Part I Overview Information


Department of Health and Human Services

Participating Organizations
 National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
 National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)

Title:  International Collaborative Oral Health Research Planning Grant (R21)

Announcement Type
This is a reissue of PAR-03-059, which was previously released on January 16, 2003. 

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines provided with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see “Key Dates” below).  

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number: PAR-06-219  

Catalog of Federal Domestic Assistance Number(s) 
93.121

Key Dates
Release/Posted Date: March 8, 2006
Opening Date:  May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  30 days before the submission date
Application Submission Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm 
AIDS Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 2, 2009 (now January 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The International Collaborative Oral Health Research Planning Grant is intended to provide support for the development of a refined study design, organizational plan, detailed protocol criteria, and budget, for implementation of cross-national studies whose rationale and basic design are considered scientifically meritorious, and which cannot be accomplished solely within the United States. “Cross-national” means that at least three countries are involved.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review and Anticipated Start Dates
        1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The NIDCR announces a grant program to support planning and protocol development of biomedical, clinical, epidemiological and behavioral/social studies in international research areas as may be identified in the Institute’s Strategic Plan or developed in consultation with the international research community.  The purpose of this initiative is to bring together international researchers through collaborative partnerships that conduct research according to common protocols. 

The planning grant is intended to provide support for the development of a refined study design, organizational plan, detailed protocol criteria, and budget, for implementation of cross-national studies whose rationale and basic design are considered scientifically meritorious, and which cannot be accomplished solely within the U.S. 

For purposes of this FOA “cross-national” means at least three countries are involved.  These three countries may or may not include the United States.

Oral conditions affect populations around the globe.  Some of these conditions are more prevalent in certain countries or regions, while others are found in virtually all countries, but to varying degrees.  There are many research topics that require international collaboration for questions to be appropriately addressed.  For example, there are many areas of research that, because of limited access to patient populations within any single country, can only be conducted by international teams of scientists with access to large groups of people with the disease/condition to be studied.  Similarly, there are areas of research where progress would be enhanced with the addition of unique scientific expertise only found internationally.  The purpose of this initiative is to bring together international researchers through collaborative partnerships that investigate these special research issues according to common protocols. 

In pursuing new scientific opportunities, the NIDCR extramural research program is organized in Centers.  To obtain further information on NIDCR’s Centers in extramural research visit  http://www.nidcr.nih.gov/Research/Extramural/default.htm.

RESEARCH ISSUES

Listed below are examples of topics supported by this program announcement.  The list is illustrative, not exhaustive and drawn from the NIDCR Strategic Plan http://www.nidcr.nih.gov/AboutNIDCR/StrategicPlan/StrategicInitiatives.htm

Applications to plan and conduct clinical trials must be submitted under a different process.  Please refer to the Clinical Trial topic area at http://www.nidcr.nih.gov/ClinicalTrials.

In each of these priority areas, a broad-based coalition of scientific talent is envisioned to encompass research needs in areas from molecular biology to the translational patient-oriented, epidemiological, behavioral, social and related health promotion sciences as may be appropriate for the research questions involved.  The product of these research planning grants would be the enhanced or new infrastructure needed to enable submission of full-scale studies in the given subject area.  These applications could then be submitted as investigator-initiated projects to the US government and/or any other potential collaborating funding agency, institution or foundation.  Those applications coming subsequently to the NIH also will be peer-reviewed according to standard NIH procedures.  Applicants should note that NIDCR funding of a planning grant does not imply a commitment by NIDCR to fund the proposed full-scale study. 

Applicants for research planning grants may request funds for activities such as but not limited to:

CRITICAL ELEMENTS OF A PROPOSAL

The planning grant proposal should describe:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement. 

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R21 Exploratory/Development Grant award mechanism. 

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. 

This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.  

2. Funds Available

The NIDCR has not set aside funds for this Funding Opportunity Announcement.  The number of awards will be dependent on their scientific merit. 

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)

  • Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
  • Organizations must comply with federal/NIH biosafety and biosecurity regulations.  See Section VI.2.  Administrative Requirements, “Cooperative Agreements Terms and Conditions of Award”. 
  • Proposed research should provide a unique research opportunity not available in the U.S.

    1.B. Eligible Individuals

    Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their organization 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.

    2. Cost Sharing or Matching

    This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

    3. Other-Special Eligibility Criteria

    The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted.  

    Section IV. Application and Submission Information


    Registration and Instructions for Submission via Grants.gov


    To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

    A one-time registration is required for institutions/organizations at both:

    PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.

    Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

    1) Organizational/Institutional Registration in Grants.gov/Get Started

    2) Organizational/Institutional Registration in the eRA Commons

    3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

    Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

    Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 

    1. Request Application Information

    Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

    Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

    For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

    Telecommunications for the hearing impaired: TTY 301-451-5936.

    2. Content and Form of Application Submission

    Prepare all applications using the SF424 (R &R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

    The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

    The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

    Required Components:
    SF424 (R&R) (Cover component)
    Research & Related Project/Performance Site Locations
    Research & Related Other Project Information
    Research & Related Senior/Key Person
    PHS398 Cover Page Supplement
    PHS398 Research Plan
    PHS398 Checklist
    PHS398 Modular Budget

    Optional Components:
    PHS398 Cover Letter File
    R&R Subaward Budget Attachment(s) Form

    Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

    Foreign Organizations

    Several special provisions apply to applications submitted by foreign organizations:

    Proposed research should provide a unique research opportunity not available in the United States.

    3. Submission Dates and Times

    See Section IV.3.A for details.

    3.A. Submission, Review, and Anticipated Start Dates

    Letter of Intent Receipt Date:   30 days before the submission date
    Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
    Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
    Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
    Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

    3.A.1. Letter of Intent

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

    Descriptive title of proposed research
    Name, address, and telephone number of the Principal Investigator
    Names of other key personnel
    Participating institutions
    Number and title of this funding opportunity

    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 30 days before the submission date.

    The letter of intent should be sent to:

    Dr. Lynn King
    Division of Extramural Activities
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-32F
    45 Center Drive, MSC 6401
    Bethesda, MD 20892-6401
    Telephone:  (301) 594-5006
    FAX: (301) 480-8303
    Email:  lynn.king@nih.gov

    3.B. Sending an Application to the NIH

    To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically PAPER APPLICATIONS WILL NOT BE ACCEPTED.

    3.C. Application Processing

    Applications may be submitted to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the submission date(s) and time, the application may be delayed in the review process or not reviewed.

    Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

    The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).

    There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons

    4. Intergovernmental Review

    This initiative is not subject to intergovernmental review.

    5. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement

    Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

    The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement

    6. Other Submission Requirements

    The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

    Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

    Application Characteristics

    Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

    Specific Instructions for Modular Grant applications

    Applications requesting direct costs in each year of $250,000 or less (excluding consortium F&A costs), must be submitted in a modular budget format using the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically Section 5.4). The modular budget 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.

    Plan for Sharing Research Data

    A data-sharing plan is required for this R21 Exploratory/Development Grant award mechanism. 

    The precise content of the data sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data.  Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of at sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).  Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement.  References to share data sharing may also be appropriate in other sections of the application. 

    Sharing Research Resources

    The development of research resources under this R21 Exploratory/Development Grant award mechanism is not anticipated.  Thus, no research resources sharing plan need be included in the application. 

    Section V. Application Review Information


    1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

    Only the review criteria described below will be considered in the review process.

    2. Review and Selection Process

    Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIDCR in accordance with the review criteria stated below.

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

    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. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

    Significance:  Does the study proposed address an important problem?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

    Approach:  Are the conceptual or clinical 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?

    Innovation:  Is the project original and innovative?  For example:  Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 

    Investigator:  Are the investigators 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?  Does the investigative team bring complimentary and integrated expertise to the project (if applicable)? 

    Environment:  Does the scientific environment in which your work will be done contribute to the probability of success?  Do the proposed experiments benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?

    2.A. Additional Review Criteria:

    In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

    Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See item 6 of the Research Plan component of the SF424 (R&R).

    Inclusion of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

    Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

    Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

    2.B. Additional Review Considerations

    Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

    Period of Support: The appropriateness of the requested period of support in relation to the proposed research.

    2.C. Sharing Research Data

    Data Sharing Plan:  The reasonableness of the data sharing plan or the rationale for not sharing research data may be addressed by the reviewers.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.  NIDCR will be responsible for monitoring the data sharing policy.  (http://grants.nih.gov/grants/policy/data_sharing).

    2.D. Sharing Research Resources

    Sharing research resources is not required for this FOA.    

    3. Anticipated Announcement and Award Dates
    Not applicable.    

    Section VI. Award Administration Information


    1. Award Notices

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

    Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

    3. Reporting

    Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

    Section VII. Agency Contacts


    We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

    1. Scientific/Research Contacts:

    John Kusiak, PhD
    Molecular and Cellular Neuroscience Program
    Center for Integrative Craniofacial Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-18A
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-7984
    FAX: (301) 480-8318
    Email: john.kusiak@nih.gov

    Yasaman Shirazi, PhD
    Epithelial Cell Regulation and Transformation Program
    Center for Integrative Craniofacial Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-18C
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-4812
    FAX: (301) 480-8318
    Email: yasaman.shirazi@nih.gov

    Lillian Shum, PhD
    Mineralized Tissue and Salivary Gland Physiology Program
    Center for Integrative Craniofacial Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-18B
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-0618
    FAX: (301) 480-8318
    Email: lillian.shum@nih.gov

    Rochelle K. Small, PhD
    Developmental Biology and Genetics Program
    Center for Integrative Craniofacial Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-18D
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-9898
    FAX: (301) 480-8318
    Email: rochelle.small@nih.gov

    Dennis F. Mangan, PhD
    Microbiology Program
    Center for Infectious Diseases and Immunology
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-12J
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-2421
    FAX: (301) 480-8319
    Email: dennis.mangan@nih.gov

    Sangeeta Bhargava, PhD
    Immunology and Immunotherapy Program
    Center for Infectious Diseases and Immunology
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-12C
    45 Center Drive
    , MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 402-4243
    FAX: (301) 480-8319
    Email: sangeeta.bhargava@nih.gov

    Mostafa A. Nokta, MD, PhD
    AIDS and Immunosuppression Program
    Center for Infectious Diseases and Immunology
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-18H
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-7985
    FAX: (301) 480-8319
    Email: mostafa.nokta@nih.gov

    Eleni Kousvelari, DDS, DSc
    Applied and Translational Research Program
    Center for Biotechnology and Innovation
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-24F
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 594-2427
    FAX: (301) 480-8318
    Email: eleni.kousvelari@nih.gov

    Rosemarie Hunziker, PhD
    Technology Development and Industrial Relations Program
    Center for Biotechnology and Innovation
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-24K
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone: (301) 451-3888
    FAX: (301) 480-8318
    Email: rosemarie.hunziker@nih.gov

    Bruce Pihlstrom, DDS, MS
    Center for Clinical Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AS-43G
    45 Center Drive, MSC 6401
    Bethesda, MD 20892-6401
    Telephone: (301) 594-4830
    FAX: (301) 480-8322
    Email: bruce.pihlstrom@nih.gov

    Richard L. Mowery, PhD
    Clinical Trials Program
    Center for Clinical Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AS-43F
    45 Center Drive, MSC 6401
    Bethesda, MD 20892
    Telephone: (301) 594-4848
    FAX: (301) 480-8322
    Email: rm33a@nih.gov

    Ruth Nowjack-Raymer, MPH, PhD
    Health Disparities Research Program
    Center for Clinical Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AS-43J
    45 Center Drive, MSC 6401
    Bethesda, MD 20892
    Telephone: (301) 594-5394
    FAX: (301) 480-8322
    Email: ruth.nowjack-raymer@nih.gov

    Patricia S. Bryant, PhD
    Behavioral and Social Sciences Research Program
    Center for Health Promotion and Behavioral Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AS-18C
    45 Center Drive, MSC 6401
    Bethesda, MD 20892-6401
    Telephone: (301) 594-2095
    FAX: (301) 480-8322
    Email: patricia.bryant@nih.gov

    Maria Teresa Canto, DDS, MS, MPH
    Health Promotion and Community-based Research Program
    Center for Health Promotion and Behavioral Research
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AS-43D
    45 Center Drive, MSC 6401
    Bethesda, MD 20892-6401
    Telephone: (301) 594-5497
    FAX: (301) 480-8322
    Email: maria.canto@nih.gov

    Peer Review Contacts:

    Dr. Lynn King
    Division of Extramural Activities
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN-32F
    Bethesda, MD 20892
    Telephone: (301) 594-5006
    FAX: (301) 480-8303
    Email: lynn.king@nih.gov

    3. Financial or Grants Management Contacts:

    Mary Daley
    Grants Management Branch
    National Institute of Dental and Craniofacial Research
    Building 45, Room 4AN44B
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402
    Telephone:  (301) 594-4808
    FAX:  (301) 480-3562
    Email:  md74u@nih.gov

    Section VIII. Other Information


    Required Federal Citations

    Use of Animals in Research:
    Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

    Human Subjects Protection:
    Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

    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 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 funding opportunity 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.

    Sharing of Model Organisms:
    NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

    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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 SF424 (R&R); 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 Clinical Research:
    The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

    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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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://stemcells.nih.gov/index.asp 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 (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(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.

    NIH Public Access Policy:
    NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

    NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

    For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://PublicAccess.nih.gov/publicaccess_manual.htm).

    Standards for Privacy of Individually Identifiable Health Information:
    The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

    Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm.

    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.

    Loan Repayment Programs:
    NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


    Weekly TOC for this Announcement
    NIH Funding Opportunities and Notices


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