This Program Announcement expires on April 30, 2004, unless reissued.

EXPLORATORY/DEVELOPMENTAL (R21) RESEARCH GRANTS
 
Release Date:  May 2, 2001

PA NUMBER:  PA-01-087
 
National Institute of Dental and Craniofacial Research
 (http://www.nidcr.nih.gov)

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE
 
The objective of this Exploratory/Developmental Grant (R21) mechanism 
is to encourage applications for one-time grants to support for 
innovative, high risk/high impact research requiring preliminary 
testing or development, exploration of the use of approaches and 
concepts new to a particular substantive area, research and development 
of new technologies, techniques or methods, or initial research and 
development of data upon which significant future research may be 
built. Applications will be considered as high impact if they 
demonstrate the potential for ground-breaking, precedent-setting 
significance, and high risk because they either lack sufficient 
preliminary data to ensure their feasibility, or involve using a new 
model system or technique. While this program announcement is intended 
to encourage innovation and high impact research, and while minimal 
preliminary data are expected to be described in the application, 
applications should clearly indicate that the proposed research and/or 
development is scientifically sound, that the qualifications of the 
investigators are appropriate, and that resources available to the 
investigators are adequate. 

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 Program 
Announcement (PA), "NIDCR EXPLORATORY/DEVELOPMENTAL GRANT (R21) 
PROGRAM," is related to several areas of emphasis in the oral health 
and oral health-related health promotion and disease prevention 
objectives.  Potential applicants may obtain a copy of "Healthy People 
2010" at: http://www.health.gov/healthypeople/.   

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or foreign for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of State and local 
governments, and eligible agencies of the Federal Government.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators. 

MECHANISM OF SUPPORT

Under this program announcement, applicants for the R21 award may 
request direct costs of up to $100,000 per year for up to two years.  
The R21 cannot be renewed, if sufficient data are generated during the 
term of the award, investigators could then apply for further funding 
through regular research grant, e.g., the research project grant (R01) 
mechanism.

Specific application instructions have been modified to reflect the 
purpose and nature of this mechanism, as well as to accommodate the 
"Modular Grant" and "Just-In-Time" streamlining efforts being 
implemented by the NIH.  Complete and detailed instructions and 
information on Modular Grant applications can be found at the website 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

The research objectives of the R21 mechanism described in this program 
announcement is to support: 1) innovative, high-risk research, 
requiring preliminary testing or development, 2) exploration of new 
approaches or concepts to a particular substantive area, 3) research 
and development of new technologies, techniques or methods, or 4) 
initial research and development of data upon which significant future 
research may be built, i.e., the data should have a high level of 
impact on the field. The research and/or development can be relevant to 
any of the branches, offices and programs of the NIDCR Division of 
Extramural Research (DER). The branches, offices and programs 
comprising the Division of Extramural Research at NIDCR are described 
in more detail on the website 
http://www.nidcr.nih.gov/research/extramural/index.htm. 

In brief, the DER at the NIDCR provides support for: (a) basic and 
clinical research on the processes that affect normal and abnormal 
development of craniofacial structures, (b) basic studies on the 
ecological, molecular, biological and physiological factors 
contributing to microbial virulence, colonization and transmission,  
(c) genetic determinants of host susceptibility to infection, (d) oral 
manifestations of HIV infection and AIDS, (e) basic and applied 
research related to head and neck cancers, (f) basic and clinical 
studies on neurobiology, pathogenesis, diagnosis, treatment or 
prevention of pain, (g) autoimmunity, (g) biomimetics, tissue 
engineering, instrumentation development and refinement (i.e., saliva 
based diagnostic technologies), and development of methods to improve 
biomaterials for the repair of orofacial structures, and (h) clinical, 
behavioral and health promotion studies related to craniofacial, oral 
and dental health.  

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a 
complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm
The revisions relate to NIH defined Phase III clinical trials and 
require: 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) all investigators to report accrual, 
and to conduct and report 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 was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

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.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts 
listed under INQUIRIES with any questions regarding their proposed 
project.

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants with the modifications noted below.  
Application kits are available at most institutional offices of 
sponsored research and may be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email GrantsInfo@nih.gov. Applications are also available on the 
World Wide Web at: http://grants.nih.gov/grants/oer.htm. 

APPLICATION INSTRUCTIONS

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets.  Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award.  It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers, and Institute staff.
  
The following instructions are to be used in conjunction with the 
information accompanying application form PHS 398 (rev. 4/98), they 
refer only to selected items in the application form.  All PHS 398 
requirements should be followed, with the exception of those items 
affected by the following instructions.  Applications not conforming to 
the requested format will be returned to the applicant without review.  
Applications will be accepted at the standard receipt dates as 
indicated in the PHS 398 kit.

o FACE  PAGE- Item 2, Check the box marked  Yes  and type the number 
and title (NIDCR Exploratory/Developmental Grant [R21] Program) of this 
program announcement.

o Item 6:  Up to a total of two years of support may be requested.

o Items 7a and 7b:  These items should be completed indicating Direct 
Costs and Total Costs [Direct Costs plus Facilities and Administrative 
(F&A) costs] for the initial budget period.

o Items 8a and 8b:  These items should be completed indicating the 
Direct and Total Costs for the entire proposed period of support.

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

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

o NARRATIVE BUDGET JUSTIFICATION- Prepare a Modular Grant Budget 
Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm 
for sample pages.)  At the top of the page, enter the total direct costs requested 
for each year. This is not a Form page.

Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

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

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

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

o OTHER SUPPORT- Do not complete this section.  It is not required and 
will not be accepted with the application.

o RESEARCH PLAN- Do not exceed a total of 10 pages inclusive of the 
following sections:  Specific Aims, Background and Significance, 
Preliminary Studies/Progress Report (evidence of feasibility), and 
Research Design and Methods.  Pertinent subject selection and 
recruitment information (e.g., inclusion of women, minorities, 
children), as it impacts on study design, should also be included.  
Tables, figures and photographs are included in the 10 page limitation.

o Item a, SPECIFIC AIMS- The applicant should begin with a statement 
that justifies the designation of  the application as an 
Exploratory/Developmental Research Grant as defined under the PURPOSE 
section of this program announcement.

The instructions for this section suggest that the applicant state  the 
hypotheses to be tested.   Since some applications submitted in 
response to this program announcement may also be design- or problem-
driven (e.g., development of novel technologies), or need-driven 
(initial research to develop a body of data upon which future research 
will build), hypothesis testing per se may not be the driving force in 
developing such a proposal and, therefore, may not be applicable.  
Thus, the application should state the hypotheses, design, problem 
and/or need which will drive the proposed research. Submission of a 
proposal under this program announcement precludes concurrent 
submission to the NIH of another application containing substantially 
the same research proposal.

o Item b, BACKGROUND AND SIGNIFICANCE- In this section it is important 
to identify clearly how the application addresses the   specific 
objectives of this program announcement. For example, identify briefly 
how this application relates to the purpose of the R21 mechanism as 
stated in this program announcement (i.e., highly innovative, high 
risk/high impact research, exploration of the use of approaches and 
concepts new to a particular substantive area, research and development 
of new technologies, techniques or methods, or initial research and 
development of a body of data upon which significant future research 
may be built).

o Item c, PRELIMINARY STUDIES/PROGRESS REPORT- Minimal preliminary data 
are expected for an Exploratory/Developmental 
Grant application.

o Item d, RESEARCH DESIGN AND METHODS- Fully describe the research 
design and methods. In many cases, an Exploratory/Developmental Grant 
mechanism will support novel research in an area or the research and 
development of new technologies.  Where appropriate, specific criteria 
by which to judge the feasibility of novel approaches (including 
milestones that will mark progress) should be explicitly described in 
this section.

o APPENDIX- Appendix materials may not be used to circumvent the page 
limitations.  Up to ten publications, submitted manuscripts or 
abstracts may be included.  Five copies of appendix materials should be 
submitted.  (Refer to PHS 398 application for additional Appendix 
guidelines.)

o CHECKLIST- This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate 
the type of agreement and the date.  All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years. The applicant should provide the 
name and phone number of the individual to contact concerning fiscal 
and administrative issues if additional information is necessary 
following the initial review.

Submit a signed original of the application and five exact photocopies, 
including the checklist, 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines. Applications will be reviewed for completeness by the 
Center for Scientific Review (CSR). Incomplete applications will be 
returned to the applicant without further consideration. Applications 
will be evaluated for scientific and technical merit by an appropriate 
scientific review group convened in accordance with the standard NIH 
peer review procedures. As part of the initial merit review, all 
applications will receive a written critique and undergo a process in 
which only those applications deemed to have the highest scientific 
merit, generally the top half of applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the appropriate National Advisory Council or Board. 

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.  Does this study address an important problem?  If 
the aims of the application are achieved, how will scientific knowledge 
be advanced?  What will be the effect of these studies on the concepts 
or methods that drive this field?

(2) Approach.  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

(3) Innovation.  Does the 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.  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

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

In addition the initial review group will examine: 

o the potential for ground-breaking, precedent setting significance 
of the proposed research, with particular emphasis on novel and 
innovative approaches that clearly require additional preliminary 
data for their value to be established, and,

o the potential to stimulate new concepts or approaches regarding 
important to biomedical/behavioral problems, or provide a 
technique/system of wide applicability.

The initial review group will examine the provisions for the protection 
of human and animal subjects, the safety of the research environment, 
and conformance with the NIH Guidelines for the Inclusion of Women, 
Children and Minorities as Subjects in Clinical Research.

AWARD CRITERIA
 
Applications will compete for available funds with all other approved 
applications.  The following will be considered in making funding 
decisions:

o the quality of the proposed project as determined by peer review, and, 

o the availability of funds.

INQUIRIES
 
Potential applicants are encouraged to call the staff members listed in 
the program announcement regarding the areas of science that NIDCR 
supports. The opportunity to clarify any issues or questions from 
potential applicants is welcome. 

Direct inquiries regarding programmatic issues to:

Rochelle K. Small, Ph.D.
Craniofacial Anomalies and Injuries Branch
National Institute of Dental and Craniofacial Research
Division of Extramural Research 
Natcher Building, Room 4AN-24K
Bethesda, MD 20892
Phone: (301) 594-9898
Fax: (301) 480-8318
Email: rochelle.small@nih.gov

Dennis Mangan, Ph.D.
Infectious Diseases and Immunity Branch
National Institute of Dental and Craniofacial Research
Division of Extramural Research
Natcher Building, Room 4AN-32F
Bethesda, MD  20892-6402
Telephone:  (301) 594-2421
FAX:  (301) 480-8318
Email:  dennis.mangan@nih.gov

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

Eleni Kousvelari, DDS, D.Sc.
Biomaterials and Biomimetics and Tissue Engineering Branch
National Institute of Dental and Craniofacial Research
Division of Extramural Research
Natcher Building, Room 4AN-18A
Bethesda, MD  20892-6402
Telephone:  (301) 594-2427
FAX:  (301) 480-8318
Email:  eleni.kousvelari@nih.gov

Kenneth Gruber, Ph.D.
Chronic Diseases Branch
National Institute of Dental and Craniofacial Research
Division of Extramural Research
Natcher Building, Room 4AN-18C
Bethesda, MD  20892-6402
Telephone:  (301) 594-4836
FAX:  (301) 480-8318
Email:  kenneth.gruber@nih.gov

Guo H. Zhang, Ph.D.
Chronic Diseases Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-18B
Bethesda, MD  20892-6402
Telephone: (301) 594-0618 
FAX:  (301) 480-8318Phone:
Email: guo.zhang@nih.gov

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

Maryann Redford, D.D.S, MPH
Director, Clinical Trials Program
Office of Clinical, Behavioral & Health Promotion Research
Promotion Research
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24B 
Bethesda, MD 20892
Phone:(301) 594-5588 
E-mail: maryann.redford@nih.gov

Patricia Bryant, Ph.D. 
Director, Behavioral and Health Promotion Research
Office of Clinical, Behavioral, and Health Promotion Research
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24E
Telehone: (301)595-2095
FAX:  (301) 480-8318 
Bethesda, MD 20892
Email: patricia.bryant@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Martin R. Rubinstein
Grants Management Branch
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN- 44A
Bethesda, MD 20892-6402
Telephone: 301-594-4800 
FAX: (301) 480-8301
E-mail: martin.rubinstein@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.121, Oral Diseases and Disorders Research Awards.  Awards are 
made under authorization of the Public Health Service Act, Title IV, 
Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) and administered under 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 and contract recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products.  In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or in some cases, a 
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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