FY 2010 Congressional Justification

FY 2010 Budget

Organization chart

Appropriation language

Amounts available for obligation

Budget mechanism table

Budget authority by activity

Major Changes in Budget Request

Summary of changes

Budget Graphs

Justification narrative

Budget authority by object

Salaries and expenses

Authorizing legislation

Appropriations history

Detail of full-time equivalent employment (FTE)

Detail of positions

Appropriation Language

For carrying out section 301 and title IV of the Public Health Services Act with respect to dental and craniofacial diseases [$402,652,000] $408,037,000 (Department of Health and Human Services Appropriation Act, 2009)

^1/Excludes the following amounts for reimbursable activities carried out by this account: FY 2008 - $1,616,000; FY 2009 Estimate - $2,200,000; FY 2010 Estimate - $2,200,000. Excludes $542,973 in FY 2008; Estimate $405,000 in FY 2009; and Estimate $405,000 in FY 2010 for royalties.

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

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

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Major Changes in the Fiscal Year 2010 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 2010 budget request for NIDCR, which is $5.4 million more than the FY 2009 estimate, for a total of $408 million.

Research Project Grants (+$9.204 million, total $249,038 million): NIDCR will support a total of 615 Research Project Grant (RPG) awards, not including SBIR/STTR. Noncompeting RPGs will decrease by 12 awards and reflect a cost increase of $8.577 million. Competing RPGs will increase by 1 award and $1.251 million. The NIH Budget policy for RPGs in FY 2010 is to provide a 2% inflationary increase for noncompeting awards and a 2% increase in average cost for competing RPGs.

Research & Development Contracts (-$5.527 million; total $23.958 million): Funding flexibility provided NIDCR the ability to support other priority areas.

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Fiscal Year 2010 Budget Graphs

History of Budget Authority and FTEs:

Distribution by Mechanism:

Change by Selected Mechanism:

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Justification of Budget Request

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

This document provides justification for the Fiscal Year (FY) 2010 activities including HIV/AIDS activities. Details of the FY 2010 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.

In FY 2009, a total of $101,819,000 American Recovery and Reinvestment Act (ARRA) funds were transferred from the Office of the Director, NIH. These funds will be used to support scientific research opportunities that help support the goals of the ARRA. The ARRA allows NIH to execute these funds via any NIH funding mechanism. Funds are available until September 30, 2010. These funds are not included in the FY 2009 Omnibus amounts reflected in this document.

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Director’s Overview

The National Institute of Dental and Craniofacial Research (NIDCR) is the lead agency in the nation’s ongoing efforts to improve oral, dental, and craniofacial health. The NIDCR pursues its mission through research, research training, and the dissemination of health information to the public and health care professionals. NIDCR has played a leadership role in establishing prevention as a cornerstone of American oral health since its inception in 1948. Past investments have positioned the Institute to confront complex dental, oral and craniofacial diseases and conditions afflicting millions of Americans. A comprehensive research agenda that encompasses prevention, early detection and management of these diseases defines current and future investments.

Oral and pharyngeal carcinomas represent the ninth most common cancer worldwide, affecting over 35,000 new patients each year and resulting in over 7,500 deaths each year in the United States alone. The 5-year survival rate for head and neck cancer patients has improved only marginally over the past 40 years, due largely to difficulties in early detection of the disease. The NIDCR has taken a multifaceted approach to alleviate the burden of this disease, and plans to increase support for head and neck cancer in FY 2010. The Institute will continue to invest in the development of new screening and detection methods to identify oral cancers at their earliest inception. NIDCR has taken a leadership role in the development of saliva-based diagnostic tests for myriad diseases and conditions throughout the body, including oral cancer. Saliva is easy to collect and poses none of the risks, fears, or invasiveness of blood tests. The miniaturization of detection devices, termed “lab-on-a-chip” may allow placement of the sentinel device directly in the mouth, yielding real-time surveillance of hundreds of biomarkers that could alert individuals to consult with their health professionals at the earliest moment of disease. This will enable oral health care professionals to assume a more prominent role in the primary health care network – an integral role in preventive medicine that will assume increasing importance as the American population ages. NIDCR is also investing in health disparities research to reduce oral cancer in high-risk groups, including community outreach, education and behavioral modification. In addition, work planned for FY2009 and FY2010 will delineate the mechanisms that underlie the specific stages of oral cancers and the progression from one stage to another. By profiling the identity of a patient’s oral cancer, the choice of chemotherapy drugs can be optimized to those that are most likely to target the internal wiring of the tumor cell and eliminate it without destroying healthy cells.

Each year, thousands of infants are born in the United States with cleft lip and/or cleft palate. Though the conditions are usually amenable to surgical correction, families undergo tremendous emotional and economic hardship during the process, and children often require many additional services, including complex dental care and speech therapy. Other craniofacial malformations are more challenging to treat. For example, children born with ectodermal dysplasia are born with malformed or missing teeth.

During FY 2009 and FY 2010 NIDCR will support the development of the FaceBase project - a broad research initiative to create a publicly available informatics platform and database capable of multi-scale analysis of craniofacial development. The comprehensive understanding of craniofacial construction will provide new opportunities for the prevention of craniofacial defects and the subsequent treatment of complex dental and craniofacial disorders using less invasive interventions, minimizing healing time, and optimizing their restored form and function. For example, bony defects can be repaired through the insertion of a small, shapeable and biodegradable scaffold into the wound. The three-dimensional scaffold, measuring only a few millimeters in diameter at most, will degrade within minutes or hours and release a natural work force of progenitor cells and other biological agents to regenerate the damaged tissue and restore its function. This research also will provide the instructions to engineer partial or complete oral structures, from tooth to salivary gland.

Chronic facial pain, including temporomandibular joint and muscle disorders and trigeminal neuralgia causes untold suffering for many Americans. Multidisciplinary research teams, including neuroscientists and geneticists are slowly untangling the complex circuitry of sensory inputs and outputs that go awry along the pain pathway, including the spinal cord and brain. Particularly important are the events surrounding the transition from acute to chronic pain. Available evidence suggests that this results from a change in the neuronal cell wiring within the brain. NIDCR continues to give high priority to supporting research on the causes and treatment of chronic pain.

NIDCR’s research is pointing the way toward future targeted therapies. For example, by selectively turning off the immune response in the oral cavity we will achieve better control of autoimmune diseases such as Sjögren’s syndrome – a disease that progressively destroys salivary and lachrymal glands. This approach will also afford a new approach to treating the chronic inflammation of the tooth-supporting periodontium. Mechanical cleansing of the tooth root will no longer serve as a primary means to treat the millions of Americans with advanced periodontal disease.

Not so long ago, a future of molecular medicine sounded more like science fiction than everyday fact. But the pace of the research and technology development has accelerated greatly over the past decade. Each week brings unexpected discoveries that draw into tighter focus the path ahead to build this future of molecular medicine in maintaining and improving overall health, including oral health. We present in the following pages the Institute’s programs and proposed initiatives that will help to build this future and which will benefit the lives of millions of Americans now and in the future.

Overall Budget Policy: NIDCR will continue to support new investigators and to maintain an adequate number of competing RPGs. NIDCR is providing a 2 percent inflationary increase for non-competing and competing grants. In addition, the NIDCR has targeted a portion of the funds available for competing research project grants to support high priority projects outside of the payline, including awards to new investigators, and early stage investigators. The Institute also seeks to maintain a balance between solicitations issued to the extramural community in areas that need stimulation and funding made available to support investigator-initiated projects. Intramural Research and Research Management and Support receive modest increases to help offset the cost of pay and other increases.

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2010 JUSTIFICATION BY ACTIVITY DETAIL

Program Descriptions and Accomplishments

Extramural Research

Oral and Craniofacial Biology

This program supports research that discovers the fundamental workings of the myriad tissues, cell types and organs systems that comprise the human face and head. Areas of focus include craniofacial development and birth defect, infectious diseases, oral cancer, orofacial pain, oral immunology; and salivary gland function. The program also supports research on novel approaches and biomaterials that enhance craniofacial tissue repair and reconstruction following damage by diseases, birth defects, trauma and injuries. Given the tremendous complexity and breadth of craniofacial biology, the program actively promotes collaboration among scientists from diverse professional backgrounds. This meeting of the minds generates more creative hypotheses and potential solutions than scientists within a single discipline could envision working alone.

A prime example of this collaborative approach is the program’s leadership role in the NIH Roadmap Initiative’s Human Microbiome Project, a multidisciplinary research effort to sequence all of the genes, or genomes, of 600 representative microorganisms sampled from microbial communities in the mouth, skin, digestive tract, and other parts of the body. A related NIDCR-supported collaborative project will decode the genes expressed by all the microbes that inhabit the mouth, information that will be analyzed for the earliest signs of developing oral disease.

In 2008, NIDCR supported scientists completed the first full catalogue of the multitude of proteins present in saliva. This 1,166–protein dictionary will serve as an essential reference point as scientists continue to validate saliva as a diagnostic fluid. The Oral and Craniofacial Biology Program also encourages studies that examine the interplay of nature and nurture. How do extrinsic factors, such as environment, diet, nutrition, and lifestyle, affect healthy oral tissues and cause disease? These integrative research approaches will generate unexpected leads into basic oral and craniofacial biology that may have otherwise remained elusive. The information will greatly solidify the scientific foundation that supports research in these areas, while also accelerating new discoveries to improve their prevention, diagnosis and potentially treatment.

Budget Policy: The FY 2010 budget estimate is $204.123 million, an increase of $2.555 million, or 1.3 percent over the FY 2009 estimate. High priority will be given to support ongoing program activities and meritorious new investigator-initiated research grants, and research training related to the institute’s mission areas. These include investments into the prevention, detection, diagnosis and treatment of craniofacial, oral and dental diseases and disorders, such as, head and neck cancer, orofacial pain disorders, craniofacial malformations, periodontitis, caries and Sjögren’s syndrome.

In the FY 2010 budget, NIDCR will continue to support current initiatives such as the ones described below and advance oral health research with new scientific discoveries:

• Harnessing Inflammation for Reconstruction of Oral and Craniofacial Tissues:
  Reconstructing oral and craniofacial tissues that are damaged by disease, injury, or birth defects is dependent on regenerating functional tissues. The goal of this research is to regenerate and rebuild damaged oral and craniofacial tissues with minimal fibrosis and scarring. Given that acute inflammation is a normal part of healing but unresolved chronic inflammation leads to tissue destruction, fibrosis, and scarring, new approaches to control the tissue microenvironment are required to overcome chronic inflammation and allow tissue regeneration.
• Metagenomic Evaluation of Oral Polymicrobal Disease: Drawing from the NIH Roadmap Initiative’s Human Microbiome Project, this initiative will investigate the role of microbial consortia in disease initiation and progression, and in the maintenance of oral health. This initiative builds upon previous research that revealed how single bacterial species interacted with the host by addressing the actual complexity of human oral diseases, and NIDCR now seeks to determine the molecular and metabolic interactions between multiple species and their host. Researchers will work to identify metagenomic information in the oral cavity and compare disease and non-disease states.

Clinical Research

Modern dentistry benefits from a wealth of powerful new technologies, better materials, and refinement of its standard techniques. But the profession still must continue to increase the level of high-quality clinical research data that is available to everyday practitioners to guide their treatment choices and interactions with patients of different cultures and socio-economic backgrounds. The NIDCR continues its efforts to catalyze the profession’s transition to a greater emphasis on evidence-based care. For example, the Institute supports a comprehensive study to understand the earliest manifestations of acute temporomandibular joint and muscle disorders (TMJD). In addition to identifying individuals most at risk, the study also examines which early interventions are most likely to prevent progression to a chronic state of pain and dysfunction.

In 2005, NIDCR began supporting three regional dental practice-based research networks, or PBRNs. By the end of September 2008, the three networks had trained about 300 dentists to become practitioner-investigators who are conducting well-designed clinical studies from their offices that address everyday issues in the delivery of oral health care. To date patients have participated in at least sixteen studies, and these findings improved clinical decision-making among the members in the treatment of early caries, treatment for post-operative sensitivity, use of dental materials, and patient education. These networks are currently participating in multiple clinical trials, and continue to enroll and train new members, accrue patients to existing studies, analyze and disseminate data, and begin new studies. The ultimate goal is to address real-world clinical issues and improve the capacity to generate information that will be of practical value to practitioners and patients alike.

Budget Policy: The FY 2010 budget estimate is $81.580 million, an increase of $1.021 million, or 1.3 percent over the FY 2009 estimate. The program plans for FY 2010 highlight continued support for the programs described below, as well as meritorious new investigator-initiated research grants, and research training related to its mission.

• Developing Complex Models of Oral Health and Behavior: This initiative will support research focusing on complex models of oral health and behavior, with the long-term goal of using these models to identify potential targets for more efficient interventions to help more people achieve and maintain good oral health. Current models, while helpful, lay out a rational, linear, unidirectional set of causes and effects that fail to capture adequately the complexity of the decision-making process for most Americans. A critical first step for this initiative will involve identifying new ways to conceptualize the numerous behavioral and social contributors to oral health.
• Interventions to Address Oral Health Disparities: The oral health of a society is strongly influenced by the social and behavioral aspects of its many subgroups and cultures. However, these baseline variables--coupled with the genetic, biological, environmental and societal interactions that influence them--are challenging to define and measure, making the design of targeted interventions difficult. Research on oral health disparities encourages efforts to explore and define these biological, social, psychological, and behavioral parameters and to propose and develop interventions. It will also encourage research on childhood behavioral and psychosocial parameters that will lead to the development and motivation of favorable nutritional, preventive, health literacy, and self-care habits. Special attention would be given to disparities in these parameters as a result of race/ethnicity, cultural and community characteristics, socioeconomic status, and other factors that lead to increased risk for suboptimal oral health.
• Extending the Service Life of Dental Resin and Composite Restorations: This initiative will address the clinical success of dental resin composite materials, with the goal of increasing the longevity of dental resin composites while learning more about the factors that decrease their durability and thus lifespan. Specifically, researchers will evaluate whether the degradation is physical, environmental, and/or attributable to the composition of dental resin composites interacting with the microbial biofilm in the oral cavity, which then facilitates secondary tooth decay.

Translational Genetics and Genomics

The head and face are masterpieces of human development. But why does each tissue, bone, and structure, from a salivary gland to a cranial bone, form in exactly the right place? And how does each structure orchestrate its three-dimensional growth and then integrate into the single composite structure that is the human head? Although these and related questions have long been out of scientific reach, primarily for technical reasons, that has begun to change now that powerful analytical tools are available to scientists for gathering vast amounts of biological data. This program places a strong emphasis on integrative research, comparative studies across species, and the emerging area of genome-wide association studies, or “GWAS”, to gather novel investigative leads into the genetics of craniofacial development and of craniofacial disorders that arise during childhood and in adults. The program aims to translate the most promising findings into clinical studies, and improved preventive measures, diagnostic tests, prenatal care, and ultimately treatments to benefit the millions of Americans with craniofacial malformations.

For example, the GWAS studies have already have led to a number of exciting preliminary findings, such as possible developmental links between cleft lip and/or palate (roof of the mouth) and a range of dental malformations. An NIDCR-supported investigator has raised the possibility that the half-century-old medical observation that some families are prone to cleft palate without cleft lip may be incorrect. Extremely subtle breaks in a lip muscle also occur in many of these families, raising the need for more accurate genetic characterizations of this common birth defect and its developmental origins.

Budget Policy: The FY 2010 budget estimate is $36.775 million, an increase of $460 thousand, or 1.3 percent over the FY 2009 estimate. Priority will be given to support highly meritorious new research projects and ongoing initiatives, such as the FaceBase project.

• The FaceBase Project - Functional Genomics of Development and Disease: Researchers investigating the cause and treatment of craniofacial malformations, which are associated with more than half of all birth defects, now possess new powerful scientific tools which allow them to tackle the next scientific frontier: mapping the molecular basis of human craniofacial development and disease. A central component of this initiative is the establishment of FaceBase, a publicly available database and informatics platform that will serve as a resource to promote enhanced understanding of the genetic and environmental influences that drive craniofacial development. These efforts will likely yield new opportunities for preventing and treating craniofacial defects, and are expected to stimulate: 1) high-throughput, genome-wide research strategies; 2) mapping and modeling of protein networks and pathways of interaction that regulate facial construction; 3) development of markers to track normal and abnormal developmental processes; and 4) development of 4D structural and molecular atlases of craniofacial growth, which will ultimately allow computational modeling of cell and tissue maturation across stages of development.

Intramural Research

The Division of Intramural Research conducts highly innovative research that addresses the great breadth of oral and craniofacial health. Focus areas include investigations into the biochemistry, development and function of teeth, bone, salivary glands, and surrounding connective tissues; immunology of the oral mucosa; the role of bacteria and viruses in oral disease; genetic disorders and tumors of the oral cavity; the cause and treatment of acute and chronic pain; and the development of improved methods to diagnose disease.

Institute scientists continue to translate their basic research findings into early, or Phase I, clinical trials of novel treatments that evaluate their safety in people. Among the first-round clinical studies now under development include a targeted – and potentially more efficient – therapy for oral cancer, prompting adult stem cells to fill in gaping wounds with new bone, and a unique compound that can selectively delete specific nerve cells from the nervous system that convey severe chronic pain. An intramural research team, in collaboration with their colleagues at NIH’s National Cancer Institute, has developed methods to recover proteins from a type of standard, archived clinical tumor samples. This innovative method helps to make accessible vast archives of tumor tissues, with accompanying case histories, for molecular analyses and may expedite the needed identification of protein markers as therapeutic targets for cancer.

Another group has identified a slight variation in a gene that is associated with primary Sjögren’s syndrome, an autoimmune disorder and common cause of dry mouth. Interestingly, this variant is associated with other autoimmune diseases, supporting the hypothesis that related autoimmune diseases share common gene variants. Other NIDCR scientists recently identified the mutations in a gene that cause two inherited disorders of dentin, the substance found below the enamel that comprises the bulk of a tooth. These disorders, known as Dentinogenesis Imperfecta (DGI) and Dentin Dysplasia (DD), can be functionally and cosmetically severe. The costs of treatment for a single DGI patient could easily exceed $30,000. The dominant nature of these genetic mutations means that about half of the children in a family that carries the mutation are seriously affected. The scientists have cracked the gene’s complex DNA code and, through multidisciplinary collaboration with their NIDCR and NIH colleagues, have begun to make sense of these poorly understood disorders. This work stands out as a clear example of the multidisciplinary strengths of NIH intramural research and its translational value to benefit public health.

Budget Policy: The FY 2010 budget estimate is $61.835 million, an increase of $940 thousand, or 1.5 percent over the FY 2009 estimate to help offset the cost of pay and other increases. Funds will allow continued support for ongoing research and modest expansion of new effort.

• Building an Artificial Salivary Gland - Substantial new effort will focus on remediation of loss of salivary function (dry mouth), which is a major cause of morbidity in individuals, predominantly female, suffering from Sjögren’s Syndrome (SS) as well as for head and neck cancer patients who have undergone radiation therapy. They will use tissue engineering approaches to construct an autonomous artificial salivary gland and to develop methods to seed damaged glands with stem cell populations that can recapitulate the embryonic salivary gland developmental program. These efforts will build on a broad and integrated research program involving many laboratories in the Division over the last few years to develop animal models of SS, to characterize salivary gland development and the program of gene expression that controls it and the physiology of saliva secretion.

Research Management and Support

This budget category supports the scientific and administrative management structures needed to effectively lead and manage the world’s largest oral health research enterprise. The Institute’s extramural staff scientists and grant specialists maintain liaison with nearly 800 grantees, and provide stewardship for the Institute’s investment in research and research training grants. The NIDCR participates in the support of the Interdisciplinary Research Consortia funded through the NIH Common Fund. Additionally, NIDCR conducts formal evaluations of its intramural and extramural research programs. These evaluations are designed to inform leadership and advisory bodies on scientific progress and new research directions in the quest to strengthen our Nation’s health.

This budget category also supports the Institute’s health communication activities. The NIDCR Office of Communications and Health Education produces and disseminates informational materials on a wide variety of topics, ranging from children’s oral health, oral cancer, and periodontal disease to oral health care for people with disabilities. Some materials are geared toward patients or the general public; others are targeted to health care professionals, teachers, or caregivers for special needs patients. The Office also disseminates information about significant research advances to the media, patient support organizations, professional organizations and the research community.

Budget Policy: The FY 2010 budget estimate is $23.724 million, an increase of $409 thousand, or 1.75 percent over the FY 2009 estimate to help offset the cost of pay and other increases. The NIDCR will use these resources to fund the scientific and administrative management and oversight activities of the Institute.

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

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1/ Reflects enacted supplementals, rescissions, and reappropriations.
2/ Excludes funds for HIV/AIDS research activities consolidated in the NIH Office of AIDS Research.

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