NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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:
Project Grants. Place Cursor Here for Definition
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.
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.
Pre-application
Coordination: Not applicable. This program is
excluded from coverage under E.O. 12372.
Application Procedure:
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 Procedure:
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.
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 24, 1997), "Audits of States, Local Governments, and Non-Profit
Organizations," nonfederal entities that expend financial assistance
of $300,000 or more in Federal awards will have a single or a
program-specific audit conducted for that year. Nonfederal entities
that expend less than $300,000 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:
75-0873-0-1-552.
Obligations:
(Grants) FY 01 $208,156,000; FY 02 est $238,351,000; and FY 03
est $259,099,000.
Range
and Average of Financial Assistance:
Grants: $1,000 to $2,217,000; Average: $256,000. NRSA:
$3,000 to $516,000; Average: $104,000. SBIR: Average Phase
I SBIR awards are for approximately $100,000; Phase II
awards may be made for amounts up to $750,000.
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.
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.
Web Site Address: http://www.hhs.gov
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.
