INTERNATIONAL COLLABORATIVE ORAL HEALTH RESEARCH PLANNING GRANT

Release Date:  March 4, 1999

RFA:  DE-99-002

P.T.

National Institute of Dental and Craniofacial Research

Letter of Intent Receipt Date:  May 1, 1999
Application Receipt Date:  June 16, 1999

THIS RFA USES THE MODULAR GRANT APPLICATION AND AWARD PROCESS.  THIS RFA
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST
BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR) will
provide grant support for planning and protocol development of biomedical,
epidemiological and behavioral studies in priority international research
areas as identified in the Institute's Strategic Plan and facilitated by the
Office of International Health (OIH), in consultation with the international
research community.  The purpose of this initiative is to bring together
international researchers through collaborative partnerships that conduct
research according to common protocols.

The planning grant is intended to provide support for the development of a
refined study design, organizational plan, detailed protocol criteria, and
budget, for implementation of cross-national studies whose rationale and basic
design are considered scientifically meritorious.  After these are completed,
planning grant awardees may submit applications to conduct the full-scale
study, in collaboration with international funding partners.

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 RFA 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 domestic for-profit and nonprofit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal government, as well as foreign academic, scientific organizations
and institutions.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

Applicants must demonstrate linkages for international collaborative efforts
with institutions in other industrialized and/or developing nations as may be
appropriate to address the scientific question.

Applicant 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.  If so, a letter
of agreement from either the GCRC Program Director or Principal Investigator
should be included with the application.

MECHANISM OF SUPPORT

The mechanism of support will be the exploratory/developmental (R21) research
grant. This mechanism provides short-duration support for preliminary studies
of a highly speculative nature which are expected to yield, with this time
frame, sufficient information to form a basis for a rigorous series of further
investigations. Applicants may request up to $75,000 in direct costs per year
for each of two years. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.

Specific application instructions have been modified to reflect the "MODULAR
GRANT APPLICATION AND AWARD" process, which has been adopted by the NIH (see
the NIH Guide, December 15, 1998).

For this RFA, funds must be requested in $25,000 direct cost modules.  A
maximum of three modules can be requested for each of 2 years.  A feature of
the modular grant is that no escalation is provided for future years, and all
anticipated expenses for all years of the project must be included within the
number of modules being requested. Only limited budget information is required
and any budget adjustments made by the Initial Review Group will be in modules
of $25,000.

More detailed information about modular grant applications, including a sample
budget narrative justification pages and a sample biographical sketch, is
available via the Internet at url:
https://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

The estimated total costs (direct plus indirect) available for the first year
of support for awards under this RFA will be $720,000.  The NIDCR plans to
support or contribute to the support of approximately six grants in response
to this RFA in Fiscal Year 2000.  Grant awards will be contingent on the
receipt of high quality applications and the availability of funds.  Usual PHS
policies governing grants administration and management will apply.  Funding
beyond the first and subsequent years of the grant will be contingent upon
satisfactory progress during the preceding years and the availability of
funds.

RESEARCH OBJECTIVES

Background

Health issues know no geographic boundaries.  Oral conditions affect
populations around the globe.  Some of these conditions are more prevalent in
certain countries or regions, while others are found in virtually all
countries, but to varying degrees.  There are many research topics that
require international collaboration to properly address the many questions. 
For example, there are many areas of research that, because of limited access
to patient populations within any single country, can only be conducted by
international teams of scientists.  Similarly, there are areas of research
where progress would be enhanced with the addition of international
collaborations.  The purpose of this initiative is to bring together
international researchers through collaborative partnerships that conduct
research according to common protocols.

In pursuing new scientific opportunities, the NIDCR recently outlined its
Strategic Plan, which focuses on and reorganizes its work into the following
areas of research:

o  Inherited Diseases and Disorders

The objective of this scientific program is to promote research that will
advance our understanding of the underlying causes of craniofacial
dysmorphologies such as ectodermal dysplasia, enamel dysplasia, cleft lip and
palate, and osteogenesis imperfecta.  These genetic malformations are
estimated to occur in about five percent of the entire U.S. population, but
prevalence is even higher within some groups in the U.S. and internationally. 
International collaboration in relevant areas such as genetic research,
epidemiology, genetic registries, and treatment modalities can help speed
progress toward the goal of improved diagnosis, treatment and prevention by
combining scientific talents from different countries to focus on selected
populations at high risk.  An international approach that includes all
disciplines relevant to craniofacial anomalies will dramatically enhance the
possibility of resolving the many complex issues surrounding these
malformations.

o  Infectious Diseases and Immunity

This program encourages and supports basic, applied and developmental research
in four broadly based scientific areas that will provide the basis for rapid
development of knowledge of the etiology, pathogenesis, epidemiology,
prevention, diagnosis, and treatment of oral infectious diseases such as
periodontitis, dental caries, and oral candidiasis, and other infectious
diseases which affect the oral and craniofacial complex such as HIV/AIDS,
noma, and leishmaniasis. Although some of these emerging or re-emerging
infectious diseases are rare in many of the industrialized parts of the world,
they are quite prevalent in some developing countries, and are increasing
rapidly in areas of poverty, malnutrition, and poor sanitary conditions. 
International collaboration can help to bring together researchers and
resources to study these infectious diseases, and help to shed light on the
epidemiology, the disease process and the role of the immune system. 
Important areas of research might include factors contributing to microbial
virulence, colonization and transmission; sequence analysis of the genome of
oral microorganisms; molecular and cellular pathogenesis; and, host response
and inflammation and the use of novel immunizing strategies, and other
prevention interventions.

o  Neoplastic Diseases

This scientific program encompasses basic and applied research related to the
prevention, etiology, early detection, progression, metastasis and treatment
of oral cancer. The continuing poor prognosis for patients with oral cancers
and the extreme disfigurement caused both by these malignancies and the
treatments currently utilized to combat them emphasize the importance of
multifaceted and innovative approaches to research in this area.  A
significant cause of mortality and poor quality of life, oral cancer is
especially prevalent in Asian countries, parts of Europe, and the United
States.  Fortunately, the international community has numerous centers of
expertise from which to draw for important collaborative studies. 
International collaboration can provide new perspectives in all aspects of the
disease, from the clarification of risk factors to the control of these risk
factors, early detection, pain management, the provision of effective
treatment, and ultimately the prevention of disease.

o  Chronic and Disabling Diseases

This multifaceted scientific program addresses research involving the chronic
disabling diseases associated with the oral/craniofacial complex such as
osteoporosis and related bone disorders, temporomandibular joint disorders,
neuropathies and neurodegenerative diseases including those involving oral
sensory and motor function, and autoimmune diseases such as Sjogren's syndrome
and rheumatoid arthritis.  Other research areas include studies aimed at
elucidating the relationship between diseases of the oral/craniofacial complex
and other systemic diseases (e.g., periodontitis in relation to diabetes, oral
pathogens and cardiovascular disease, and oral pathogens and low birthweight
infants).

o  Biomaterials, Biomimetics and Tissue Engineering

This scientific program supports and encourages basic, clinical and applied
research in the areas of biomimetics, tissue engineering and biomaterials in
order to enhance the development of natural and synthetic materials used for
the repair, regeneration, restoration and reconstruction of oral and
craniofacial tissues and organs. The biomimetics aspect of the portfolio
focuses on interdisciplinary materials science research that combines
information from the study of biological structures and their function with
physics, mathematics, chemistry and engineering, with the goal to develop
novel materials (e.g., adhesives, new filling materials, temporomandibular
joints).  International coordination and networking is required for developing
promising materials in the laboratory, conducting biologic assessment, and
implementing clinical trials.

o  Behavior, Health Promotion and Environment

This scientific program encourages and supports research aimed at assessing
the interactive role of socio-environmental, behavioral, genetic and
biomedical factors in oral/craniofacial diseases and conditions.  Oral health
promotion and disease prevention are keys to meeting public health objectives
and enhancing clinical and biomedical interventions related to oral health. 
Removing inequalities in oral health is a prominent component of the U.S.
Healthy People 2000 goals.  International collaborative research is vital to
understanding differences in health status among subgroups in a population
resident in various settings, as well as the impact of various national
systems of oral health care and education on oral health outcomes.  Other
topics for international research include traditional health beliefs and
practices, systems of health care financing, and targeted community-based
health promotion/disease prevention programs.

Applications under this RFA must contain research planning proposals which fit
within these strategic areas.  Further information about these research topics
may be obtained from NIDCR's Extramural Research website at
http://www.nidcr.nih.gov/research/extramural/sciprog.htm.

In each of these priority areas, a broad-based coalition of scientific talent
is envisioned to encompass research needs in areas from molecular biology to
the translational patient-oriented, epidemiological, behavioral, social and
related health promotion sciences as may be appropriate for the research
questions involved.  The product of these research planning grants would be
the enhanced or new infrastructure needed to enable submission of full-scale
studies in the given subject area.  These applications could then be submitted
as investigator-initiated projects to the US government and/or any other
potential collaborating funding agency, institution or foundation.  These
subsequent applications also will be peer-reviewed according to standard NIH
procedures.  Applicants should note that NIDCR funding of a planning grant
does not imply a commitment by NIDCR to fund the proposed full-scale study

Applicants for research planning grants may request funds for activities such
as but not limited to:

o  Travel expenses of individuals from multiple sites to planning meetings for
the project.

o  Preliminary studies to guide selection of and/or refine research agenda,
questions, and hypotheses

o  Analyses of existing data needed for refinement of study design and
protocols

o  Preparation of detailed protocols. These protocols must be included in the
Final Report for this award.

The planning grant proposal should describe:

o  The scientific rationale for choice of the research question which would
require international collaboration.

o  The need for international collaboration.

o  The principal hypotheses to be tested, and the rationale for doing so.

o  The organizational approach and timetable to be followed in building an
international coalition, defining the research agenda and developing a
specific international collaborative research protocol.

o  The participants in the planning process, their roles in the development of
the plan, and their experience in related studies.

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, Volume 23,
Number 11, March 18, 1994, which is available via the WWW. at:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by May 1, 1999, a letter of intent
that includes a descriptive title of the proposed research, the name, mailing
address, FAX, email address and telephone number of the Principal Investigator
and the identities of other key personnel and participating institutions and
departments, and the number and title of this RFA and .  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. H. George Hausch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45 (Natcher), Room 4AN-38D
Bethesda, MD  20892-6402

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  Application kits 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
301/710-0267, email: GrantsInfo@nih.gov.  Application forms are also available
on the NIH World Wide Web at: https://grants.nih.gov/grants/forms.htm.

BUDGET INSTRUCTIONS

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities
and Administrative (F&A) costs] for the initial budget period.  Items 8a and
8b should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.)
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  The total cost for a consortium/contractual arrangement is
included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.

o  OTHER SUPPORT - Form Page 7.  This form must be completed for applications
in response to this RFA to allow awards to be negotiated and made on or before
April 2000.

o  CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the type
of agreement and the date. It is important to identify all exclusions that
were used in the calculation of the F&A costs for the initial budget period
and all future budget years.

The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this RFA and will be returned without further review.

The RFA label available in the application form PHS 398 must be affixed to the
bottom of the face page.  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 on
line 2 of the face page of the application form and the YES box must be
marked.

Submit a signed, typewritten original of the application, including the
checklist, and three signed, exact, single-sided photocopies, in one package
to:

CENTER FOR SCIENTIFIC REVIEW
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 exact copies of the application must
also be sent to:

Dr. H. George Hausch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45 (Natcher), Room 4AN-38D
Bethesda, MD 20892-6402

Applications must be received by June 16, 1999.  If an application is received
after that date, it will be returned without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review (CSR) and responsiveness by the NIDCR.  Incomplete and/or
non-responsive applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the RFA will
be evaluated for scientific and technical merit by a special emphasis panel
convened by the Scientific Review Section, Division of Extramural Research,
NIDCR.  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 and Craniofacial Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological and behavioral systems, improve the prevention, diagnosis and
control of disease, and enhance health. The reviewers will comment on the
following aspects of the application in their written critiques in order to
judge the likelihood that the proposed research will have a substantial impact
on the pursuit of these goals.  Each of these criteria will be addressed and
considered by the reviewers in assigning the overall score weighting them as
appropriate for each application.  Note that the application does not need to
be strong in all categories to be judged likely to have a major scientific
impact and thus deserve a high priority score.  For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.

Significance.  Does this proposal address an important U.S or international
problem?  If the aims of the application are achieved, how will scientific
knowledge be advanced?  What will be the effect of these studies on the
concepts or methods that drive this field?  To what degree does the proposed
collaboration present opportunities for furthering research through the use of
unusual talents, resources, populations, or environmental conditions in other
countries?

Approach.  Are the conceptual framework, design and methods adequately
developed, well integrated, and appropriate to the aims of the project?  Does
the applicant acknowledge potential problem areas and consider alternative
tactics?  Does the applicant propose concepts and strategies sensitive and
appropriate to the potential research partners internationally?

Innovation.  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

Investigators.  Are the investigators appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers partners?

Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed collaborative
arrangements take advantage of unique features of the scientific environment? 
Is there evidence of collaborative institutional support?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

Schedule

Letter of Intent Receipt Date:  May 1, 1999
Application Receipt Date:       June 16, 1999
Scientific Review Date:         October 1999
Advisory Council Date:          January 2000
Earliest Award Date:            April  2000

AWARD CRITERIA

The earliest anticipated date of award is April 2000.  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 NIDCR staff and the National Advisory Dental and
Craniofacial Research Council in making funding recommendations. In addition,
the NIDCR 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 NIDCR is likely to select the more cost-competitive application for
funding.

INQUIRIES

Written, email and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Judy Small
Craniofacial Anomalies and Injuries Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2425
FAX:  (301) 480-8318
Email:  Judy.Small@nih.gov

Dr. Dennis Mangan
Infectious Diseases Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2421
FAX:  (301) 480-8318
Email:  Dennis.Mangan@nih.gov

Dr. Ann Sandberg
Neoplastic Diseases Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2419
FAX:  (301) 480-8318
Email:  Ann.Sandberg@nih.gov

Dr. Eleni Kousvelari
Biomaterials and Biomimetics and Tissue Engineering Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2427
FAX:  (301) 480-8318
Email:  Eleni.Kousvelari@nih.gov

Dr. Ken Gruber
Chronic Diseases Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-4836
FAX:  (301) 480-8318
Email:  Ken.Gruber@nih.gov

Dr. Norman Braveman
Clinical, Behavioral and Health Promotion
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2089
FAX:  (301) 480-8318
Email:  Norman.Braveman@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Martin Rubinstein
Office of Grants Management
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Martin.Rubinstein@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.866 and 93.846.  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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