COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY

NIH GUIDE, Volume 26, Number 25, August 1, 1997

RFA:  DE-97-002

P.T. 04; K.W. 0715048, 0710030

National Institute of Dental Research

Letter of Intent Receipt Date:  March 1, 1998
Application Receipt Date:  May 8, 1998

THIS REQUEST FOR APPLICATIONS (RFA) IS A REVISION OF THE RFA
APPEARING IN THE MAY 30 ISSUE OF THE NIH GUIDE.  THIS REVISION
CORRECTS THE RESEARCH OBJECTIVES SECTION IN THE FULL TEXT OF THE
RFA.

PURPOSE

The National Institute of Dental Research (NIDR) invites
applications for Comprehensive Oral Health Research Centers of
Discovery (COHRCD). Each COHRCD will be organized around an
unifying scientific theme related to dental, oral and craniofacial
diseases and disorders. Individual COHRCDs will encompass a full
range of outstanding multidisciplinary research pertinent to these
diseases and disorders and will be expected to: include basic,
translational and applied research projects with behavioral, health
services and clinical research components; accelerate transfer of
research findings to application by health professionals and the
public as well as to facilitate the development of marketable
products and other effective health promoting interventions;
support research concerning demonstration and outreach programs;
and enhance the training of health professionals and the public
concerning health promotion and the prevention, improved diagnosis
and treatment of the dental, oral or craniofacial diseases and
disorders relating to the chosen theme.

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), Comprehensive Oral
Health Research Centers of Discovery, is related to the priority
area of 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: 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by all domestic for-profit and non-
profit organizations, public and private, including universities,
colleges, hospitals, laboratories, units of State and local
governments and eligible agencies of the Federal government.
Applicants need not have submitted proposals or been awarded funds
for the developmental grants for these centers (RFA:  DE-96-004)
nor are applicants required to use the same central theme as the
one that may have been supported through the developmental grants.
Foreign organizations are not eligible to apply;  however, domestic
applications may include international components.  The NIDR
encourages applications that include investigators who are
racial/ethnic minority individuals, women and persons with
disabilities.  Although an application must be submitted from a
single institution, collaborative arrangements with other
institutions are strongly encouraged.  Also, applications are not
restricted to traditional dental, oral and craniofacial research
settings.

MECHANISM OF SUPPORT

The mechanism for the support of applications in response to this
RFA is the Comprehensive Center (P60).  Choice of an appropriate
theme and the direction and execution of the proposed activities
are solely the responsibility of the applicant.  This RFA is a one-
time solicitation by NIDR and applicants may apply for and receive
up to five years of support.  The earliest possible award date will
be May, 1999.

FUNDS AVAILABLE

It is anticipated that the NIDR will allocate approximately $16.5
million to support seven COHRCDs provided that sufficient
applications of high scientific merit are received.  The direct
costs requested for the initial year of these applications may not
exceed $1.5 million.  The $1.5 million direct cost limit includes
any indirect costs associated with subcontracts listed as part of
the application.  Requested increases in direct costs for
subsequent years may not exceed 3 percent.  Although support for
this program is provided for in the financial plans of the NIDR,
the award of grants pursuant to this RFA is contingent upon the
availability of appropriated funds.  Policies that govern research
grant programs of the National Institutes of Health (NIH) will
prevail.

RESEARCH OBJECTIVES

Background

The NIDR has very effectively utilized the center concept to
advance research in oral biology, periodontology, cariology,
craniofacial anomalies, aging and materials science.  Specialized
research centers were designed to intensify research in these areas
and have been and continue to be successful in accomplishing this
aim.  However, it is becoming increasingly apparent that future
meaningful insights concerning the mechanisms involved in the
induction and progression as well as in the prevention, diagnosis
and treatment of dental, oral and craniofacial diseases and
disorders must consider not only basic research but also extensive
integration of basic, clinical and behavioral sciences; health
services and epidemiologic research as well as demonstration,
education and outreach activities.  The establishment of the
COHRCDs addresses this need to accommodate all aspects of certain
dental, oral and craniofacial disease processes by stimulating
increased collaborations, partnerships and leveraged funding.  It
is an opportune time to implement this expansive approach to
optimally utilize the current rapid advances being made in
biomedical and behavioral sciences.  To redirect efforts towards
the far-reaching aims described in this RFA, a previous RFA (DE-96-
004,  Developmental Grants:  Comprehensive Oral Research Centers)
announcing support to develop plans for these centers was issued.

Goals and Objectives

It is the intent of the current RFA to provide support for COHRCDs. 
These comprehensive centers will broaden the expertise available
and approaches taken in addressing major research themes within the
mission of the NIDR.  Choice of the theme is the responsibility of
the applicant.  The objectives of the COHRCDs are to: (1) foster
integrated biomedical, behavioral, social science and health
services research and development at the fundamental, clinical and
applied levels and to facilitate transfer of the acquired findings
to marketable products and other effective health promoting
interventions; (2) initiate and expand research on community
education, screening, counseling and related services programs; and
(3) promote research related to education of health professionals
and the public concerning the etiology, prevention, diagnosis and
treatment of dental, oral and craniofacial diseases and disorders.

Five organizational components are required for each COHRCD: (1) a
biomedical, behavioral, social science and health services research
base; (2) a demonstration research component that will, among other
things, provide a means for developing effective and efficient
outreach and community liaison functions; (3) a component that
facilitates and manages research concerning education of health
professionals and future scientists as well as the immediate and
extended communities within which the center resides; (4) a
technology transfer component that would support developmental
activities to move fundamental and clinical research products and
processes from the laboratory to the marketplace; and (5)
administrative and research support cores, including biostatistics,
appropriate to the focus of the research. While a strong base of
biomedical or behavioral research is an essential prerequisite, all
components indicated above need not be developed to the same
degree, acknowledging the variety of strengths present within a
given group of researchers.  Details of the various components of
the COHRCDs including all collaborating units as well as
acquisition of complementary funding to expand the potential
scientific yield of each center must be addressed.  Shared
resources will be used to enhance productivity, stimulate
collaborative efforts and increase cost effectiveness.

Award of a COHRCD indicates that the applicant group and the
research they propose is at a level of excellence unparalleled in
a field.  A COHRCD might be located within a single institution
but, preferably, would involve consortia with other institutions
such as universities, research institutes, hospitals, computer
facilities, regional centers, health departments, industry and
primate centers.  These comprehensive centers may include free-
standing specialized centers, program projects, and investigator-
initiated research projects as integral components and could
typically include research cores, newly proposed research projects,
support for feasibility studies and support for demonstration and
outreach research.  Support will not be provided for routine
patient care costs or training expenses.  The strength of the
COHRCDs lies in the fact that, as thematically-based organizations,
they will be capable of incorporating the full range of expertise
needed to accomplish the desired objectives.

Each COHRCD must be a clearly defined organizational entity with a
Director responsible for management of the center.  Evidence of
his/her strong and effective scientific leadership must be
provided.  The Director will be responsible for the organization
and operation of the center, for communication within the center
and with the NIDR on scientific and administrative matters, for
maintaining high quality research efforts and for ensuring
effective collaboration and communication among scientists and
cooperating institutions.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority
groups and their subpopulations must be included in all NIH
supported biomedical and behavioral research projects involving
human subjects, unless a clear and compelling rationale and
justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects
should read the "NIH Guidelines for Inclusion of Women and
Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Vol.
23, No. 11, March 18, 1994.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 1, 1998, a
letter of intent that includes the number and title of this RFA and
a descriptive title for the COHRCD grant.  Potential applicants
also are asked to provide the name, mailing address, FAX, email
address and telephone number of the Center Director and the
identities of other key personnel and participating institutions
and departments.

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 estimating the potential
review workload and avoiding conflict of interest in the review.

The letter of intent is to be sent to Dr. Ann L. Sandberg at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be
used in applying for these grants.  These forms are available at
most institutional offices of sponsored research and may be
obtained from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@od.nih.gov.

The RFA label available in the PHS 398 application form kit must be
affixed to the bottom of the face page of the original and the
original must be placed on top of the entire package. 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, the RFA title (Comprehensive Oral Health
Research Centers of Discovery) and number DE-97-002 must be typed
in item 2 of the face page of the application form and the YES box
must be checked.  The instructions accompanying Form PHS 398 must
be followed as far as possible.

Submit a signed, typewritten original of the application, including
a cover letter, the checklist and three signed photocopies in one
package to:

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Dr. H. George Hausch
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-38D
45 Center Drive MSC 6402
Bethesda, MD 20892-6402

Applications must be received by May 8, 1998.  If an application is
received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIDR.  If NIDR staff finds that the
application is not responsive to the RFA, is incomplete or exceeds
the direct cost limit, it will be returned without further
consideration.  Waivers of the receipt deadline and budget
limitation will not be granted.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDR in accordance with the review
criteria stated below.  As part of the initial merit review,
applications may be subjected to a streamlined review process to
determine their scientific merit relative to other applications
received in response to the RFA.  The NIDR will withdraw those
judged to be in the bottom tier of applications.  Those determined
to be competitive will be evaluated for scientific and technical
merit by the review committee.   Secondary review of the
applications will be conducted by the National Advisory Dental
Research Council.

Factors to be considered in the evaluation of the applications
include:

o  institutional (preferably multi-institutional) environment and
the institution's(s') commitment to the COHRCD;

o  evidence of an organizational structure that will promote
interdisciplinary and multifactorial research that includes all of
the required components;

o  potential impact of proposed activities on future health
benefits within the chosen thematic area;

o  scientific and administrative qualifications, experience and
commitment of the COHRCD director as well as his/her ability to
provide effective leadership and the arrangements for an assistant
director to administer the center in the director's absence and
replace the director should it become necessary;

o  qualifications of the key personnel;

o  evidence of the establishment of effective collaborations among
COHRCD investigators, cores and other groups (public health
organizations, other institutions, etc.);

o  scientific excellence of the proposed COHRCD's basic, clinical,
health services and behavioral research base as well as other
components which applicants may wish to include (e.g.,
epidemiologic research);

o  appropriateness and relevance of the cores, their modes of
operation and the suitability of their facilities;

o  the provision of an environment conducive to training of health
professionals;

o  approach and potential effectiveness of outreach research;

o  evidence that the COHRCD will be able to establish partnerships
with other research organizations and agencies that can provide
educational and outreach activities;

o  feasibility of success of the demonstration research;

o  evidence of the availability of appropriate study populations
and ability of the COHRCD to recruit adequate samples consistent
with the NIH guidelines;

o  evidence of the ability to develop potentially marketable
products
and other effective interventions;

o  appropriateness of the budget for the proposed activities;

o  ability to obtain and effectively utilize leveraged funding; and

o  a plan for monitoring and evaluating the productivity of each of
the components and the entire COHRCD.

AWARD CRITERIA

The earliest anticipated date of award is May, 1999. Applicants
should be aware that, in addition to scientific merit, program
priorities and program balance, the total cost of the proposed
project and the availability of funds will be considered by the
NIDR staff and the National Advisory Dental Research Council in
making funding recommendations.  In addition, the NIDR values
complementary funding from other public and private sources
including foundations and industrial concerns.  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.

INQUIRIES

Written, email 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. Ann L. Sandberg
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-24A
45 Center Drive MSC 6402
Bethesda, MD 20892-6402
Telephone:  (301) 594-2419
FAX:  (301) 480-8318
Email:  ann.sandberg@nih.gov

Direct inquiries regarding grants management issues to:

Mr. Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
45 Center Drive, MSC 6402
Bethesda, MD 20892-6402
Telephone:  301-594-4800
Email:  Martin.Rubinstein@nih.gov

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.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all
tobacco products.  In addition, Public Law 103-227, the Pro-
Children Act of 1994, prohibits smoking in certain facilities (or
in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early
childhood development services are provided to children.  This is
consistent with the PHS mission to protect and advance the physical
and mental health of the American people.

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