Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

FaceBase 2: Craniofacial Development and Dysmorphology – Data Management and Integration Hub (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-DE-14-005

Companion Funding Opportunity

RFA-DE-14-004, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.121

Funding Opportunity Purpose

The NIDCR-funded FaceBase Consortium (www.facebase.org) was established in 2009 to advance craniofacial research by creating comprehensive datasets on craniofacial development and dysmorphologies and disseminating them to the wider craniofacial research community.  Operationally, the Consortium links individual “spoke” projects, each creating and contributing individual datasets, analytic tools, and other resources to a central data management and integration hub which, in turn, disseminates them publicly.  This Funding Opportunity Announcement (FOA) solicits grant applications for the role of the FaceBase data management and integration hub.  As the Consortium’s public face, the hub is charged with the critical functions of collecting datasets and analytic tools developed by the spoke projects, curating and integrating those resources, and disseminating them to the wider research community through the FaceBase website.  The hub is expected to work closely with the spoke projects in developing efficient processes for depositing and organizing data, to lead the Consortium in the development of sophisticated methodologies for searching and visualizing integrated FaceBase data, and to coordinate Consortium-wide activities such as working group and Steering Committee meetings, and the annual Consortium-wide meeting.

Key Dates
Posted Date

April 5, 2013

Open Date (Earliest Submission Date)

July 22, 2013

Letter of Intent Due Date(s)

July 22, 2013

Application Due Date(s)

August 22, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November, 2013

Advisory Council Review

January, 2014 

Earliest Start Date

May, 2014 

Expiration Date

August 23, 2013   

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

With the expiration of the current round of FaceBase cooperative agreements in April, 2014, the NIDCR seeks applications for the role of the FaceBase Data Management and Integration hub.  The FaceBase hub is the bioinformatics heart of the Consortium charged with collecting, curating and integrating datasets, analytic tools, and other resources received from the FaceBase spoke projects and then disseminating them through the FaceBase website.  As part of fulfilling these functions, the hub is expected to lead the consortium in the development and application of innovative methods for displaying and searching data.

Background:  The growing utilization of large, publicly available ‘omics datasets (e.g., genomic, transcriptomic, or proteomic data) has made it clear that such data can be used to advance both focused, hypothesis-driven studies and global, systems-level analyses.  The FaceBase Consortium was established to advance craniofacial research through the creation and wide prepublication dissemination of a variety of datasets and other resources whose nature and scope would generally place them outside the grasp of individual labs.  The Consortium’s ultimate goal is managing and integrating those data in such a way that the broader research community can readily obtain and analyze pertinent information using the approaches of systems biology and other state-of-the-art quantitative approaches.  The current Consortium consists of 10 research/technology projects (spokes) and a central data management and integration hub working collaboratively to make resources available to the wider community and to foster new collaborations both within and outside of the Consortium.  Datasets and tools created by the current iteration of the Consortium are freely available to the wider scientific community through the FaceBase website, www.facebase.org.

Investigators interested in submitting applications to this FOA are encouraged to visit the FaceBase website to better understand the nature of the existing FaceBase datasets, the spoke and hub organization of the Consortium, and potential opportunities that can be productively exploited during its next iteration.  Detailed descriptions of the current FaceBase projects can be found on the FaceBase website and in the FaceBase white paper (Hochheiser et al., Dev Biol. 2011, 355:175-82).  Potential applicants are also encouraged to read the companion FOA soliciting applications for new spoke projects (RFA-DE-14-004) in order to better understand the types of spoke projects likely to be included in the next iteration of the Consortium.

FaceBase’s Data Management and Integration hub’s roles include but are not limited to:

Consortium organization:  The current organizational structure (a hub and spoke arrangement) will be retained for the next iteration of FaceBase.  The success of FaceBase absolutely requires collegial interactions and robust collaborations between all members and components of the Consortium.  All Program Directors/Principal Investigators (PDs/PIs) in the Consortium are required to participate in Steering Committee activities and to cooperate with the NIDCR-appointed Project Scientists and Program Official as described in the Terms and Conditions of the cooperative agreements.  Consortium PDs/PIs will meet annually with the Scientific Leadership Group and with NIDCR staff to showcase accomplishments and to negotiate milestones.  The annual Consortium meeting is hosted on a voluntary and rotating basis by FaceBase PDs/PIs at their home institutions or in the Bethesda, MD area.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDCR intends to commit up to $2.0 million total costs to this FOA in fiscal year 2014 in order to fund one award.

Award Budget

Up to $2.0 million in annual total costs. 

Award Project Period

5 years

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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 support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institutes of Health
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, Maryland 20892 (Courier 20817)
Telephone: (301) 594-5593
Fax: (301) 480-8303
Email: yasaman.shirazi@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and must be followed, with the following exceptions:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The budget should include funds supporting the annual Consortium meeting as well as travel by the hub PD(s)/PI(s) and select hub personnel to that meeting. The hub budget can also include funds supporting the travel of a small number of FaceBase hub or spoke project trainees to the annual meeting. (Funds supporting travel by spoke project personnel are included in their project’s budget).

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:  The Research Strategy must address all the points below.

Milestones and Timeline:  The application must include a timeline as well as PD/PI-determined, hub-specific milestones for each proposed year of funding.  These milestones must be concrete and provide quantitative and specific targets; they should not be a restatement of the specific aims.  Describe specific outcomes to be achieved and the metrics by which the accomplishment of the milestones will be assessed.

Biology expertise:  Although the activities of the FaceBase hub are largely in the areas of computer science and informatics, the hub must be able to communicate effectively with the experimentally oriented spoke projects if the Consortium is to achieve its goals.  This requires that the hub have personnel with sufficient knowledge of both worlds to serve as liaisons and translators between experimentalists and informaticists.  Applicants for the FaceBase hub are therefore expected to demonstrate that their teams include biology expertise sufficient to allow them to function in this way.  The areas of expertise included should cover both the existing data already within FaceBase and the high programmatic priority areas described in the accompanying FOA for new spoke projects (RFA-DE-14-004).

Relationship to current FaceBase data or resources:  Applicants responding to this FOA should describe how the proposed structure of the next iteration of the hub will accommodate and improve upon the existing organization and functionality of the FaceBase website.  Should a different hardware or software architecture be proposed, the application should describe how existing FaceBase datasets and tools can be quickly and efficiently migrated to that new architecture without disrupting community access to FaceBase resources.

Collaboration and Interaction Plan

FaceBase’s Consortium structure mandates robust and productive collaborations between the constituent projects to achieve the Consortium’s goals.  Applicants should describe prior or ongoing experience in functioning as part of a research Consortium or other collaborative activities to meet individual study and collaborative goals.  Describe how the proposed organization of the hub will enhance FaceBase’s Consortium structure and facilitate collaboration with and among the spoke projects.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCR Referral Office by email at yasaman.shirazi@nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the project present or identify unique opportunities or resources that are likely to be valuable to the broader craniofacial research community?

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the investigators have collective expertise in the biological aspects of craniofacial development and dysmorphology sufficiently broad to allow them to productively interact with spoke projects from a variety of disciplines?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the proposed architecture of the hub use:

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

To what extent do the proposed hub architecture and bioinformatics tools complement or enhance what has already been created for FaceBase, and to what extent do they contribute to the further development of the Consortium?

Is there an efficient architecture proposed for the receipt of materials from the spoke projects by the hub?

Are the processes described for data quality control and security both implementable and appropriate?

Are the proposed interfaces for displaying, searching, and disseminating the resulting data or tools intuitive and implementable?

Will the proposed hub architecture facilitate analyses using systems biological or other quantitative approaches?

Is the overall structure proposed for the hub likely to create a resource that is more valuable to the wider craniofacial research community than the individual components created by the spoke projects?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones and Timeline

Are the milestones and timelines quantitative, reasonable and appropriate?

Collaboration and Interaction

Are the plans for disseminating research findings, data, tools, and methods to Consortium members and the wider community both adequate and consistent with achieving the Consortium’s goals?

Is there an implementable plan for collaboration and interaction with the Consortium’s spoke projects?

Is there evidence provided that the applicant has the ability to function productively within a larger Consortium?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Dental and Craniofacial Research  in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

The size of the award is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

3. Anticipated Announcement and Award Dates

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 eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD/PI will have the primary responsibility for defining the details for the project within the guidelines of RFA-DE-14-005 and for performing the scientific activities. PDs/PIs will agree to accept close coordination, cooperation, and participation of NIDCR staff in those aspects of scientific and technical management of the project as described below under NIDCR staff responsibilities. The PDs/PIs will:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIDCR staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The role of the NIH Program staff members will be to facilitate and not to direct the activities.  It is anticipated that decisions in all activities will be reached by consensus of the Steering Committee and that the NIDCR Project Scientists will be given the opportunity to offer input to this process. Other NIDCR staff may assist and advise the Consortium on relevant programmatic and scientific issues.  The Project Scientist will:

Additionally, an NIDCR Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The NIDCR Program Official will:

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Steven B. Scholnick, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-3977
Email: scholnis@nidcr.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-5593
Email: yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-4798
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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NIH Funding Opportunities and Notices



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