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.

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

The Neuroimaging Informatics Tools and Resources Clearinghouse (NITRC) (http://www.nitrc.org), originally funded by the NIH Blueprint for Neuroscience Research in 2006, is a dynamic inventory of web-based neuroimaging informatics resources: software, data, and tools accessible via any computer connected to the internet. The purpose of the NITRC project is to promote the enhancement, sharing, adoption, and evolution of neuroimaging informatics tools and resources by providing access, information, and forums for interaction for the user community and the associated developers. The NITRC project was designed to improve scientific research and promote sharing of previously funded research and initiatives and to encourage community interaction and collaboration. NITRC facilitates finding and comparing neuroimaging resources for functional and structural neuroimaging analyses. The goals of NITRC are to catalog and point to standardized information about neuroimaging tools, or resources. In 2011, the scope of NITRC was expanded to provide enhanced services such as virtual computing, and data storage.

The functionality of the Neuroimaging Informatics Tools and Resources Clearinghouse (NITRC) has enabled three distinct components to flourish

• NITRC-R: the NITRC resource for software and tool exchange.
• NITRC-IR: the NITRC image repository of publicly accessible, anonymized, and curated, clinical neuroimaging data.
• NITRC-CE: the NITRC compute environment permitting researchers around the globe the ability to do computations on neuroimaging datasets.

NITRC-R has become the major web-based collaborative environment enabling the distribution, enhancement, and adoption of neuroinformatics resources. It currently hosts more than 748 tools and resources in areas such as magnetic resonance imaging (MRI), electroencephalography (EEG), magnetoencephalography (MEG), multi-modal, positron emission tomography, single photon emission computed tomography (PET / SPECT), computed tomography (CT), clinical neuroinformatics, imaging genomics, optical imaging, and computation neuroscience.

NITRC-IR currently comprises a curated repository of more than 6,000 human subjects' DICOM and NIfTI-1 images, which are searchable by metadata such as handedness, gender, and grouping. This data is registered on INCF Dataspace and is a Tier 3 resource on the Neuroscience Information Framework (NIF). NITRC-IR is the data repository for the 1000 Functional Connectomes (resting state), the ABIDE study (resting state), CANDIShare (T1 and manual segmentations), ADHD200 (resting state), INDI NKI/Rockland (resting state), PING (structural, diffusion, and resting state), CoRR (test-retest reliability and reproducibility), as well as international studies such as Beijing Enhanced DTI, Beijing Eyes Open Eyes Closed, Beijing Short TR study, Study Forrest rev003 (structural brain scans, physiological measurements, technical confounds), IXI study (normal, healthy subjects MRI scans).

NITRC-CE is an on-demand, virtual computing platform built upon a NeuroDebian operating system. It is pre-configured with a number of neuroimaging applications (for example, AFNI, FSL, etc.). NITRC-CE can be implemented by researchers within their academic infrastructure, or there are implementations made available through commercial cloud providers (such as Amazon Web Services, and Microsoft VM Depot).

The objectives of this FOA are to:

• Maintain the NITRC-R resources and tools
• Maintain the NITRC-IR image repository
• Maintain the NITRC-CE compute environment
• Provide support for the current NITRC production and development environments
• Provide support for the operation of core services such as the systems used to perform regular software updates for the compute environments, curate data coming to the image repository, and streamlining the tools and resources.
• Provide user training and support on the use of NITRC.
• Identify and add relevant neuroimaging datasets and neuroimaging informatics tools and resources.
• Work with subject matter experts to identify new neuroinformatics areas of focus for NITRC.org to include on its site.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 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.

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).

Applicants must obtain 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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:

Vinay M. Pai, PhD
Telephone: 301-451-4781
Email: vinay.pai@nih.gov

The applicants are encouraged to send the letter of intent by email to the email address above, but as an alternative, the physical letter may also be sent to:

Vinay M. Pai, Ph.D.
National Institute of Biomedical Imaging and Bioengineering, NIH, DHHS
6707 Democracy Blvd., Suite 200
Bethesda, MD 20892

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.

The PD/PI and their team are required to have skills in system installation, including extensions, migrations, bug corrections, as well as skills in Nipype and python programming. The research team must demonstrate a track record in web portal administration, database administration and curation, cloud-based compute environment development, and familiarity with automated web discovery and search techniques, web services, and utilities provided by NIH and other major data repositories. The applicant must demonstrate extensive domain knowledge of publicly available US and international resources, tools, and data associated with neuroimaging informatics for implementing and maintaining the Neuroimaging Informatics Tools and Resources Clearinghouse. The PD(s)/PI(s) and team must demonstrate their ability to identify and provide appropriate neuroimaging informatics and neuroinformatics experience and expertise that cover the expanded scientific scope to curate and evaluate tools and resources data and to moderate forum discussion on the NITRC site. The team should have a demonstrated ability to exploit current and emerging technologies to keep the Neuroimaging Informatics Tools and Resources Clearinghouse (NITRC) as a scientific and dynamic system that can adapt to rapid change in the field

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, with the following additional instructions:

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

Research Strategy: The research strategy should address the following:

• Plans for the maintenance and upkeep of the NITRC-R resource, the maintenance and upkeep of the NITRC-IR database, and the maintenance and upkeep of the NITRC-CE platform, to achieve the objectives of providing resource curation, maintenance, and support of the Neuroimaging Informatics Tools and Resources Clearinghouse Resource Curation, Maintenance, and Support:
  
• Maintenance and upkeep of the NITRC-R resource
  Provide a plan to curate and maintain the contents of the NITRC-R resource. This involves curation of new tools and resources that have been identified by contributors, curation of resources that have been flagged by one of NITRC's validation pipelines, updates and fixes to tools and resources based on user feedback, and via communication with resource providers. Such tasks would mainly include support maintenance of existing tools and resources. This would also include providing the users with a friendly user interface to search, browse, filter, and compare tools and resources.
• Maintenance and upkeep of the NITRC-IR database
  Provide a plan to curate and maintain the contents of the NITRC-IR database. This involves updates and fixes to data sources interoperability and linkout descriptions, curation and maintenance of data source views and integrated views, troubleshooting problem data sources, and curation of prioritized data sources from the user community and the NIH.
• Maintenance and upkeep of the NITRC-CE platform
  Provide a plan to curate and maintain the NITRC-CE platform. This includes maintaining and updating on an as-needed basis the cloud-based virtual machine installations of neuroimaging and neuroinformatics tools.
• Plans for infrastructure maintenance, maintenance operation of production services, and support of core services, for achieving the goal of providing infrastructure, maintenance and support for NITRC Infrastructure, Maintenance, and Support:
• Infrastructure maintenance
  Detail a plan to support the current NITRC production and development environments. This includes ensuring that the NITRC website continues to be compatible with the newest releases of all major web browsers, is a web service interface for automated interactions, and allows for easy scalability for use beyond tools/resources currently present.
• Maintenance Operation of production services
  Explain how operations of the core website will be maintained to ensure that it is fully available with an uptime of 99.5% or better, on a 24-hour basis. Explain how critical bugs will be fixed to enable smooth functioning of NITRC. Also provide plan for incremental and full website data backup, and timely hardware upgrading to ensure adequate storage and full access.
• Core services support
  Explain how core services will be supported. This includes ensuring timely hardware and software updates, providing users means to select amongst neuroimaging tools and resources (e.g. using rating system, usage statistics, comparative metrics, data sheets, user guides, etc.), and providing means to upload and update new tools or resources. It also includes maintaining and updating the cloud-based federated neuroimaging data storage system. It also includes implementing and maintaining virtual machine installations of a set of selected neuroimaging and neuroinformatics tools to enable neuroscience data analysis in the cloud environment.
• Identifying and adding data, tools, and resources, as well as working with subject matter experts to identify areas of expanding scientific scope of NITRC:
• Identify and add data and tools/resources
  Need to identify, solicit, evaluate, and integrate the neuroimaging informatics tools and resources for expanded scope. Such tools and resources could be from, but are not limited to, the imaging modalities of: functional MRI, structural MRI, optical imaging, PET, CT, EEG, MEG, and SPECT. Additional tools could include, but are not limited to, the following: genetic imaging, computational neuroscience (including large-scale and multi-scale modeling), electrophysiology that interfaces with imaging for structural and functional research, clinical neuroinformatics, computational neuroscience, genomics and genetics.
• Work with subject matter experts to identify areas for expanding scientific scope
  Work with subject matter experts (SMEs) to develop new use cases, and new neuroimaging and neuroinformatics tools and resources for expanding the scientific scope of NITRC.org. These cases, tools, and resources must be based on the needs and real-world scenarios of neuroscience research.
• Identify outreach, documentation and user support:
• Outreach and User support
  Provide user support by responding to questions via forms. Provide users means to comment on the NITRC use experience. Also do outreach by developing effective approaches to actively promote widespread use of NITRC-R, NITRC-IR, and NITRC-CE.
• Documentation:
• Detail the plan to provide the software source code and executables, use cases, system design documents to the general public. These should also include installation guides, user guides, specifications for website, system, database and user-interface design, and software release and functionality testing reports.

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:

Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A dissemination plan guided by the following principles is thought to promote the largest impact:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.
• Given the long-term goals of this initiative to create software and tools for pediatric data science research that will serve as a resource to biomedical researchers across the nation, applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

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

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, note the following: NITRC is intended to be a scientifically and technically dynamic system, evolving to reflect current science and exploit emerging technologies.

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?

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 PD/PI and their team have skills in system installation, including extensions, migrations, bug corrections, as well as skills in Nipype and python programming? Has the research team demonstrated a track record in web portal administration, database administration and curation, cloud-based compute environment development, and familiarity with automated web discovery and search techniques, web services, and utilities provided by NIH and other major data repositories? Has the applicant demonstrated extensive domain knowledge of publicly available US and international resources, tools, and data associated with neuroimaging informatics for implementing and maintaining the Neuroimaging Informatics Tools and Resources Clearinghouse? Have the PD(s)/PI(s) and team demonstrated their ability to identify and provide appropriate neuroimaging informatics and neuroinformatics experience and expertise that cover the expanded scientific scope to curate and evaluate tools and resources data and to moderate forum discussion on the NITRC site? Have the PD(s)/PI(s) and team demonstrated the ability to exploit current and emerging technologies to keep NITRC as a scientific and dynamic system that can adapt to rapid change in the field?

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?

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?

How well do the plans for the maintenance and upkeep of the NITRC-R resource, the maintenance and upkeep of the NITRC-IR database, and the maintenance and upkeep of the NITRC-CE platform, achieve the objectives of providing resource curation, maintenance, and support of the Neuroimaging Informatics Tools and Resources Clearinghouse? How well do the plans for infrastructure maintenance, maintenance operation of production services, and support of core services, achieve the goal of providing infrastructure, maintenance and support for NITRC? How well does the applicant address the problems of identifying and adding data, tools, and resources? Is the plan for working with subject matter experts to identify areas of expanding scientific scope of NITRC satisfactory? How well does the applicant address the problems of outreach, documentation and user support?

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?

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.

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

Not Applicable

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); and 4) Software Sharing Plan..

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 Center for Scientific Review, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• 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 on the basis of established PHS referral guidelines 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 Advisory Council of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). 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.

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 Part 75, 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:

• Resource Curation, Maintenance, and Support

Maintenance and upkeep of the NITRC - R resource
Provide a plan to curate and maintain the contents of the NITRC-R resource. This involves curation of new tools and resources that have been identified by contributors, curation of resources that have been flagged by one of NITRC's validation pipelines, updates and fixes to tools and resources based on user feedback, and via communication with resource providers. Such tasks would mainly include support maintenance of existing tools and resources. This would also include providing the users with a friendly user interface to search, browse, filter, and compare tools and resources.

Maintenance and upkeep of the NITRC-IR database
Provide a plan to curate and maintain the contents of the NITRC-IR database. This involves updates and fixes to data sources interoperability and linkout descriptions, curation and maintenance of data source views and integrated views, troubleshooting problem data sources, and curation of prioritized data sources from the user community and the NIH.

Maintenance and upkeep of the NITRC-CE platform
Provide a plan to curate and maintain the NITRC-CE platform. This includes maintaining and updating on an as-needed basis the cloud-based virtual machine installations of neuroimaging and neuroinformatics tools.

• Infrastructure, Maintenance, and Support:

Infrastructure maintenance
Detail a plan to support the current NITRC production and development environments. This includes ensuring that the NITRC website continues to be compatible with the newest releases of all major web browsers, is a web service interface for automated interactions, and allows for easy scalability for use beyond tools/resources currently present.

Maintenance Operation of production services
Explain how operations of core website will be maintained to ensure that it is fully available with an uptime of 99.5% or better, on a 24-hour basis. Explain how critical bugs will be fixed to enable smooth functioning of NITRC. Also provide plan for incremental and full website data backup, and timely hardware upgrading to ensure adequate storage and full access.

Core services support
Explain how core services will be supported. This includes ensuring timely hardware and software updates, providing users means to select amongst neuroimaging tools and resources (e.g. using rating system, usage statistics, comparative metrics, data sheets, user guides, etc.), and providing means to upload and update new tools or resources. It also includes maintaining and updating the cloud-based federated neuroimaging data storage system. It also includes implementing and maintaining virtual machine installations of a set of selected neuroimaging and neuroinformatics tools to enable neuroscience data analysis in the cloud environment.

• Identify areas of coverage in neuroinformatics

Identify and add data and tools/resources
Need to identify, solicit, evaluate, and integrate the neuroimaging informatics tools and resources for expanded scope. Such tools and resources could be from, but are not limited to, the imaging modalities of: functional MRI, structural MRI, optical imaging, PET, CT, EEG, MEG, and SPECT. Additional tools could include, but not limited to, the following: genetic imaging, computational neuroscience (including large-scale and multi-scale modeling), electrophysiology that interfaces with imaging for structural and functional research, clinical neuroinformatics, computational neuroscience, genomics and genetics.

Work with subject matter experts to identify areas for expanding scientific scope
Work with subject matter experts (SMEs) to develop new use cases, and new neuroimaging and neuroinformatics tools and resources for expanding the scientific scope of NITRC.org. These cases, tools, and resources must be based on the needs and real-world scenarios of neuroscience research.

• Outreach, documentation and user support

Outreach and User support
Provide user support by responding to questions via forms. Provide users means to comment on the NITRC use experience. Also do outreach by developing effective approaches to actively promote widespread use of NITRC-R, NITRC-IR, and NITRC-CE.

Documentation:
Need to detail the plan to provide the software source code and executables, use cases, system design documents to the general public. These should also include installation guides, user guides, specifications for website, system, database and user-interface design, and software release and functionality testing reports.

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

Blueprint Project Scientist(s): A designated Blueprint Program Official(s) acting as Project Scientist(s) will have the following responsibilities:

• Serve as a resource for specific information on Blueprint's programmatic intentions and priorities, and will help to foster collaborations among different data, research resources, and investigators
• Play an active role in developing in integrating resources and data across websites
• Identify relevant research questions and searches.
• In instances where significant involvement in the design of studies and/or analysis of results has occurred, the Blueprint Project Scientist may cooperate with awardees as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH staff require internal clearances.

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.

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 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.

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 CenterTelephone: 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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Vinay M. Pai, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Michael Steinmetz, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: steinmem@nei.nih.gov

Bradley Wise, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: wiseb@nia.nih.gov

John Matochik, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-7319
Email: jmatochi@mail.nih.gov

Lisa Freund, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6879
Email: freundl@mail.nih.gov

Steven Grant, Ph. D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8869
Email: steven.grant@nih.gov

Janine Simmons, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6652
Email: janine.simmons@nih.gov

Fred Friedman, Ph. D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-4058
Email: ffriedma@mail.nih.gov

Patrick Frost Bellgowan, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: patrick.frostbellgowan@nih.gov

Lois Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email: lois.tully@nih.gov

Hollander, Jonathan
National Institute of Environmental Health (NIEHS)
Telephone: 919 541-9467
Email: jonathan.hollander@nih.gov

Williamson, John
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2583
Email: john.williamson@nih.gov

Joe Rudolph
Center for Scientific Review (CSR)
Telephone: 301-408-9098
Email: josephru@mail.nih.gov

Eunica Haynes
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: haynese@mail.nih.gov

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@nei.nih.gov

Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
Email: properr@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Suezette Epps
National Institute on Drug Abuse (NIDA)
Telephone: 301-617-3882
Email: eppss@mail.nih.gov

William James
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919.541-1403
Email: williamsjr@niehs.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov

Carow, Shelley
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301 594-3788
Email: carows@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.