RELEASE DATE:  January 16, 2003
PA NUMBER:  PAR-03-059

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. A replacement R21 (PAR-06-219) funding 
opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter. 

EXPIRATION DATE: January 17, 2006, unless reissued. 

National Institute of Dental and Craniofacial Research (NIDCR) 


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


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, and which cannot be 
accomplished solely within the U.S.  (For the purposes of this PA, "cross-
national" means that at least three (3) countries are involved.)  After these 
are completed, planning grant awardees may submit applications to conduct the 
full-scale study, in collaboration with international funding partners.


Dental, oral and craniofacial diseases and disorders are among the most 
common health problems affecting the people of the United States and around 
the world. The burden imposed by a variety of dental, oral and craniofacial 
diseases and disorders range from birth defects such as cleft lip and palate, 
which occurs in every 1 in 525 to 714 live births, to injuries to the head 
and face, resulting in nearly 20 million emergency room visits per year, to 
devastating head and neck cancers, accounting for 8000 deaths and over 30,000 
new cases per year in the U.S. alone.  In the U.S., the treatment of over 1.2 
million cancer patients each year can lead to painful mouth ulcers, 
mucositis, rampant dental caries, fungal infections, impaired taste and loss 
of function of the salivary glands.  Oral infections still remain common in 
our populations.  Dental caries is experienced by 45% of school children and 
94% of adults have experienced this infection at some point in life.  
Periodontal infections occur in 90% of individuals older than 13 years and 
may be associated with other systemic diseases or conditions such as 
diabetes, cardiovascular disease, respiratory infections, and pre-term/low 
birth weight babies. Orofacial pain is likely to have been experienced by 
over 20% of adults in the past six months, is a major component of 
temporomandibular joint diseases (TMD) for at least 6% of adults, and is a 
major component of Bell's palsy, trigeminal neuralgia and fibromyalgia.  
Salivary gland dysfunction in the form of Sjogren's syndrome affects between 
1 and 4 million Americans while over 30,000 individuals who have cystic 
fibrosis are also at higher risk for concomitant salivary gland dysfunction. 
Further, over 500 prescription drugs have xerostomic (dry mouth) side 
effects, increasing the risk for both bacterial and fungal oral infections as 
well as other oral conditions.  Oral candidiasis is commonly found in HIV-
infected patients.

These health issues, though prevalent in the U.S., 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 for 
questions to be appropriately addressed.  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 
with access to large groups of people with the disease/condition to be 
studied.  Similarly, there are areas of research where progress would be 
enhanced with the addition of unique scientific expertise only found 
internationally.  The purpose of this initiative is to bring together 
international researchers through collaborative partnerships that investigate 
these special research issues according to common protocols.

In pursuing new scientific opportunities, the NIDCR organizes its work into 
the following areas of research:

o   Microbiology and Microbial Pathogenesis Program

The objective of this program is to support basic and translational research 
on the role of oral microbes in health and disease. To this end, three broad 
scientific areas have been identified that will provide the basis for rapid 
development of knowledge of the etiology, pathogenesis, diagnosis, treatment, 
and prevention of oral infectious diseases. These interrelated areas are: (i) 
Biofilms and Microbial Ecology, (ii) Microbial Genomics, and (iii) Microbial 
Virulence and Disease Pathogenesis.

o   Immunology and Immunotherapy Program

This program supports basic and translational research on the immune aspects 
of oral diseases. To this end, the program is composed of six major areas of 
research: host responses to microbes, head and neck cancer immunology, 
autoimmunity, antimicrobial agents and immunotherapy, biomarkers, and 

o   AIDS and Immunosuppression Program

This program supports basic and translational research on HIV infection and 
AIDS to advance understanding of the underlying molecular and genetic 
mechanisms that result in the transmission of HIV and development of oral 
complications associated with HIV-infection and AIDS. 

o   Biotechnology and Biomaterials Program

The purpose of this program is to support basic and translational research on 
synthetic restorative materials, biomimetics and tissue engineering.

o   Developmental Biology and Mammalian Genetics Program

Through this program, the Institute supports basic and translational research 
to understand the development of tooth and bone, and to identify the genetic 
and environmental contributions to craniofacial disorders. The objective of 
this scientific program is to elucidate the underlying causes of craniofacial 
disorders, thereby advancing the fields of diagnosis, treatment, and 

o   Epithelial Cell Regulation and Transformation Program

This program supports basic and translational research on the molecular 
mechanisms of oral epithelial cell regulation, and investigations on the 
molecular events involved in the initiation of oral epithelial cell 
transformation to premalignant and malignant lesions and mucositis. This 
program also supports and encourages basic and translational research related 
to early diagnosis, prevention, and treatment of oral neoplasias.

o   Physiology, Pharmacogenetics and Injury Program

This program supports basic and translational research on normal and abnormal 
functions of the salivary gland, tooth and bone; physiology and cell biology 
of injury, trauma and wound healing; and pharmacogenetics of drugs used in 
treatment of salivary as well as tooth and bone disorders.

o   Molecular and Cellular Neurobiology Program

The Institute supports basic and translational research on neurophysiology; 
tissue innervation; neuropathies with specific emphasis on Temporomandibular 
Joint Disorders (TMDs); the development of biomarkers for use in diagnostics 
and prognostics; and the development of therapeutics.

o   Behavioral and Social Sciences Research Program

This program supports basic behavioral and social science research relevant 
to oral diseases, health promotion, and health care.  The research supported 
draws on the expertise of sociologists, psychologists, anthropologists, 
public health and health policy experts, health services researchers, 
economists, and dental researchers and includes a number of multi-
disciplinary projects.  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 
which would serve to reduce health disparities within a society.

o   Population Sciences Program

This program supports research aimed at:  (1) describing the distribution of 
oral, dental and craniofacial diseases and disorders; (2) understanding risk 
and protective factors of these diseases and disorders and their 
interactions;  (3) identifying oral health disparities among population sub-
groups and (4) developing and evaluating interventions for prevention, early 
detection, and treatment of oral diseases and disorders.

Applications to plan and conduct clinical trials must be submitted under a 
different process.  Please refer to the Clinical Trial topic area at

Applications under this PA must contain research planning proposals which fit 
within these strategic areas.  Further information about these research 
topics may be obtained from NIDCR's website at

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.  
Those applications coming subsequently to the NIH 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 

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

The planning grant proposal should describe:

o   Importance and relevance of the scientific question.  Describe the 
research project(s) under consideration and the potential for advancing the 
science and improving health.

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

o   Justification of the need for a global approach.   Is the problem 
global in nature?  Why is a multicountry project necessary to answer the 
question?  Why can't the question be answered with a single-site study?

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.

o   Ability of the Principal Investigator to bring together the necessary 
international network.  While the actual building of the network is to be 
done after the planning grant is awarded, there must be clear evidence of 
commitment from researchers and institutions in other countries.  Letters of 
commitment, including biosketches, by collaborating partners should be 
included.  Describe the mechanism for identification and selection of 
additional collaborators.  A proposal involving several (three or more) 
countries is expected.

o   Identifiable outcome of the grant.  What products/documents are 
expected from the grant?  How will this be used in developing the next stages 
of research?

o   Justification for the budget.  Include specific plans for the use of 
the funds (e.g., salaries, meetings, travel, preliminary data collection, 
etc.) and the way in which this will be used to facilitate the expected 
outcomes and specific products of the planning grant.  If applicable, 
describe other support from collaborating partners.


This PA will use the NIH R21 award mechanism(s).  As an applicant, you will 
be solely responsible for planning, directing, and executing the proposed 
project.  Applicants may request up to $100,000 in direct costs per year for 
each of two years.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.


You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations


Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   


We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 

o Direct your questions about scientific/research issues to:

Kevin S. Hardwick, DDS, MPH
Office of International Health 
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS13
Bethesda, MD  20892
Telephone:  301-594-2765
FAX:  301-402-7033

Rochelle K. Small, PhD
Developmental Biology and Mammalian Genetics Program 
Cellular and Molecular Biology, Physiology and Biotechnology Branch 
Division of Basic and Translational Sciences 
National Institute of Dental and Craniofacial Research 
Building 45, Room 4AN-18D 
45 Center Drive, MSC 6402 
Bethesda, MD 20892-6402 
Telephone:  (301) 594-9898 
Fax:  (301) 480-8318 

Dennis F. Mangan, PhD
Infectious Diseases and Immunity Branch
Division of Basic and Translational Sciences 
National Institute of Dental and Craniofacial Research 
Building 45, Room 4AN-12J
Bethesda, MD 20892-6402
Telephone:  301 594-2421 
Fax:  301 480-8319

Yasaman Shirazi, PhD
Epithelial Cell Regulation and Transformation Program
Division of Basic & Translational Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Dr., Room 4AN-18C
Bethesda, MD  20892-6402
Telephone:  301-594-4812
Fax:  301-480-8318

Eleni Kousvelari, DDS, DSc 
Cellular and Molecular Biology, Physiology and Biotechnology Branch 
Division of Basic and Translational Sciences 
National Institute of Dental and Craniofacial Research 
Building 45, Room 4AN-12K 
Telephone:  (301) 594-2427 
Fax:  (301)480-8318 

Patricia S. Bryant, PhD 
Behavior and Social Sciences Research Program 
Clinical, Epidemiology and Behavioral Research Branch 
Division of Population and Health Promotion Sciences 
National Institute of Dental and Craniofacial Research 
Building 45, Room 4AS-43A 
45 Center Drive, MSC 6402 
Bethesda, MD 20892-6402 
Telephone:  (301) 594-2095 
Fax:  (301) 480-8318 

Maria Teresa Canto, DDS, MPH 
Population Sciences Program 
Clinical, Epidemiology and Behavioral Research Branch 
Division of Health Promotion and Population Sciences 
Building 45, Room 4AN-43B 
45 Center Drive, MSC 6402 
Bethesda, MD  20892-6402 
Telephone:  (301) 594-5497 
Fax:  (301) 480-8318 

o Direct your questions about peer review issues to:

Dr. H. George Hausch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44F MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
Fax:  (301) 480-8303

o Direct your questions about financial or grants management matters to:

Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44B
45 Center Drive MSC 6402
Bethesda, MD  20892-6402
Telephone:  301-594-4808
Fax:  301-480-3562


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

As with most applications to NIH, the research plan is limited to 25 pages.  
Publications may not be submitted, but color/glossy photographs and other 
appendix material (surveys, questionnaires, etc.) is permitted.      

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted on standard receipt dates.  See 

submitted in a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and three signed 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)

In order to facilitate the review of applications assigned to the NIDCR, the 
applicant must, at the same time, mail or deliver two copies of the 
application to:

Dr. H. George Hausch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44F MSC 6402
Bethesda, MD  20892-6402

APPLICATION PROCESSING:  Applications must be received by or mailed on or 
before the receipt dates listed above.  The CSR will not accept any 
application in response to this PA that is essentially the same as one 
currently pending initial review unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is essentially the 
same as one already reviewed.  This does not preclude the submission of a 
substantial revision of an application already reviewed, but such application 
must include an Introduction addressing the previous critique.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  A special emphasis panel convened by 
NIDCR in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o   Receive a written critique.
o   Undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed and assigned a priority score.
o   Receive a second level review by the National Advisory Dental and 
Craniofacial Research Council.


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(; a 
complete copy of the updated Guidelines is available at
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 

The NIH maintains a policy 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 is available at 

policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Internet addresses (URLs) should not be used to provide information necessary 
to the review because reviewers are under no obligation to view the internet 
sites.  Reviewers are cautioned that their anonymity may be compromised when 
they directly access an Internet side.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
PA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at


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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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