Full Text DE-92-03

PERIODONTAL DISEASES RESEARCH CENTERS

NIH GUIDE, Volume 21, Number 12, March 27, 1992

RFA:  DE-92-03

P.T. 04

Keywords: 
  Periodontal Diseases 
  Pathogenesis 
  Etiology 
  Epidemiology 
  Diagnosis, Medical 
  Disease Prevention+ 


National Institute of Dental Research

Letter of Intent Receipt Date:  August 17, 1992
Application Receipt Date:  September 16, 1992

PURPOSE

The National Institute of Dental Research (NIDR) invites applications
for support of categorical Periodontal Diseases Research Centers to
conduct multidisciplinary research on the etiology, epidemiology,
prevention, risk assessment and diagnosis, pathogenesis, and treatment
of the periodontal diseases.

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.  This Request
for Applications (RFA), Periodontal Diseases Research Centers, is
related to the priority area of improving oral health. Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (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

Applications may be submitted by United States non-profit, public and
private organizations, such as dental and medical schools, universities
and research institutions.  Applications from foreign institutions are
not eligible.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health specialized center
grant (P50).  Funding for the five existing NIDR-supported Periodontal
Diseases Research Centers will terminate in Fiscal Year 1993.  New
awards will be made for five years, and the earliest funding date is
August 1, 1993.  This RFA is a one-time solicitation; issuance of a
subsequent request for new and competing continuation applications is
dependent on program needs and the availability of funds.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant institution;
however, periodic consultation with NIDR staff will be expected.  This
may take the form of periodic site visits.

FUNDS AVAILABLE

The NIDR expects that $1 million in direct costs will be available to
fund grants in response to this RFA.  If a sufficient number of highly
meritorious applications are received, it is anticipated that two or
three awards will be made.  Each award will not exceed $500,000 in
direct costs for the first year.  However, where indirect costs are
assigned to a subcontract and counted as direct costs on the parent
grant, the allowable direct cost may be exceeded by the amount of the
indirect costs assigned to the subcontract.  Increases in recurring
costs for subsequent years will be limited to four percent.  Award of
grants pursuant to this RFA is contingent upon the receipt of funds.

RESEARCH OBJECTIVES

Background

Periodontal diseases include a constellation of primarily inflammatory
lesions initiated by microorganisms, which adversely affect the
gingiva, periodontal connective tissues and alveolar bone.  The
associated destruction of periodontal supporting structures is one of
the leading causes of tooth loss.  Reports of the average prevalence of
gingivitis range from forty to nearly 100 percent of the population.
Studies of employed United States adults show that about 50 percent of
18-19 year old subjects exhibit at least one periodontal site with 2 mm
or more attachment loss.  Prevalence increases to about 80 percent at
35-39 years of age, and exceeds 90 percent for those over 60 years old.
Prevalence and severity of the various periodontal diseases appear to
be substantially greater in certain populations, particularly
disadvantaged groups and medically-compromised patients.  Most of the
early-onset and rapidly progressive forms of periodontitis have been
associated with systemic disturbances and periodontal lesions are
reported as being more frequent and severe in patients with diabetes,
neutrophil abnormalities, and some immunodeficiency disorders.  There
is considerable evidence that the periodontal diseases are initiated by
microorganisms that colonize the teeth and adjacent periodontal
tissues.  Significant progress has been made in defining the oral
microflora and in describing microbial subsets with pathogenic
potential.  Moreover, a substantial body of knowledge has evolved to
explain mechanisms of periodontal tissue destruction and to provide
strategies for restoration and maintenance of periodontal health. The
NIDR encourages the submission of center grant applications that
combine these research findings with new, innovative and
multidisciplinary research, which will make fundamental contributions
to eliminating periodontal diseases as causes of tooth loss.

Goals of the Centers

The primary goal of the Periodontal Diseases Research Centers program
is to support multidisciplinary basic and clinical research leading to
the prevention and control of the periodontal diseases.  The following
research areas are given as examples that may be particularly
appropriate for inclusion in the application for support. However, no
priorities are implied and the examples should not constrain applicants
from proposing other research topics or investigative approaches.

o  Apply molecular methods for increasing our understanding of soft and
hard tissue destruction resulting from the periodontal diseases,
elucidate the fundamental mechanisms involved in normal metabolism,
pathogenic destruction and repair of the periodontal tissues, and
employ these new methods to further describe the natural history of the
disease process.

o  Further describe the epidemiology, characteristics and progression
of periodontal diseases in specific populations, including, but not
limited to, medically compromised patients, women, racial and ethnic
minorities, children, older adults and individuals with limited access
to health care services.

o  Evaluate the relative efficacy of molecular (salivary, genetic),
behavioral, social or other markers in predicting the risk of
periodontal diseases for individual patients.

o  Develop and test new diagnostic methodologies that can be employed
clinically to detect the onset and progression of periodontal diseases.

o  Investigate the potential of vaccines and other preventive
strategies to deter specific bacterial colonization of tooth and
mucosal surfaces.

o  Improve existing therapeutic methods and their delivery, with an
emphasis on periodontal repair and regeneration.

Center Characteristics

Each research center will be an identifiable unit within a larger
institution, already committed to some aspects of research relevant to
the biology of the periodontium in health and disease.  The center will
consist of a cluster of interrelated projects, some of which may be
fundamental and others may involve epidemiological, clinical, or
behavioral studies.  Some funds may be used to support pilot projects.
These various projects should not constitute a collection of
individual, unrelated investigations more appropriately supported by
individual research project or small grants.  Core resources such as
animal facilities, computer services, and equipment to be shared by
investigators will be provided, although budgetary constraints preclude
expenditures for very expensive items of equipment or major
renovations.

The center director will provide strong and effective scientific and
administrative leadership.  The director will be responsible for
maintaining high quality research, ensuring effective collaboration
among individual investigators and communicating with NIDR staff.  The
director will be assisted by an advisory committee of consultants that
includes members who are not associated with the applicant institution.
It is expected that this advisory committee would have been consulted
during preparation of the application and will advise the director on
the merits and progress of present and future research projects.

STUDY POPULATIONS

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

NIH policy 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 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 carefully assess the feasibility of including
the broadest possible representation of minority groups.  However, 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.

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 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.

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 August 17, 1992, a
letter of intent that includes a descriptive title of the proposed
center, the name, address and telephone number of the center director,
the identities of other key personnel, 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 subsequent applications, the
information that it contains is helpful in planning for the review of
applications.  It allows NIDR staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be addressed to:

Matthew Kinnard, Ph.D.
Acting Director, Periodontal Diseases Program
Extramural Program
National Institute of Dental Research
5333 Westbard Avenue
Westwood Building, Room 509
Bethesda, MD  20892
Telephone:  (301) 496-7784

APPLICATION PROCEDURES

Prospective applicants are advised to communicate with program and
grants management staff of the NIDR Extramural Program as early as
possible in the planning phase of application preparation.  NIDR staff
are available to assist applicants to ensure that the objectives,
structure, and the budget format for the proposed center are
acceptable.

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892; and from the program
administrator named above.

The RFA label available in the form PHS 398 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, the RFA title and number must be typed in item 2a of the face
page of the application form and the YES box checked.

The instructions accompanying form PHS 398 must be followed as far as
possible, but some modification 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 research and pilot project and core must be
identified by number and investigator.  A consolidated budget for the
complete center for the entire project period must be presented (see
page 5, form PHS 398).  Separately detailed, annual and total budgets
for the entire project period for each research project and core must
be presented (use pages 4-5, form PHS 398).  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 the budget
requests is required.

Provide a summary of financial support from non-NIDR sources for
studies that will complement and expand the program supported by the
NIDR.  Explain how these studies will further the goals of the center
and make it more cost effective.

Under Research Plan, describe the goals of the center and discuss the
background and significance of the topics being addressed.  Explain how
each research and pilot project and the cores will contribute to
achieving those goals.  Describe the organizational and administrative
structure, the responsibilities of the director and individual
investigators, and the proposed mechanisms for monitoring scientific
progress.  Describe the relationship of all existing and pending
institutional research projects that may be relevant to the center,
regardless of funding source.

Each research project must be presented as in a research project grant
application, that is, the instruction pages 19-24 of form PHS 398 must
be followed.  Each project must be described within the 25-page
limitation that applies to research project grant applications. Each
pilot project must be presented in 400 words or less.  Describe the
cores and explain how they will relate to the projects that will
utilize their resources.

Abstracts (page 2, form PHS 398) must be completed for the entire
application, each research project, the combined pilot research
projects, and the combined cores.

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

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

Dr. George Hausch
Chief, Scientific Review Office
Extramural Program
National Institute of Dental Research
Westwood Building, Room 519
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by September 16, 1992.  If an application
is received after that date, it will be returned to the applicant.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by NIDR staff for
completeness and responsiveness.  Applications that are incomplete,
nonresponsive to this RFA, or exceed the first year budget limit of
$500,000 in direct costs will be returned to the applicant without
further consideration.  However, whenever indirect costs are assigned
to a subcontract and counted as direct costs on the parent grant, the
allowable direct cost maximum may be exceeded by the amount of the
indirect costs assigned to the subcontract.  Waivers of the receipt
date deadline and budget limitation will not be granted.  Those
applications that are complete and responsive will be evaluated in
accordance with the criteria stated below for scientific and technical
merit by a special review committee convened by the NIDR Scientific
Review Office.  Applications may be subjected to triage by the review
committee to determine the scientific merit relative to other
applications received in response to this RFA.  The NIDR will withdraw
from further competition those applications judged by triage to be
noncompetitive for award and notify the applicant and institutional
official.  Applications judged to be competitive will undergo further
scientific merit review.  This review may involve an applicant
interview or site visit.  The second level of review will be provided
by the National Advisory Dental Research Council.

Major factors to be considered in the evaluation of applications
include:

o  The extent to which the center will promote advances in knowledge of
the biology of the periodontium and of the etiology, epidemiology, risk
factors and diagnosis, prevention, pathogenesis, and treatment of the
periodontal diseases, that could not be achieved or that would be
achieved more slowly if the component projects were funded separately.

o  The extent to which the various research and pilot projects and the
cores have been combined into an effective and cohesive program and the
adequacy of plans to ensure efficient collaboration, interaction, and
dissemination of information among investigators.

o  The scientific and administrative qualifications, experience and
commitment of the center director and his/her ability to provide
effective leadership. Provisions for replacement of the director if it
becomes necessary.

o  The competence of the center investigators and their commitment to
accomplishing the proposed research goals.

o  The scientific merit of each proposed project, including its
significance, originality, feasibility, experimental design, and
methods, including those for data management and analysis.

o  The institutional environment, including its commitment to the
proposed center, and to multidisciplinary, collaborative research of
the highest quality.

o  The adequacy of laboratory, clinical, and animal facilities to meet
the needs of the proposed studies.

o  The plans for establishing and developing the center, for monitoring
research, for reviewing changes in research directions, and for the use
of scientific advisory processes.

o  The availability and appropriateness of study populations and the
utilization of women and minorities as study subjects.

o  The technical merit and justification for core resources requested
and the appropriateness of the budget for each component project.

o  The appropriateness of the budget and period of support for research
and pilot projects, cores, and for the entire center.

o  For competitive renewal applications, the extent to which the goals
and specific aims of the previous application have been achieved.

The inclusion of projects that are deemed to have little or no
scientific merit or that are deemed peripheral to the center's
objectives may be considered a reflection of the director's judgement
and may adversely affect the rating.  Component projects without
significant and substantial merit will not be recommended for further
consideration.  If such projects are not deemed essential to the
success of the center, they will be recommended for deletion.

AWARD CRITERIA

Awards will be made on the basis of the abailability of funds with
consideration being given to program balance and also from results
obtained through the NIH peer review mechanism.  In addition
the NIDR appreciates the value of complementary funding from other
public and private sources, including foundations and industrial
concerns, for activities that will complement and expand those
supported by the NIDR. Such support will be considered in making any
award.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic issues
to Dr. Matthew Kinnard at the address under LETTER OF INTENT.

Direct inquiries concerning fiscal matters to:

Theresa Ringler
Grants Management Officer
Extramural Program
National Institute of Dental Research
Westwood Building, Room 518
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7437

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.121.  Awards are 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 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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