SMALL GRANT PROGRAM FOR THE NIDCR

Release Date:  February 14, 2001

PA NUMBER:  PAR-01-053

National Institute of Dental and Craniofacial Research

Application Receipt Dates:  April 3 and August 3, 2001
                            December 3, 2001; April 3 and August 3, 2002
                            December 3, 2002; April 3 and August 3, 2003

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

This Program Announcement (PA) supersedes all previous announcements of the 
National Institute of Dental and Craniofacial Research (NIDCR) Small Grant 
(R03) Program under PA 91-036 (DE) and its extensions.  The NIDCR Small Grant 
(R03) Program has been modified to provide support ONLY to new investigators 
for pilot research that is likely to lead to a subsequent Individual Research 
Project Grant (R01) application. The research must be focused on one or more of 
the areas within the biomedical and behavioral scientific mission of the NIDCR:  
craniofacial anomalies and injuries; infectious diseases and immunity; 
neoplastic diseases; chronic diseases; biomimetics, bioengineering, and tissue 
engineering; and clinical, behavioral and health promotion research. 

The Small Grant Program is designed to support basic and clinical research of 
scientists who are in the early stages of establishing an independent research 
career.

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) " SMALL 
GRANT PROGRAM FOR THE NIDCR," is related to the priority area of Oral Health.  
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, 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.  Foreign institutions and United 
States organizations located in foreign countries are not eligible to apply for 
this program.

Individuals defined as New Investigators and eligible for the NIDCR Small Grant 
Program include former and current :  (1) recipients of Individual Research 
Career Development Awards, such as the Mentored Clinical Scientist Development 
Award (K08), Scholar Development and Faculty Transition Award (K22) and the 
Mentored Patient Oriented Research Career Development Award (K23);  (2) 
appointees in Institutional Research Career Development Award programs, such as 
the Dentist Scientist Award (K16) and the Mentored Clinical Scientist 
Development Program Award in Dental, Craniofacial and Oral Health Research 
(K12);  (3) recipients of individual National Research Service Awards (NRSA), 
such as the Predoctoral Dental Science Fellowship (F30) and the Postdoctoral 
Fellowship (F32) awards; and (4) trainees in the Institutional NRSA program  
(T32).  However, any current support by the F32 and T32 mechanisms must be 
terminated before support in the NIDCR Small Grant Program begins.
 
Individuals who are current or previous recipients of NIH Research Project 
Grants (R01, R03, R15, R21, R29, R55, P01, and P20) and Center Grants (P50 and 
P60) as well as principal investigators of research subprojects of Program 
Project (P01) and Center (P50 and P60) awards are not eligible for the R03 
mechanism.  Other NIH and Federal grant supported activities may also preclude 
eligibility for this award.  Potential applicants are advised to contact the 
NIDCR program staff listed under INQUIRIES in order to ascertain eligibility 
for this program.  Individuals who are planning to re-enter research careers 
and are ineligible for the R03 award as defined above should consider applying 
under the NIH re-entry supplement program described in PA-99-106.

Only one small grant application from an individual Principal Investigator will 
be considered by NIDCR per receipt date and only two revisions of a previously 
reviewed small grant application may be submitted.

The work proposed may not overlap significantly with the aims of currently 
supported projects in which the applicant has participated during the last five 
years.  However, the proposed work may be an extension of previously supported 
projects in which the applicant has participated.
 
Applications for research focused on projects outside the NIDCR mission will 
not be accepted for potential funding by NIDCR.  Other questions about 
eligibility may be directed to one of the program officials listed under 
INQUIRIES.

MECHANISM OF SUPPORT

This program will use the NIH small grant (R03) award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for an 
application submitted in response to this PA may not exceed two years. The 
NIDCR small grant is a $50,000 per year direct cost award.  The Small Grant 
funds may not be used to supplement projects currently supported by Federal or 
non-Federal funds, or to support thesis or dissertation research.  These grants 
may not be renewed.

Specific application instructions have been modified to reflect "MODULAR GRANT" 
and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  Complete 
and detailed instructions and information on Modular Grant applications can be 
found at: http://grants.nih.gov/grants/funding/modular/modular.htm. 

RESEARCH OBJECTIVES

The R03 mechanism described in this program announcement will support research 
and/or development relevant to all the branches, offices and programs of the 
NIDCR Division of Extramural Research.  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/sciprog.htm

In brief, the different branches and offices at the NIDCR support research in:  
(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) sequence analysis of 
the entire genome of oral microorganisms; (d) genetic determinants of host 
susceptibility to infection; (e) basic and applied research related to oral 
cancers; (f) basic and clinical studies on neurobiology, pathogenesis, 
diagnosis, treatment or prevention of pain; (g) autoimmunity; (h) 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 (i) 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 are 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

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

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 301/435-0714, email GrantsInfo@nih.gov. 

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.

FACE PAGE:  Item 2, type "NIDCR Small Grant Program" in "Title" box, and check 
the "YES" box, indicating response to Program Announcement.

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

Items 7a and 7b:  These items should be completed indicating Direct Costs 
($50,000) and Total Costs [$50,000 plus Facilities and Administrative (F&A) 
costs] for the initial budget period.

Items 8a and 8b:  These items should be completed indicating the Direct (i.e., 
either $50,000 or $100,000) and Total Costs (i.e., either $50,000 or $100,000 
plus F&A) for the entire proposed period of support.

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.

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.

NARRATIVE BUDGET JUSTIFICATION

Prepare a Modular Grant Budget Narrative page.  For sample pages, see: 
http://grants.nih.gov/grants/funding/modular/modular.htm.

At the top of the page, enter the total direct costs requested for each year 
(i.e., $50,000).  This is not a Form Page.

Under Personnel, list all project personnel, including their names, percent of 
effort, and roles on the proposed project.  Under the NIDCR Small Grant 
Program, a minimum of 25% effort of the PI must be committed to the project. 
The PI may request salary support, but significant justification together with 
Institutional commitment should be provided.  Salary support may also be 
requested for technical support staff.  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.

The Small Grant Program overall research budget may also include small 
equipment, supplies, and travel.  These grant funds may not be used to support 
thesis or dissertation research.

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 and organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and role on the proposed project.  Indicate whether the collaborating 
institution is foreign or domestic.  The total cost for a 
consortium/contractual arrangement is included in the overall requested $50,000 
direct cost amount.  Include the Letter of Intent to establish a consortium.

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 then any honors.
o  Provide information, including overall goals and responsibilities on 
research projects ongoing or completed during the last three years and  
identify all sources of previous and current research funding.
o  List selected peer-reviewed publications with full citations.

OTHER SUPPORT

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

RESEARCH PLAN

Do not exceed a total of 10 pages inclusive of the following sections:  
Specific Aims; Background and Significance; Preliminary Studies/Progress Report 
(or other 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.

For revised applications, an additional introduction (not to exceed one page) 
is permitted.  This introduction should respond to the comments and concerns of 
the Initial Review Group delineated in the summary statement.

Applications that exceed the page limit or requirements for type size and 
margins will be returned to the investigator.  (Refer to PHS 398 application 
for details.)

The 10 page limit does not include information regarding safety and ethical 
issues related to subjects in research (Human Subjects, Inclusion of Children 
as Participants in Research, Vertebrate Animals) or Consortia and Literature 
Cited (Section E-I).

APPENDIX

Appendix materials may not be used to circumvent the page limitations.  
However, letters of support may be used to describe the Institutional support 
for the Principal Investigator (including salary and percent effort available 
for research), to establish the Principal Investigator's research as separate 
and distinct from those of a former mentor, or to denote collaborative or 
consultant relationships.  Up to three publications, submitted manuscripts or 
abstracts may also be included.  Five copies of appendix materials should be 
submitted.  (Refer to PHS 398 application for additional Appendix guidelines.)

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 each budget period.

The applicant should provide the name and telephone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is required following initial review.

Use the mailing label in the application kit to mail the original and three 
copies of the application to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

To ensure that the application is received in sufficient time for the review, 
send an additional two copies of the application to:

Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44
Bethesda, MD  20892

Schedule

Application Receipt Dates:  Dec 3, Apr 3, and Aug 3
NIDCR Committee Review:     Feb/Mar, Jun/Jul, and Oct/Nov
Council Review:             May, Oct, and Jan
Earliest Funding:           Aug, Jan, and May

If the receipt date falls on a weekend, it will be extended to the following 
Monday; if the date falls on a holiday, it will be extended to the following 
business day.

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness and for responsiveness to this 
PA by NIH staff.  Incomplete and/or non-responsive applications may be returned 
to the applicant without further consideration.  Applications will be reviewed 
for scientific and technical merit in accordance with the standard NIH 
procedures by a scientific review group (SRG) convened by the NIDCR.  As part 
of the initial review, all applications will receive a written critique. Those 
applications deemed to have the highest merit, generally the top-half of 
applications under review, will be discussed, assigned a priority score, and 
receive a second level of review by the NIDCR Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance the understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written review, comments on the following aspects of the application will be 
made 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 the assignment of the overall score.

(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?

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

AWARD CRITERIA

The awarding of grant funds is contingent on:  (1) the receipt of applications 
of high scientific merit; (2) responsiveness to this Program Announcement, 
including the eligibility of investigators; (3) relevance to the mission of the 
NIDCR; and (4) the availability of funds.

INQUIRIES

Inquiries concerning this program announcement are encouraged.  The opportunity 
to clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Rochelle K. Small
Craniofacial Anomalies and Injuries Branch
National Institute of Dental and Craniofacial Research 
Natcher Building, Room 4AN-24K
Bethesda, MD 20892-6402
Phone: (301) 594-9898
Fax: (301) 480-8318
Email: rochelle.small@nih.gov

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

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

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

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

Dr. Norman Braveman
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

Dr. Maryann Redford
Director, Clinical Trials Program
Office of Clinical, Behavioral and Health Promotion Research
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-24B
Bethesda, MD 2089-6402
Telephone:(301) 594-5588 
FAX:  (301) 480-8318
Email: maryann.redford@nih.gov

Dr. Guo H. Zhang
Director, Salivary and Bone Research Program 
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

Dr. Patricia Bryant 
Director, Behavioral and Health Promotion Research Program
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 Rubinstein
Grants Management Branch
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  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, and 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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