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

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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 DiversityinResearch portfolio enhances research onminoritycraniofacial-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.

Funding for fiscal year 2007 is estimated as follows: 451 noncompeting research project grants at $171,443,000, 169 competing grants at $54,177,000, 34 SBIR/STTR awards at $8,330,000, 8 research centers at $15,259,000, 90 grants in the career development award program at $12,350,000, 27 other research grants at $12,275,000, and 337 positions in the NRSA program at $14,910,000.

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.

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Eligibility Requirements

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.

Beneficiary Eligibility

Any nonprofit or for-profit organization, company or institution engaged in biomedical research.

Credentials/Documentation

Grants: Applications for grants must show the objectives, methodology, and resources for the specific research project and must present the applicant's competence and interest. NRSA and career development awards: (1) Individual Candidates: the applicant's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training, must be included in the application. (2) Institutional Candidates: the applicant institution must show the objectives, methodology, and resources for the research training program, the research qualifications and experience of directing staff to train students, the criteria to be used in selecting individuals for awards, and a detailed budget and justification for the amount of grants funds requested. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. 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, applicant organization (small business concern) must present in a research plan an idea 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. Grant forms PHS 6246-1 and 6246-2 are used to apply for Phase I and Phase II awards, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II awards respectively.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

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.

Award Procedures

Grants: All accepted applications competing for grants are reviewed by two advisory groups -- the initial review group composed of nongovernmental peer scientists and the second the National Advisory Dental Research Council. For grants costing less than $50,000, review by a competent staff group may be substituted for Council review. Career development awards and NRSAs: All accepted applications are reviewed by an appropriate initial scientific review group. The Advisory Council provides secondary review of institutional NRSAs and all career development awards. NIDR staff provides expedited secondary review of individual NRSA and small grant applications. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. 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

New Research Grants, all program project and all Career Development Awards: February 1, June 1, and October 1. Renewal Research Grants, Supplementals, Revised Research Grants and Career Developmental Awards: March 1, July 1, and November 1. NRSA: Individual - April 5, August 5, and December 5; Institutional - September 10. Small Grants: April 3, August 3, and December 3. SBIR: April 15, August 15, and December 15. STTR: December 1, only.

Authorization

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.

Range of Approval/Disapproval Time

Grants: From 6 to 9 months. NRSA: From 6 to 9 months. Small grants: About 6 months. SBIR/STTR: About 7-1/2 months.

Appeals

A Principal Investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html.

Renewals

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 Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

Grants: Approval of a project includes a determination of support for the authorized project period (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 (PHS-398, Rev. September 1991) 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.

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.

Audits

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

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

Account Identification

75-0873-0-1-550.

Obigations

(Grants) FY 07 $288,744,000; FY 08 est not available; and FY 09 est not reported.

Range and Average of Financial Assistance

Research Grants: $1,000 to $5,613,000; $318,000. NRSA: $8,000 to $677,000; $154,000. SBIR: Average Phase I SBIR awards are for approximately $100,000; Phase II awards may be made for amounts up to $750,000.

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.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

Program Contacts: Division of Basic and Translational Sciences: Dr. Ann Sandberg, (301) 594-2419; Ann.Sandberg@nih.gov; Division of Extramural Activities: Dr. H. George Hausch, (301) 594-2904; HauschG@de45.nidr.nih.gov; Division of Population and Health Promotion Sciences: Dr. Dushanka V. Kleinman, (301) 496-9469; Kleinman@od13.nidr.nih.gov; Division of Intramural Research: Dr. Henning Birkedal-Hansen, (301) 496-2687; bb96r@nih.gov; Use the same telephone numbers for FTS. Address for all contacts: Division of Extramural Research, National Institute of Dental and Craniofacial Research, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892.

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.