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Oral Diseases and Disorders Research

Dental and Craniofacial Research
Number: 93.121
Agency: Department of Health and Human Services
Office: National Institutes of Health

Program Information 

Program Number/Title (010):
93.121 Oral Diseases and Disorders Research
Federal Agency (030):
National Institutes of Health, Department of Health and Human Services
Authorization (040):
Public Health Service Act, Title IV, Section 301; 2012 Defense Authorization Act.
Objectives (050):
To improve oral, dental and craniofacial health through research, research training, and the dissemination of health information. The research portfolio supports basic, clinical and transitional research from molecular biology to patient-oriented and community-based clinical investigations. The Developmental Biology and Genetics Program supports research on etiology, pathogenesis, epidemiology, prevention, diagnosis, and treatment of inherited craniofacial-oral-dental diseases and disorders (e.g., ectodermal dysplasia, cleft lip and palate, amelogenesis imperfecta, dentionogenesis imperfecta, osteogenesis imperfecta, and other inherited diseases that have craniofacial-oral-dental manifestations) as well as on normal craniofacial-oral-dental development, and genome-wide association studies. 2. The Translational Genetics and Genomics program supports genetic/genomic research using epidemiologic and family-based methods, gene discovery using high throughput technologies, and gene-environment interactions. 3. The Microbiology Program supports basic and translational research on the role of oral microbes in health and disease including the etiology, pathogenesis, diagnosis, treatment, and prevention of oral infectious diseases. Areas of interest include biofilms and microbial ecology, microbial genomics and metagenomics, microbial virulence and disease pathogenesis, prevention and treatment. 4. The AIDS and Immunosuppression Program supports basic, translational and clinical research on HIV infection and AIDS to advance understanding of the underlying molecular, cellular, and genetic mechanisms that enable or prevent HIV infection and development of oral complications associated with AIDS and AIDS malignancies. 5. The Immunology and Immunotherapy Program supports basic and translational research on the immune aspects of oral diseases such as caries and periodontal diseases. The program includes host responses to microbes, immunology of biofilms, oral inflammation, systemic diseases, immunotherapy, immunopathologies, and host susceptibility to infection. 6. The Epithelial Cell Regulation and Transformation Program supports basic and translational research on the molecular mechanisms of oral epithelial cell regulation as they relate to the development and progression of diseases of the oral mucosa, including head and neck cancer. The program also supports and encourages the application of genomic, proteomic, and imaging technologies through research on the early diagnosis, prevention, and treatment of head and neck cancers. 7. The Mineralized Tissue and Salivary Gland Physiology Program supports basic and translational research on craniofacial skeletal biology and pathobiology including the physiology of tooth, bone and cartilage, and associated disorders and diseases, saliva and salivary glands, and pharmacogenetics. The goal of the program is to promote interdisciplinary and multidisciplinary approaches to advance the understanding of normal and abnormal processes underlying oral, dental and craniofacial diseases and disorders. 8. The Molecular and Cellular Neuroscience Program supports basic and translational research on orofacial pain and neuropathies, temporomandibular joint and muscle disorders, development of biomarkers for diagnostics and prognostics and development of therapeutics. 9. The Tissue Engineering and Dental and Craniofacial Rengenerative Medicine Program supports basic and translational research on the reconstruction, remodeling and repair of the oral and craniofacial tissues damaged as a result of disease or injury. The goal of this scientific program is to promote interdisciplinary and multidisciplinary approaches to engineering of biocompatible oral and craniofacial tissue constructs and their functional integration into the host tissue microenvironment. The program also supports efforts that employ bioengineering approaches for restoration, remodeling and regeneration of diseased and injured native host tissues. 10. The Dental and Biomaterials Program supports basic and translational extramural research on dental materials and devices, dental implants, biocompatibility of dental restorative materials, and biomaterials for craniofacial reconstruction. 11. The Behavioral and Social Sciences Research Program supports basic and applied BSS research to promote oral health, to prevent oral diseases and related disabilities, and to improve management of craniofacial conditions, disorders and injury. 12. The Center for Clinical Research supports clinical trials, dental practice based research networks, epidemiology research, and health disparities research. The Research Training and Career Development Program insures the future of dental and craniofacial research by developing an outstanding and diverse scientific work force through training and fellowship programs designed primarily for graduate, and post-doctoral stages of education, including dual degree (DDS, PhD) programs, as well as for continued career development of scientists and retraining of mid-career scientists. Diversity fellowships serve to expand the diversity of the scientific work force by supporting the training of predoctoral students from underrepresented groups. The Small Business Innovation Research (SBIR) program seeks to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. The Small Business Technology Transfer (STTR)STTR program seeks to stimulate and foster scientific and technological innovation and foster technology transfer through cooperative research and development carried out between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Types of Assistance (060):
PROJECT GRANTS
Uses and Use Restrictions (070):
Research Grants: Research Grants and cooperative agreements provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation in the oral health sciences. They are awarded to universities, colleges, medical and dental schools, hospitals, and other nonprofit and for-profit institutions. Awards include investigator-initiated project grants, exploratory and developmental grants, small grants, program project grants, center grants, and career development awards. Individual and institutional Dentist Scientist Awards provide support for research career development in both clinical and basic science. National Research Service Awards (NRSAs) provide support directly to individuals for research training in specified biomedical areas, and can be made to institutions to enable them to accept individuals for research training. Individuals who receive NRSAs may be obligated upon termination of the award to comply with service and payback provisions. SBIR Phase I grants (duration of approximately 6 months) provide support to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants support the continuation of the research initiated in Phase I to further develop the commercial products or process initiated in Phase I. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (duration of typically 1 year) support cooperative efforts between small businesses and research institutes to determine the scientific and technical merit, and commercial feasibility of a product or process with potential for commercial application. Phase II funding is based on the results of the research initiated in Phase I and the scientific and technical merit, and commercial potential of the Phase II application.
Eligibility Requirements (080)
Applicant Eligibility (081):
Grants: Scientists at universities, medical and dental schools, hospitals, laboratories, and other public or private nonprofit and for-profit institutions. NRSA and career development awards: (1) Nonprofit domestic organizations may apply for institutional awards. (2) Individual candidates or applicants must arrange sponsorship by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. (3) All awardees must be citizens, or non-citizen nationals, of the United States or have been admitted to the United States for permanent residence, except for K99/R00 and T90/R90 grants. (4) To be eligible, postdoctoral NRSA and career development awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Institutional applicants must be able to provide the staff and facilities suitable for the proposed research training. SBIR and STTR grants: Can be awarded only to domestic small business concerns that meet the following criteria: 1) Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2) Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; 3) Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; no single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, 4) Has, including its affiliates, not more than 500 employees, and 5) meets the other regulatory requirements found in 13 C.F.R. Part 121. For STTR awards, the small business must "partner" with a research institution in a cooperative research and development project . In both Phase I and Phase II for both SBIR and STTR, the research must be performed in the U.S. and its possessions. To be eligible for funding, all grant applications must be evaluated for scientific merit and program relevance by a peer scientific review group and the National Advisory Dental and Craniofacial Research Council.
Beneficiary Eligibility (082):
Health professionals, graduate students, health professional students, scientists, researchers, any nonprofit or for-profit organization, company or institution engaged in biomedical research.
Credentials/Documentation (083):
Grants: Applications for research grants must include the objectives (specific aims), research strategy, significance, innovation, methodology, and resources for the specific project, and must present the relevant background and experience of the applicant. NRSA and career development awards: (1) Individual Candidates: the applicant's academic record, research experience, citizenship, institutional sponsorship, proposed research area, and plan for training, must be included in the application. (2) Institutional Candidates: the application must include the objectives, methodology, and resources for the research training program, the research qualifications and experience of participating faculty in training students and fellows, and the criteria to be used in selecting individuals for support. Costs will be determined in accordance with OMB Circular No. A-87 for State and Local Governments. Costs for for-profit organizations are determined in accordance with the Federal Acquisition Regulations Subpart 31.2. For other than State and Local Government grantees, costs will be determined by Health and Human Services (HHS) Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, the applicant organization (small business) must present an idea in the research plan that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. OMB Circular No. A-87 applies to this program.
Application and Award Process (090)
Preapplication Coordination (091):
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedures (092):
OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 applies to this program. Applications for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/forms.htm). Applications may not be submitted in paper format unless required by the Funding Opportunity Announcement (http://grants.nih.gov/grants/guide/index.html). A registration process through Grants.gov is necessary before submission. Applicants are strongly encouraged to start the registration process at least four weeks prior to the applications submission date.
Award Procedure (093):
Grants: All accepted applications competing for research project grants, career development awards, and NSRA awards are reviewed by two advisory groups. Primary review is conducted by an initial review group composed of extramural peer scientists, and secondary review by the National Advisory Dental and Craniofacial Research Council (NADCRC). Secondary review of NRSA fellowship applications is conducted by NIDCR staff rather than by the NADCRC. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate initial review group and by the NADCRC. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Deadlines (094):
Contact the headquarters or regional office, as appropriate, for application deadlines.
Range of Approval/Disapproval Time (095):
> 180 Days. Research Project Grants and NSRA: From 6 to 9 months. SBIR/STTR: About 7-1/2 months.
Appeals (096):
From 90 to 120 days. A Principal Investigator (PI) may question the technical or procedural aspects of the review of his/her application by communicating with the program staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page: http://grants.nih.gov/grants/peer_review_process.htm#Appeals and in the Notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.
Renewals (097):
> 180 Days. Grants: Applications for approval beyond the approved project period must be submitted at least 6 to 9 months in advance of the termination date. NRSA: Institutional Awards may be made up to 5 years. No individual may receive NIH/NRSA support at the postdoctoral level for more than 3 years, unless a specific waiver is requested and approved.
Assistance Consideration (100)
Formula and Matching Requirements (101):
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance (102):
Grants: Approval of a project includes a determination of support for the authorized project period (generally not to exceed 5 years). Awards to support the project are made on an annual basis. At the time of initial award, the grant provides funds for the conduct of the project during the first budget period (usually 12 months) and the Notice of Grant Award (Form PHS-1533) indicates the support recommended and expected to be made available for the remainder of the project beyond the approved project period, an application for renewal must be submitted in accordance with the deadline dates and instructions attached to the form. SBIR Phase I awards are generally for 6 months; Phase II awards normally are for 2 years. STTR Phase I awards are generally for 1 year; Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: Awards are made annually.
Post Assistance Requirements (110)
Reports (111):
No program reports are required. No cash reports are required. Annually. Annually. No performance monitoring is required.
Audits (112):
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Records (113):
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Financial Information (120)
Obligations (122):
(Project Grants) FY 12 $318,095,082; FY 13 est $319,170,000; and FY 14 est $318,531,660
Range and Average of Financial Assistance (123):
FY2011: research project grants: range $16,000-$2,842,000, average $383,000; NRSA: range $6500-$919,000, average $125,000; SBIR/STTR: range $68,000-$993,000; average $308,000. Career development: range $32,000-$181,000, average $120,000.

FY2012: research project grants: range $15,000-$9,976,266, average $415,717; NRSA: range $4,980-$970,980, average $97,327; SBIR/STTR: range $149,688-$970,980, average $387,958. Career development: range $6,391-$273,131, average $121,504.
Program Accomplishments (130):
Not Applicable.
Regulations, Guidelines, and Literature (140):
Grants: 42 CFR 66; 45 CFR 74; NIDCR Grants and Funding website (http://www.nidcr.nih.gov/GrantsAndFunding/), NIH Grants website (http://grants.nih.gov/grants/oer.htm). Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Information Contacts (150)
Regional or Local Office (151) :
None.
Headquarters Office (152):
Dr. Alicia Dombroski, 6701 Democracy Blvd.; Room 660, MSC 4878 , Bethesda, Maryland 20892 Email: adombroski@nidcr.nih.gov Phone: (301) 594-4805 Fax: (301) 480-8303.
Website Address (153):
http://www.hhs.gov; http://www.nidcr.nih.gov
Examples of Funded Projects (170):
Fiscal Year 2013: No Current Data Available Fiscal Year 2014: No Current Data Available Fiscal Year 2015: No Current Data Available
Criteria for Selecting Proposals (180):
The primary criteria for evaluating grant applications include assessment of: (1) the scientific merit, significance and overall impact of the proposed study and its objectives; (2) the competency of the proposed investigator(s) to successfully pursue the project; (3) the innovation and novelty of the concepts, approaches, or methodologies; (4) the technical adequacy of the experimental design and approach; (5) the adequacy of the available proposed facilities and resources; (6) the necessity of the budget components requested in relation to the proposed project; and (7) the relevance and importance to the posted institute program objectives. Also evaluated, where applicable, but not scored are: (1) protections for human subjects; (2) inclusion of women, minorities, and children; (3) animal welfare; and (4) adequate protection of research personnel and/or the environment, biosafety, biocontainment and the security of select agents. In addition, the following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: the potential of the proposed research for commercial application. Phase II grant applications will reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the technological innovation, originality, or societal importance of the proposed research; and (4) the potential of the proposed research for commercial application.

NRSA individual fellowship applications will be evaluated for: (1) overall impact/merit; (2) suitability of the applicant; (3) qualifications of the sponsor(s)/collaborator(s); (4) scientific merit of the research training plan; (5) training potential; and (6) institutional environment and commitment to training. NRSA institutional training grants are assessed for: (1) overall impact; (2) merit of the training program and institutional environment; (3) the experience and success of the training program directors, PIs, and mentors; (4) the trainee recruitment plan and selection; and (5) the training record of the program and/or institution.

Career Development applications will be evaluated for: (1) overall impact; (2) qualifications of the candidate; (3) the career plan and career goals/objectives of the candidate; (4) scientific merit of the research plan. (5) qualifications of the mentor(s), consultant(s) and collaborator(s); and (5) institutional environment and commitment to career development.