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DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTHNational Institute of Dental and Craniofacial ResearchFY 2009 BudgetPage No.Organization chart.2Appropriation language.3Amounts available for obligation.4Budget mechanism table.5Budget authority by program.6Major Changes in Budget Request.7Summary of changes.8Budget Graphs .10Justification narrative.11Budget authority by object.22Salaries and expenses.23Authorizing legislation.24Appropriations history.25Detail of full-time equivalent employment (FTE). 26Detail of positions.27NIDCR-1

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NATIONAL INSTITUTES OF HEALTHNational Institute of Dental and Craniofacial ResearchFor carrying out section 301 and title IV of the Public Health Services Act with respect todental and craniofacial diseases 396,632,000 390,535,000 (Department of Healthand Human Services Appropriation Act, 2008)NIDCR-3

National Institutes of HealthNational Institute of Dental and Craniofacial ResearchAmounts Available for Obligation 1/FY 2007FY 2008ActualEnacted 389,703,000 396,632,000000-6,929,000Source of FundingAppropriationPay cost add-onRescissionSubtotal, adjusted appropriationFY 2009Estimate ,00000Comparative transfer to NIBIB-33,00000Comparative transfer to OD-15,00000-284,00000-1,00000Comparative transfer to NIDCR437,000455,0000Comparative transfer under Director's one percent transfer authority 00000389,801,000390,158,000390,535,000Real transfer under Director's one-percenttransfer authority (GEI)Comparative transfer to NCRRComparative transfers to the Office of theAssistant Secretary for Admin. and Mgmt. and tothe Office of the Assistant Secretary for PublicAffairsSubtotal, adjusted budget authorityUnobligated balance lapsingTotal obligations1/ Excludes the following amounts for reimbursable activities carried out by this account:FY 2007 - 992,000 FY 2008 - 1,400,000 FY 2009 - 1,100,000Excludes 1,384,000 in FY 2008 and 1,384,000 in FY 2009 for royalties.NIDCR-4

NATIONAL INSTITUTES OF HEALTHNational Institute of Dental and Craniofacial Research(Dollars in Thousands)Budget Mechanism - TotalFY 2007FY 2008FY ntMECHANISMResearch Grants:Research Projects:NoncompetingAdministrative , competingSubtotal, RPGsSBIR/STTRSubtotal, RPGsResearch Centers:Specialized/comprehensiveClinical researchBiotechnologyComparative medicineResearch Centers in Minority InstitutionsSubtotal, CentersOther Research:Research careersCancer educationCooperative clinical researchBiomedical research supportMinority biomedical research supportOtherSubtotal, Other ResearchTotal Research GrantsResearch Training:Individual awardsInstitutional awardsTotal, TrainingResearch & development contracts(SBIR/STTR)Intramural researchResearch management and supportTotal, NIDCRChangeNo. Amount0(13)- 4,7163,000433 169,040(26)6,003468 180,619(3)600468 8Includes FTEs which are reimbursed from the NIH Roadmap for Medical 5FTEs1121756432820-8969-887915349377

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Major Changes in the FY 2009 Budget RequestMajor changes by budget mechanism and/or budget activity detail are briefly describedbelow. Note that there may be overlap between budget mechanism and activity detailand these highlights will not sum to the total change for the FY 2009 budget request forNIDCR, which is 0.4 million more than the FY 2008 estimate, for a total of 390.5million.Research Project Grants: The NIH Budget policy for RPGs in FY 2009 is to provide noinflationary increases in noncompeting awards and no increase in average cost forcompeting RPGs.Specialized Centers for Oral, Dental, and Craniofacial Research (- 3.5 million; total 0million): Within the Research Centers budget mechanism, the NIDCR supports twospecialized research centers categorized within the integrative biology research subactivity. This centers program will have completed its funding cycle.Research and Development Contracts ( 3.5 million; total 24.7 million): Funding forresearch contracts will be increased to bolster support for several research areas,including support for clinical trials oversight and management activities, and for genomewide association studies (integrative biology).NIDCR-7

NATIONAL INSTITUTES OF HEALTHNational Institute of Dental and Craniofacial ResearchSummary of ChangesFY 2008 EnactedFY 2009 estimated budget authority 390,158,000390,535,000377,000Net changeFY 2008Enacted BaseBudgetFTEsAuthorityCHANGESA. Built-in:1. Intramural research:a. Annualization of January2008 pay increaseb. January FY 2009 pay increasec. One less day of payd. Payment for centrally furnished servicese. Increased cost of laboratory supplies,materials, and other expensesChange from BaseBudgetFTEsAuthority 22,823,00022,823,00022,823,00010,437,000 otal1,336,0002. Research management and support:a. Annualization of January2008 pay increaseb. January FY 2009 pay increasec. One less day of payd. Payment for centrally furnished servicese. Increased cost of laboratory supplies,materials, and other expensesSubtotalSubtotal, Built-in 10,17910,17910,1793,751,000 01,868,000NIDCR-8

NATIONAL INSTITUTES OF HEALTHNational Institute of Dental and Craniofacial ResearchSummary of Changes--continuedCHANGESB. Program:1. Research project grants:a. Noncompetingb. Competingc. SBIR/STTRTotalFY 2008Enacted BaseNo.Amount46816730665 181,219,00051,199,0008,520,000240,938,00083. Other research4. Research trainingChange from BaseNo.Amount0303( 2. Research centers5. Research and development contracts(887,000)Subtotal, extramuralFTEs6. Intramural 83,000)7. Research management and supportSubtotal, programTotal 77,000

Fiscal Year 2009 Budget GraphsHistory of Budget Authority and FTEs:Funding Levels by Fiscal Year391.8388.7 389.8270390.5390.2266260 390FTEs(Dollars inMillions) 400FTEs by Fiscal Year 380245250240240242240 370230 3602005200520062007200820062009Fiscal YearDistribution by Mechanism:FY 2009 Budget Mechanism(Dollars in thousands)Research Centers 14,0504%Other Research 12,2983%Research ProjectGrants 240,05162%Research Training 15,9344%R&D Contracts 24,6526%IntramuralResearch 60,40015%RM&S 23,1506%Change by Selected Mechanisms:FY 2009 EstimatePercent Change from FY 2008 MechanismResearch Project GrantsResearch CentersOther ResearchResearch TrainingR&D ContractsIntramural ResearchRes. Mgmt. & 09

Justification of Budget RequestAuthorizing Legislation:Section 301 and title IV of the Public Health Service Act, asamended.Budget Authority:FTE240FY 2007ActualBA 389,807,000FY 2008FY 2009EnactedEstimateFTEBAFTEBA240 390,158,000 242 390,535,000Increase orDecreaseFTEBA2 377,000This document provides justification for the Fiscal Year (FY) 2009 activities of theNational Institute of Dental and Craniofacial Research (NIDCR), including NIH/AIDSactivities. Details of the FY 2009 HIV/AIDS activities are in the “Office of AIDSResearch (OAR)” Section of the Overview. Details on the Common Fund are located inthe Overview, Volume One. Program funds are allocated as follows: CompetitiveGrants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.Director’s OverviewThe National Institute of Dental and Craniofacial Research (NIDCR) is the lead agencyin the nation’s ongoing efforts to improve oral, dental, and craniofacial health. TheNIDCR pursues its mission through research, research training, and the disseminationof health information to the public and practitioners.Established in 1948, NIDCR has long supported the research of individual scientiststhrough its multi-faceted research programs. The Institute’s research has traditionallycut across diverse fields of scientific disciplines in order to address the numerouscomplex diseases and conditions that fall under its mission. As more powerful newtechnologies and sophisticated biomedical research tools become available, NIDCR’sresearch is evolving to include large-scale projects that meld the investigative strengthsof two or more often unrelated scientific disciplines. These collaborative projects havethe potential to generate novel strategies that more readily work through old problemsand transform areas of research in unexpected ways.NIDCR recently has expanded its clinical research portfolio and engaged in several “bigscience” projects. These large-scale projects attempt to assemble a more detailedsnapshot of the biological topography of a given tissue or disease process. With thismore comprehensive view of the biological landscape, scientists can search moresystematically for new diagnostic and therapeutic leads and move them more rapidlyinto clinical testing. A good example is a consortium of scientists that recentlyNIDCR-11

completed a parts list of the proteins that are at work in the salivary glands. This firstever catalogue, like a Webster’s dictionary to a writer, provides an essential resource todesign future saliva-based tests for human diseases.Another exciting example is in the area of craniofacial development. As noted below inthis year’s budget request, NIDCR is launching an initiative that brings together variousresearch disciplines to explore the developmental programming that creates thestructures of the human face and head. This initiative represents an unprecedentedopportunity for the institute’s traditional research communities. Scientists now canbegin to unravel more systematically how nature assembles the myriad parts of thehead and face, from tooth to jawbone to cranial vault. This initiative will help to definethe genetic programs of the various craniofacial structures and will provide the firstworking blueprints to build three-dimensional replacement tissues or more naturallyrepair a damaged tooth or cleft palate.The NIDCR continues to set the scientific bar high. The diverse array of tools in theresearch toolbox has never been better, and the opportunities have never been moreprofound in their potential impact. As highlighted in the following pages, the discoveriesthat are being seeded and harvested will have a transforming effect now and in theyears to come on the nation’s public health.NIDCR-12

2009 JUSTIFICATION BY ACTIVITY DETAILProgram Descriptions and AccomplishmentsExtramural ResearchIntegrative BiologyThis program integrates scientists from diverse professional backgrounds to solveseemingly intractable research problems by generating more creative hypotheses andpotential solutions than could be envisioned by a single discipline working alone. Anexample of integrative biology is the emergence of genome-wide association studies, orGWAS, which meld the investigative power of genetics, computer science,mathematics, and other research disciplines to scan the breadth of human DNA forinherited “misspellings” in the genetic code that are linked to a given disease.The NIDCR recently began support of GWAS studies that focus on tooth decay andorofacial clefts. Still a major public health problem among certain communities in thiscountry, tooth decay is the most prevalent of all dental diseases. Cleft lip and/or cleftpalate is one of the most common of all birth defects.1,2 The expectation is this powerfuland proven research approach will generate unexpected new leads into the basicbiology of these conditions that may have otherwise remained elusive. This informationwill greatly solidify the scientific foundation that supports research in these fields, whilealso accelerating new discoveries to improve their diagnosis and potentially theirtreatment.Budget Policy: The FY 2009 estimate for the Integrative Biology program area is 185.5 million, a decrease of 0.5 million, or 0.3 percent from the FY 2008 estimate.The program plans for FY 2009, along with expected outputs, follow. High priority will begiven to support ongoing programs, such as the ones described above, meritorious newinvestigator-initiated research grants, and research training related to the institute’smission areas. These include investments into the prevention, detection, diagnosis andtreatment of craniofacial, oral and dental diseases and disorders, such as periodontitis,caries, head and neck cancer, craniofacial birth defects, orofacial pain disorders andxerostomia. In FY 2009, this program will launch two new initiatives. The FaceBase Project: More than half of all birth defects are associated with someform of craniofacial malformation. Although scientists have had success identifyingindividual genes and mutations that contribute to an oral cleft or a tooth1U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. “Surveillance forDental Caries, Dental Sealants, Tooth Retention, Edentulism, and Enamel Fluorosis—United States, 1988-1994 and1999—2002”, Morbidity and Mortality Weekly Report, August 25, 2005.2U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. “Improved NationalPrevalence Estimates for 18 Selected Major Birth Defects – 1999-2001”, Morbidity and Mortality Weekly Report,January 6, 2006.NIDCR-13

malformation, it has become increasingly clear that the story is more complex.Indeed, many of these conditions are caused not by one altered gene but theinterplay of myriad genes and their protein products and environmental elementsduring craniofacial development. To tap more directly into this dynamicdevelopmental process, NIDCR will launch the FaceBase Project. This initiative willhelp to establish consortia of various collaborative research projects that focus onspecific sequences of events of craniofacial development and associated disorders.Two central resources will support the consortia.o The first is a data coordination and bioinformatics component. It will ensurethat the large amounts of new data generated from the initiative are properlyand seamlessly stored, analyzed, and made available for sharing.o The second is a technology development component that will hammer outnew tools to broadly observe or read the developmental process as it unfolds.Taken together, these projects and resources will yield a more completeunderstanding of the molecular machinery that nature employs to build ahuman head, face, and mouth. Assembling this detailed information isabsolutely critical as scientists begin to devise improved strategies thatprevent expensive and often demoralizing malformations of the face. Harnessing Inflammation for Reconstruction of Oral and Craniofacial Tissues: Manypeople have noticed a puffy redness, or inflammation, of their gums; others mayhave had a swelling in their jaw. Such symptoms involve an acute, highly complexinterplay of immune cells that actively thwart infection and promote healing.However, the inflammatory process can go awry. Acute inflammation can progressto chronic inflammation, setting in motion a destructive cycle of tissue degradationand disease. To better control the chronic inflammation associated with various oraland craniofacial conditions, scientists must learn to decipher the molecular cross talkinvolved in the inflammatory process, from its onset to its resolution. This newknowledge is clinically important, as the tools of modern biotechnology andnanotechnology in recent years have laid the scientific foundation to one day reengineer damaged oral and craniofacial tissues and make them whole again.Recognizing both a need and an opportunity, NIDCR has launched an initiative to fillin the knowledge gaps that are interspersed throughout the inflammatory processand that disrupt our understanding of its progression. Identifying these gaps willprovide a complete picture of the normal resolution of acute inflammation and theaberrant transition into chronic inflammation. Strategies also will be developed tointroduce genes and proteins that overcome inflammation and promote thereconstruction of damaged tissues. This initiative, like all research in the IntegrativeBiology Program, places a premium on teamwork and assembling a diversity ofscientific expertise to develop novel approaches and creative solutions.NIDCR-14

Clinical ResearchThe NIDCR began nearly four years ago to invest more of its resources to supportlarge, randomized Phase III clinical trials; such trials are the final investigative step inthe clinical development process, and test the safety and efficacy of an investigationaltreatment against the standard of care in a well-defined group of patients. Each will yieldhigh quality data that have the potential to change healthcare practice and policy andimprove the nation’s public health. Currently, the Institute supports four ongoing PhaseIII trials and has plans to launch several additional studies during FY 2008 and FY 2009.In FY2007, two large, NIDCR-supported clinical trials (the Obstetrics and PeriodontalTherapy study and the Trial to Enhance Elderly Teeth) published their results. The firststudy found that periodontal therapy was not effective in reducing adverse birthoutcomes in pregnant women with periodontal disease; however, it did show that dentalcare provided during pregnancy was safe and effective in reducing the burden ofperiodontal disease. These findings are of immense value to both the practicingobstetrical and dental community because there has been a reluctance to providedental care to expectant mothers due to concerns about the safety of providing suchcare during pregnancy. The second study was designed to assess the clinicaleffectiveness of a daily chlorhexidine (CHX) mouth rinse for reducing the incidence ofdental caries in community-dwelling elders. Previous studies suggested that CHX couldreduce caries in at-risk children, but evidence for its effectiveness against caries in adultpopulations was inconclusive. This study demonstrated no effect on the preservation ofsound tooth structure in low-income older adults with irregular access to professionaldental care and a history of poor home care. These results are important because theolder adults in this study represent the broader population of community-dwelling adultswho lack dental insurance or who are irregular dental attendees in North America.A very important case-control study will be completed in FY2008. It is a collaborativeproject of all three NIDCR-supported Practice-Based Research Networks that willidentify dental risk factors for osteonecrosis of the jaws (ONJ). Many adult dentalpatients take oral and intravenous bisphosphonates for treatment of osteoporosis andcomplications of certain cancers. Unfortunately, some of these patients develop ONJ.This case-controlled study is designed to identify factors that may contribute to thedevelopment of this serious complication.Budget Policy: The FY 2009 estimate for the Clinical Research Program is 61.0million, a decrease of 0.2 million, or 0.3 percent from the FY 2008 estimate. Theprogram plans for FY 2009 include support for the new initiatives and ongoing programsdescribed below, as well as meritorious new investigator-initiated research grants, andresearch training related to its mission. Developing Complex Models of Oral Health and Behavior: Traditional modelsassume that behavior is driven by people carefully weighing the risks andbenefits of their choices. The models lay out a rational, linear, unidirectional setNIDCR-15

of causes and effects. While helpful, these models fail to capture adequately thecomplexity of the decision-making process for most Americans. Thisshortcoming has led groups ranging from funding agencies to policy makers tocall for new approaches that better capture the complexity of the process. Tomeet this need, NIDCR will actively encourage research that builds on theexisting models and identifies new ways to conceptualize the numerousbehavioral and social contributors to oral health. The initiative’s long-term goal isto use these models to identify potential targets for more efficient interventions tohelp more people achieve and maintain good oral health. Practice-Based Research Networks: In 2005, the institute began supportingthree regional dental practice-based research networks, or PBRNs. Theirmission is to create large networks of practicing dentists and dental hygienists toparticipate in conducting clinical studies on various issues in oral healthcare.This initiative grew out of the recognition that dental professionals frequently lackhigh quality research data to guide their treatment decisions. The PBRNs seekto provide that needed data and to greatly facilitate the translation of thesefindings into clinical practice. After an initial planning and organizational process,the PBRNs have begun to develop their first clinical protocols. The first round ofstudies include evaluations of how dentists currently diagnose and treat toothdecay in both mildly and heavily affected teeth. Other studies will includerandomized, controlled trials evaluating computer-assisted learning for thetreatment of dental needle phobics and comparisons of the outcomes of twodifferent techniques frequently used when treating deep dental decay. The threePBRNs are presently engaged collaboratively in a study to assess the dental riskfactors for osteonecrosis of the jaw in patients treated with bisphosphonates.Larger and more complicated randomized clinical trials are planned and will behighlighted in subsequent years. Oral Health Disparities Centers Initiative: In 2001, NIDCR initiated five OralHealth Disparities Centers, located in various regions of the country. Thesecenters have worked to design innovative, science-based strategies to improvethe oral health of low income and minority Americans. Funding for these centerswill conclude in mid 2008 and to maintain this research momentum, NIDCR re issued a Request for Applications, or RFA. This RFA was an open competition,meaning previous funding as an oral health disparities center was not aprerequisite. New centers will be required to conduct interventional trialsdesigned to determine the best methods for disease prevention and translation ofresearch findings in communities with health disparities. During FY 2008, grantapplications will be reviewed and the most meritorious selected for award. Thesecenters will require NIDCR funding support for several fiscal years.Biotechnology and InnovationThe NIDCR continues to support high quality research to produce cutting edge devicesfor oral health. Toward this end, the Institute employs interdisciplinary researchNIDCR-16

strategies that emphasize basic and translational studies. A nice example of thisstrategy at work is in the program’s funding of biomimetics - copying the secrets ofnature to design better synthetic materials.Recently, NIDCR grantees combined biomimetics, nanotechnology, and various existingtechnologies to develop a new medical adhesive that combines the natural adhesivestrategies of the lizard gecko and the marine mussel. Another program accomplishmentbrings us closer to annotating the salivary proteome. NIDCR-supported scientists andtheir teams have finished compiling a comprehensive roster of the more than 1,100proteins that are normally present in saliva. Most of the proteins are not yet fullycharacterized. A database that lays out for the research community the raw data fromthese projects is now available online. The next step in the process is to createtechnologies and methodologies to establish a community-based annotation server forthe human salivary proteome in order to assist those who study the salivary glands andaccelerate their searches for better ways to treat Sjögren’s syndrome and other chronicconditions that affect normal saliva production. The software is under development andshould be online in the near future.Budget Policy: The FY 2009 estimate for the Biotechnology and Innovation Programarea is 60.5 million, a decrease of 0.2 million, or 0.3 percent from the FY 2008estimate. Priority will be given to support ongoing programs and highly meritorious newresearch projects. In the FY 2009 budget, NIDCR will continue to support innovativeprojects such as the one described below: Annotation of the Salivary Proteome: NIDCR supported scientists and theirteams have finished compiling a comprehensive roster of the proteins that arenormally present in saliva from the major salivary glands. The roster containsmore than 1,100 distinct proteins, most of which are not fully characterized. Thedatabase that lays out for the research community the raw data from theseprojects is available online. The next step in the process is to createtechnologies and methodologies to establish community-based annotation serverfor the human salivary proteome. For instance, scientists might click on aparticular uncharacterized protein and submit their own research datademonstrating that the protein also is present in the brain, where it functions in aspecific way. In this way, raw data can become detailed entries that assist thosewho study the salivary glands and accelerate their searches for better ways totreat Sjögren’s syndrome and other chronic conditions that affect normal salivaproduction. The software is under development and should be online in the nearfuture.NIDCR-17

Portrait of a Program: Salivary DiagnosticsFY 2008:FY 2009:Change: 7.7 million 7.7 million 0Over the last several decades, scientists have begun to talk more actively about using a person’s salivato detect a range of oral and systemic diseases. Unlike blood, which involves a painful needle stick, mustbe carefully processed, and often sent elsewhere for analysis, saliva could be collected quickly andpainlessly and then analyzed right there in a dentist or doctor’s office. The test results could be deliveredwithin minutes, allowing patient and health professional to consult immediately and develop a plan offollow up care.But as part of creating the scientific infrastructure, the researchers needed to catalogue the genes andprotein content of normal saliva, giving them a point of comparison to detect the other molecules thatmight appear and be indicative of a developing disease. Toward this end, NIDCR supported largecollaborative projects that created the first complete record of the genes and proteins found in saliva. Nolonger must researchers look to see if a disease-linked protein also happens to be found in saliva. Nowthey could cast a wide analytical net and look for patterns of protein content in people who have oral orautoimmune diseases. Recently, showing the diagnostic power of this approach for the first time, anNIDCR grantee identified 43 proteins and 16 peptides that were present at abnormally higher or lowerlevels in the saliva of people with primary Sjögren’s syndrome. This surpasses previous efforts to identify3protein biomarkers for this condition. Primary Sjögren’s disease affects roughly two million Americans ,primarily women, and can be difficult to diagnose. Collaborations have begun between scientists in theUnited States and Europe to validate the most informative of these proteins as telltale signs of Sjögren’ssyndrome. Diagnostic tests for various cancers also are being developed. With this parts list of salivarygenes and proteins now in place, similar findings should emerge in the years ahead and lay the scientificfoundation for point-of-care salivary diagnostics in the future.Intramural Research ProgramThe NIDCR’s Division of Intramural Research (DIR) conducts basic, translational, andclinical research that covers a variety of areas relevant to oral health. These areasinclude investigations into the biochemistry, structure, function, and development ofbone, teeth, salivary glands, and connective tissues; the role of bacteria and viruses inoral disease; genetic disorders and tumors of the oral cavity; the cause and treatment ofacute and chronic pain; and the development of improved methods to diagnosedisease.NIDCR scientists have played an important role in organizing the Head and NeckTissue Array Initiative, a consortium develo

NATIONAL INSTITUTES OF HEALTH National Institute of Dental and Craniofacial Research For carrying out section 301 and title IV of the Public Health Services Act with respect to dental and craniofacial diseases . 396,632,000 390,535,000 (Department of Health and Human Services Appropriation Act, 2008) NIDCR-3

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