and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.
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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by collaborating partners are not included in the direct cost.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign Organizations: Several special provisions apply to applications submitted by foreign organizations:
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 301-710-0267, 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/grants/policy/nihgps_2003/NIHGPS_part4.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.
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/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/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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