NIDCR CLINICAL PILOT DATA GRANT

RELEASE DATE:  December 4, 2002 

PA NUMBER:  PAR-03-043 (This PAR has been reissued, see PAR-06-025)
                       (see clarification NOT-DE-04-002)

EXPIRATION DATE:  This Program Announcement expired on October 19, 2005

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov)
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR) 
announces a grant program to support the collection of clinical pilot 
data to be used in preparing applications for definitive Phase III 
clinical trials.  These pilot data grants should focus on research that 
is particularly innovative and/or potentially of high impact to 
craniofacial, oral, and dental research.  High impact research may 
involve small feasibility studies in which the technological, 
methodological, or theoretical approach to a problem lacks sufficient 
preliminary data.  This grant is not intended to support small pilot 
clinical trials.  The applications must develop new research relevant 
to the NIDCR mission in craniofacial, oral, and dental research.

RESEARCH OBJECTIVES

The National Institute of Dental and Craniofacial Research is committed 
to identifying effective preventive, diagnostic, and treatment 
approaches to craniofacial, oral, and dental diseases and disorders 
that will improve health by supporting well-designed, definitive Phase 
III clinical trials.  Before proceeding to a Clinical Trial Planning 
Grant and then to the full-scale Phase III clinical trial, pilot 
clinical data are often required.  

The objective of the NIDCR Clinical Pilot Data Grant is to provide a 
mechanism for the collection of preliminary data that is necessary to 
support the development of definitive Phase III clinical trials to 
evaluate interventions for the treatment or prevention of craniofacial, 
oral, and dental conditions and promote craniofacial, oral, and dental 
health.  By providing resources to collect essential data required for 
the design of a subsequent full-scale Phase III clinical trial, it is 
anticipated that applicants will be in a better position to address in 
a definitive way the core design issues that are involved in clinical 
trial research.  The research supported under this award may involve 
limited pilot testing of novel experimental hypotheses, design-driven 
development of new or novel techniques or technologies, and/or the 
acquisition of a body of data that has potentially high-impact on 
craniofacial, oral, and dental research.  The NIDCR Clinical Pilot Data 
Grant may include but is not limited to:  collection of preliminary 
data for establishing measures of effectiveness and/or safety; testing 
and documenting recruitment mechanisms and their effectiveness; short-
term studies to address questions to optimize the design of the 
definitive trial; small studies to refine an intervention strategy 
(e.g., dosage, duration, delivery system, etc.); and, the development 
and testing of participant inclusion criteria and data collection 
instruments.  

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) R21 
Exploratory/Development Grant 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, 
and the annual direct costs may not exceed $100,000 per year.  This 
award 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.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Before submitting an application for an NIDCR Clinical Pilot Data 
Grant, the investigator should submit a brief description of the 
proposed Phase III clinical trial to the NIDCR for review for 
programmatic relevance.  See http://www.nidcr.nih.gov for details or 
contact one of the persons listed in WHERE TO SEND INQUIRIES under 
scientific/research issues.

WHERE TO SEND INQUIRIES

Inquiries are encouraged early in the development of a NIDCR Clinical 
Pilot Data Grant.  The opportunity to clarify any issues or questions 
from potential applicants is welcome and highly encouraged.  Inquiries 
may fall into three areas:  scientific/research, peer review, and 
financial or grants management issues:

o Direct your questions about scientific/research issues to:

Dr. Richard Mowery
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4As43F, MSC 6401
Bethesda, MD 20892-6401
Telephone:  (301) 594-4848
FAX:  (301) 480-8322
Email: rm33a@nih.gov

Or 

Dr. Bruce Pihlstrom
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4As43H, MSC 6401
Bethesda, MD 20892-6401
Telephone:  (301) 594-4830
FAX:  (301) 480-8322
Email:  pihlstrb@mail.nih.gov

o Direct your questions about peer review issues to:

Dr. H. George Hausch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4An-44F, MSC 6401
Bethesda, MD 20892-6401
Telephone:  (301) 594-2904

o Direct your questions about financial or grants management matters 
to:

Ms. Anne Welkener
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-55, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4806
Email:  Anne.Welkener@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.
The title and number of the program announcement must be typed in 
Section 2 on the face page of the application. As with most 
applications to NIH, the research plan is limited to 25 pages. All 
information for review of the NIDCR Clinical Pilot Data Grant 
application must be included in the body of the application; appendices 
will not be considered during the review for this mechanism.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: The modular grant 
format simplifies the preparation of the budget in these applications 
by limiting the level of budgetary detail.  Applicants request direct 
costs in $25,000 modules.  Section C of the research grant application 
instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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)

In order to facilitate the review of applications assigned to the 
NIDCR, the applicant must, at the same time, mail or deliver two copies 
of the application to:

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

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTES 
OF HEALTH AND THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL 
RESEARCH WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e., FED EX, UPS, DHL, etc.).  This policy for 
applications addressed to the Center for Scientific Review was 
published in the NIH Guide to Grants and Contracts at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.  

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened by NIDCR in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed 
to have the highest scientific merit, generally the top half of 
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.

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the NIDCR in accordance with 
the review criteria stated below.  As part of the initial merit review 
all applications will receive a written critique and undergo a process 
in which only those applications deemed to have the highest scientific 
merit, generally the top half of applications under review, will be 
discussed and assigned a priority score.

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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you 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 the proposed pilot activities 
on the concepts or methods that drive this field?  Will a successful 
outcome from this pilot work lead directly to the development of a 
definitive Phase III clinical trial that would likely advance the field 
of craniofacial, oral, or dental research?

(2) Approach:  Are the conceptual framework, design, and methods 
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?  Will the project generate a new body of data that 
provides a foundation for important new clinical trials research?

(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?  Is the principal investigator an independent researcher?

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program 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 CLINICAL RESEARCH: 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 an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
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 requires 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.

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 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.   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 PA 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 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  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 HIN grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Part 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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