FY 2011 Congressional Justification

FY 2011 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 [$413,236,000] $423,511,000 (Public Law 111-117, Consolidated Appropriations Act, 2010,)

^1/Excludes the following amounts for reimbursable activities carried out by this account: FY 2009 - $2,031,000; FY 2010 - $2,500,000; FY 2011 - $2,500,000. Excludes $486,356 in FY 2009; and $400,000 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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Major Changes in the Fiscal Year 2011 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 2011 budget request for NIDCR, which is $10.435 million more than the FY 2010 Estimate, for a total of $423.511 million.

Research Project Grants (RPGs; +$3.267 million; total $256.143 million): NIDCR will fund a projected 154 awards in FY 2011, approximately the same number as in FY 2010. About 450 noncompeting RPG awards, totaling $193.960 million also will be made in FY 2011.

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Fiscal Year 2011 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) 2011 activities of the National Institute of Dental and Craniofacial Research (NIDCR), including HIV/AIDS activities. Details of the FY 2011 HIV/AIDS activities are in the “Office of AIDS Research (OAR)” Section of the Overview. Details on the Common Fund are located in the Overview, Volume One. Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

Director’s Overview

The great American inventor Thomas Edison once said, “The value of an idea lies in the using of it.” Today, as scientists generate new knowledge at a pace and scale that Edison could have never imagined, his wisdom carries a special urgency. How can researchers ensure the translation of new ideas into new treatments that bring value to human health and well-being? The National Institute of Dental and Craniofacial Research (NIDCR) is investing in the development of new knowledge and the translation of these ideas into practice to improve the dental, oral, and craniofacial health of Americans.

NIDCR plays a leading role in building the needed broad knowledge base that feeds the translational pipeline. Head and neck cancer is the 6th most common cancer among men worldwide, and up to 80 percent of these cancers occur in developing countries in Asia, South America, and Africa. NIDCR scientists and their colleagues organized the Head and Neck Cancer International Tissue Array Initiative, involving research centers in eight countries. Each center contributed patient tumor samples, creating a community hub and resource to enable global studies of head and neck cancer. In a complementary effort, researchers at NIDCR recently embarked on an effort to catalog the diversity of the micro-RNAs – small RNA molecules that regulate genes involved in the initiation, progression and metastases of human cancers – expressed in head and neck cancer lesions worldwide. This may provide new opportunities for head and neck cancer diagnosis and treatment targeted for each geographical region based on their cancer micro-RNAome. Additionally, the NIDCR recently launched the Oral Cancer Genome Project (OCGP) to develop a comprehensive catalog of the genetic changes that occur in oral and pharyngeal cancers, a subset of head and neck cancer that collectively kill more than 7,500 Americans each year.

NIDCR is also working to understand the genetic contributions to Sjögren’s syndrome, an autoimmune disease that progressively destroys salivary and lachrymal (tear) glands and confers an increased risk for lymphoma and other disorders. Building on prior investments that established patient registries, NIDCR launched a multi-stage case-control genome-wide association study of Sjögren’s syndrome in 2009. The institute also recently issued the first 11 research and technology grants of its new FaceBase Consortium. The five-year initiative will create a publicly available, all-inclusive database that details the genetic basis of craniofacial construction and the development of craniofacial diseases and disorders, such as cleft lip and palate. Major efforts, such as FaceBase and OCGP, as well as the expanding role of genome-wide association studies in the NIDCR portfolio, show the tremendous potential that now exists to define the molecular dynamics of these conditions and make real progress in preventing them in future generations.

Several of NIDCR’s research investments are already beginning to translate into clinical leads that one day could benefit the current generation of Americans. As highlighted in the attached research portrait, a novel treatment using a natural substance called resiniferatoxin, or RTX, offers the ability to control a pain-sensing neuronal pathway, potentially eliminating severe chronic pain. NIDCR also is supporting the translational effort to develop lab-on-a-chip devices. These are miniaturized, fully automated, all-in-one tests that potentially can be customized to diagnose most diseases, from head-and-neck cancer to cardiovascular disease. Such quick, point-of-care diagnoses would provide immediate results to patients and prompt advice from their providers.

The final stage of translational research involves bringing research results into the clinic and the community in the most effective ways. The Nation’s oral health has improved greatly over the years - but not for all Americans. Chronic dental and oral conditions remain among the most common health problems that afflict disadvantaged and underserved communities. The NIDCR Health Disparities Research Program supports a full spectrum of research studies that identify practical, sustainable approaches so that more disadvantaged Americans may experience good oral health. The recent functional integration of three separate Health Disparities Centers in California, Colorado, and Massachusetts, is building a nationwide network to research disparities in Early Childhood Caries in different populations and developing innovative strategies to address the needs of underserved groups. The enhanced communication, efficiency, and comparability of research results resulting from this collaborative effort have made it a model for coordinating health-based research groups.

The success of translational research requires cross-fertilization among basic, translational, and clinical researchers as well as practitioners and trainees from all relevant established and emerging disciplines. NIDCR’s three regional dental practice-based research networks, or PBRNs, provide a new mechanism for general practitioners to participate in clinical studies, training nearly 700 practitioner-investigators to date and connecting them to an academic hub. So far, over 30,000 patients have participated in sixteen studies, including a valuable study to determine risk factors for developing bisphosphonate-associated osteonecrosis of the jaw. In the next three years, the PBRNs will focus on completing 30 additional clinical studies and disseminating results to dental practitioners and patients.

Following a comprehensive evaluation of the extramural training program, NIDCR is moving to adopt a new program that encourages the training of multidisciplinary teams. NIDCR will also shift resources to provide a greater emphasis on individual fellowships and career awards, which the evaluation showed to be more effective in developing independent researchers. To further respond to the critical need to increase the cadre of scientists engaging in oral, dental and craniofacial research, NIDCR is investing in an expanded career transition award, specifically supporting dual degree dentist-scientists, allowing them time for specialty training and focused research.

As these examples illustrate, NIDCR-supported researchers are continually generating new information and using more powerful research tools to fill in the major puzzle pieces of dental, oral, and craniofacial development and disease. With an increasing knowledge base, the NIDCR looks to the future with confidence that the prospect for translating these novel ideas into effective treatments for people has never been better.

Overall Budget Policy: In FY2011, NIDCR will support new investigators on R01 equivalent awards at success rates equivalent to those of established investigators submitting new R01 equivalent applications. NIDCR will continue 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. Funds are included in R&D contracts to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program (TRND), the Basic Behavioral and Social Sciences Opportunity Network (OppNet), as well as increased support for other HHS agencies through the program evaluation set-aside.

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2011 JUSTIFICATION BY ACTIVITY DETAIL

Program Descriptions and Accomplishments

Extramural Research

Oral and Craniofacial Biology

This program supports research to discover how the various cell types, tissues and organ systems form and maintain the function of the human face, mouth and head. Areas of research focus include: oral microbiology and infectious diseases, oral immunology, oral complications of immunosuppression, oral cancer, chronic pain and the development, function and pathophysiology of bones, teeth, temporomandibular joint and salivary glands. The program also supports research on novel bioengineering approaches and development of new biomaterials that will enhance craniofacial tissue repair, reconstruction and regeneration following damage by diseases, birth defects, trauma and injuries. Of potentially great public health importance is the program’s ongoing efforts to:

• Define the transition from acute to chronic pain as a part of the trans-NIH Blueprint for Neuroscience Research.
• Play a leading role in building a future of saliva-based, point-of-care, diagnostic tests. This included creating miniaturized “lab-on-a-chip” technologies as the diagnostic platform and working out the biology to detect molecules in saliva that are indicative of developing diseases.
• Gain a comprehensive understanding of the role played by the oral microbiome, the complex microbial community of the mouth, in health and disease. Every person hosts a unique set of hundreds of microbes, and because microbes colonize sites throughout the body, the lessons learned in the readily accessible oral cavity will have application not only in learning to better prevent oral diseases but chronic conditions throughout the body. As a part of the trans-NIH Roadmap’s Human Microbiome Project, the NIDCR has launched an initiative titled “Metagenomic Evaluation of Oral Polymicrobial Disease” that will examine the relationship between specific microbiomes and specific disease states. The objective is to demonstrate how these differences in microbial populations might be utilized for guiding treatment options or predicting clinical outcomes.
• Launch the Oral Cancer Genome Project (OCGP) to develop a comprehensive catalog of the many genomic changes that occur in oral and pharyngeal cancers. The NIDCR anticipates that the “blueprint” of the genomic alterations in oral cancer will be achieved within two years. Discovery and analysis of these validated targets could lead to new tests to help clinicians detect cancer earlier, new targets for therapeutic development, new treatments tailored to each patient’s cancer type, and, ultimately, new strategies for preventing cancer.

Budget Policy: The FY 2011 budget request for this program is $220.485 million, an increase of $5.024 million, or 2.33 percent over the FY 2010 Enacted Level. Priority will be given to support highly meritorious new research projects and ongoing initiatives.

Clinical Research

High-quality clinical, behavioral, and social sciences research are essential to ascertain the natural history, risk factors and best treatments of oral and craniofacial diseases. NIDCR continues its efforts to catalyze the profession’s transition to one that delivers care based on robust evidence by supporting multi-center Phase III clinical trials. The NIDCR also supports research to better understand the social and behavioral influences on oral health and management of craniofacial conditions. To maintain the highest quality of intervention research, the program encourages the identification of the mechanisms of action of behavioral and social interventions, and the testing and monitoring of intervention fidelity. Some highlights of this program include:

• In FY 2009, NIDCR functionally integrated three separate Health Disparity Centers at the University of California, San Francisco, the University of Colorado, Denver, and Boston University that are working on ways to prevent a debilitating and very expensive condition to treat - early childhood caries (ECC). Through better coordination of the research studies, maximum comparability and validity will be ensured. These Centers encompass a wide variety of study sites (e.g. community health centers, participants' homes, educational and social service agency settings), and American Indian, Hispanic, and African-American populations are participating, as well as other underserved groups of young children and their families. Many of these studies apply Motivational Interviewing as a means of improving patient compliance and community oral health promotion activities within their ongoing efforts targeting caregivers with children from birth to five years old, aimed at caries risk reduction and lowering incidence of ECC.
• Two new Phase III clinical trial studies were recently launched. One study will compare two time points (six months versus 12 months) for surgical closure of a cleft palate, or roof of the mouth, to determine if palate closure at six months will improve the child’s speech and reduce the need for additional surgeries. The second study is designed to answer questions about periodontal disease, a common complication of diabetes. Previous small-scale studies suggest that treating the chronic periodontal disease of persons with Type II diabetes helps them control their blood sugar levels. These preliminary findings are being tested in a large, multi-center trial.
• Other on-going Phase III clinical trials supported by NIDCR are testing ways to prevent dental decay among adults. Adult tooth decay afflicts the majority of Americans ages 55 and older and is the most common chronic disease at midlife.

Budget Policy: The FY 2011 budget request for this program is $63.868 million, an increase of $1.455 million, or 2.33 percent over the FY 2010 Enacted Level. Priority will be given to support highly meritorious new research projects and ongoing initiatives.

• Developing Effective Behavioral Interventions that Meet the Needs of Diverse Populations: In oral health, as is the case throughout medicine, one intervention clearly does not fit all. This initiative encourages novel and much-needed research to develop behavioral and social interventions that address a range of oral and/or craniofacial health needs. The main aims of this initiative are to ensure that the behavioral and social intervention research supported by the NIDCR is relevant to the communities we serve, and draws from and contributes to an already sizeable body of knowledge about behavior change, without starting from scratch for each target population. Another focus is to encourage cross-talk between fields, or even within fields, which can speed the improvement of oral, and craniofacial health. With improved cross talk, it will be possible to develop new interventions - including surveys, focus groups, draft intervention manuals, assessment measures, etc. – and more rapidly and efficiently adapt them to new target populations, as needed.
• Collaborative Research on the Transition from Acute to Chronic Pain: New Models and Measures in Clinical and Pre-clinical Chronic Pain Research: As a 8K marathon or even a day bending in the garden so often reminds us, pain affects everyone differently. But studying pain, especially orofacial pain, can be problematic for very fundamental reasons. Existing animal models of temporomandibular joint and muscle disorders (TMJD) and other orofacial pain conditions inadequately reflect the human pain state. Indeed, current measures of pain in animals are mainly focused on evoked acute pain responses and do not correspond to the spontaneous, ongoing, or recurrent pain found in many chronic pain conditions. New animal models that could be used to study the transition from acute to chronic pain in temporomandibular joint and muscle disorders or orofacial pain disorders, coupled with the development of new functional and behavioral assays of acute and chronic pain could provide powerful new tools to the research community. This initiative provides the means to enhance our understanding of the biological underpinnings of chronic pain conditions and the responses of patients to therapeutic interventions.

Translational Genetics and Genomics

The head and face are among the body’s most developmentally complex structures. 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. Along these lines, NIDCR recently launched a bold bioinformatics initiative to provide the first comprehensive compilation of the biological instructions required to construct the middle region of the human face (including the nose, upper lip, and the palate) and precisely define the genetics underlying its common developmental disorders, such as cleft lip and palate. Termed “FaceBase”, this publicly accessible database will allow scientists to more rapidly and effectively generate hypotheses and accelerate the pace of their research. Its organizers anticipate that FaceBase will have a prototype ready within the next year and a fully functioning database soon after.

Budget Policy: The FY 2011 budget request for this program is $49.543 million, an increase of $1.191 million, or 2.5 percent over the FY 2010 Enacted Level. Priority will be given to support highly meritorious new research projects and ongoing initiatives.

• Building a Genetic and Genomic Knowledge Based in Dental and Craniofacial Conditions and Diseases: Through relatively low-cost DNA genotyping technology, genome-wide association studies (GWAS) can produce rapid genome scans of large groups of people to help identify genes that affect risk of developing a specific disease. While GWAS and their follow-up studies have yielded unexpected and often exciting insights into the genetic component of many common diseases, the approach has not been widely adopted to study oral diseases, such as temporomandibular joint and muscle disorders (TMJD), oral cancer, Sjögren’s syndrome, and periodontal disease. This initiative hopes to change that. It encourages GWAS, their follow-up studies, and other genetic studies on oral diseases that (a) identify variations in the genome that may affect disease risk and (b) characterize and understand the effects of these genetic variants and their influence on disease risk.

Intramural Research

The Division of Intramural Research (DIR) performs highly innovative research that covers nearly all aspects of oral and craniofacial health. Areas of strong research focus include the biochemistry, development, and function of teeth, bone, salivary glands, and surrounding connective tissues; immunology of the mucosal system; 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. Examples of projects in these areas include:

• NIDCR scientists continued a multi-faceted approach to understand the basic biology of head and neck cancer and then translate these discoveries for further clinical study. Investigators developed a mouse model that reproducibly (100%) develops oral cancer of the tongue in response to a chemical surrogate for tobacco exposure. Using this model, they showed that the immunosuppressive drug rapamycin both causes the cancer to regress, and can prevent cancer formation when administered before the tobacco surrogate. The investigators anticipate initiating a Phase I trial of rapamycin in patients with oral cancer in 2010.
• DIR investigators demonstrated in an animal model that bone marrow stromal cells ease sepsis, a serious medical condition that affects 18 million people worldwide each year. This and other emerging studies point to potential use of BMSCs as modulators of the immune system.
• NIDCR investigators and their NIH colleagues have enrolled patients in a Phase I clinical trial using a single injection of the drug resiniferatoxin (RTX) into the spinal canal to alleviate intractable pain in patients with terminal cancer.
• NIDCR scientists developed a novel laser-based method for creating patterns of extracellular matrix molecules. This method, which uses equipment readily available in many biomedical science laboratories, will allow scientists to study the extracellular cues and cellular mechanisms for cell migration, which is an essential feature of embryonic development and in invasion during metastasis of cancers.

Budget Policy: The FY 2011 budget request for this program is $64.575 million, an increase of $1.575 million, or 2.5 percent over the FY 2010 Enacted Level to help offset the cost of pay and other increases. Funds will allow continued support for ongoing research and modest expansion of new effort.

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 to inform leadership and advisory bodies on scientific progress and new research directions. This budget category also supports the Institute’s Office of Communications and Health Education, which 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 2011 budget request for this program is $25.040 million, an increase of $1.190 million, or 5.0 percent over the FY 2010 Enacted Level 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.