scholars Program in FY 2014. This activity complements other NIAMS IRP training opportunities for investigators who have completed their degrees or are interested in other fields within the NIAMS mission, such as the Adult Rheumatology Fellowship Program and a pediatric rheumatology training program in partnership with Childrenís National Medical Center in Washington, D.C.

Budget Policy: The FY 2016 budget estimate for this program is $54.680 million, an increase of $0.542 million or 1.0 percent above the FY 2015 Enacted level. NIAMS plans for FY 2016 include maintaining a focus on translational research in order to facilitate patient-oriented studies in the areas of arthritis, musculoskeletal, and skin diseases, including their genetic, inflammatory, and immune underpinnings. NIAMS will also continue a long-standing commitment to multidisciplinary training of rheumatology research fellows to strengthen the pipeline of highly qualified physician-scientists in this field. Both efforts will continue to synergize with the NIAMS Community Health Center facility in Silver Spring, Maryland. NIAMS is also continuing participation in an NIH Funding Opportunity Announcement to promote collaborations between intramural and extramural investigators in order to leverage the unique research opportunities and resources available at the NIH Clinical Center.

Program Portrait: Growing Muscle and Bone Portfolios in the NIAMS IRP

FY 2015 Level: $1.382 million
FY 2016 Level: $1.382 million
Change: $0.000 million

In FY 2014, NIAMS added two research teams to its existing cadre of bone, joint, and muscle scientists. In partnership with the Johns Hopkins Universityís Myositis Center, the Muscle Disease Unit focuses on understanding the underlying mechanisms of inflammatory muscle diseases such as dermatomyositis, polymyositis, statin-triggered necrotizing myopathy, and inclusion body myositis. The Laboratory of Muscle Stem Cells and Gene Regulationís new RNA Molecular Biology Group is explaining how defects in proteins that interact with RNA can disrupt translation of genetic messages and lead to neuromuscular diseases that include myotonic dystrophy and oculopharyngeal muscular dystrophy.

While the Laboratory of Muscle Stem Cells and Gene Regulation explores the molecular basis of disease, investigators in the Clinical Trials Outcomes Branch are conducting comparative effectiveness research into how patients respond to treatments that are routinely used in clinical practice. They have mined an international database of medical records to compare the risks and benefits of two anticoagulants — warfarin and low-molecular-weight heparin Ė that are commonly prescribed after total joint replacement. Warfarin is taken in the form of a pill, but the patient is required to undergo blood tests and monitoring while taking it, whereas low molecular weight heparin, administered via an injection, requires no monitoring or blood tests. The researchers found low-molecular-weight heparin increases the risk for bleeding and superficial infections post-surgery, while warfarin is associated with reduced risk of postoperative infection despite its more complicated monitoring regimen. Other work includes examining large clinical databases to understand the occurrence of rare fractures of the thigh bone following prolonged use of a class of commonly prescribed osteoporosis drugs, as well as a clinical trial that will help primary care physicians and other health care providers identify women who are at high risk for this rare but devastating complication.

 

Research Management and Support (RMS): The NIAMS RMS budget supports the scientific, administrative management, and information technology activities associated with the Instituteís day-to-day operations. In FY 2014, the Institute managed more than 1,246 research grants and centers, as well as 37 research and development contracts and 286 individual and institutional full-time research training positions. NIAMS supported 540 clinical research studies, including 74 clinical trials. The Institute worked with researchers, healthcare professionals, and health advocacy organizations to update the Instituteís Long-Range Plan, a broad outline of scientific opportunities and challenges that will guide the Institute's priority-setting for FYs 2015-2019. As part of the Instituteís efforts to engage with patients and the general public, NIAMS launched a new page on the social media site Google Plus and a dedicated channel on the video sharing site YouTube to provide a single, convenient platform to view video resources and other NIAMS content. Complementing the Instituteís existing Facebook and Twitter pages, Google Plus and YouTube broaden NIAMSí reach to members of the "millennial generation." NIAMS regularly posts messages in Spanish on its social media channels. When NIAMS publications in Chinese, Korean, and Vietnamese are available, the Instituteís communications in English include links to those materials as well as to English-language resources.

Budget Policy: The FY 2016 budget estimate for this program is $29.089 million, an increase of $0.288 million or 1.0 percent above the FY 2015 Enacted level. Plans for FY 2016 include working with national and community partners to develop and disseminate meaningful health information for racial and ethnic minority populations through its National Multicultural Outreach Initiative (NMOI). NIAMS also will continue to enhance its social media presence through outlets such as Facebook and Twitter, and expects to implement a content management system that will tailor the information displayed on the Instituteís website to the interests of different audiences.

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Budget Authority by Object Class

Budget Authority by Object Class1
(Dollars in Thousands)
 
FY 2015
Enacted

FY 2016
President's Budget

FY 2016 +/-
FY 2015
Total compensable workyears:
Full-time employment 243 243 0
Full-time equivalent of overtime
and holiday hours
0 0 0
Average ES salary $182 $182 $0
Average GM/GS grade 12.1 12.1 0.0
Average GM/GS salary $101 $101 $1
Average salary, grade
established by
act of July 1, 1944
(42 U.S.C. 207)
$98 $99 $1
Average salary of ungraded positions $117 $117 $0

OBJECT CLASSES
FY 2015
Enacted
FY 2016 President's Budget FY 2016 +/-
FY 20154
Personnel Compensation
11.1 Full-time permanent $14,323 $14,740 $417
11.3 Other than full-time permanent 9,129 9,429 300
11.5 Other personnel compensation 623 642 19
11.7 Military personnel 347 357 10
11.8 Special personnel services payments 2,307 2,385 79
11.9 Subtotal, Personnel Compensation $26,728 $27,553 $825
12.1 Civilian personnel benefits $7,406 $7,606 $200
12.2 Military personnel benefits 223 229 7
13.0 Benefits to former personnel 0 0 0
Subtotal, Pay Costs $34,357 $35,388 $1,031
21.0 Travel and transportation of persons $642 $628 -$13
22.0 Transportation of things 142 140 -2
23.1 Rental payments to GSA 13 12 -1
23.2 Rental payments to others 0 0 0
23.3 Communications, utilities and miscellaneous
charges
595 587 -8
24.0 Printing and reproduction 0 0 0
25.1 Consulting services $1,486 $1,403 -$83
25.2 Other services 3,623 3,531 -91
25.3 Purchase of goods and services
from government accounts
48,661 52,358 3,697
25.4 Operation and maintenance of facilities $24 $23 $0
25.5 R & D contracts 3,718 1,619 -2,099
25.6 Medical care 4,351 4,356 5
25.7 Operation and maintenance of equipment 1,128 1,120 -8
25.8 Subsistence and support of persons 0 0 0
25.0 Subtotal Other Contractual Services $62,990 $64,411 $1,420
26.0 Supplies and materials $4,686 $4,262 -$424
31.0 Equipment 2,652 2,449 -203
32.0 Land and structures 0 0 0
33.0 Investments and loans 0 0 0
41.0 Grants, subsidies and contributions 415,451 425,354 9,903
42.0 Insurance claims and indemnities 0 0 0
43.0 Interest and dividends 0 0 0
44.0 Refunds 0 0 0
Subtotal Non-Pay Costs $487,171 $497,844 $10,673
Total Budget Authority by Object Class $521,528 $533,232 $11,704

1/Includes FTEs whose payroll obligations are supported by the NIH Common Fund.


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Salaries and Expenses

Salaries and Expenses
(Dollars in Thousands)
OBJECT CLASSES FY 2015
Enacted
FY 2016
President's Budget
FY 2016 +/-
FY 2015
Personnel Compensation:
Full-time Permanent (11.1) $14,323 $14,740 $417
Other than Full-time Permanent (11.3) 9,129 9,429 300
Other Personnel Compensation (11.5) 623 642 19
Military Personnel (11.7) 347 357 10
Special Personnel Services Payments (11.8) 2,307 2,385 79
Subtotal Personnel Compensation (11.9) $26,728 $27,553 $825
Civilian Personnel Benefits (12.1) $7,406 $7,606 $200
Military Personnel Benefits (12.2) 223 229 7
Benefits to Former Personnel (13.0) 0 0 0
Subtotal, Pay Costs $34,357 $35,388 $1,031
Travel & Transportation of Persons (21.0) $642 $628 -$13
Transportation of Things (22.0) 142 140 -2
Rental Payments to Others (23.2) 0 0 0
Communications, Utilities & Misc. Charges (23.3) 595 587 -8
Printing and Reproduction (24.0) 0 0 0
Other Contractual Services:
Consultant Services (25.1) 52 41 -11
Other Services (25.2) 3,623 3,531 -91
Purchases from government accounts (25.3) 34,600 35,327 727
Operation & Maintenance of Facilities (25.4) 24 23 0
Operation & Maintenance of Equipment (25.7) 1,128 1,120 -8
Subsistence & Support of Persons (25.8) 0 0 0
Subtotal Other Contractual Services $39,426 $40,042 $616
Supplies & Materials (26.0) $4,686 $4,262 -$424
Subtotal Non-Pay Costs $45,491 $45,659 $169
Total Administrative Costs $79,848 $81,048 $1,200


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Details of Full-Time Equivalent Employment (FTEs)

Details of Full-Time Equivalent Employment (FTEs)
FY 2014
Actual
FY 2015
Est.
FY 2016
Est.
Civilian Military Total Civilian Military Total Civilian Military Total
Intramural Research Program
Direct: 125 1 126 125 1 126 125 1 126
Reimbursable: 9 9 9 9 9 9
Total: 134 1 135 134 1 135 134 1 135
Office of Extramural Activites
Direct: 50 2 52 51 2 53 51 2 53
Reimbursable:
Total: 50 2 52 51 2 53 51 2 53
Office of the Director
Direct: 55 55 55 55 55 55
Reimbursable:
Total: 55 55 55 55 55 55

Total
239 3 242 240 3 243 240 3 243
Includes FTEs whose payroll obligations are supported by the NIH Common Fund.
FTEs supported by funds from Cooperative Research and Development Agreements. 0 0 0 0 0 0 0 0 0

FISCAL YEAR

Average GS Grade
2012 11.8
2013 11.6
2014 12.1
2015 12.1
2016 12.1


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Detail of Positions

Detail of Positions1
GRADE
FY 2014
Actual

FY 2015
Enacted

FY 2016
President's Budget
Total, ES Positions 1 1 1
Total, ES Salary 181,500 181,500 181,500
GM/GS-15 18 18 18
GM/GS-14 31 31 31
GM/GS-13 43 43 43
GS-12 27 28 28
GS-11 10 10 10
GS-10 0 0 0
GS-9 11 11 11
GS-8 10 10 10
GS-7 6 6 6
GS-6 4 4 4
GS-5 0 0 0
GS-4 0 0 0
GS-3 0 0 0
GS-2 0 0 0
GS-1 0 0 0
Subtotal 160 161 161
Grades established by Act of July 1, 1944 (42 U.S.C. 207)
Assistant Surgeon General 1 1 1
Director Grade 1 1 1
Senior Grade 2 2 2
Full Grade 0 0 0
Senior Assistant Grade 0 0 0
Assistant Grade 0 0 0
Subtotal 4 4 4
Ungraded 99 99 99
Total permanent positions 164 165 165
Total positions, end of year 263 264 264
Total full-time equivalent (FTE)
employment, end of year
242 243 243
Average ES salary 181,500 181,500 181,500
Average GM/GS grade 12.1 12.1 12.1
Average GM/GS salary 100,338 100,516 101,395

1/Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

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