PLANNING GRANTS FOR RESEARCH TO PREVENT OR REDUCE ORAL HEALTH DISPARITIES

Release Date:  January 11, 2002

RFA:  RFA-DE-02-005
 
National Institute of Dental and Craniofacial Research
 (http://www.nidcr.nih.gov)
National Center on Minority Health and Health Disparities
 (http://www.ncmhd.nih.gov)
Office of Research on Women's Health
 (http://www4.od.nih.gov/orwh)

Letter of Intent Receipt Date:  March 21, 2002
Application Receipt Date:       April 18, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED 
IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR), the 
National Center on Minority Health and Health Disparities (NCMHD), and the 
Office of Research on Women's Health (ORWH) invite applications for planning 
grants (R21) to develop the research collaborations, plans and infrastructure 
necessary to conduct scientifically meritorious research on determinants of 
oral health disparities and prevention or reduction of oral health 
disparities in selected populations currently under-represented in NIDCR's 
grant portfolio.  Research topics and oral conditions, and populations 
relevant to eliminating oral health disparities are discussed in NIDCR's "A 
Plan to Eliminate Craniofacial, Oral and Dental Health Disparities" 
http://www.nidcr.nih.gov/research/health_disp.asp.  Potential applicants 
should refer to this document for a listing and explanation of research 
topics and populations of interest to the Institute.  In particular low-
income rural populations, special needs populations including those with 
neurodevelopmental disorders, and all race/ethnic populations are of 
interest.  Race/ethnic study populations underrepresented in the NIDCR 
research portfolio include Hispanic (Central American, Cuban-American, Puerto 
Rican, and others), American Indian or Alaskan Native, and Asian or Pacific 
Islander populations.  Much remains to be learned about the broad array of 
factors which by themselves or in combination contribute to disparities in 
the oral, dental, and craniofacial diseases, disorders and conditions amongst 
these populations, how oral health disparities impact upon quality of life, 
and what interventions improve quality of life and prevent or reduce the 
inequalities across the lifespan.

The purpose of the planning grants will be to support the organization of 
research teams and the development of elements essential for conducting 
successful research to prevent, reduce and ultimately eliminate a specific 
oral health disparity (or oral health disparities) within the selected 
population.  The planning grants are intended to provide support for the 
development of a refined research question (s), specific study design, 
organizational plan, detailed protocol including details regarding access to 
the population, and budget.  Applications must address the specific health 
disparity (or disparities) that the research plan will address, and the 
population(s) in which the study(s) will be conducted.  In addition, 
investigators must indicate collaborators involved in the development of the 
research plan, indicate how the planning process will facilitate 
collaboration and the scientific merit of the research plans being developed, 
and specify what facilities and administrative procedures will be used.  
Investigators are encouraged to develop plans for research that would utilize 
innovative approaches and that show some potential to become sustainable in 
the population once external research funding is removed. If applicants are 
at the stage of testing research methods and instruments or the collection of 
preliminary data related to the prevention and reduction of oral health 
disparities, they are asked to refer to a pilot grant RFA that is being 
released simultaneously.

If any findings from pilot studies are already available, they should be 
discussed in relationship to the planning process proposed.  The purpose of 
the planning grant is to develop plans and collaborative arrangements that 
will provide a sound foundation for conducting scientifically meritorious, 
single or multi-site studies to prevent or reduce specific oral health 
disparities.  The primary emphasis of this RFA is on planning so that 
applicants can be prepared to initiate research on the topic and with the 
population identified.  It is anticipated that after the planning is 
completed awardees would submit applications to conduct investigator 
initiated (R01 or IRPG) research.   

Awards under this RFA are not intended to serve as an alternative mechanism 
of support for projects not receiving funding as competitive 
continuation applications.

The current RFA and two other RFAs being issued concurrently ("Pilot Grants 
to Prevent or Reduce Oral Health Disparities" (DE-02-004) and  "Research 
Infrastructure and Capacity Building for Minority Institutions to Reduce Oral 
Health Disparities" (DE-02-003) reflect a strong commitment on the part of 
the National Institutes of Health to encourage research that contributes to 
preventing or reducing health disparities.  If applicants are developing 
clinical trials related to health disparities research, they should refer and 
respond to the previously released NIDCR Clinical Trial Pilot Grant planning 
program announcement 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-157.html.  

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 Request for 
Applications (RFA) is related to oral health, which is one of the priority 
areas indicated in "Healthy People 2010".  Other priority areas and their 
potential for reducing and ultimately eliminating oral health disparities 
should also be considered.  These include nutrition, unintentional injury 
prevention, violence and abuse prevention, educational and community-based 
programs and access to care.   Potential applicants may obtain "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private institutions, such as universities, 
colleges, hospitals, laboratories, faith-based organizations, units of State 
and local governments, and eligible agencies of the Federal government.  In 
order to capitalize on opportunities to increase the diversity of populations 
and topics addressed and to increase the number of institutions developing 
expertise in research relevant to oral health disparities, NIDCR will 
typically fund no more than one planning grant application in response to 
this RFA at any single institution.   In addition, institutions with 
substantial funding that resulted from NIDCR Centers for Research to Reduce 
Oral Health Disparities RFA and applicants for the companion RFAs  ("Pilot 
Grants to Prevent or Reduce Oral Health Disparities" and  "Research 
Infrastructure and Capacity Building for Minority Dental Institutions to 
Reduce Oral Health Disparities") WILL NOT be eligible to apply for this 
planning grant.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.  

To be responsive to this RFA, an applicant must propose collaborative 
affiliations with other entities to address oral health disparities in under-
represented populations.  The collaboration can be with entities from within 
the institution as well as with other institutions. This collaboration should 
be for the purpose of facilitating and addressing the scientific objective 
that is the main focus of the research to be planned and used for increasing 
prospects for translating findings into sustainable programs should study 
findings indicate that a specific intervention does prevent or reduce oral 
heath disparities.  Collaborations may include colleges, schools, 
departments, or organizations representing the spectrum of researchers (such 
as dental, social, genetic, molecular; nutrition, or clinical research 
epidemiologists; biostatisticians; anthropologists; and social and behavioral 
scientists), health professionals (such as physicians; physicians assistants; 
nurses; dentists; dental hygienists; nutritionists, community health 
workers), sectors which may influence health (such as health policy, urban 
planning, food and nutrition organizations and caterers, employers, social 
workers, nursing home administrators, school boards), or other academic 
institutions and State and Local health agencies and health financing 
agencies (such as state Medicaid, Medicare and third party payers).  Other 
examples of collaborations include institutions that may serve as promoters 
of health through health policy, healthy literacy, or as alternative care 
delivery sites (such as infant, child or adult day care facilities, 
residential facilities and institutions, schools, worksites), or which 
maximize opportunities to nest oral health programs within larger health 
promoting activities (such as Healthy Communities, Healthy Cities, Healthy 
Schools, community-based participatory research projects, Women, Infant and 
Children Supplemental Food Program, Project Head Start, and faith-based 
initiatives).  Interdisciplinary approaches are encouraged. The role of 
collaborations in fostering the project's continuation after the research 
phase must be discussed. 

Planning support is for new projects and may not be used to supplement 
research projects already being supported or to provide interim support for 
projects under review.  Simultaneous submissions of applications for planning 
grants under this RFA and for the other two RFAs being simultaneously 
released will not be accepted.  

Applicants are encouraged to contact program staff listed on the RFA with 
questions they may have concerning the selection of the RFA most appropriate 
to their specific research interests, needs and goals.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Exploratory/ 
Developmental Research Grant (R21) award mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant.  This RFA is a one-time solicitation.  Applicants may 
apply for continuation of projects developed under this program using 
traditional, unsolicited grant mechanisms (e.g., R01, IRPG).  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and be reviewed according to the 
customary peer review procedures.  

Funding under this RFA will be up to a maximum of $100,000 direct costs per 
year for up to a maximum of two years.  For those applications that include a 
subcontractual/consortium arrangement, direct costs of up to $125,000 per 
year may be requested, in order to allow for F&A costs on those consortium 
arrangements, however this increase may be used only to offset the additional 
F&A costs for the subcontract consortium and for no other reasons.  The 
anticipated award date is September 30, 2002.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001). 
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

The NIDCR and NCMHD intend to fund in FY 2002 up to five new planning grants 
in response to this RFA.  An applicant may request a project period for a 
maximum of two years and a budget of up to $100,000 in direct costs per year 
and up to $125,000 in direct costs for those applications that include a 
subcontractual/consortium arrangement.  Although the financial plans of the 
Institute and Center provide for support of this program, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  

RESEARCH OBJECTIVES

Background  

Oral, dental and craniofacial diseases, disorders and conditions are amongst 
the most common health problems affecting children and adults of the United 
States and have been elucidated in "Oral Health in America: A Report of the 
U.S. Surgeon General"  (U.S. Department of Health and Human Services, 2000) 
and the NIDCR "A Plan to Reduce and Eliminate Craniofacial, Oral, and Dental 
Health Disparities."  Optimal prevention early detection, and treatment of 
oral diseases or conditions such as dental caries, orofacial and dental 
injuries, periodontal diseases, oral manifestations of or sequelae of other 
diseases and conditions such as diabetes, birth defects and other special 
needs and HIV infection, and oral and pharyngeal cancers are not readily 
available to many populations.  Moreover, socioenvironmental, biological and 
behavioral factors combine with differential access to health care to create 
a disproportionately higher burden of craniofacial, oral and dental diseases 
and disorders in some population groups, including those who are poor and 
part of racial and ethnic minorities. Thus innovative yet sustainable 
approaches to prevent or reduce disparities warrant exploration.  

People in the United States who are poor continue to suffer from the 
consequences of oral diseases and conditions to a greater extent than those 
who have greater resources. America's poorest children have almost five times 
as much tooth decay as children of higher income families and nearly twice as 
many low-SES children 2-9 years of age have at least three decayed or filled 
primary teeth compared to higher SES children.   Eighty percent of decay 
experienced by low-income children aged 2-5 years remains untreated.  In 
addition, the rate of untreated dental caries is twice as high among low SES 
children than for those at higher income levels at ages ranging through 
adolescence.  The disparity in the treatment of caries amongst the poor 
compared with the non-poor continues into adulthood.

Periodontal diseases, which can at the most extreme result in the loss of all 
teeth, are also not distributed evenly amongst the poor and non-poor. About 
14 percent of U.S. adults aged 45-54 and 23 percent of those aged 65-74 years 
old have severe periodontal disease that may put them at risk of loosing all 
of their teeth.  As reported in the NIDCR "A Plan to Reduce and Eliminate 
Craniofacial, Oral, and Dental Health Disparities," adults at the lowest SES 
level had more severe periodontal diseases than the non-poor.  Disparities in 
the prevalence of severe periodontal diseases amongst the poor and other 
segments of the population put them at greater risk to tooth loss and 
potentially to other serious conditions.   Recent research has suggested that 
severe periodontal disease may have an impact well beyond those isolated to 
the oral cavity and include serious systemic consequences.   The relationship 
between periodontal disease and diabetic control, preterm labor, and 
atherosclerosis are amongst the associations being explored. 

Disparities in oral health status exist by race and ethnicity in the United 
States as well.  The NIDCR "A Plan to Reduce and Eliminate Craniofacial 
Health Disparities" reports that a higher proportion of poor Mexican-American 
children and non-Hispanic black children ages 2-9 have untreated primary 
teeth compared to poor non-Hispanic whites.  The Plan goes on to report that 
the disparities are even greater when comparing non-poor minority children to 
white children of similar age and income status.  The prevalence of early-
onset periodontitis in 13-17 year olds occurs twice as often in African 
Americans than in Hispanics and ten times more frequently than in whites. 
With respect to adults, the proportion of untreated dental caries is higher 
amongst non-Hispanic blacks and Mexican Americans compared to their non-
Hispanic white counterparts. A higher percentage of non-Hispanic Blacks 
across the adult life span exhibit at least one tooth site with severe 
periodontal attachment loss compared to other groups.  Disparities also exist 
with regard to oral and pharyngeal cancer by race/ethnicity.  African 
American men have a five-year survival rate for oropharyngeal cancer that is 
much lower (31% versus 55%) than that of white (SEER, 1999).   The average 
age of diagnosis for African Americans is about ten years younger that that 
for whites, but only 19% of newly diagnosed oral and pharyngeal cancers in 
black men will be at the local stage as compared with 38 percent for 
white males. 

National data are limited for other oral, dental craniofacial conditions that 
can have serious consequences such as craniofacial injuries and disorders.  
It is known that there are more than 20 million visits to emergency 
departments for craniofacial injuries every year and close to six million 
orofacial injuries are treated by dentists in private dental offices.  The 
leading causes of oral and craniofacial injuries are sports, violence, falls, 
and motor vehicle collisions.  Differential wearing of protective sports 
headgear and mouthguards by school-aged children has been found amongst 
children whose parent's had lower education level, by females, and by 
race/ethnicity.  But the differences were not consistent across sports.   
Domestic violence, child abuse, spousal and elder abuse, and abuse of the 
disabled are often manifested as injuries to the craniofacial tissues 
and dentition.   

There is a dearth of data for children and adults who have neurodevelopmental 
disabilities and other special needs though proceedings of a recent 
conference devoted to children with special needs indicate that the extent 
and severity of oral, craniofacial and dental diseases are serious. The 
conference proceedings also provide insight into the challenges faced by 
parents, caregivers and providers with respect to the prevention and 
treatment of oral, dental and craniofacial disease and conditions in special 
needs populations.

Research conducted over the past half century has provided much insight into 
our understanding of some of the factors that contribute to oral diseases and 
conditions, as well as, methods for prevention and treatment in traditional 
clinical settings. However, the disparities that exist within segments of the 
U.S. population indicate that a better understanding of the interplay of 
biological, environmental and behavioral determinants of oral, dental and 
craniofacial diseases and conditions is needed.  In addition, a full range of 
research into the development of new or innovative application of existing 
methods of prevention and treatment may be warranted. 

Many questions remain unexplored with respect to the determinants of 
disparities in oral health status amongst the poor, the geographically and 
otherwise isolated, and amongst racial/ethnic minorities.  The impact of oral 
health status on oral health related quality of life and approaches to 
mitigate the impact needs investigation.  The common risk/health factor 
approach, psychophysiology, social cohesion and social capital, and health 
literacy are but a few of the new areas being explored by social 
epidemiologists and others.  While the testing of innovative models of 
delivering dental services is warranted, these approaches alone are unlikely 
to be sufficient to eliminate disparities in health.  Equity in the receipt 
of traditional dental services that are available, accessible, affordable or 
acceptable may not be possible.  Thus the sustainability of interventions 
once external research funding is diminished or ceases is a critical issue 
for preventing or reducing oral health disparities. 

Research Scope

Current constraints on researchers make the complex and time-consuming 
process of planning research relevant to the prevention, reduction and 
ultimate elimination of oral health disparities challenging.  Some of the 
challenges are the limited numbers of investigators with expertise in the 
numerous areas of research, which health promotion encompasses, lack of well-
established research infrastructures and lack of interdisciplinary, 
multisectoral teams with expertise in research focused on the determinants of 
oral health disparities, community-based development and interventions, 
health care provision innovations or policy-related approaches to preventing, 
reducing and eliminating oral health disparities.  These planning grants will 
provide a mechanism for early peer review of the overall rationale and 
general design of the potential oral health disparities research, and provide 
successful applicants resources to assist in the development of detailed 
study plans and collaborations.  In addition, the planning grants are 
intended to help to facilitate single or multi-site research projects in 
areas of research relevant to specific populations of interest to the 
National Institute of Dental and Craniofacial Research, the National Center 
on Minority Health and Health Disparities and the Office of Research on 
Women's Health.

Research that explores the broad array of determinants of disparities in 
oral, dental craniofacial status or that addresses a full range of health 
promotion approaches with the prevention or reduction of health disparities 
within under-represented populations are encouraged.  The range of activities 
that may be supported by this planning grant includes the acquisition of data 
and analyses necessary to clarify/refine research question, the 
identification and development of a collaborative and resource base including 
the necessary human resource expertise, development of research questions / 
hypotheses, theory / conceptual framework to which the research will 
contribute, the development of the design of the study or studies and 
specific study protocol or protocols. In developing the research question (s) 
to be considered in this planning grant applicants may want to consider the 
following topics.  The topics are not listed in priority order, nor are they 
comprehensive or restrictive.  The final selection of a topic is the choice 
of the applicant.

O Exploratory research to identify determinants of specific oral health 
disparities in understudied populations.  Research across the broad spectrum 
of potential determinants could include such areas as gene/environment 
interactions, molecular variations, cultural factors, socioeconomic factors, 
health literacy level, social support, social cohesion, or other 
socioenvironmental and behavioral factors.

O Studies designed to promote oral health and/or target underlying 
determinants of oral health disparities in understudied populations.  Such 
studies may, for example, address biological issues such as nutrition or 
immune function, community, institutional or family-based approaches to 
promote health, strategies to strengthen community capacity or to modify 
health-influencing policies, such as youth access to smokeless tobacco, 
tobacco, methods to improve health literacy, approaches to reorient health 
services to allow for increased health care access and utilization of 
preventive services, methods to improve self-care behaviors and skill building. 

O Studies designed to prevent oral disease or conditions such as craniofacial 
and dental injuries, caries (coronal or early child hood caries) periodontal 
diseases, oral mucosal pathologies including oral pharyngeal cancers) in 
under-represented populations with oral health disparities.  

O Studies that explore novel and/or multidisciplinary approaches to the 
delivery of preventive and other health care services and their impacts upon 
oral health disparities. In addition, studies are encouraged to develop and 
test methods for accelerating the transfer of effective preventive or 
treatment methods and technologies into a full range of settings.

O Studies designed to investigate factors contributing to the excess 
morbidity and mortality associated with craniofacial and oral diseases (e.g. 
periodontal diseases, oral and pharyngeal cancer and precancer, autoimmune 
diseases) or differences in responses to treatments within these populations.

O Analyses of baseline data that are essential to establish the needed sample 
size and to evaluate the intervention outcome(s).

O Studies of the impacts of disparities in oral health status on other 
outcomes such as overall health, nutrition, indices of quality of life, work 
loss or school absences or other social and economic outcomes and effects of 
interventions on these outcomes.

O Studies of the genetic and molecular events/pathways and their interplay 
with physical, environmental, and other factors as these influence oral 
health disparities or interventions to influence their impacts, such as 
exposures to environmental toxins, sex/gender differences, genetic 
differences in scarring with implications for keloid formation and with 
implications for wound healing.

Special Instructions

Investigators are expected to demonstrate the scientific importance of the 
topic(s) they have selected and relevance to NIDCR's "A Plan to Eliminate 
Craniofacial, Oral, and Dental Health Disparities."  Specifically, applicants 
must provide a context in which the planning grant is proposed, including a 
complete statement of the health disparity related problem in the specified 
population that a subsequent full scale (R01 type) study would address.  To 
be responsive to this RFA, it is essential that the applicant document 
significant institutional and community support. Applicants are urged to 
insure that at least all of the review criteria are addressed in 
their applications.  

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 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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
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 Phase III clinical trials that:  a) all 
applications or proposals and/or protocols to 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 differences.

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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

Program staff may also provide additional relevant information concerning 
the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, 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 site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The 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:  
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this RFA.  
Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIDCR staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent to Dr. Nowjack-Raymer at the address 
listed under INQUIRIES, below, by March 21, 2002.

APPLICATION PROCEDURES 

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

Applicants are strongly encouraged to contact one of the NIH program staff 
listed at the end of this document with any questions regarding the 
responsiveness of their proposed project to the goals of this RFA.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH.  Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  This 
version of the PHS 398 is available in an interactive, searchable format. For 
further assistance contact GrantsInfo, Telephone 301/435-0714, Email:  
GrantsInfo@nih.gov.  The instructions in the PHS 398 application kit must be 
adhered to, except where they have been modified by the following 
Supplemental Instructions.

Research Plan 

Do not exceed a total of 15 pages for the research plan (sections a-d).  This 
limitation includes the introductory justification paragraph described below, 
tables and figures, but not sections e-1.  Do not use the appendix to 
circumvent the 15 page limit by including tables or figures in the appendix 
that should appear in the research plan. As part of the description, 
applicants must identify briefly how this application relates to the purpose 
of the R21 mechanism as stated in this RFA.  Special attention should be paid 
to explaining how the work proposed in the application will help contribute 
to understanding of the determinants of oral health disparities and/or 
intervening to prevent or reduce oral health disparities.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be 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 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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)

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

Dr. George Hausch
Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44F
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Hausch@nih.gov

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
responsiveness to this RFA by 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 an appropriate peer review group 
convened by the NIDCR in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique and may undergo a process in which only those applications deemed to 
have the highest scientific merit, generally the top half of the applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Dental and Craniofacial 
Research Council.  

Review Criteria 

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 the application in order to judge the likelihood that the research 
planned could have a substantial impact on the pursuit of these goals 
particularly with respect to the prevention or reduction of oral health 
disparities.  Each of these criteria will be addressed and considered 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 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.

Detailed information regarding the rationale for the studies being planned 
will be expected.  Information necessary includes the health disparity (s) 
that exists, populations to be studied, and collaborative relationships to be 
developed with other researchers, community-based and other organizations, 
health and other agencies at the state or local level, health care 
practitioners, policy makers or other resources necessary to successfully 
implement the research being planned. 

(1) Significance:  This criterion focuses on the research questions/aims to 
be addressed by a full scale (R01 type) study that would follow from the 
planning.  Reviewers are asked to assess whether answers to the 
questions/aims posed for the full scale study are important ones with respect 
to reducing or preventing oral health disparities.  Does this application 
address an under-represented population and a specific topic relevant to 
preventing or reducing oral health disparities?  Is the main research 
question/aim of a subsequent full scale (R01 type) study an important 
question/aim that when addressed may ultimately help to prevent or reduce 
oral health disparities? What will be the effect of the results coming from 
that study in generating concepts, methods, or findings that provide the 
foundation for outcomes that prevent or reduce oral health disparities? 

(2) Approach:  Does the applicant identify collaborative, infrastructure and 
human resource needs that are critical to carrying out the full scale (R01 
type) study? Does the applicant acknowledge potential problem areas that will 
be addressed during the planning process, consider alternative approaches and 
discuss why the proposed approach is superior?  Does the applicant 
demonstrate that once the planning is completed that a full scale (R01 type) 
study could be carried out?

(3) Innovation: This criterion focuses on the full scale (R01 type) study 
resulting as an outcome of the proposed planning.  If available, does the 
full project employ novel concepts, approaches or methods?  Are the aims 
original and innovative?  Does the project challenge existing paradigms or 
develop new methodologies or technologies?

(4) Investigator:  This criterion applies to the planning grant. The 
reviewers are asked to determine the following: Does the investigator, and/or 
other members of the research team, show adequate and appropriate expertise 
to conduct the work?  Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers (if any)?  Have 
appropriate steps been outlined towards expanding infrastructure and 
collaboration for planning to conduct health disparities research on the 
topic identified?

(5) Environment:  This criterion applies to both the planning and the 
subsequent full scale (R01 type) study. In each case the reviewers are asked 
to determine the following: Does the scientific environment in which the work 
will be done contribute to the probability of success?  Does the proposal 
take advantage of unique features of the scientific environment or plan to 
employ useful collaborative arrangements?  Is there evidence of 
institutional, collaborative and community support? Is there evidence that 
the appropriate under represented population is available to the investigation?

In addition to the above criteria, in accordance with NIH policy, 
applications also will be reviewed with respect to the following:

O The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects also will 
be evaluated.

O The reasonableness of the proposed budget and duration in relation to the 
proposed research.

O The adequacy of the proposed protection for humans and the environment, to 
the extent they may be adversely affected by the project proposed in 
the application.

SCHEDULE

Letter of Intent Receipt Date:    March 21, 2002
Application Receipt Date:         April 18, 2002
Peer Review Date:                 June 2002
Council Review:                   August 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA 

Criteria that will be used to make award decisions include:

o feasibility and adequacy of planning process to develop high quality 
scientific project (as determined by peer review)
o availability of funds
o programmatic priorities

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.
 
Direct inquiries regarding scientific programmatic issues to:

Ruth Nowjack-Raymer, M.P.H., Ph.D.
Program Director
Research to Reduce Oral Health Disparities
Division of Population and Health Promotion Science
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 3AN-44D
Bethesda, Maryland  20892-6402
Telephone:  (301) 594-5394
Email:  Ruth.Nowjack-Raymer@nih.gov

Jean Flagg-Newton, Ph.D.
Deputy Director
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD  20892-5465
Phone:  (301) 402-1366
Fax:  (301) 402-7040
E-mail: flaggnej@od.nih.gov or jf41v@nih.gov

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women's Health
NIH Office of the Director
1 Center Drive, Room 201, MSC 0161
Bethesda, MD  20892
Phone:  (301) 496-7853
Fax:  (301) 402-1798
E-mail:  beggl@od.nih.gov


Direct inquires regarding review issues to:

Dr, George Hausch
Scientific Review Branch
Division of Extramural Activities 
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A
Bethesda, Maryland  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Hausch@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Kevin Crist
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A,
Bethesda, Maryland  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Kevin.Crist@nih.gov


AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.121 (NIDCR) Oral Diseases and Disorders Research Awards.  Awards are made 
under authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and administered under NIH grants policies 
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  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 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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