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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 Public Health Services Act with respect to arthritis and musculoskeletal and skin diseases $547,891,000.

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Amounts Available for Obligation

¹Excludes the following amounts for reimbursable activities carried out by this account:
FY 2010 - $3,550     FY 2011 - $7,550     FY 2012 - $11,550

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Budget Mechanism Table

1/ All items in italics are "non-adds"; items in parenthesis are subtractions

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Major Changes in the Fiscal Year 2012 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 2012 budget request for NIAMS, which is $9.132 million more than the FY 2010 Comparable, for a total of $547.891 million.

Research Project Grants (+$3.424 million; total $354.682 million): NIAMS will support a total of 1,024 Research Project Grant (RPG) awards in FY 2012. Noncompeting awards will increase by 46 awards and $19.984 million. Competing RPGs will decrease by 59 awards and $16.392 million. The NIH budget policy for RPGs in FY 2012 is to provide an inflationary increase of 1% in noncompeting awards and allow a 1% increase in the average cost of competing RPGs. NIAMS continues to place a priority on support to new investigators.

Research Training (+$0.850 million; total $16.404 million): NIAMS will support 312 pre- and postdoctoral trainees in full-time training positions, the same number as in FY 2010. An across-the-board stipend increase of 4 percent has been provided in FY 2012. When coupled with the 2 percent increase in stipend levels provided in FY 2011, the total reflects a 6 percent increase in stipends over FY 2010. The increase in stipend levels will allow NIAMS to sustain the development of a highly qualified biomedical research workforce.

Intramural Research (+$1.661 million; total $56.670 million): In FY 2012 the NIAMS research plans include a continued 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 mechanisms.
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Summary of Changes

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Fiscal Year 2012 Budget Graphs

History of Budget Authority and FTEs:

Distribution by Mechanism:

Change by Selected Mechanisms:

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Budget Authority by Activity

1. Includes FTEs which are reimbursed from the NIH Common Fund for Medical Research.
2. Includes Real Transfers and Comparable Adjustments as detailed in the "Amounts Available for Obligation" table.

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Authorizing Legislation

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Appropriations History

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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):

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

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a broad range of research, training, and information dissemination activities related to arthritis, musculoskeletal, and skin diseases. Some are rare disorders, but many are very common, and all have a major influence on the quality of people's lives. Diseases addressed by NIAMS affect individuals of all ages, of all racial and ethnic backgrounds, and across all economic strata; many disproportionately affect women and minorities. Over the years, NIAMS-funded research teams have made significant progress in uncovering the causes and improving the treatment of many disorders of the bones, muscles, joints, and skin. Many of the Institute's ongoing activities are advancing the five initiatives put forth by the NIH Director.

As part of its mandate to devise strategies to treat, and even prevent, the diseases within its mission, NIAMS is committed to supporting timely and informative investigator-initiated clinical trials. Implementation of a clinical trial can require a substantial commitment by the Institute in terms of financial and personnel resources. NIAMS has enhanced its clinical trials portfolio by initiating a two-part grant process. Beginning with its FY 2012 awards, NIAMS will strongly encourage investigators to apply for a clinical trial planning grant in advance of support for the full clinical trial. Moreover, in FY 2011 and FY 2012, the Institute will fund a series of exploratory, short-term clinical studies by investigators who have new ideas for clinical trials but need preliminary data. It will continue its FY 2010 effort to leverage the Nation's considerable investment in large clinical studies by encouraging investigators to tap established resources when asking research questions that they could answer through existing trials and clinical studies. Examples of ongoing NIAMS-supported clinical research include:

• A large, multicenter trial comparing the outcomes of surgery and nonoperative treatments for patients with low back pain. Findings continue to provide clinicians with data that are guiding discussions with their patients regarding treatment options.¹
• Comparative effectiveness research to evaluate treatments for children and adults who have rheumatic or skin diseases.
• New clinical trials of a treatment for children who have a rare blistering skin condition (recessive dystrophic epidermolysis bullosa), and a treatment for children with a rare brittle bone disease (osteogenesis imperfecta). These interventions are based on strategies derived from animal models of these diseases.

¹Weinstein JN, et al. Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine. 2010 Jun 15;35(14):1329-38.PMID: 20453723.

NIAMS recognizes the important role animal studies play in translating basic science discoveries into improved human therapies, and the promise that tissue engineering and regenerative medicine hold for musculoskeletal and skin diseases. In FY 2011, NIAMS will support pre-clinical animal studies that have the potential to lead immediately to human trials of tissue engineering and regenerative medicine therapies. The awards will allow investigators to develop large animal models, demonstrate the pre-clinical efficacy of tissue engineering or regenerative medicine therapies in musculoskeletal and skin conditions, and collect other data required for clinical trials.

As part of the Institute's planning process, NIAMS hosted a full-day discussion with extramural investigators to identify research needs related to the integration of psychosocial and behavioral therapies with other treatments for patients with musculoskeletal or rheumatic diseases. Research into how health care providers can combine non-invasive, non-pharmacological approaches with other modalities to improve patients' function could directly influence health care reform by allowing individuals to benefit more fully from existing treatments. Another scientific planning meeting addressed research needs and opportunities regarding how increased exercise contributes to disease prevention and increased overall health. Because exercise effects are systemic, exploration of the mechanisms linking exercise and disease prevention may also contribute to the benefits of physical activity as a treatment for multiple diseases and disorders.

Efforts to encourage collaborative, multi-disciplinary research are a large component of the Institute's strategy to reinvigorate and empower the biomedical research community. In FY 2010, NIAMS funded research under a trans-NIH solicitation that it spearheaded in partnership with the National Aeronautics and Space Administration (NASA); the project requires biomedical researchers, NASA engineers, and astronauts to collaborate to answer fundamental questions surrounding human health issues such as osteoporosis. NIAMS will consider funding additional grants under the NASA program in FY 2011 and FY 2012.

Recognizing that the scale and complexity of today's biomedical research problems demand that scientists move beyond their individual disciplines and explore new organizational models for team science, NIAMS will continue to evaluate the success of the Building Interdisciplinary Research Teams (BIRT) initiative in FY 2012. This program has provided support to grantees to facilitate the establishment of collaborations with other groups of investigators. Ongoing assessments of this initiative will allow the NIAMS to examine how the biomedical research community is using this opportunity to develop new disciplines and approaches with which to tackle increasingly complex questions.

Other FY 2012 plans include offering institutions the opportunity to establish Multidisciplinary Clinical Research Centers or Centers of Research Translation focusing on rheumatologic, musculoskeletal, or skin conditions. Support for both types of centers stem from the Institute's commitment to develop new and better treatments that improve patient care and public health. Researchers at an existing center were part of a multi-site study that recently published exciting findings about treatments for people with a rare autoimmune disease that destroys blood vessels (anti-neutrophil cytoplasmic antibody-associated vasculitis).²

²Stone JH et al. Rituximab versus cyclophosphamide for induction of remission in ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. PMID: 20647199

NIAMS devoted a portion of its annual scientific planning retreat to key gaps and opportunities in the Institute's comparative effectiveness research portfolio. Staff discussed specific disease areas-such as rheumatoid or juvenile idiopathic arthritis, psoriasis, and osteoporosis-that NIAMS-funded researchers are addressing or that are primed for future comparative effectiveness research efforts. Institute staff and extramural researchers discussed strategies that NIAMS could establish to engage key stakeholders and enhance its interactions with patients, health care providers, and researchers when bolstering its comparative effectiveness research investment. Discussion also focused on approaches to develop a research base to enable future comparative effectiveness research opportunities (e.g., the leveraging of electronic medical records and coordination via clinical research networks to generate or obtain outcomes data).

Overall Budget Policy: The FY 2012 request for NIAMS is $547.891 million or an increase of $9.132 million or 1.7 percent over the FY 2010 Comparable level. Investigator-initiated research project grants and research conducted by new scientists continue to be the Institute's highest priorities. Funds are included in R&D contracts to reflect NIAMS share of NIH-wide funding required to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program, the Basic Behavioral and Social Sciences Opportunity Network (OppNet), and support for a new synchrotron at the Brookhaven National Laboratory, For example, each IC that will benefit from the new synchrotron will provide funding to total NIH's commitment to support this new technology--$10 million.

NIH will provide an increase of four percent for stipends levels under the Ruth L. Kirschstein National Research Service Award training program to continue efforts to attain the stipend levels recommended by the National Academy of Sciences. This will build on the two percent increase in stipend levels for FY 2011. Stipend levels were largely flat for several years, and the requested increase will help to sustain the development of a highly qualified biomedical research workforce.

Program Descriptions and Accomplishments

Arthritis and Rheumatic Diseases: The goals of this program are to advance high-quality basic, translational, and clinical biomedical and biopsychosocial research to treat, cure, and prevent arthritis and other rheumatic diseases. It utilizes 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. NIAMS is committed to pursuing new opportunities that identify risk factors for these disorders, to enhance disease prediction, and advance prevention strategies. In FY 2011, NIAMS held a roundtable discussion on the molecular indicators of the earliest stages of autoimmune rheumatic diseases, before the appearance of symptoms, to explore the application of basic research findings to disease prevention, early diagnosis, and therapeutic intervention. The Institute also cosponsored a conference held on the NIH campus on translating scientific advances into clinical treatment of pain disorders, including arthritis and other rheumatic diseases.

Budget Policy: The FY 2012 budget estimate for this program is $115.603 million, an increase of $1.626 million or 1.4 percent over the FY 2010 Comparable level. In FY 2012, NIAMS will implement the testing and validation of tools created by the Common Fund's Patient-Reported Outcomes Measurement Information System (PROMIS) initiative, to measure health care outcomes in the diverse populations represented by the NIAMS portfolio, including arthritis and other rheumatic diseases. The Institute will also support studies utilizing genomics and high throughput technologies to enable researchers to identify and study gene variants associated with rheumatic diseases and other conditions within the NIAMS mission.

Musculoskeletal Development and Repair: 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. It studies the causes and treatment of acute and chronic injuries including repetitive stress and sports injuries, and is funding a long-term study into the effectiveness of various treatments for patients who have low back pain. The program 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. As part of its FY 2010 scientific planning effort, NIAMS organized a discussion on research directions regarding chronic low back pain. NIAMS also solicited input from the scientific community on emerging research needs and opportunities related to osteoarthritis that occurs following an acute, traumatic injury to a joint. In FY 2011, the Institute collaborated with physicians and health professionals to explore further the strong association between joint injury and the development of osteoarthritis, and how research in this area can be applied to patient care. NIAMS also partnered with professional societies to address how advances in tissue engineering can be applied to musculoskeletal diseases, and how advances in genetics and genomics can be leveraged to develop therapies against osteoarthritis.

Budget Policy: The FY 2012 budget estimate for this program is $132.684 million, an increase of $1.869 million or 1.4 percent over the FY 2010 Comparable level. In FY 2012, NIAMS will continue to promote the use of the Osteoarthritis Initiative (OAI) data and images, as described below (see Program Portrait: The Osteoarthritis Initiative). The OAI provides an unparalleled state-of-the-art database showing both the natural progression of the disease and information on biomarkers, x rays and outcome measures. This database should allow investigators to identify potential new disease targets and develop tools for understanding how to measure clinically meaningful improvements.

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Bone Biology and Diseases: This program studies the regulation of bone formation, resorption, and mineralization, and the effects of hormones, growth factors, and cytokines on bone cells. It 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. Although bone mass is closely related to fracture risk, the trait does not lend itself readily to a dichotomy between people who are at risk of fracture and those who have strong, healthy bones. NIAMS has encouraged investigators to collect high-density genotype information on participants, so subsequent studies to identify genetic risk factors (as well as new targets for therapeutic intervention) can leverage these resources. As in recent years, the NIAMS will continue to support the field's burgeoning interest in the genetics of bone diseases and research related to the integration of bone with other organ systems affected by chronic illness.

Budget Policy: The FY 2012 budget estimate for this program is $69.593 million, an increase of $0.981 million or 1.4 percent over the FY 2010 Comparable level. Program plans for FY 2012 include efforts to encourage research that builds on initial discoveries regarding the human genomics of complex bone diseases.

Muscle Biology and Diseases: This program 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 muscular dystrophies, inflammatory myopathies, muscle ion channel diseases, disuse atrophy, skeletal muscle injury and loss of muscle mass associated with aging and diseases). It focuses on fundamental biology of muscle development, physiology, and muscle imaging. As part of its FY 2010 scientific planning effort, the Institute organized a discussion on an emerging therapeutic approach that scientists are testing against diseases such as Duchenne muscular dystrophy. Other FY 2010 activities included renewal of a major research effort, under the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers program, to develop treatments to inhibit muscle scarring and enhance muscle regeneration.

Budget Policy: The FY 2012 budget estimate for this program is $74.891 million, an increase of $1.057 million or 1.4 percent over the FY 2010 Comparable level. For FY 2012, the program will continue to participate in the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers program. Other FY 2012 plans include renewing an effort to encourage applications for training and career development in the muscular dystrophies including, but not limited to, Duchenne, myotonic, facioscapulohumeral, and congenital disease.

Skin Biology and Diseases: This program supports basic, translational, and clinical research in skin, including work on the developmental and molecular biology of skin, the study of skin as an immune organ, and the genetics of skin diseases. The Institute is pursuing opportunities in developing artificial skin, and imaging technologies for diagnosis and tracking progression of skin diseases. In FY 2010, a session at the Institute's annual scientific planning retreat focused on research on the bacteria that live on human skin (i.e., the skin microbiome), which relies heavily on high throughput sequencing technologies. The discussion addressed ongoing research on the skin microbiome's role in maintaining health and causing disease. In FY 2011, NIAMS conducted a roundtable discussion on itch research to explore the potential application of basic research models to human studies that pertain to the development of new therapies where itching is a primary symptom.

Budget Policy: The FY 2012 budget estimate for this program is $70.818 million, an increase of $0.997 million or 1.4 percent over the FY 2010 Comparable level. In FY 2012, the Institute will encourage multidisciplinary research projects on the biology of itch, towards the development of new, effective treatments. NIAMS will also continue its support of research on the influence of imbalances in the skin microbiome on skin diseases, such as eczema.

Intramural Research Program: The mission of this program 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. The program conducts clinical studies on the genetics, etiology, pathogenesis, and treatment of a variety of rheumatic, autoimmune, inflammatory, joint, skin, and muscle diseases. The program has recently expanded its capacity by diversifying its current expertise, connecting with future scientists, and investing in new technologies. The addition of clinical staff with backgrounds in health outcomes research, including orthopaedics and pediatric rheumatology, has complemented ongoing scientific pursuits. Furthermore, the program's continued support for scientific and clinical fellows, in addition to providing laboratory access to promising local high school students, is an important investment in the research pipeline.

Budget Policy: The FY 2012 budget estimate for this program is $56.670 million, an increase of $1.661 million or 3 percent over the FY 2010 Comparable level. NIAMS plans for FY 2012 include a continued 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 mechanisms. NIAMS will also continue its commitment to multidisciplinary training of rheumatology research fellows, including interactions with other NIH intramural training programs with common scientific interests, to strengthen the pipeline of highly qualified physician-scientists in this field. The Institute's intramural research program also anticipates building upon its recent collaborative scientific activities in rheumatic diseases across various Institutes at NIH. This mimics the continued research partnerships that NIAMS scientists have with experts around the world, which have led to fundamental insights into basic biology and the genetics of diseases that carry the promise of new treatments and interventions.
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Research Management and Support (RMS): NIAMS' RMS supports the scientific, administrative management, and information technology activities associated with day-to-day operations. It supports long-term investments in the research enterprise, including the review and financial management of applications for grants and contracts, and dissemination of research. In FY 2010, the Institute managed 1,261 research grants and centers, as well as 55 research and development contracts and 312 individual and institutional full-time research training positions. NIAMS supported 535 clinical research studies, including 59 clinical trials. In FY 2010, NIAMS released its Long-Range Plan for FY 2010 through FY 2014. The plan brings attention to many areas that need to be addressed in the coming years in order to propel progress related to the understanding, diagnosis, treatment, and prevention, of diseases within the NIAMS mission. To further its commitment to information dissemination, NIAMS expanded its use of social media tools in order to facilitate the rapid distribution of research-based materials. NIAMS also used these tools for recruitment efforts in the Institute's Intramural Research Program to help maintain a strong stream of new investigators interested in the diseases and conditions within the NIAMS portfolio.
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Budget Policy: The FY 2012 request for RMS is $27.632 million, an increase of $0.941 million or 3.5 percent over the FY 2010 Comparable level. In FY 2012, the Institute will celebrate its 25th anniversary by highlighting achievements of NIAMS-supported scientists and future research directions within the Institute's mission. National leaders in arthritis and musculoskeletal and skin diseases research, along with patient representatives, will participate in a scientific symposium to discuss how support provided by NIAMS has helped to shape the biomedical and behavioral science landscapes. They also will discuss future research and training needs and opportunities. Additionally, NIAMS will continue to sponsor roundtable discussions and a scientific retreat with extramural investigators and lay representatives to inform the Institute's priority-setting and strategic planning process. These meetings help to position NIAMS to appropriately guide research efforts and improve the health of the American public.

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Budget Authority by Object

Includes FTEs which are reimbursed from the NIH Common Fund for Medical Research

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Salaries and Expenses

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Details of Full-Time Equivalent Employment (FTEs)

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Detail of Positions