Full Text DE-92-04

CLINICAL CORE CENTERS FOR PREVENTIVE AND OPERATIVE DENTISTRY

NIH GUIDE, Volume 21, Number 29, August 14, 1992

RFA:  DE-92-04

P.T. 04

Keywords: 
  Dentistry 
  Oral Diseases 
  Disease Prevention+ 


National Institute of Dental Research

Letter of Intent Receipt Date:  October 31, 1992
Application Receipt Date:  December 3, 1992

PURPOSE

The National Institute of Dental Research (NIDR) invites  applications
for the support of Clinical Core Centers for Preventive and Operative
Dentistry (CCCPOD).  The Centers are intended to serve as focal points
for strengthening the Nation's oral health clinical research
capability, enhancing clinical decision-making, and facilitating the
development of new approaches for dental caries diagnosis, prevention,
and treatment in the light of recent knowledge of caries etiology and
pathogenesis.  The research will focus on early identification of
patients at risk for dental caries through identification of
microbiological and biochemical markers and on the full range of
treatments, from non-operative interventions such as the use of
antibacterial and remineralization procedures, to minimal intervention
such as preventive resin restorations, to different types of large
restorations needed for the treatment of carious lesions.  The research
also will include the study of failed restorations due to recurrent
caries or for any other reasons.

The overall intent of this RFA is to attract clinical researchers and
clinicians with experience in dental materials science, molecular
biology, biochemistry, pulp biology, clinical preventive and operative
dentistry as well as those involved in the prevention, diagnosis, and
treatment of dental caries.  These researchers will conduct
multi-disciplinary research on early diagnosis and early treatment of
caries, making the distinction between caries as a disease and caries
as a lesion.  Particular emphasis is placed on the assessment of the
presence and severity of infection and prompt treatment prior to
evidence of clinical symptoms.  The research also should focus on the
development of optimal cavity preparations for different types of
restorative materials.  The principle of cavity preparations must be
based on the premise of maintaining tooth structure to prevent the need
for large restorations and more complex sequelae.  The research should
include development and testing of maintenance and health promotion
programs and studies on why restorations fail.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas, and to "Oral
Health 2000," a major collaborative initiative between the PHS and
professional and private research organizations to improving oral
health in the adult and elderly population groups in the U.S.A.  This
RFA, Clinical Core Centers For Preventive and Operative Dentistry, is
related to the priority area of reducing health disparities among
Americans by improving oral health.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0
or Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

This competition is open to domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the federal Government.  Foreign organizations are
not eligible to apply, but domestic applications may include
international components.  Although an application must be submitted
from a single institution, it may include consortia arrangements with
other institutions provided these arrangements are clearly delineated
and formally and officially confirmed by signed statements from the
responsible official(s) of each institution.  Applicant institutions
must provide clear evidence of having a suitable clinical research base
to ensure appropriate utilization of the added resources that the NIDR
would provide through the CCCPOD.  This must include meritorious
ongoing clinical research projects and/or the capability to develop
such clinical research, accompanied by firm funding commitments that
ensure that appropriate clinical research projects will be active at
the time of a CCCPOD award.

MECHANISM OF SUPPORT

The CCCPODs will be supported by the National Institutes of Health
(NIH) Center Core Grants (P30).  Clinical Core Center applications
funded under this RFA will be supported for a period of five years,
commencing as early as September 1, 1993.  This RFA is a one time
solicitation.  Subsequent support will be contingent upon program needs
and availability of funds.  In addition to support for pilot or
feasibility projects, support will be provided for core resources, the
sharing of which will facilitate the total research effort.  Each core
unit must be utilized by at least two projects.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.

FUNDS AVAILABLE

Applicants may request up to $300,000 in direct costs for the first
year.  If indirect costs are assigned to a subcontract and counted as
direct costs, the direct cost maximum of $300,000 may be exceeded by
the amount of the indirect costs assigned to the subcontract.  Budget
increases of no more than four percent per year may be requested for
each of the subsequent four years.  The NIDR expects to commit up to
$0.9 million to fund applications submitted in response to this RFA.
It is anticipated that one or two awards will be made, however, this
funding level is contingent upon the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NIDR, the award of grants
pursuant to this RFA is also contingent upon the availability of funds
for this purpose.

RESEARCH OBJECTIVES

Background

Historically, operative dentistry has been the primary nucleus of
dental practice.  It includes everything from prevention of caries and
remineralization of initial carious attacks to complex restorative
treatment.  More than a century of clinical experience has provided
traditions for treatment that are deep-rooted in the dental profession.

However, these contemporary times demand reconsideration of established
views and conventional clinical procedures. Increased longevity has
presented the clinician with an aging population with dental care needs
different from those of the younger population, which has benefited
from early research that confirmed that fluoride prevents caries. Quite
different types of dental care will be required in the next few decades
for those who have had the benefit of caries prevention programs and
those who had most of their teeth filled prior to the preventive era.

The NIDRs surveys of children showed dramatic improvement in the oral
health of children today.  Half the children between five and seventeen
years of age have no cavities in their permanent teeth.  The treatment
needs of children, therefore, will particularly focus upon maintenance
of non-restored or minimally restored teeth.  Use and effectiveness of
sealants, preventive resin restorations, and remineralizing agents must
be assessed.  And it must not be taken for granted that the great
improvement in the oral health of the children of today is a lifelong
improvement. Long-term follow-up studies are essential to ascertain a
continued positive benefit.

In contrast, the 1985-1986 NIDR national survey of working adults and
older adults attending senior centers showed substantial deficiencies
in adults' oral health, with seniors having the worst overall oral
health status; over forty percent are missing all their teeth.  The
adult generations, with many and large restorations, will require
maintenance of their restorations in the coming decades.  A focus on
longevity of restorations and operative techniques with minimum removal
of tooth tissues in the replacement and repair of failed restorations
will be important.

Furthermore, there is a need for the development of saliva, pellicle,
and plaque analysis tests that will establish the presence of infection
and the subsequent risk of patients for primary and secondary carious
lesions.  This will aid in the early diagnosis of both the infection
and lesions. Treatment approaches for "active" versus "inactive"
carious lesions should be investigated.

The NIDR surveys also identified groups of individuals who are at high
risk for developing caries, including patients with systemic diseases,
individuals who receive orofacial radiation therapy for cancer or who
take certain medications, members of minority groups, rural residents,
and those who are economically disadvantaged.  This knowledge presents
a challenge to preventive and operative dentistry to identify
individuals at risk, to reduce risk where possible, to utilize the best
available means of early detection to minimize progression, and to
prevent disease.

These and other epidemiological studies coupled with scientific
knowledge gained through the broadened scope of dental research have
advanced our understanding that caries is a multifactorial disease.
Although bacteria on the teeth are the immediate cause of dental
caries, a large number of microbiological, environmental, and host
factors interact to determine whether or not an individual will be
affected, and the nature and extent of the disease if affected.  These
factors include bacterial flora, fluoride exposure, level of sucrose
consumption, nutritional status, underlying systemic disease, salivary
proteins, oral hygiene, and others.  This multifactorial nature of
caries presents a variety of opportunities for prevention.

The technological revolution that has occurred in the biomedical
sciences with the explosion of cellular and molecular biology and the
advent of the tools of biotechnology holds the promise of more
biologically-oriented technologies for early detection and prevention
of tooth decay. Inclusion of these topics would open up applications in
entirely new areas of vaccine development and microbiology beyond
diagnostic applications.  Diagnostic probes based on microbial genetics
and improved saliva substitutes developed using genetic engineering are
but a few examples of what is on the horizon of the new preventive
operative dentistry. Much research is needed to bring these
possibilities into the reality of clinical practice.

Materials science, too, has made significant advances, and new
materials are continually being introduced to clinicians.  Many of
these new materials are based on principles and concepts different from
those of traditional restorative dental materials.  For example,
instead of materials that require mechanical retention, we now have
materials that attach to microscopic components of the tooth structure
that have been revealed by acid etching and materials that are
chemically bonded to dental tissues. Public demand has fueled the
search for tooth-colored restorative materials to provide a more
esthetic alternative to alloys.  And public awareness of the importance
of biocompatibility testing, examining the interaction of restorative
materials within the environment of the mouth, has increased efforts to
assess the safety of materials that may remain in the mouth for an
individual's lifespan.

But the search for new and improved dental restorative materials and
techniques must continue.  The principle of cavity preparations must be
based on "tooth saving techniques" rather than "extension for
prevention," i.e., the treatment of caries must maintain tooth
structure to prevent the need for large restorations and endodontics
sequelae.  Research is needed to determine the clinical significance of
leakage; assess the relationship of restorative materials and
techniques to post-operative pain, pulp pathology, and potential cusp
fracture or tooth loss; and develop improved and standardized methods
for evaluation of restoration quality that are correlated with clinical
data on caries and caries progression.  Comparisons of in-vitro data
with in-vivo data for assessment of restoration performance should
discriminate between statistical significance and clinical relevance.

Center Goals

The CCCPODs are intended to serve as focal points for strengthening the
nation's oral health clinical research capability and facilitating the
development of new approaches to the prevention and treatment of caries
and failed restorations.  Center goals will include:  (1) developing
state-of-the-art clinical research capacity through supporting shared
resources and facilities (core units) that strengthen and expand
relevant clinical research; (2) providing a nucleus around which
additional clinical studies funded through government or private
sources can be conducted; and (3) facilitating and stimulating clinical
research to improve oral health in children, adults, senior citizens,
and other people at high risk for caries.  These high-risk individuals
include persons with systemic diseases or oral conditions that increase
the risk for recurrent disease, segments of the population that have
not shared in the gains in oral health seen in much of the U.S.
population.

Some examples of research areas to be addressed might include, but
should not be limited to, studies:

o  Identifying high-risk patients before overt infection and clinical
disease occurs.

o  Improving clinical diagnosis of carious lesions.

o  Establishing criteria for clinical decision-making, for both
non-invasive and invasive methods for treating the infection throughout
its clinical course.

o  Developing databases for clinical decision-making.

o  Identifying which stages in the infection can be handled by
preventive measures and which stages require concurrent operative
intervention.

o  Conserving tooth structure through non-invasive or minimally
invasive intervention.

o  Developing criteria for when and how to replace existing
restorations.

o  Assessing treatment patterns in preventive and operative dentistry.

o  Developing methods to increase the longevity of dental restorations.

o  Establishing optimal cavity preparations for different restorative
materials.

o  Testing methods for assessing oral health and disease status,
including reproducible clinical diagnoses, and developing interventions
to prevent and treat caries in medically compromised patients.

o  Investigating the use of ultrasonics to estimate remaining dentin
thickness between cavity walls and underlying pulp.

o  Investigating the use of fiber optic/microscopic techniques for
diagnosis and treatment of dental hard tissues.

o  Investigating the use of dentinal fluid to assess the health of the
underlying pulp.

o  Investigating the use of new technologies such as laser doppler flow
meters to measure pulpal blood flow to evaluate pulpal health of
traumatized teeth.

o  Developing techniques for sealing dentin, enamel, and cementum in a
manner that prevents their demineralization.

Other examples of potential CCCPOD-supported activities and
collaborations include:

o  Enhancing opportunities for translating new scientific  knowledge
into improved methods for preventing primary and secondary caries
infections and clinical sequelae and failure of  restorations.

o  Encouraging effective interdisciplinary collaboration among
researchers and clinicians with expertise relevant to this initiative,
especially interaction among disciplines of dental materials science,
molecular biology, biochemistry, cariology, pulp biology, and clinical
operative dentistry.

o  Developing and providing core research resources to expand and
strengthen ongoing funded clinical research projects by, for example:

- Expanding biostatistical participation in implementing projects.

-  Developing improved computer facilities for direct data entry.

-  Developing and providing laboratory services or facilities to
enhance ongoing research.

-  Fostering the training of clinical research scientists by providing
improved opportunities for collaboration and expanded environments for
clinical research.

o  Developing research opportunities utilizing health care outreach
activities in rural areas, dental clinics, minority communities,
nursing home settings, senior centers, work sites, or other settings
where individuals at high risk of oral disease can be reached for
participation in separately funded clinical research  projects.  Core
resources may not be used to support the cost of delivering health care
services, but may be used to develop and utilize opportunities for
implementing relevant clinical studies.

Center Characteristics

Strong and effective scientific leadership must be provided.  The
application should specify provisions that will be made for replacement
of the director with a suitably qualified alternative should
circumstances require.  CCCPOD directors will be responsible for the
organization and operation of the program and for communication with
the CCCPOD Advisory Panel and with the NIDR on scientific and
administrative matters.   Directors will be responsible for maintaining
high-quality research efforts and for ensuring effective collaboration
among CCCPOD scientists.  It is essential that the various elements of
the CCCPOD be interrelated and that their utilization facilitates an
enhanced quality and quantity of clinical oral health research.

Each CCCPOD must be a clearly defined organizational entity within a
dental school or dental research institution with a director
responsible for management of the Center.  Funding is intended to
support core research resources and facilities that will accelerate the
scientific productivity of, or enrich the potential clinical "pay-offs"
from, clinical research projects pertinent to improving oral health in
children, adults, and high-risk populations.  The Center must include
a minimum of three core units.  One unit must be an administrative
core.  A biostatistics core unit is also mandatory.  The biostatistics
component may be incorporated into the administrative core.  Other core
resources proposed must directly relate to ongoing and planned oral
health clinical research relevant to adults and high-risk groups.

Examples of core units include:

o  Diagnostics Core:  May provide and develop methods and/or
instrumentation to detect early signs or markers of oral disease or
dysfunction and to monitor the efficacy of treatments.  Particular
attention should be devoted to defining criteria to ascertain
appropriate timing of replacement of restorations and the calibration
of clinicians in diagnoses related to operative dentistry.

o  Laboratory Core:  May provide resources to carry out adjunct studies
on clinical trial patients or general population samples.  Laboratory
cores could, for example, include:  biomaterials sciences, pulp
biology, behavioral/social sciences, pharmacology, microbiology,
immunology, nutrition, or molecular biology.  The composition of the
laboratory core(s) should reflect  the resource needs and added
research opportunities arising from ongoing clinical research
activities.

o  Unique Clinical Facilities Core:  May provide resources to
facilitate research that cannot be carried out in conventional
health-care settings, such as the use of mobile units for clinical
studies involving elderly or physically disabled individuals or
work-site based dental operatories for preventive interventions with
employed adults.  Collaboration with general dental practice is
essential.  Priority must focus on "real life dentistry" rather than
operative dentistry performed by specially trained dentists who work
without time constraints in a dental school environment on selected
patients.

o  Administrative Core:  Funds for the Center Director and
administrative staff will be provided.  This core unit should ensure
that CCCPOD participants are provided with shared support services that
enhance their research.  The Director will be responsible for
monitoring the overall quality and the scope of activities.  The
administrative core may provide limited funds to facilitate improved
accrual of patient populations for pilot studies and for subsequent
studies supported through collateral funding.  Complementary funding
from sources other than NIDR should be obtained for costs associated
with information transfer and outreach programs.  The core will convene
an advisory panel of experts from outside the applicant institution at
least once a year to review Center activities.  The Center Director
will be expected to utilize panel recommendations in guiding and
strengthening CCCPOD activities.  Pilot and feasibility studies also
will be administered through the administrative core and will remain
under the purview of the CCCPOD Director.

o  Biostatistics, Experimental Design, Data Management and Analysis
Core:  This core may provide the staff and other resources needed to
enhance programs of clinical research through the application of
epidemiology, sampling, biostatistics, and related support
methodologies.  Specifically, it should foster and strengthen
biostatistician-clinical investigator interaction in the design and
conduct of clinical research.

The above examples are not intended to describe the full range of
possible activities nor to direct applicants to these areas.  Inclusion
of core units of all these types in a single proposed center is not
required nor even necessarily advisable.  In structuring CCCPOD
applications, applicants should consider their institution's areas of
special clinical research potential, its profile of currently funded
clinical research projects, and determine which areas present the
greatest need for shared resources.  Cores may provide support for
personnel, including the necessary expertise to direct cores,
equipment, supplies, services, facilities, and limited travel.  In
addition, they may provide funds for the integration of activities with
other research centers in the same or related biomedical or
behavioral/social science areas for purposes of program enrichment.
This award also will provide up to 20 percent of total Center costs for
pilot and feasibility studies. These are the only research studies that
will be directly supported by this mechanism.  Each pilot or
feasibility study should not extend for a period of more than two
years.

The goals are to provide start-up funds for new projects, to train
young investigators under the direction of clinical scientists and to
encourage established investigators to utilize recent research
developments.  Detailed procedures for the review and selection of
feasibility/pilot studies should be included in the application.

It is anticipated that following the completion of the pilot or
feasibility studies, investigators will apply for independent support
to extend preliminary findings.  The CCCPOD will not provide direct
funding for ongoing research projects.  These must be funded through
other sources or support mechanisms.  Policies governing research grant
programs of the NIH will prevail.

APPLICANTS FROM INSTITUTIONS THAT HAVE A GENERAL CLINICAL RESEARCH
CENTER (GCRC) FUNDED BY THE NIH NATIONAL CENTER FOR RESEARCH RESOURCES
MAY WISH TO IDENTIFY THE GCRC AS A RESOURCE FOR CONDUCTING THE PROPOSED
RESEARCH.  IN SUCH A CASE, A LETTER OF AGREEMENT FROM EITHER THE GCRC
PROGRAM DIRECTOR OR PRINCIPAL INVESTIGATOR COULD BE INCLUDED WITH THE
APPLICATION.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

The NIH policy, as applied to this RFA, is that applicants for NIH
clinical research grants will be required to include minorities and
women in study populations so that research findings can be of benefit
to all persons at risk of the disease, disorder or condition under
study; special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 (rev.
9/91) in items 1-4 of the Research Plan and summarized in item 5, Human
Subjects.  Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, the NIH recognizes that it may not be feasible or appropriate
in all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by the applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.

If the representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed and the
justification for the selected study population is inadequate, it will
be considered a scientific weakness or deficiency in the study design
and will be reflected in assigning the priority score to the
application.  For foreign awards, the policy on inclusion of women
applies fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States' populations,
including minorities.

All applications for clinical research submitted to the NIH are
required to address these policies.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 31, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone of the Principal
Investigator (PI), the identities of other key personnel and
participating institutions, and the number and title of this RFA.
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 is helpful in planning for the timely review of
applications.  It allows NIDR staff to estimate the potential review
workload and to avoid possible conflict of interest in review.

The letter of intent is to be addressed to:

Joyce A. Reese, D.D.S, M.P.H.
Director, Biomaterials, Pulp Biology and Dental Implants Program
Extramural Program
National Institute of Dental Research
Westwood Building, Room 505
Bethesda, MD  20892-4500
Telephone:  (301) 496-7884
FAX:  (301) 496-4180

APPLICATION PROCEDURES

Applications are to be prepared on form PHS 398 (rev. 9/91),
Application for PHS Grant, which may be obtained from the Office of
Grants Inquiries, Division of Research Grants National Institutes of
Health, 5333 Westbard Ave, Room 449, Bethesda, Maryland 20892,
telephone 301-496-7441, and from most institution's Office of Research
and Sponsored Programs.  The RFA label available in the PHS 398
application form must be affixed to the bottom of the face page of the
original application.  Failure to use this label could result in
delayed processing of the application such that it may not reach the
review committee in time for review.  In addition, in order to identify
the application as a response to this RFA, check "yes" on item 2a on
the face page of the application and enter the RFA title "Clinical Core
Centers for Preventive and Operative Dentistry" and the RFA number
DE-92-04.

The instructions accompanying form PHS 398 are to be followed as much
as possible, but some modifications will be necessary.  For example, a
new Table of Contents must be prepared giving page numbers for all
items in the application.  Pagination must be consecutive throughout
the application.  Each project, including pilot or feasibility projects
and core units, must be identified by number and PI.  A consolidated
budget for the complete CCCPOD for the entire project period must be
presented (use page 5, form PHS 398).  Separate, detailed, annual and
total budgets for the entire project period for each project and core
must be presented (use pages 4-5, PHS 398).  In addition, a summary
table should be included providing budget totals for each pilot project
and core unit, as well as the entire program, for all years of support.
Direct and indirect costs are to be given.  Funds may be requested for
professional, technical, and administrative personnel, consultant
services, equipment, supplies, travel, patient costs directly related
to the research, minor renovations, and other costs.  Detailed
justification of budget requests will be required.  In both planning
and presenting the total project and each core or pilot/feasibility
project, specific attention should be given to efforts to contain costs
and ensure cost-competitive implementation of research goals.  In
accordance, provide a summary of financial support from NIDR and
non-NIDR sources for studies that will complement and expand the
program supported by the CCCPOD grant.  Explain how these will further
the goals of the CCCPOD and make it more cost effective.  Awardees will
be expected to update this information on an annual basis.

Under Research Plan, describe the goals of the center and explain how
the proposed core resources and pilot/feasibility studies will
contribute toward achieving those goals.  Describe the administrative
structure, the responsibilities of the center director, individual
investigators, advisory groups, and the proposed mechanisms for
monitoring scientific progress.

Each core unit must be presented as in a research project grant
application, that is, the instruction pages 19-24 of form PHS 398
should be followed.  The 25 page limitation will apply to each core
unit and pilot/feasibility study.  Abstracts (page 2, form PHS 398)
must be completed for the entire application and for each core unit,
and each pilot or feasibility study proposed for initiation during the
first two years of the award.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed exact photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892-4500**

At the time of submission, two additional copies of the  application
must also be sent to:

H. George Hausch, Ph.D.
Chief, Scientific Review Office
Extramural Program
National Institute of Dental Research
Westwood Building, Room 519
Bethesda, MD  20892-4500
Telephone:  (301) 496-7658

Applications must be received by December 3, 1992.  If an application
is received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

Applications will be evaluated by a special review committee, convened
by the NIDR Scientific Review Branch.  Prior to the initial review, a
triage mechanism may be used to screen applications that are
noncompetitive to the RFA.  The PI and the institution will be notified
if this occurs.  "Applicant interviews or site visits may not be
conducted, and the application should therefore be complete".
Secondary review will be conducted by the National Advisory Dental
Research Council.  Applications must be received by December 3, 1992,
so they can be reviewed and considered for funding in Fiscal Year 1993.
Applications judged to be noncompetitive or nonresponsive to the RFA,
and those received after December 3, 1992 or exceeding the budget
limitation will be returned without review.  Waivers of the receipt
deadline and budget limitation will not be granted.

Major factors to be considered in evaluation of applications include:

o  The scientific, clinical and administrative qualifications,
experience and commitment of the center director and his/her ability to
provide effective leadership;

o  The potential of the CCCPOD to advance and promote high-quality
clinical dental research relevant to improving the oral health in
high-risk and adult populations;

o  The adequacy of plans to ensure efficient collaboration,
interaction, and dissemination of information among investigators and
effective monitoring of progress toward CCCPOD goals. e.g., external
and internal review committees;

o  Availability of a base of ongoing, meritorious clinical research
projects or projects with firm funding commitments permitting optimal
utilization of CCCPOD resources;

o  The commitment of the institution to the proposed CCCPOD;

o  The appropriateness and relevance of proposed pilot or feasibility
projects to be conducted during the first two years of the award;

o  The scientific merit, appropriateness and relevance of the proposed
pilot/feasibility projects, and core units, the soundness of the
methodology proposed in the research plan;

o  The appropriateness and relevance of the proposed clinical and
laboratory facilities;

o  The competence of individuals participating in core units and
pilot/feasibility studies and their commitment to the goals of the
CCCPOD;

o  The appropriateness of the budget;

o  The feasibility and relevance of plans for fostering training in
clinical research methodology for dental faculty and new investigators
through utilizing existing funded projects, pilot/feasibility projects,
and/or training grant mechanisms supported by the NIH or by other
public or private funds; and

o  The availability of appropriate clinical and study populations; the
effectiveness of efforts to include women and minorities in study
populations, to the extent consistent with the projected conduct of
pilot and feasibility studies.

The inclusion of pilot projects or cores deemed to have limited
scientific merit or that are considered peripheral to the CCCPOD's
objectives, may be considered a reflection of the center director's
judgment and may adversely affect the rating of the application.
Component pilot projects or cores lacking significant and substantial
merit will not be recommended for further consideration.  Pilot
projects or cores with only adequate merit that are not deemed
essential to success of the CCCPOD may be recommended for deletion.

AWARD CRITERIA

In addition to scientific merit, program priorities, and program
balance, the total cost of the CCCPOD to the NIDR will be considered by
NIDR staff and the National Advisory Dental Research Council in making
funding recommendations.  One consideration will be the extent to which
complementary projects, supported from non-NIDR funds, contribute to
the cost-effectiveness of the proposed CCCPOD.  In circumstances in
which applications have similar scientific merit, but vary in
cost-competitiveness, the NIDR is likely to select the more
cost-competitive application for funding.  Applicants are encouraged to
seek additional support from public and private sector sources, such as
industry, foundations, or other government agencies to support studies
that expand and complement the research supported by the CCCPOD.  A
description of the objectives and funding for these studies must be
included in the application.  Following funding, interim peer review to
evaluate progress may be conducted by the NIDR.  Funding for subsequent
years may be contingent on successful outcomes of such reviews.

INQUIRIES

The opportunity to clarify any issues or questions from potential
applicants are welcome.

Direct inquiries regarding programmatic issues to Dr. Joyce A. Reese at
the address listed under LETTER OF INTENT.

Direct inquiries regarding fiscal matters to:

Ms. Theresa Ringler
Chief, Grants Management Section
National Institute of Dental Research
Westwood Building, Room 518
Bethesda, MD  20892
Telephone:  (301) 496-7437
FAX:  (301) 402-1260

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.1212.  Awards will be made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241 and 285) and administered under PHS
grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part
74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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