Full Text DE-96-004
NIH GUIDE, Volume 25, Number 13, April 26, 1996
RFA:  DE-96-004
P.T. 04

  Oral Diseases 
  Biomedical Research, Multidiscipl 

National Institute of Dental Research
Letter of Intent Receipt Date:  August 15, 1996
Application Receipt Date:  November 14, 1996
The National Institute of Dental Research (NIDR) invites applications
for Developmental Grants to support the planning of multidisciplinary
Comprehensive Oral Health Research Centers of Discovery (COHRCDs).
The aim of the COHRCD program is to support the full range of
outstanding multidisciplinary research on oral, dental and
craniofacial diseases and disorders.  Each COHRCD will be organized
around an unifying scientific theme pertinent to these diseases and
disorders and will be expected to:  include projects encompassing
basic research as well as translational and applied research
including behavioral, health services, and clinical research;
accelerate transfer of  research findings to application by health
professionals and the public and facilitate the development of
marketable products; support demonstration research and outreach
programs; and enhance the training of health professionals and the
public concerning health promotion and the prevention, improved
diagnosis and treatment of specific oral, dental, and craniofacial
diseases and disorders.  The one year planning grant is expected to
lead to the development of an organizational infrastructure necessary
for the establishment of a COHRCD and the eventual submission of an
application to support its activities.
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 RFA,
Developmental Grants:  Comprehensive Oral Research Centers, 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. 017-00100473-1) through
the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-512-1800).
Applications may be submitted by 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.  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
oral, dental, and craniofacial research settings.
This RFA will use the Developmental Grant (P20) mechanism.  Choice of
an appropriate theme and the planning, direction, and execution of
the proposed project are solely the responsibility of the applicant.
This RFA is a one-time solicitation with an anticipated award date of
July 1997.
It is expected that the NIDR will allocate approximately $2.0 million
to support developmental grants with a budget limit of $100,000
direct costs each during FY 97, provided that the applications
received are of high scientific merit.  The $100,000 direct costs cap
includes any indirect costs that are part of subcontract costs.
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.  Policies that
govern research grant programs of the National Institutes of Health
(NIH) will prevail.
Over the past four decades, the NIDR has championed the creation of
centers to foster basic science research in dental school
environments, to intensify a focus on several important infectious
oral diseases, and more recently to broaden the scope of dental
research.  These efforts have increasingly advanced the mission of
the NIDR and continue to evolve.  Now, as we approach the 21st
Century, new science opportunities are readily apparent in a climate
of major national changes in health care management, especially with
respect to university health science centers.  It is further evident
that most important human diseases require a paradigm that includes
integration among behavioral, environmental, and biological sciences
[e.g., inherited craniofacial-oral-dental diseases and disorders,
acquired craniofacial-oral-dental diseases and disorders (i.e.,
emerging and re-emerging infectious diseases, neoplastic diseases,
and chronic disabling diseases and disorders such as osteoporosis and
related bone disorders, temporomandibular joint disorders,
neuropathies and neurodegenerative diseases)].  It is also evident
that increased collaborations, partnerships and leveraging funding
are essential to maximize exemplary science and patient-oriented
opportunities.  Regarding the latter, the NIDR has previously
provided only limited support for demonstration research, a necessary
component for testing the effectiveness and efficacy of many types of
interventions, and an area recommended by an advisory panel that
reviewed NIDR's Centers Grant Program in 1985.
It is the intent of this RFA to offer support for collaborative
planning and development of the organizational infrastructure
necessary for a COHRCD.  Scientific areas covering a wide spectrum of
coordinated research efforts, from laboratory studies to outreach and
demonstration research programs, should be identified as should key
personnel and resources.  Organizational plans and agreements should
be established.  In these planning efforts, applicants are strongly
encouraged to identify and, where possible, secure commitments for
complementary resources that would expand the potential scientific
yield of COHRCD activities.
It is anticipated that the COHRCD program will focus on the need to
broaden the expertise and approaches taken in addressing major
research themes within the mission of the NIDR.  Specifically, the
NIDR is interested in supporting thematic research conducted by
groups of outstanding scientists who have distinguished themselves in
their own areas of investigation. These activities would span the
entire range of  research approaches possible under the umbrella of a
comprehensive center supported through the P60 mechanism at an
initial funding level of no more than $1.5 million in direct costs
per center. The objectives of these centers should typically include:
(1) fostering integrated biomedical, behavioral, social science, and
health services research and development at the fundamental, clinical
and applied levels; (2) initiating and expanding research on
community education, screening, counseling and related services
programs; and (3) promoting research related to education of health
professionals and the public concerning the etiology, prevention,
diagnosis and treatment of oral, dental and craniofacial diseases.
Award of a COHRCD is typically indicative of the fact that the
applicant group and the research they propose is at a level of
excellence unparalleled in a field.  A COHRCD can be located within a
single institution or, preferably, may 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 from basic to clinical research studies, clinical trials
and demonstration research.
Each COHRCD must be a clearly defined organizational entity with a
director responsible for management of the center.  Strong and
effective scientific leadership must be provided. The director will
be responsible for the organization and operation of the center and
for communication within the center 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 scientists and cooperating institutions.
The COHRCDs will be organized around a central theme, the choice of
which is the responsibility of the applicant but which must be within
the mission of the NIDR.  Five organizational components are
required: (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 findings from
the laboratory to the marketplace; and (5) administrative and
research support cores, including biostatistics, appropriate to the
focus of the research.
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.  The policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)
and supersedes and strengthens the previous policies concerning the
inclusion of minorities in study populations which have been in
effect since 1990.  The policy contains some provisions that are
substantially different from the 1990 policies.
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
reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994. Investigators may obtain copies from these sources or
from the program staff listed under INQUIRIES.  Program staff may
also provide additional relevant information concerning the policy.
Prospective applicants are asked to submit, by August 15, 1996, a
letter of intent that includes a descriptive title for the COHRCD
Developmental Grant; the name, address, FAX, email address, and
telephone number of the Center director; and the identities of other
key personnel and potential 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 planning
for the timely review of the applications.  It allows NIDR staff to
estimate the potential review workload and to avoid possible
conflicts of interest in the review.
The letter of intent is to be addressed to Dr. Ann Sandberg at the
address listed under INQUIRIES.
Prospective applicants are encouraged to communicate with program and
grants management staff of the NIDR's Division of Extramural Research
as early as possible in the planning phase of application
preparation.  Advice and suggestions by staff may materially assist
applicants to ensure that the COHRCD Developmental Grant's
objectives, structure and budget format are acceptable.
Applications are to be prepared on the grant application form PHS 398
(rev.5/95).  Applications kits are available at most institutional
offices of sponsored research and may be obtained from the Grants
Information Office, Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
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 (Developmental Grants:  Comprehensive Oral
Research Centers) and number DE-96-004 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.
Submit a signed, typewritten original of the application, including a
cover letter (if appropriate), the checklist, and three signed
photocopies, in one package to:
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 November 14, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.
Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and responsiveness by the NIDR.
Incomplete applications or those that exceed the budget limit of
$100,000 direct costs will be returned to the applicant without
further consideration.  Waivers of the receipt deadline and budget
limitation will not be granted.  If NIDR staff find that the
application is not responsive to the RFA, it will be returned without
further consideration.
Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit
review, all applications will receive a written critique and undergo
a process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under
review, will be discussed, assigned a priority score, and receive a
second level review by the National Advisory Dental Research Council.
Factors to be considered in the evaluation of the applications are:
o  the plan for developing the organizational infrastructure to
support and operate the COHRCD;
o  the institutional or multi-institutional environment, the
institution's (s') commitment to the COHRCD, and evidence of an
organizational structure that will promote multidisciplinary and
collaborative basic, translational and applied research;
o  the scientific and administrative qualifications, experience and
commitment of the COHRCD director and his/her ability to provide
effective leadership;
o  the qualifications of the key personnel;
o  evidence that the COHRCD will pursue commitments for complementary
o  evidence that the COHRCD will be able to establish partnerships
with organizations that can provide educational and outreach
o  evidence that collaborations among basic, translational and
applied research areas will facilitate and accelerate the transfer of
laboratory findings to innovative and productive studies involving
patients and populations either within the COHRCD or through outside
collaborations with other institutions and/or industry;
o  evidence of the availability of appropriate study populations and
ability of the COHRCD to recruit adequate samples consistent with the
NIH guidelines; and
o  the plan for evaluating and monitoring the organizational
infrastructure and productivity for each of the components and the
entire COHRCD.
The earliest anticipated date of award is July 1997.  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
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. Ann 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
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 amd 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
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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