PILOT GRANTS FOR RESEARCH TO PREVENT OR REDUCE ORAL HEALTH DISPARITIES

Release Date:  Janaury 11, 2002

RFA:  RFA-DE-02-004

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)
National Institute of Nursing Research
 (http://www.ninr.nih.gov)

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 
National Institute of Nursing Research (NINR) invite applications for pilot 
research focusing on the determinants, prevention/reduction, or impacts of 
oral health disparities in populations currently under-represented in NIDCR's 
grant portfolio.  This RFA is being issued concurrently with two other RFAs 
("Planning Grants for Research to Prevent or Reduce Oral Health Disparities" 
DE-02-005 and "Research Infrastructure and Capacity building for Minority 
Dental Institutions to Reduce Oral Health Disparities" DE-02-003).  Together 
they reflect a strong commitment on the part of the National Institutes of 
Health to encourage research that contributes to preventing or reducing 
health disparities. 

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. 

Support provided through this mechanism may include testing of research 
methods and instruments as well as collection of preliminary data in these 
populations.  The ultimate aim of the pilot study should be to develop a 
sound scientific foundation for subsequent R01-level single or multi-site 
studies to prevent or reduce oral health disparities. Awards under this RFA 
are not intended to support or supplement ongoing research or serve as an 
alternative mechanism of support for projects not receiving funding as 
competitive applications.

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 RFA "Pilot Grants for 
Research to Prevent or Reduce Oral Health Disparities" is related to oral 
health, which is one of the priority areas indicated in "Health People 2010".  
Other priority areas and their potential contributions toward reducing and 
ultimately eliminating oral health disparities should also be considered.  
Examples include nutrition, unintentional injury prevention, violence and 
abuse prevention, tobacco use, educational and community based programs, and 
access to health care.  Potential applicants may obtain a copy of "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, 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 expanding their research efforts 
or research capacity relevant to oral health disparities, NIDCR will 
typically fund no more than one pilot grant application in response to this 
RFA at any single institution.  It should be noted that applications for this 
RFA will not be accepted from institutions with significant funding from the 
NIDCR Centers for Research to Reduce Oral Health Disparities RFA, nor will 
pilot grant applications be accepted from institutions responding as primary 
applicants to the two companion RFAs focused on developing research capacity 
in minority dental schools and/or fostering research planning for 
investigators who consider themselves not as yet fully ready to implement 
pilot research projects. Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as Principal Investigators.

If applicants are developing clinical trials relevant to health disparities 
research, they should refer to and respond to the previously released NIDCR 
Clinical Trial Pilot Grant program announcement 
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-158.html.)  Applicants 
are encouraged to contact program staff listed on this RFA with questions 
they may have concerning which RFA best matches their needs and goals

MECHANISM OF SUPPORT

This RFA invites grants for support through the National Institutes of Health 
(NIH) Exploratory/ Developmental Grant (R21) award mechanism.  Responsibility 
for the planning, direction, and execution of the proposed project will be 
solely that of the applicant.  Funding under this RFA will be up to a maximum 
of $125,000 direct costs per year for up to a maximum of three years. For 
those applications that include a subcontractual/consortium arrangement, 
direct costs of up to $175,000 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.  This RFA is a one-time solicitation.  Awards are 
not renewable and supplements will not be allowed.  The anticipated award 
date is September 30, 2002.

Use of the R21 mechanism for pilot studies is intended, in part, to encourage 
innovative new research directions and exploration of approaches and concepts 
new to a particular area or study population.  As such, this mechanism can 
encourage the entry of investigators to a field, extend the range of research 
support on a topic, and encourage new research approaches, new 
collaborations, or research with new or under-studied populations.  
Applications will typically be expected to provide less preliminary data than 
would be the case for other funding mechanisms.  Applicants should, however, 
make clear that the proposed pilot research is scientifically sound, that the 
long term research goals are both scientifically significant and relevant to 
the aim of preventing or reducing oral health disparities, that the 
qualifications of the investigators are appropriate, and that resources 
available to the investigators are adequate for the work proposed.  Those 
applicants that are not at the point of conducting pilot research but rather 
need to develop plans and collaborative arrangements that will provide a 
sound foundation for conducting scientifically meritorious studies to prevent 
or reduce oral health disparities are encouraged to refer to the planning 
grant RFA that is being released simultaneously.

FUNDS AVAILABLE 

The NIDCR and NCMHD intend to fund in FY 2002 up to seven new pilot grants in 
response to this RFA.  An applicant may request a project period for a 
maximum of three years and a budget of up to $125,000 in direct costs per 
year and up to $175,000 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 program, awards resulting from this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.
 
RESEARCH OBJECTIVES

Background  

"Oral Health in America: A Report of the Surgeon General" (2000) indicates 
that oral, dental, and craniofacial diseases and disorders are among the most 
common health problems affecting people in the US.  Many population subgroups 
in our society lack access to optimal prevention, early detection, and 
treatment of oral diseases or conditions such as early childhood caries, 
dental caries, periodontal diseases, oral and pharyngeal cancers, orofacial 
and dental injuries, oral manifestations or sequelae of other diseases such 
as HIV infection or diabetes, and birth defects affecting the dental and 
craniofacial structures.   Moreover, biological, behavioral, and 
socioenvironmental 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 racial and ethnic 
minorities and those who are poor.  Difference in the prevalence of diseases 
and conditions exist by gender as well. While gains have been made in the 
oral health status of Americans over the past decade, not all groups have 
demonstrated comparable benefit.  This disparity in oral health among diverse 
populations has become a major focus of the research supported by NIDCR as 
outlined in NIDCR's "A Plan to Eliminate Craniofacial, Oral and Dental Health 
Disparities."

People in the United States who are poor suffer from the consequences of oral 
diseases and conditions to a greater extent than do those with greater 
resources. America's poorest children have nearly five times as much tooth 
decay as children of higher income families.  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.  
Disparities in caries treatment for the poor as compared with the non-poor 
continue into adulthood. 

Periodontal diseases, which can ultimately result in the loss of all natural 
teeth, disproportionately affect the 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 losing all of their teeth.  
As reported in the NIDCR "A Plan to Eliminate Craniofacial, Oral, and Dental 
Health Disparities," adults with the lowest at the lowest SES level had more 
severe periodontal diseases than the non-poor.  Disparities in the prevalence 
of severe periodontal diseases among the poor and other segments of the 
population put them at greater risk for tooth loss, impaired nutrition and 
quality of life, and potentially 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 being explored. 

In the US racial and ethnic disparities in oral health status also are 
common. For example, 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.  These disparities are even greater 
when comparing non-poor minority children to white children on 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 exhibited 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% vs 55%) than that of 
whites (SEER, 1999).   The average age of diagnosis for African Americans is 
about 10 years younger than 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.    Domestic violence, child abuse, spousal and elder abuse, 
and abuse of the disabled are often manifested as injuries to the 
craniofacial tissues and dentition, but epidemiological data remains meager.  

There is also a dearth of oral health data for children and adults who have 
neurodevelopmental disabilities and other special needs, although 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 provides insight into the daunting 
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 to date has contributed to our understanding of some of the factors 
that contribute to oral diseases and conditions and has yielded more 
effective clinical measures that can be used in health care settings to 
prevent or treat oral diseases. However, the striking oral health disparities 
which persist within segments of the U.S. population suggest the need for a 
better understanding of the interplay of biological, environmental, and 
behavioral determinants of oral, dental and craniofacial diseases and conditions.  

Intervention research, including that which addresses policy, environmental 
or institutional changes that could contribute to potentially sustainable 
positive outcomes, may be warranted.  Collaborations with other academic 
institutions, schools, faith-based and other community organizations, or with 
local, community, or state public health agencies may be necessary to 
increase prospects for reducing or preventing oral health disparities. 

Goals and Scope

A primary goal of this RFA is to stimulate pilot research which will develop 
sound methods and preliminary data which will serve as the foundation for 
subsequent full scale (R01 type) supported research to prevent or reduce oral 
health disparities in populations under represented in NIDCR's health 
disparities portfolio.  In developing the research question (s) to be 
considered in such research, applicants should refer to NIDCR's "A Plan to 
Eliminate Craniofacial, Oral and Dental Health Disparities" 
(http://www.nidcr.nih.gov/research/health_disp.asp).  Listed below are 
illustrative topics. The topics are not presented 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, 
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, 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 or genetic differences in keloid formation 
with implications for scarring and implications for wound healing. 

SPECIAL REQUIREMENTS 

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 Disparities." Specifically, applicants must 
provide a context in which the pilot 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, an experimental 
or other appropriate study design to address that problem, and the gap in 
knowledge that needs to be filled via the pilot research proposed in this 
application before the subsequent full scale (R01 type) study can be 
launched.  Applicants are also expected to show that they are ready to 
initiate relevant pilot studies, as indicated, for example, by their 
demonstrable access to appropriate study populations and the scientific 
quality and appropriateness of the pilot studies they propose.  In addition, 
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 the RFA to which 
the application is responding.  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 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 must also 
be sent to:

H. George Hausch, Ph.D.
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 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 the CSR and 
responsiveness by program staff of the participating institutes.  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 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 proposed 
research will have a substantial impact on the pursuit of these goals.  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.

(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 
pilot research.  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 study address a 
population and topic relevant to reducing oral health disparities? Is the 
main research question/aim of a subsequent full scale (R01 type) study an 
important question/aim that when answered 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 gaps that are critical to carrying 
out the full scale (R01 type) study?  Are the conceptual framework, design, 
methods, and analyses adequately developed, well integrated, and appropriate?  
Does the applicant acknowledge other potential approaches and discuss why the 
proposed project is superior?  To what degree will support of the proposed 
pilot study help develop an initial database for future research to prevent 
or reduce oral health disparities?  Does the applicant demonstrate that once 
the pilot study is completed 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 pilot study:  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 for both the pilot study and the 
subsequent full scale (R01 type) study.  In each case the reviewers are asked 
to determine the following: Is the investigator appropriately trained and 
well suited to carry out the work?  Does the investigator and/or other 
members of the research team show adequate and appropriate expertise to 
conduct the research? Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers?  

(5) Environment:  This criterion applies for both the pilot study 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 proposed 
research take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements?  Is there evidence of institutional 
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, all 
applications will also 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 will also 
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, animals or 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
Scientific Review Date:           May/June, 2002
Advisory Council Review:          August 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities

INQUIRIES

Inquiries concerning this RFA are encouraged.  Applicants are encouraged to 
ask questions or seek any information they may need to clarify the goals or 
requirements set forth in this solicitation.

Direct inquiries regarding 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 Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 3AN-44D
Bethesda, MD  20892-6401
Telephone:  (301) 594-5394
FAX:  (301) 480-8254
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

Janice Phillips, Ph.D., FAAN
Program Director
Health Promotion, Risk Reduction and Oncology Research
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6152
FAX:  (301) 480-8260
Email:  Janice.Phillips@nih.gov

Direct inquiries regarding review issues to:

H. George Hausch, Ph.D.
Scientific Review Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Huasch@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, MD  20892-6402
Telephone:  (301)-594-4800
FAX:  (301) 480-8301
E-mail:  Kevin.Crist@nih.gov

Ms. Cindy McDermott
Chief Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-12
45 Center Drive, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6869 
FAX:  (301) 451-5648
E-mail:  mcdermoc@mail.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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