Content provided by the Catalog of Federal Domestic Assistance
93.121 Oral Diseases and Disorders Research
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service Act, as amended, Title IV, Section 301, Public Law 78-410; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
To obtain improved information on craniofacial-oral-dental health promotion, disease prevention, diagnostics, therapeutics, and fundamental scientific research that fuels the engine of patient-oriented and community-based clinical or applied research. The research portfolio is divided into several over-lapping programs which support basic, clinical and transitional research from molecular biology to patient-oriented and community-based clinical investigations. 1. Inherited Diseases and Disorders 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. Developmentally related disorders such as occlusion defects and those acquired through trauma is included. 2. Infectious Diseases Program supports research on etiology, pathogenesis, epidemiology, prevention, diagnosis and treatment of oral infectious diseases (i.e., viral, bacterial, fungal and parasitic) such as dental caries, periodontitis, oral candidiasis, herpes, hepatitis, and HIV/AIDS. Included is research on immunity with special emphasis on mucosal and salivary immunity; and on the oral manifestations of systemic infectious diseases and the development of new diagnostics and therapeutics. 3. Neoplastic Diseases Program supports research on the etiology, pathogenesis and metastasis, epidemiology, prevention, diagnosis, and treatment of oral and pharyngeal neoplastic diseases. 4. Chronic Disabling Diseases Program supports the full range of research involving such diseases associated with the craniofacial-oral-dental complex. These include osteoporosis, osteoarthritis, and related bone disorders, temporomandibular joint diseases and disorders, neuropathies and neurodegenerative diseases including those involving oral sensory and motor functions, and autoimmune diseases such as Sjogren's syndrome. Also included is research aimed at elucidating the relationship between chronic diseases of the craniofacial-oral-dental complex (e.g., periodontitis) and other systemic diseases (e.g., diabetes). 5. Biomaterials, Biomimetics and Tissue Engineering Program supports research to enhance the development of natural and synthetic therapeutics and biomaterials used for the repair, regeneration, restoration, and reconstruction of craniofacial-oral-dental molecules, cells, tissues, and organs. 6. Behavior, Health Promotion and Environment Program supports research aimed at assessing the interactive roles of sociological, behavioral, economic, environmental, genetic, and biomedical factors in craniofacial-oral-dental diseases and disorders. Included are studies aimed at examining the impact of oral health care delivery systems, clinical decision-making, and education on health outcomes. The Institute also supports Comprehensive Oral Research Centers of Discovery, each of which is organized around a unifying scientific theme pertinent to diseases and disorders of the craniofacial-oral-dental complex, integrates basic, clinical, applied and behavioral research, accelerated science-technology transfer, provides a vehicle for cross-disciplinary and collaborative research, and provides health professionals and the public with the latest information about craniofacial-oral-dental health. The Research Training and Career Program insures the future of craniofacial-oral-dental research by developing an outstanding and diverse scientific work force through programs designed for high school, undergraduate, graduate, and post-doctoral stages of education and for continued career development of scientists and retraining of mid-career scientists. The Diversity in Research portfolio enhances research on minority craniofacial-oral-dental health issues, expands the diversity of the scientific work force, and increases the research capacity of minority institutions and of those serving primarily minority populations. The Clinical Trials and Clinical Core Centers portfolio recognizes the increasing need to establish a strong foundation for the support of meritorious clinical research. The Technology Transfer portfolio responds to the increasing partnering of the Institute's Division of Extramural Research with industry in craniofacial-oral-dental research. It expands on the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and works closely with the industrial R&D community to identify new opportunities for fostering collaborative efforts. The 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 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:
USES AND USE RESTRICTIONS:
Research Grants: Research Grants 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, program project grants, center grants, career development awards to enable investigators with outstanding research potential to develop their careers, and small grants. Individual and institutional Dentist Scientist Awards are made to provide research career development in both clinical and basic science areas. National Research Service Awards (NRSAs) can be made 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 (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or process. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally 1-year duration) are able to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperation effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.
Applicant Eligibility: 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. (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 grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Pre-application Coordination: Not applicable. This program is excluded from coverage under E.O. 12372.
Formula and Matching Requirements: This program has no statutory formula or matching requirements.
POST ASSISTANCE REQUIREMENTS:
Reports: Grants: Annual and terminal reports on progress, expenditures, and inventions in accordance with 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. Reports are required after termination of NRSA to ascertain compliance with the service and payback provisions.
Account Identification: 75-0873-0-1-552.
In 2001 the research supported by NIDCR produced some important discoveries and new information in our understanding of disorders affecting the oral, dental and craniofacial structures. In fiscal year 2001, 507 new and competing research project grant applications were received; 172 were awarded at a cost of $53,169,000. The Institute also supported 432 noncompeting research project grants at $119,985,000; 34 SBIR/STTR awards at $5,242,000; 19 research centers at $18,667,000; 90 positions in the career development award program at $8,489,000, $132,000 for minority biomedical research support, 13 other research grants at $2,472,000, and 281 positions in the NRSA program at $9,708,000. In fiscal year 2002, the NIDCR expects to support 435 noncompeting research project grants at $138,126,000, 179 competing grants at $57,698,000, 44 SBIR/STTR awards at $6,700,000, 13 research centers at $22,619,000, 107 positions in the career development award program at $10,163,000, $142,000 for minority biomedical research support, 15 other research grants at $2,903,000, and 303 positions in the NRSA program at $11,250,000. Funding for fiscal year 2003 is estimated as follows: 453 noncompeting research project grants at $155,805,000, 177 competing grants at $59,380,000, 57 SBIR/STTR awards at $7,110,000, 13 research centers at $23,288,000, 107 positions in the career development award program at $10,463,000, $150,000 for minority biomedical research support, 15 other research grants at $2,903,000, and 303 positions in the NRSA program at $11,585,000.
REGULATIONS, GUIDELINES, AND LITERATURE:
Grants: 42 CFR 66; 45 CFR 74; Leaflet, entitled, "Grant and Contract Research Programs at the National Institute of Dental Research", Grant Application Kit. 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.
Regional or Local Office: Not applicable.
EXAMPLES OF FUNDED PROJECTS:
(1) Research center support coordinated studies of periodontal diseases, clinical cores, dental caries, oral biology, craniofacial disorders, oral cancer, minority oral health, and materials sciences; (2) genomic sequencing of bacterial oral pathogens; (3) metalloproteinases in developing enamel; (4) genetic basis of ectodermal dysplasia; (5) biofilms, including studies of microbial ecology, physiology and transmission; (6) prevention and control of infectious diseases including behavioral approaches, antibiotics and vaccines; (7) development of anti-streptococcal antibodies in genetically engineered plants; (8) endodontic treatment and management of oral AIDS-Kaposi's sarcoma for HIV positive patients; (9); development of HIV diagnostic assays utilizing saliva; (10) epidemiology of HIV associated opportunistic oral infections; (11) papilloma viruses in oral cancer; (12) regulated expression of extra-cellular matrix proteins in oral cancer; (13) biobehavioral aspects of temporomandibular disorders (TMD); 14)pharmacological management of TMDs; (15) brainstem mechanisms controlling jaw movement; (16) neural control of swallowing and mastication; (17) construction of chimeric salivary molecules; (18) etiology and pathology of Sjogren's syndrome; (19) guided bone regeneration with morphogenic protein; and (20) computer assisted detection of dental caries.
CRITERIA FOR SELECTING PROPOSALS:
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to the announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. 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 qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing proposed means for (a) safeguarding human and animal subject, and/or (b) protecting against or minimizing any adverse effect on the environment.