Recovery Act Limited Competition: Research and Research Infrastructure "Grand Opportunities" (GO) (RC2): NIDCR Guidelines

RFA-OD-09-004
http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-004.html

Areas of Scientific Priority:

For the “GO” Initiative, the following scientific areas are considered high-priority. Only those applications that focus on these topics will be considered for possible funding:

(1)  Testing Mechanisms of Action Hypotheses in Behavioral and/or Social Interventions
Understanding the mechanisms of action of behavioral and social interventions related to oral health (i.e., how and for whom interventions work) is key to developing interventions that are efficacious, cost effective, and sustainable. Research is encouraged that identifies and tests the mechanisms of action of behavioral or social interventions aimed at improving oral health. Studies should include adequate measurement and design elements to allow for a rigorous test of mechanisms. Studies could test mechanisms of action of interventions meant for patients or for care providers.  Investigators are encouraged to utilize non-traditional research designs and measurement to adequately capture mechanisms data. For example, a series of well-designed case studies with extensive measurement may be preferable to a randomized controlled trial with periodic measurement in answering some mechanisms of action questions. Contact: Dr. Melissa Riddle, 301-451-3888, riddleme@mail.nih.gov.

(2) Treatment of Tobacco and Drug Dependence in Multiple Dental Clinics
Approaches to Screening, Brief Intervention, and Referral to Treatment (SBIRT) for tobacco, alcohol or other drug abuse provide a promising tool for oral health care providers. Studies are needed that test the effectiveness, cost-effectiveness, and/or sustainability of SBIRT approaches across multiple dental clinics. Studies should focus on evidence-based SBIRT approaches for wide-scale implementation. Investigators with access to existing networks of oral care providers are especially encouraged to apply. Responsive projects include: efficacy/effectiveness testing of one or more evidence-based SBIRT approach(es) in established or new oral health networks; cost-effectiveness studies of delivering SBIRT for tobacco, alcohol or other drug abuse in dental settings; and studies testing sustainability of SBIRT in dental settings. Contact: Dr. Melissa Riddle, 301-451-3888, riddleme@mail.nih.gov.

(3) Validation of Biomarkers of Oral Disease or Salivary Biomarkers
Biomarkers from many sources (tissues or fluids) that predict the presence or activity of oral diseases have been proposed. Other studies have identified salivary biomarkers that have the potential to diagnose many diseases. Validation studies are needed to advance the clinical application of these proposed biomarkers. Applications responsive to this topic will propose validation studies with clearly defined milestones and measurable outcomes that can be completed in a two-year period.  Preliminary data that support further testing of the proposed biomarker(s) must be included in the application.  The objective of this research topic is not to support new biomarker discovery.  Contact: Dr. Jane Atkinson, 301-435-7908, jatkinso@mail.nih.gov; or Dr. Lillian Shum, 301-594-0618, shuml@mail.nih.gov.

(4) Detection of Oral Premalignant and Malignant Lesions
Approximately 35,000 Americans are diagnosed each year with oral cancer, and it is believed that early detection is associated with better outcomes.  The sensitivity and specificity of visual and tactile oral examination, the standard screening technique for malignant and premalignant lesions, is unknown. Adjunctive tests have been developed and compared to the standard screening, but their utility overall as a screening tool is also uncertain. The NIDCR seeks projects that will provide preliminary data that will allow for planning of definitive randomized clinical trial(s) to support or refute the role of available oral cancer screening techniques as an evidence-based US public health intervention.  Responsive projects will give special consideration to higher risk populations such as individuals over 50 years of age, tobacco users and alcohol users, and those infected orally with human papillomavirus.   Applicants would need to submit a future application for an NIDCR Clinical Trial Implementation grant for support of any proposed clinical trials, which could be considered for support through regular NIDCR appropriated funds. Contact: Dr. Holli Hamilton, 301-451-3852, hamiltonho@nidcr.nih.gov.

(5) Genome-wide Studies in Craniofacial, Dental, and Oral Conditions: Data Generation, Analysis, and Integration
Improved genome-wide technologies and statistical methods to integrate and interpret different types of information can be used to better understand the genetic basis of craniofacial, dental, and oral conditions and gene-environment interactions. New genome-wide data generated through this initiative, added to the broadly shared data resources available to genetic researchers through the database of Genotypes and Phenotypes (dbGaP), will help accelerate progress as will broad sharing of new statistical methods and programs. The goal of applications responding to this topic will be to conduct genome-wide studies of craniofacial, dental, or oral conditions, and/or develop and apply statistical methods to analyze, integrate, and interpret different types of information to better understand genetic factors in craniofacial, dental, or oral conditions. Medical sequencing, fine-mapping, and replication studies may be included. Recruitment of new cohorts will not be considered responsive. Contact: Dr. Emily Harris, 301-594-4846, harrisel@nidcr.nih.gov.

(6) Multidisciplinary Approaches to Craniofacial Regeneration and Preclinical Testing
Craniofacial defects due to congenital abnormalities, disease and trauma present major challenges to optimal reconstruction, but they can be overcome by the integrated effort of multidisciplinary teams that take advantage of recent scientific and technological advances. The goal of applications responding to this topic will be to apply multidisciplinary and interdisciplinary approaches to promote regeneration and reconstruction of tissues and organs of the craniofacial complex, including but not limited to oral mucosa, periodontium, tooth, salivary gland,  temporomandibular joint, and bony and cartilaginous structures of the head.  These projects are expected to bring together expertise of basic biologists, bioengineers, chemists, and clinicians working collaboratively to design, test and validate innovative tissue and organ regeneration strategies in large animal models such as dogs and minipigs, and to advance these strategies to the stage where they could be tested in clinical trials. Contact: Dr. Nadya Lumelsky, 301-594-7703, Nadya.Lumelsky@nih.gov.

(7) Oral Cancer Genome Analysis
Genetic analysis of tumors has proved invaluable in unraveling genetically altered core pathways and key molecules involved in tumorigenesis. A comprehensive catalog of somatic changes in oral cancer will be a powerful driver for oral cancer research at multiple complementary levels. The goal of applications responding to this topic will be to conduct discovery research aimed at characterizing the oral cancer genome utilizing state-of-the-art technological approaches. Studies could include identification and characterization of gene expression signature profiles and transcriptomes, presence of gene amplifications and deletions, determining gene copy number, and chromosomal translocations. Contact: Dr. Yasaman Shirazi, 301-594-4812, Yasaman.Shirazi@nih.gov.

(8)  Human Pain Phenotypes and Pain Circuitry
A better understanding and characterization of human pain states and the identification of changes in neural pathways during the transition from acute to chronic pain will enhance our ability to predict those at risk for developing chronic pain conditions and to identify patients likely to respond favorably to therapeutic interventions.  The goal of applications responding to this topic will be to engage in the development of new, minimally invasive and quantitative measures of human pain, including, but not limited to, the use of imaging modalities such as fMRI or PET to assess functional activity in different brain regions; and development and use of cutting edge techniques including imaging technologies such as diffusion tensor imaging (DTI) and diffusion spectrum magnetic resonance imaging (DSI) to evaluate changes in neural connectivity and circuitry during the transition from acute to chronic pain states.  The accomplishment of these goals would be a powerful means to enhance our understanding of the biological mechanisms and circuitry underlying the development of these chronic pain conditions and to better predict the varied responses of patients to therapeutic interventions.  Contact: Dr. John Kusiak, 301-594-7984, John.Kusiak@nih.gov.

Funding Priorities:

Overall, the NIDCR expects to allocate $10,000,000 to this ARRA program.

Letters of Intent

Letters of Intent (LOI) are due April, 27, 2009 and should be sent via e-mail as a Word document, or as a PDF file or within the text of an e-mail to:

Email address: lynn.king@nih.gov

If it is not possible to transmit the LOI electronically, a paper copy may be sent to Dr. King:

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd, Rm 662
Bethesda, MD  20892-4878
Courier service zip code: 20817

The Letter of Intent should contain the following information:

• Descriptive title of proposed research.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.
  

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDCR staff to estimate and plan for the potential review workload. Prospective applicants are asked to consider including the following in the LOI:

• Description of the research areas, including any subprojects
• Significance of the proposed research
• Rationale why the application is not suitable for the Challenge Grant program
• Evidence that the project is ready for immediate implementation
• Key personnel
• Direct, contract F&A, and total costs for each year
• Description of how the goal and outcomes of the project match the goals of the ”GO” grants program and Recovery Act
• Preliminary list of the expected 2-year outcomes and deliverables.

Letters of Intent do not need the signature of an Institutional Official.

Contact Information:

• Program Contact(s): see Contact following each topic of interest
  
  
• Grants Management Contact: Mary Daley, 301-594-4808, md74u@nih.gov
  
  
• For questions concerning review of GO grants:
  Lynn Mertens King, Ph.D.
  Chief, Scientific Review Branch
  NIDCR
  Phone: 301-594-5006
  E-mail: Lynn.King@nih.gov