RESEARCH INFRASTRUCTURE AND CAPACITY BUILDING FOR MINORITY DENTAL INSTITUTIONS 
TO REDUCE ORAL HEALTH DISPARITIES

RELEASE DATE:  February 14, 2002

RFA:  RFA-DE-02-003

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov)
National Center on Minority Health and Health Disparities (NCMHD)
 (http://www.ncmhd.nih.gov)

LETTER OF INTENT RECEIPT DATE:  March 15, 2002
APPLICATION RECEIPT DATE:       April 17, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

Purpose of this RFA
Research Objectives
Mechanism(s) of Support
Funds Available
Eligible Institutions
Individuals Eligible to Become Principal Investigators
Special Requirements
Where to Send Inquiries
Letter of Intent
Submitting an Application
Peer Review Process
Review Criteria
Receipt and Review Schedule
Award Criteria
Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Dental and Craniofacial Research (NIDCR) and the 
National Center on Minority Health and Health Disparities (NCMHD) invite 
applications from minority dental schools for the development of research 
infrastructure and capacity to carry out research aimed at reducing oral 
health disparities.  The purposes of this Request for Application (RFA) are 
to augment and strengthen the institutional infrastructure and capacity for 
these institutions to conduct basic, clinical and behavioral research with 
the objective of reducing oral health disparities through support of 
assessment and planning activities as well as the development of 
collaborative research arrangements with other, research 
intensive, institutions. 

Minority dental schools represent a rich source of talent containing the 
cultural sensitivity and perspective needed for studying health disparities 
in craniofacial, oral and dental health.  However, these institutions have 
not yet totally developed nor sustained a critical mass of faculty and 
research resources to conduct scientifically meritorious research on diseases 
and disorders that disproportionately affect the populations they serve.  The 
intent of this research infrastructure program is to strengthen the research 
environments of minority dental schools through grant support to develop 
and/or expand existing capacities for conducting research in oral 
health disparities. 

RESEARCH OBJECTIVES

Background

As described in the "Oral Health in America:  A Report of the Surgeon 
General" (NIH Pub No. 00-4713) oral, dental and craniofacial diseases and 
disorders are among the most common health problems affecting the people of 
the U.S.  Diseases and disorders affecting the mouth and its surrounding 
tissues go beyond dental caries and periodontal diseases.  They include birth 
defects such as cleft lip and palate, oral soft tissue lesions, chronic oral-
facial pain conditions, oral and pharyngeal cancers, dentofacial injuries, 
and many other diseases and disorders.  Oral manifestations of systemic 
diseases (i.e., Sjogren's syndrome, diabetes and HIV infection) and side 
effects from drugs and/or treatment add to the burden of oral illness. 

Many of these craniofacial, oral and dental diseases and disorders have a 
disproportionately higher burden on particular population subgroups, and 
addressing disparities in oral health among diverse populations of the United 
States continues to be a major focus of the research supported by NIDCR as 
outlined in the Institute's document "A Plan to Eliminate Craniofacial, Oral 
and Dental Health Disparities."  This plan is available on the NIDCR homepage 
(http://www.nidcr.nih.gov/research/health_disp.asp).  The plan emphasizes 
that eliminating oral health disparities requires more than an understanding 
of the biology and lifestyle of an individual; it also must take into account 
the political, social and cultural environment where an individual lives.  
The need to understand the unique social and cultural context of particular 
population groups that exhibit health disparities in the U.S. points to a 
pivotal role that minority dental schools play in improving the oral health 
of these populations.  Dental schools at minority institutions represent a 
rich source of talent with appropriate cultural sensitivity and perspectives 
needed in basic, clinical, epidemiological, and behavioral research.  These 
schools conduct high quality programs for educating minorities to pursue 
clinical practices, however, they have had difficulties in developing and 
sustaining independent programs in biomedical, clinical and behavioral 
research.  The limited involvement of minority dental schools in oral health 
research and the lack of a significant number of minority scientists trained 
in this area must be addressed if we are to develop a stronger national oral 
health research effort aimed at understanding the disparities caused by oral 
diseases and conditions.  The prospect of establishing an oral health 
research program in a minority dental school that is collaborating with a 
research-intensive academic center would take maximum advantage of their 
respective expertise and experience.  

Objectives and Scope

This two phase initiative is designed to provide resources to minority dental 
schools for the development (Phase I) and implementation (Phase II) of an 
institutional plan to enhance their infrastructure for research, to recruit 
and/or retain personnel with research expertise relevant to the objectives of 
this solicitation, and to establish partnership/collaborations with other 
institutions that will lead to research aimed at reducing oral 
health disparities.  

Specific Objectives 

During Phase I, the applicant will be required to carry out a needs 
assessment and, from it, develop a comprehensive plan to expand and sustain 
the research infrastructure.  During Phase II, the institutions will be 
expected to implement the proposed strategies for research infrastructure and 
capacity building.  At the end of the funding period the awardees will be 
expected to have strengthened their capacity to proceed with the submission 
of scientifically meritorious developmental grants for specific research 
areas to reduce oral health disparities, to have established 
partnerships/collaborations with other academic institutions, and to have 
initiated training and career development programs relevant to the mission of 
the NIDCR.  

For purposes of this announcement, infrastructure enhancement and capacity 
building may be defined as both personnel and equipment in a biomedical 
research environment.  Examples include but are limited to the following: 

o Limited research equipment support (up to $10,000)
o Support for collaborative linkages with established scientists at 
other institutions
o Special courses/seminars for faculty or students
o Administrative support for managing the project
o Faculty development and release time 
o Consultant expertise 
o Limited costs associated with establishing research linkages with community 
oral health treatment services
o Limited library/information resources 
o Pilot work that forms the basis for individual research projects (Phase II 
of this RFA) 
o Data management and statistical analysis needs (Phase II of this RFA)  

To ensure the success of this initiative, the Principal Investigator must 
organize an Internal Advisory Committee and a Scientific and Program 
Advisory Committee.  

Internal Advisory Committee

The Internal Advisory Committee will be comprised of staff of the minority 
dental school.  The committee will have the responsibility for directing and 
monitoring the activities of the U24 program.  This committee must define the 
chain of responsibility for decision making and administration beginning at 
the level of the Dean and including all key staff (e.g., Sponsored Programs 
Administrator and Department Chair).  This committee will establish a time-
line for proposed activities.  This committee must also develop opportunities 
for information exchange, seminar presentations, and research training 
opportunities for faculty and students.

Scientific and Program Advisory Committee 

The Scientific and Program Advisory Committee will be composed of 
approximately six members of distinguished senior scientists and 
collaborating partners.  This Committee must provide a multidisciplinary and 
objective perspective, expert attention to the many factors during the course 
of the research program, and considerable judgment.  Additional members with 
specific scientific expertise may be added during Phase II to ensure an 
adequate review of the scientific program relative to the research projects 
proposed.  This Committee will also review the proposed pilot projects for 
Phase II.  The chair of the Committee will be elected by and from the 
Advisory Committee.  Annually, the committee will assess the productivity of 
the grant, make recommendations for the future direction of the 
Infrastructure and Capacity Building initiative, and provide advice and 
guidance about personnel matters and the allocation of resources.  This 
Committee will also review the proposed pilot projects for Phase II.  The 
SPAC's recommendations, in the form of a written annual report, are to be 
submitted to the Principal Investigator and NIDCR.  This report will be used 
by the Principal Investigator to guide and direct the development of the U24.  
The Principal Investigator generally will be expected to accept and implement 
the recommendations of the SPAC; in those situations where the 
recommendations are not feasible to implement, the Principal Investigator 
must provide a thorough explanation and rationale to the NIDCR.  The 
application should include plans for the development of the Committee, but 
should not include specific names.

The Principal Investigator, NIDCR staff, other ex-officio members and 
consultants are non-voting members of this Committee.  

Specific information on the application requirements of Phase I and II is 
described in the section under SUBMITTING AN APPLICATION.  

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) U24 award 
mechanism.  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.  This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation applications based 
on this project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  However, 
at this time, it is not known if this RFA will be reissued.  The anticipated 
award date is September 30, 20002.  

This RFA uses just-in-time concepts.  

The U24 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."  It is not known, if this RFA will be reissued.  

The total project period for an application submitted in response to this RFA 
may not exceed three years.  The three-year award will include a one-year 
Planning Phase (Phase I) and a two-year Implementation Phase  (Phase II).  
The submitted application must describe plans for both Phases.  It is 
critical that the application contain strong evidence of the minority 
institution's commitment of fund to this initiative for Phases I and II.  
This may be in the form of matching funds (real dollars); faculty release 
time, etc.).  However, Phase II plans proposed in the application will be 
considered to be preliminary pending the outcome of Phase I and awardees are 
expected to submit a more-detailed supplemental application for Phase II, on 
August 1, 2003, at which time NIDCR will conduct an interim Peer Review of 
the Phase II supplemental/application.  The peer review will allow for an 
evaluation of progress made during Phase I as well as serve as an assessment 
of detailed plans for Phase II relative to the goals and objectives of this 
RFA.  The interim Peer Review will be composed of outside consultants 
selected by NIDCR.  Award of Phase II funds will be contingent on successful 
outcome of the interim Peer Review.  

Awardees are expected to continue support of the research programs after the 
initial three years through regular competitive NIH research and training 
programs or from other sources.  

FUNDS AVAILABLE

The NIDCR intends to commit approximately $1 million in FY 2002 to fund up to 
three new grants in response to this RFA.  Phase I is a one-year project and 
a budget of $350,000 total costs.  Phase II will be funded for two years up 
to $500,000 total costs per year.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size of each grant will vary.  Although the financial 
plans of the NIDCR provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  

ELIGIBILE INSTITUTIONS

You may submit an application if your institution is a minority dental 
institution.  Minority dental institutions are defined as a Historically 
Black College/University or a Hispanic-Serving Institution either in the 
United States or in territories under U.S. jurisdiction.  

The applicant must propose collaborative affiliations with other entities.  
The collaboration can be with entities from within the parent institution as 
well as other institutions and should be for the purpose of facilitating and 
addressing the objectives outlined in this RFA.  For example, 
partnerships/collaborations may include but not be limited to with the 
Centers for Research to Reduce Oral Health Disparities, academic health 
centers including schools of public health, the National Center for Research 
Resources (NCRR) Research Centers for Minority Institutions (RCMI) Clinical 
Research Infrastructure Initiative, the National Institute of Neurological 
Disorders and Stroke (NINDS) Specialized Neuroscience Centers, and the 
National Cancer Institute (NCI) Comprehensive Minority Institution/Cancer 
Center Partnership. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATAORS

The individual submitting the application should be a senior institutional 
official, e.g., Dean, Associate Dean/Director for Research, or an individual 
who has received a competitive or independent research award funded by NIH.  

SPECIAL REQUIREMENTS

There are a number of Special Requirements and Provisions that each minority 
institution must comply with: 

o Each minority dental school is limited to applying for only ONE Research 
Infrastructure and Capacity Building for Minority Dental Institutions to 
Reduce Oral Health Disparities award.  

o Where applicable, NIDCR encourages applicants to build on existing research 
projects, and training and career development opportunities developed from 
the Regional Research Centers in Minority Oral Health or other NIDCR 
funded grants.  

o The application must include a "Letter of Commitment" from the minority 
dental school's leadership committing to the establishment of the 
Infrastructure Grant.  The letter should detail the resources the institution 
is willing to provide including office and laboratory space, guarantees of 
protected time for faculty and students to perform the research and training 
activities and other administrative responsibilities for the Principal 
Investigator and other key staff.  

o For each collaborative partner there must be written "Letters of 
Commitment" from the institution illustrating the level of support, including 
any additional resources necessary to ensure that these partnerships will 
have the maximum chance for success.  

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The following Terms and Conditions of 
Awards are in addition to, and not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS grant administration regulations in 45 CFR 
Part 74 and 92, and administered under the NIH grants Policy Statement.

The administrative and funding instrument used for this process is a 
cooperative centers agreement (U24), an "assistance" mechanism (rather than 
an "acquisition" mechanism) in which substantial NIH scientific and 
programmatic involvement with the awardee is anticipated during the grant 
award.  The NIH purpose is to support and stimulate the activity by working 
jointly with the recipient in a partner role, but it is not to assume 
direction, prime responsibility or a dominant role in the activity.  The 
prime responsibility for the research resides with the awardees, although 
some activities may be carried out as collaboration among the awardees with 
coordination and facilitation by the NIDCR-DPHPS staff as described below.

1. Awardees Rights and Responsibilities:

a. Awardees have primary authorities and responsibilities to define 
objectives and approaches, and to plan, conduct, analyze, and publish 
results, interpretations, and conclusions of their studies.  

b) Awardees will retain custody of and have primary rights to data developed 
under these awards, subject to Government rights of access consistent with 
current HHS, PHS, and NIH policies.

c) The Principal Investigator must organize an Internal Advisory Committee.  
The committee will be comprised of staff of the minority dental school.  They 
will also have the responsibility for directing and monitoring the activities 
of the U24 program.  The committee must define the chain of responsibility 
for decision-making and administration beginning at the level of the Dean and 
including all key staff (e.g., Sponsor Programs Administrator and Department 
Chair).  This committee will also establish a time-line for proposed 
activities.  This committee must also develop opportunities for information 
exchange, seminar presentations, and research training opportunities for 
faculty and students.  

d) The Principal Investigator must organize a Scientific and Program Advisory 
Committee that will be composed of approximately six members of distinguished 
senior scientists and collaborating partners.  This committee must provide a 
multidisciplinary and objective perspective, expert attention to the many 
factors during the course of the research program, and considerable judgment.  
Additional members with specific scientific expertise may be added during 
Phase II to ensure an adequate review of the scientific program relative to 
the research projects proposed.  The chair of the committee will be elected 
by and from the Advisory Committee.  Annually, the committee will assess the 
productivity of the grant, make recommendations for the future direction of 
the Infrastructure and Capacity Building initiative, and provide advice and 
guidance about personnel matters.  The SPAC's recommendations, in the form of 
a written annual report, are to be submitted to the Principal Investigator 
and NIDCR.  This report will be used by the Principal Investigator to guide 
and direct the development of the U24.  The Principal Investigator generally 
will be expected to accept and implement the recommendations of the SPAC; in 
those situations where the recommendations are not feasible to implement, the 
Principal Investigator must provide a thorough explanation and rationale to 
the NIDCR.  

The Principal Investigator, NIDCR staff, other ex-officio members and 
consultants are non-voting members of this committee. 

e) Awardees agree to follow the advice and recommendations of the Scientific 
and Program Advisory Committee, whenever possible, in meeting the intent of 
this initiative. 

d) The Principal Investigator and collaborators/partners should plan and 
budget for regular meetings to discuss the progress and direction of its 
activities and to ensure that the necessary interactions are taking place.  

e) The Principal Investigator, collaborative partners, and other designated 
individuals will attend an annual meeting to be organized by NIDCR staff in 
Washington, DC.  The budget must include costs for attendance of this meeting.

f) The Principal Investigator will submit annual progress reports (including 
recommendations of the Scientific and Program Advisory Committee) to the 
NIDCR that describe activities and accomplishments during the previous 
funding period.

2. NIDCR-Division of Population and Health Promotion Sciences (DPHPS) 
Staff Responsibilities  

a) The NIDCR-DPHPS Project Coordinator will have substantial 
scientific/programmatic involvement in the award performance period through 
contributions to the planning and assessment activities, providing technical 
assistance, advice on future directions and ancillary support, and 
coordination beyond normal program stewardship for grants.  The Project 
Coordinator will also provide assistance to recipients of the award in 
developing collaborative research and funding assignments, the institutional 
environment, resources and other infrastructure and administrative areas. 

b) The NIDCR-DPHPS Project Coordinator together with the External Advisory 
Committee will help the applicant institution and Principal Investigator 
establish reasonable time lines to achieve the developmental goals of 
this initiative.  

c) The NIDCR-DPHPS Project Coordinator will organize an annual meeting of all 
funded Principal Investigators or their designees to share progress and 
research insights that may benefit all of the projects.  

d) The NIDCR-DPHSP Program Director, who is responsible for normal program 
stewardship will work closely with the Principal Investigators to facilitate 
collaborations with other NIDCR-funded research scientists and to leverage 
the resources available for this effort.  The Program Director will also 
assist, where warranted, in data analyses, interpretations, and the 
dissemination of study findings to the research community and health 
care recipients.   

3. Arbitration

When an agreement between an awardee and NIDCR staff cannot be reached on 
scientific/programmatic issues that may arise after the award, an arbitration 
panel will be formed.  The panel will consist of one person selected by the 
awardee, one person selected by NIDCR staff, and a third person selected by 
these two members.  The decision of the arbitration panel, by majority vote, 
will be binding.  This special arbitration procedure in no way affects the 
right of an awardee to appeal an adverse action in accordance with PHS 
regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CRF 
Part 16.  

WHERE TO SEND INQUIRIES

Written, email and telephone inquiries concerning this RFA are encouraged, 
particularly early in the application development process.  The opportunity 
to clarify any issues or answer questions from potential applicants is 
welcome.  Direct inquiries regarding programmatic issues to: 

Ms. Lorrayne Jackson 
Project Coordinator
Division of Population and Health Promotion Sciences 
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4AN24J
Bethesda, MD  20892-6402 
Telephone:  (301) 594-2616 
Fax:  (301) 480-8318
Email:  Lorrayne.Jackson@nih.gov

Dr. Ruth Nowjack-Raymer
Program Director
Health Disparities and Health Promotion Research
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 3AN-44D
Bethesda, MD  20892-6402
Telephone:  (301) 594-5394
Fax:  (301) 435-8254
Email:  Ruth.Nowjack-Raymer@nih.gov

Direct your questions about peer review issues to: 

Dr. George Hausch
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

Direct your questions about financial or grants management matters to:

Mr. Kevin Crist
Grants Management Branch 
Division of Extramural Activities
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4AN-44F
Bethesda, MD  20892-6402 
Telephone:  (301) 594-4800
Fax:  (301) 402-1517
Email:  Kevin.Crist@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information: 

O Descriptive title of the proposed research
O Name, address, and telephone number of the Principal Investigator
O Names of other key personnel
O Participating institutions
O 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 by the date listed at the beginning of 
this document.  The letter of intent should be sent to:  

Dr. George Hausch
Division of Extramural Activities 
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4AN44F
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Hausch@nih.gov

SUBMITTING AN APPLICATION

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.

SUPPLEMENTAL INSTRUCTIONS:

Allowable Costs

NIDCR recognizes that institutions are different and require different types 
of research infrastructure development activities and initiatives, depending 
upon particular needs and circumstances.  Accordingly, this announcement 
provides general rather than specific guidance on the types of developmental 
activities appropriate under the Research Infrastructure and Capacity 
Building for Minority Dental Institutions to Reduce Oral Health Disparities 
Award.  Support may be requested for, but is not limited to, the following: 

1. Administrative costs (not to exceed 20% of the total direct costs per 
year) for managing the partnership, such as salaries for key personnel and 
equipment to support an administrative structure.  

2. Planning and evaluation may include the costs for travel for internal and 
external activities (key personnel); travel and per diem for the Scientific 
and Program Advisory Committee members, workshops, seminars, retreats and 
other forums to strengthen, stabilize and consolidate interactions and 
cooperation in areas of existing high priority; to identify new areas of 
opportunity and high priority as the partnership evolves; and for recruitment 
and resources. 

3. Developmental costs for:

a. selecting the areas of greatest promise for implementation of specific 
types of research programs based on potential to result in a successful 
research publication or grant in Phase I, and

b. for the purchase of equipment (up to $10,000) or conduct of pilot programs 
in training and career development in Phase II. 

Direct costs for construction, renovation or for salaries for teaching or 
other non-research activities are not allowable in this grant.  

Application Requirements

The application should contain the following: 

Phase I – Institutional Research Development Plan (Year 1) 

o Describe the approach that will be used for assessing your institution's 
(including other schools and departments) capacity to conduct state-of-the-
art research on basic and clinical research related to oral health 
disparities (applicants are encouraged to use outside, independent expertise 
to provide leadership in this step of the assessment); 

o Provide a description of all research activities that currently exist in 
the dental schools as well as in the academic health center including school 
of public health or at institutions at additional sites deemed by the 
applicant institution to fall within a feasible distance for frequent 
interactions and research collaborations;  

o Propose a process for identifying gaps and opportunities in health 
disparities research which the minority institution intends to address in 
this award (if applicable, include a description of health-disparities 
related ongoing basic and clinical research or studies funded previously that 
have potential for further study); 

o Provide a description of equipment, space and other resources available to 
support the development of the plan and the extent to which the enhancement 
of these resources is needed; and 

o Provide a detailed statement of the minority institution's leadership 
financial commitment (matching funds/real dollars) to sustaining and 
supporting the development of their research infrastructure and enhancing 
their capacity to carry out research aimed at reducing oral health 
disparities throughout the funding period and beyond the award.  The 
statement must address specific resources that will be dedicated to the 
objectives of this RFA, protected time for faculty, space that will be 
dedicated to this effort, and discretionary resources that will be made 
available to the Principal Investigator.  

Phase I may include funding for technical assistance for:  a) identifying a 
consultant with expertise in evaluating the minority institution's 
infrastructure; b) conducting workshops, seminars, retreats and other forms 
of communication to identify the area of research and the research intensive 
academic center(s) with which to partner.  At the end of Phase I, the dental 
school must identify a promising area of research in oral health disparities, 
a collaborating academic health center(s) and should provide a detailed 
description of the steps to establish the research program.   

Phase II - Implementation of the Institutional Research Development 
Plan (Years 2-3): 

o Description of procedures to be used to translate the results of the 
assessment obtained in Phase I into an implementable action plan that will 
result in infrastructure development during Phase II (include plans for 
administration of research, recruitment and retention of individuals 
experienced in conducting research, staff training and mentoring, statistical 
and other data management consultation, and collaboration with 
other institutions).

o A time-line outlining the process and steps to establish the necessary 
infrastructure to support the research program; 

o Provide a detailed statement of the minority institution's leadership 
financial commitment (matching funds/real dollars) to implementing Phase II 
of this RFA.  The statement must address specific resources that will be 
dedicated to the objectives of this RFA, protected time for faculty, space 
that will be dedicated to this effort, and discretionary resources that will 
be made available to the Principal Investigator. 

o Description of the proposed area(s) of research; short-term pilot projects 
may be proposed; evidence of procedures for selecting pilot projects and the 
quality and scientific merit of the project.  

o Plans for initiation of a training program for faculty/students in the area 
of research identified; and

o Evidence of a strong collaboration with a research-intensive institution 
for research and research training.

By completion of Phase II, it is anticipated that the minority dental school 
and its collaborators will be prepared to submit scientifically meritorious 
applications for support of research on reducing oral health disparities.  

In addition, NIDCR encourages pre-application consultations with individual 
partnerships either as telephone conference calls, videoconference meetings, 
or meetings at which the involved individuals are present.  

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/01) 
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 marked.  The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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) 

At the time of submission, two additional copies and all appendix material of 
the application must also be sent to:  

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

APPLICATION PROCESS:  Applications must be received by April 17, 2002.  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 the 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.  Applications must 
meet all eligibility requirements as described above and must address all 
programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA.  

PEER REVIEW PROCESS 

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to eligibility requirements and responsiveness to the Special 
Requirements and Provisions by the NIDCR.  

Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities (DEA) at NIDCR in 
accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:  

o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the National Advisory Dental and 
Craniofacial Research Council and by the National Center on Minority Health 
and Health Disparities Council.

Review Criteria

The goals of NIH-sponsored research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  For 
this RFA, the review criteria are not organized under the traditional 
headings of Significance, Approach, Environment, Investigator and Innovation 
typically used for NIH research grants.  Reviewers will have to use 
considerable flexibility in determining the merit of a broad range of 
possibilities that can strengthen the research capabilities of minority 
dental schools, expand training and career development opportunities for 
minority faculty and students, and to increase the effectiveness of minority 
dental schools in establishing partnerships/collaborators with other 
institutions that will lead to research aimed at reducing oral 
health disparities.  

With respect to Phase I Planning: 

Adequacy of the proposed processes to develop a plan for creation and/or 
enhancement of research infrastructure and capacity, which will ultimately 
translate into initiation of new or the enhancement of existing research 
aimed at reducing oral health disparities.  The adequacy of the plan is 
evidenced by:  

a. Adequacy of the conceptual framework for the needs assessment addressing 
the gaps and opportunities of the institution and the institution's capacity 
to conduct biomedical, behavioral or clinical research on oral 
health disparities; 

b. Acknowledgement of potential problems and consideration of alternatives

c. A well-prepared application that is reflective of close, effective 
interaction between the Principal Investigator, co-investigators 
and collaborators. 

d.  The adequacy and duration of the initial planning stage needed to 
identify areas of potential collaboration. 

e. The quality and merit of the documented planning process used for 
identifying areas for ready prioritization including the selection of 
leadership to carry out the process.

f.  Appropriateness and adequacy of the description of all research 
activities, equipment, research space that currently exist in the dental 
school as well as in the academic health center including school of public 
health or at institutions at additional sites deemed by the applicant 
institution to fall within a feasible distance for frequent interactions and 
research collaborations. 

g. The qualifications, experience and time commitment of the 
Principal Investigator.

h. The appropriateness and adequacy of the specific faculty and scientists 
identified for the Internal Advisory Committee from the minority dental 
school and their ability to contribute effectively to each aspect of this 
planning effort.

i. The adequacy of the qualifications and experience of each proposed member 
of Scientific and Program Advisory Committee to evaluate and monitor the 
progress of the partnerships in achieving its priorities and objectives, to 
recommend mid- course changes in approaches and tactics, and to help the 
partnership evaluate and take advantage of new opportunities.  

j.  Adequacy of the proposed processes to modify initial Phase II plans using 
information gained from the Phase I assessment.

With respect to Phase II Implementation Plan: 

Appropriateness and adequacy of the plan for creation or enhancement of 
research infrastructure and capacity that will ultimately translate into 
initiation of new or enhancement of existing research aimed at reducing oral 
health disparities.  The adequacy of the plan is evidenced by: 

a. Extent to which the plan will build on current institutional support for 
conducting research to reduce oral health disparities and significantly 
augment and improve the support of research; 

b. Extent to which the plan will enhance institutional capacity and 
individual faculty research development plans and the degree to which the 
components enhance one another in achieving the overall objectives. 

c. Likelihood that research projects in the area of oral health disparities 
will emerge from this effort and that such projects will be of sufficient 
scientific merit to be successful in securing competitive grant support.

d. Quality and appropriateness of the proposed organizational and 
administrative structure proposed.  Is the organizational and administrative 
structure deemed likely to support meeting the goals of this solicitation?

e. Appropriateness of the collaborators/partners identified for achieving the 
goals/ objectives outlined in the RFA.

f. Degree to which the resource/infrastructure identified will contribute to 
the overall priorities and objectives of the implementation plan.

g. Degree to which the proposed resource/infrastructure will provide long-
term stability to the activities of the minority dental institution. 

h. Adequacy of the implementation plan to recruit individuals that are 
committed to basic and clinical research to reduce oral health disparities. 

i. Adequacy of the design and quality of each of the internal planning and 
evaluation processes proposed to achieve the objectives and priorities of the 
implementation plan.

For both Phase I and II

Level of institutional support to ensure achievement of objectives of this 
RFA as evidenced by: 

a. Assurances of both direct and "in-kind" support and, specifically, the 
adequacy of the resources (e.g., discretionary resources, space, faculty 
positions, protected time for research, etc.) that the minority dental school 
and the collaborators/partners will provide to promote the successful 
improvement of the achievement of the priorities and objectives of 
this partnership.

b. Letters of support and the degree to which the letters of support from the 
institutional leaders address the need for mentoring of inexperienced 
Principal Investigator/investigators or for specific institutional 
commitments to ensure the success of the collaboration.

c. The level of authority of officials committing to this joint effort at the 
minority dental school and collaborators/partners that gives confidence that 
these commitments will be stable and long lasting.

d. The degree to which the letters of commitment from the leadership of the 
minority dental school and the collaborators/partners address and fully 
support the priorities and objectives of the implementation plan of 
the partnership.  

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 15, 2002
Application Receipt Date:       April 17, 2002
Peer Review Date:               June/July 2002
Council Review:                 September 2002
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

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998:  http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
The amended policy incorporates:  the use of a NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase II 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 differences.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
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 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy required 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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identified(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned 
without review.  

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 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.  
Unless otherwise specified in a 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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.  

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 is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.121 (NIDCR) Oral Diseases and Disorders 
Research Awards and is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency Review.  
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 described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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