It is critical that applicants follow the Research (R) 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.

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

With the expiration of the current round of FaceBase cooperative agreements in April, 2019, the NIDCR seeks renewal applications for the role of the FaceBase Data Management and Integration hub. The FaceBase hub is the bioinformatics heart of this NIDCR-supported effort and is charged with collecting, curating, and integrating datasets, analytic tools, and other resources, and then disseminating them freely to the research community through the FaceBase website.

Background: Recent years have seen significant growth in the utilization of large, publicly available omics datasets (e.g., genomic, transcriptomic, or proteomic data) to advance both focused, hypothesis-driven studies and global, systems-level analyses. FaceBase was established in 2009 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. Its goal has been 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. These efforts are supported, in part, by a Program Announcement devoted to secondary analysis of FaceBase data (PAR-16-362).

At the time of FaceBase’s inception, large craniofacial datasets were relatively uncommon. In response, FaceBase 1 and FaceBase 2 were each comprised of 10 research/technology projects (spokes) which generated relevant datasets and supplied them to the FaceBase hub for dissemination to other researchers. Since the last FaceBase RFA was issued in 2014, an increasing number of relevant datasets are being produced by researchers outside of the consortium. This affords the NIDCR an opportunity to restructure FaceBase to take advantage of the creation of these datasets and to broaden FaceBase’s scope. The FaceBase 3 initiative will therefore be comprised of only the Data Management and Integration Hub whose charge will be to work with the wider craniofacial research community to improve the resource and make it more useful to that community. The FaceBase 3 hub will continue to acquire new craniofacial datasets from a variety of investigator-initiated projects.

The scope of this initiative includes but is not limited to:

• a significant emphasis on improving and expanding the existing software behind the FaceBase hub without redesigning or rebuilding the underlying architecture. Software improvements are expected to result in improved search capabilities that employ user-defined parameters to reach across multiple datasets and data types.;
• improved curation, integration, and dissemination of existing FaceBase datasets;
• development/adoption of cutting edge methods of data manipulation and display that allow users to better probe and visualize FaceBase datasets (as opposed to fixed presentations of data);
• extension of curation/annotation efforts to datasets produced by relevant research projects. The hub will be charged with working with investigators from these projects to make their data conform to community standard ontologies (for example, the Ontology of Craniofacial Development and Malformation (OCDM)), the FaceBase data models, community data standards, and the NIH-supported FAIR principles so that these new data can be integrated with other datasets held by FaceBase and disseminated to the wider community through the hub website;
• development and implementation of quality control tools and procedures to ensure the integrity of datasets and metadata disseminated through the FaceBase hub;
• outreach to members of the craniofacial research community that are not proficient in bioinformatics/data science to facilitate their use of FaceBase. This can include creation of publicly available tutorials, How to use FaceBase tables at relevant scientific meetings, etc.;
• identification of resources outside of FaceBase that can either be integrated into FaceBase’s website or linked to from a comprehensive craniofacial resources page.

Leading this project will require a degree of expertise in both bioinformatics/data science and craniofacial biology likely to be beyond the abilities of a single PD/PI. Applications to this FOA must use the Multiple-PD/PI model.

See Section VIII. Other Information for award authorities and regulations.

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

Eligibility for funding through this RFA is limited to the renewal of award(s) currently funded through RFA-DE-14-005.

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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

Leadership Team

Leading this project will require a degree of expertise in both bioinformatics/data science and craniofacial biology likely to be beyond the abilities of a single PD/PI. Applications to this FOA must use the Multiple-PD/PI model.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, i 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Telephone: 301-594-5593
Fax: 301-480-8303
Email: yasaman.shirazi@nih.gov

Leadership Team

Leading this project will require a degree of expertise in both bioinformatics/data science and craniofacial biology likely to be beyond the abilities of a single PD/PI. Applications to this FOA must use the Multiple-PD/PI model.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific FOA, the Research Strategy section is limited to 30 pages

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

Investigators must submit a justified, individual budget for each year of support requested.

The budget should include sufficient funds to ensure that personnel levels are adequate for efficient liaison with researchers contributing datasets to FaceBase. Applicants should plan that the donor’s personnel costs for their work on data curation will be supported by the donor’s funding source.

The budget should also include funds supporting travel by the hub PD/PIs and/or select hub personnel to scientific meetings where they will conduct outreach activities to increase awareness of FaceBase resources in the wider research community and training activities to enable research community users to take fuller advantage of FaceBase resources. Funds should also be budgeted to support these user training efforts through the development of online FaceBase tutorials.

All instructions in the SF424 (R&R) Application Guide must be followed. Separate budgets must be prepared for each subcontract proposed.

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

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

Research Strategy

Relationship to current FaceBase architecture

Applicants responding to this RFA must describe how any proposed changes to the software behind the next iteration of the hub will integrate with, and improve upon the existing software architecture and functionality of the FaceBase website.

Dataset quality control and assurance

FaceBase’s utility to the research community is absolutely dependent on the integrity of the datasets and metadata it contains. The application must describe the systems that will be put in place to assure the quality of the datasets being added to the repository. This system should include a plan for assessment of the rigor and reproducibility of the datasets chosen for incorporation in to FaceBase.

Outreach and User Training Plan

In order to incorporate research community-generated datasets, the FaceBase 3 hub will need to be able to identify relevant datasets as they become available and work with those investigators to make their datasets compatible with the FaceBase data models. The application should describe the process through which appropriate datasets will be identified for incorporation into FaceBase.

In addition, the FaceBase 3 hub is required to develop training efforts to enhance the ability of the wider craniofacial researcher community to make fuller use of the repository. The Research Strategy section of the application should describe plans to accomplish both of these goals.

Plan for monitoring FaceBase usage by the community

The FaceBase 3 hub will implement a system through which the hub PD/PI(s) and the NIDCR program staff can monitor usage of the website and data repository. This system must report information about the numbers and research areas of users with FaceBase accounts, dataset downloads, use of FaceBase reference pages, etc., as well as standard web statistics (e.g., the number of unique users, page views, etc.)

Data Science/Bioinformatics and Craniofacial Biology expertise

The FaceBase hub investigators must be familiar with current approaches to data ingest, curation, management, visualization, and dissemination including the implementation of features such as digital object identifiers (DOIs), community-standard ontologies, and the NIH-supported FAIR principles. Similarly, while the activities of the FaceBase hub are largely in the areas of computer science and informatics, the hub must be able to fully comprehend how the various FaceBase datasets may relate to one another, and to communicate effectively with research groups depositing data in FaceBase and with researchers making use of this resource. Applicants for the FaceBase hub are therefore expected to demonstrate that their teams include craniofacial biology expertise sufficient to allow them to function in this way.

The application should describe how the team will leverage these individual areas of expertise and how those areas of expertise can be combined synergistically.

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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The goal of FaceBase since its inception has been the prompt, prepublication dissemination of all its data and tools to the wider research community. This goal extends to novel software or informatics approaches developed by the hub (e.g., novel viewer applications for retrieving and overlaying various types of data onto a diagrammatic representation of a developing embryo; innovative methods for simultaneously searching multiple data types, etc.). Applications to this RFA must include a resource sharing plan describing in detail how such tools will be disseminated to the wider research community (for example, dissemination through GitHub, the FaceBase hub itself, etc.) as appropriate and consistent with achieving the goals of this program.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by the NIDCR/NIH. Applications that are incomplete, non-compliant 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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 sufficiently broad expertise in the biological aspects of craniofacial development and dysmorphology to allow them to productively interact with investigators from a variety of craniofacial research disciplines?

Do the investigators have sufficiently broad expertise in bioinformatics/computational biology/data science to allow them to continue to develop the FaceBase hub? Do they have expertise in current approaches to data ingest, curation, management, visualization, and dissemination?

Are plans proposed for reaching out for additional expertise as needed?

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 application propose:

innovative conceptual approaches and interfaces for displaying and searching data?

innovative approaches to facilitate collaborations between the hub and researchers depositing data in FaceBase including procedures and tools for dataset curation?

innovative tutorials and training strategies for facilitating the research community’s use of this resource?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are proposed structural changes to the hub’s software architecture likely to improve FaceBase’s utility to the research community, for example, facilitating access to the data and search capabilities?

Are the plans for identifying appropriate research community-generated datasets adequate and are suitable plans proposed that will aid the donors of those datasets in making them compliant with FaceBase data models, etc.? Are the proposed mechanisms for ensuring the quality and integrity of FaceBase datasets adequate and feasible? Are they sufficient to foster research community trust in the quality of FaceBase datasets?

Are the plans for disseminating research findings, data, tools, and methods to the wider community adequate? This criterion includes plans for obtaining, securing, and disseminating individually identifiable human subjects data, as appropriate and consistent with achieving the goals of the program.

Are the proposed research community outreach and user training plans likely to increase the utility of FaceBase to the craniofacial research community and the usage of FaceBase by that research community? Are the proposed mechanisms for monitoring research community use of FaceBase adequate?

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?

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?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

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.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDCR, 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:

• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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

The PI(s) will have the primary responsibility for defining the details for the project within the guidelines of RFA-DE-19-003 and for performing the scientific activities. PI(s) 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 under "NIDCR Program Staff Responsibilities". The PIs will:

manage and coordinate project activities scientifically and administratively at the awardee institution and with any collaborating institutions;

determine project design and experimental approaches, develop protocols and modify as needed, propose and negotiate project milestones, collect data, monitor and assure data quality and security, analyze and interpret data, and prepare publications;

assess and determine, in coordination with the NIDCR Program Official and Project Scientist(s), the appropriateness of new datasets from investigator-initiated projects for incorporation into FaceBase. For human subjects data, these activities will include collecting relevant IRB approvals, etc. from data contributors and sharing those documents with NIDCR personnel prior to acceptance of the dataset for inclusion in FaceBase;

collaborate with research groups whose data are relevant to the goals of FaceBase in order to help them to deposit, organize and update data or tools in FaceBase;

coordinate, monitor, and assure quality control of datasets obtained by FaceBase according to any approved plans for timely sharing of research resources and data generated through the award;

continue to improve the design of and otherwise enhance the FaceBase web interface, and to provide the research community with access to the data;

participate in periodic discussions with the NIDCR staff and the Scientific Leadership Group through teleconferences, web conferences, or face-to-face meetings;

provide NIDCR staff with access to FaceBase usage data;

submit two progress reports per year in a standard format. One report will be the annual noncompeting renewal application required for all NIH multi-year awards. The other will be a midyear report in a format specified by the NIDCR program staff working with the FaceBase hub. Additional reports may be requested by the NIDCR program staff when appropriate;

assume accountability to officials of the awardee organization and to the NIDCR for the performance and the proper conduct of the research supported by the U01 mechanism in accordance with the terms and conditions stated in the FOA;

upon completion of the project, release all study design materials and procedure manuals into the public domain and/or make them available to the scientific community and the NIDCR, according to any approved plans, for the conduct of research at no charge other than the costs of reproduction and distribution;

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.

NIH 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 of the hub. It is anticipated that the NIH Project Scientists will be given the opportunity to offer input into the discussion of FaceBase hub issues. Other NIDCR staff may assist and advise the FaceBase hub on relevant programmatic and scientific issues. The program staff will:

participate in the process of coordinating collaborative research efforts and setting research priorities;

provide advice in the development of operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;

work with hub personnel to identify datasets for potential inclusion in FaceBase and participate in decisions on the inclusion of those datasets. NIDCR personnel will be responsible for deciding whether datasets containing information from identifiable human subjects can be included within the FaceBase repository.

be responsible for making decisions governing the dissemination of restricted access data from human subjects through the FaceBase hub (i.e., individual level human data and data from identifiable human subjects);

serve as a liaison to the NIDCR and NIH, and as an information resource for the awardees about craniofacial research activities;

select members to form the Scientific Leadership Group to assess the progress of the FaceBase hub;

serve as a liaison between the hub PIs and the Scientific Leadership Group;

prior to funding, negotiate milestones with the applicant, incorporating recommendations from the scientific review panel, with the final negotiated milestones becoming a condition of the award, including appropriate language to recognize that the project includes research whose outcomes are unpredictable;

monitor compliance with those milestones and adjust them if needed annually at the award anniversary dates to incorporate the group's accomplishments and progress and to reflect any recommendations of the Scientific Leadership Group;

provide advice in the management and technical performance of the award;

assist in promoting the availability of FaceBase data and related resources developed in the course of this program to the scientific community at large;

enforce a policy for timely release of data;

and consult as needed with other NIDCR and NIH staff as well as non-NIH experts in the field in order to carry out these responsibilities.

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. The NIDCR Program Official will:

review the progress of the project for compliance with NIH Grants Policy;

make recommendations, with input from the Scientific Leadership Group, to the NIDCR for continued funding based on scientific performance, progress towards achieving project and FaceBase objectives according to the milestones agreed to at the time of the award, and compliance with the Terms and Conditions of the award;

conduct more frequent progress review and require that the awardee submit quarterly progress reports should problems arise in the conduct of the study;

and, with input from the Scientific Leadership Group, recommend to the NIDCR withholding or reducing support, suspending, or terminating the project for the lack of progress or failure to comply with stated policies, terms and conditions of the award.

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 PI(s) chosen without NIH staff input, 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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

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

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

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.

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 Part 75.