NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the instructions in the Multi-Project Instructions for 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

This Funding Opportunity Announcement (FOA) invites applications for Center Core Grants to support the NINDS mission, which is to seek fundamental knowledge about the brain and nervous system, and to use that knowledge to reduce the burden of neurological disease.  In pursuit of this mission, NINDS supports basic, translational, and clinical research on the normal and diseased nervous system.  For an overview of NINDS see http://www.ninds.nih.gov/about_ninds/ninds_overview.htm.

The Centers will provide cutting edge resources (cores) and facilities to investigators who have existing NINDS-funded research projects, and to other investigators pursuing research consistent with the NINDS mission. The Centers should enhance the effectiveness of ongoing research and facilitate new research directions. They should provide services that would be impractical for individual labs, either because of ongoing requirements for specialized expertise, or because of associated economies of scale. Their support is intended to increase resource accessibility and to capitalize on potential synergies that would not be attained through independent funding of separate research projects.

To be responsive to this Funding Opportunity Announcement, an institution or consortium must meet the following program requirements.

Cores and Core services must be specifically targeted to neuroscience research.  Resources (cores) that are general to biomedical sciences are not appropriate for this FOA, unless a specific unmet neuroscience research need can be demonstrated.

Centers must support at least six Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) from one or more organizations who hold qualifying NINDS-funded research projects.  Qualifying projects include R01 and other awards of similar scale and duration of at least four years, as specified in Section III.3. Additional Information on Eligibility.

Service provided by the Cores to the qualifying projects must be for activities within the scope of the projects' funded Specific Aims, although support from the Core will not duplicate existing funding for projects' activities.

All of the qualifying investigators must be significant users of the Center, and no more than 25% of the effort from a single Core facility can be devoted to projects directed by any single investigator.

The qualifying projects are necessary, but must not be the only projects supported by the Cores.  It is expected that the Cores will serve a wide base of neuroscience investigators beyond the qualifying projects.

A Core must provide services that are not available to investigators elsewhere either off-site (e.g., commercially) or via other facilities at the host institution or one or more consortium institution(s). Exceptions to this requirement may be allowable in infrequent cases, but only if the Core adds substantial and demonstrable value both for potential users and for support of the NINDS mission.

Core facilities and personnel should be focused on a service mission, with a goal of meeting the needs of a variety of potential users. Awards will not support independent research that is separate from the goal of service to Center users.  Center personnel may receive partial funding from other sources for independent research, but their effort towards Center activities must be documented as described below.

In infrequent cases, technology development may be appropriate for a given Core, but only insofar as this development enhances the service to Center users.  Applicants considering technology development efforts are encouraged to contact NINDS Scientific/Research staff to discuss alternative grant mechanisms.

The following is a partial list of types of activities that may be appropriate for individual Core facilities: Animal models, Animal Surgery, Behavioral Testing, Specialized Cell Culture, Histochemistry, Specialized Imaging or Microscopy, Pathology, Physiology, and Statistical/Computational Analysis.

The program will not provide funding for Cores that support clinical trials or provide patient services.  For services associated with clinical research, investigators should contact the NINDS Office of Clinical Research (http://www.ninds.nih.gov/research/clinical_research/).

The program will not provide funding for chemistry services associated with candidate therapeutic lead optimization.  For services associated with translational research, investigators should consider the NINDS Cooperative Program in Translational Research (http://www.ninds.nih.gov/research/translational/index.htm), and can contact the NINDS Office of Translational Research (http://www.ninds.nih.gov/funding/areas/translational_research/index.htm).

Applications proposing exceptional opportunities for dissemination of induced pluripotent stem cell (iPSC) lines or related resources may be allowable, but as stated in NOT-NS-14-032 (NINDS Requirements for Induced Pluripotent Stem Cell Development and Resource Sharing), we expect iPSC lines to be developed in the context of funded research project aims, to ensure that the value of each line is established from the perspective of specific research outcomes.  Investigators proposing such resources are expected to provide strong justification as to why their unique circumstances warrant a Core resource. In addition, investigators proposing iPSC development must explicitly describe, in detail, how they will follow NINDS guidelines described in NOT-NS-14-032 for non-redundant development, quality control, Freedom to Operate conditions, and cell line dissemination.

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 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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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)
• 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 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.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.  Additionally, an institution is eligible for a maximum of one NINDS Center Core Grant.

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).

Qualifying Research Projects

Applicant organizations must have a minimum of six qualifying research projects directed by at least six separate Program Director(s)/Principal Investigator(s). All qualifying projects must be substantial users of the Cores, and Core services must be within scope of the funded aims of the awards identified as qualifying projects.  No more than 25% of the effort from a single Core facility can be devoted to projects directed by any single investigator.

Qualifying projects are defined for the purpose of this FOA as NINDS-funded research projects using the R01, U01, R35, R37, P01, P50, U54, DP1 (Pioneer) and DP2 (New Innovator) activity codes (for general descriptions/definitions, see http://grants.nih.gov/grants/funding/funding_program.htm) . Multicomponent awards such as Program Projects (P01) and Centers (P50 or U54) each count as only one qualifying project toward the minimum requirement. The number of funding years remaining for each qualifying project should be included; pending applications and projects in no cost extension are to be excluded.

Grant mechanisms with durations of less than four years are ineligible as qualifying projects. However, Brain Initiative projects, Pathway to Independence (R00) awards, smaller research projects (R21 and R03), fellowships, career (K) awards, and unfunded pilot projects are eligible to use Center services, but these investigators/awards do not count toward the minimum required number of qualifying projects.

Consortium Agreements

Consortium arrangements between applicant organizations are allowed, and qualifying research projects may be included from each organization.  Applications with participation by more than one organization must demonstrate that facilities and services will be local and accessible for users from each organization, and that users from each organization have a compelling need for the services of the proposed Center.  Of the six qualifying projects, at least three must come from the applicant organization. The composition of the proposed Steering Committee must include representation from the respective organizations sufficient to fully support the interests of potential users from each organization.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Randall R. Stewart, Ph.D. 
Program Director for Channels, Synapses and Circuits
National Institute of Neurological Disorders and Stroke 
National Institutes of Health 
Neuroscience Center, Room 2135 
6001 Executive Blvd. 
Bethesda, MD 20892-9523
(For courier delivery:  Rockville, MD 20852)
Telephone: 301-496-1917
Email: stewartr@ninds.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core (use for Scientific Cores)	6

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of one
• Scientific Cores : required, minimum of one

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Facilities and Other Resources: Describe the research environment for the Center and the commitments by the institution for research that is within the NINDS mission. The host institution should be a locus for neuroscience research and the primary users established investigators in their respective fields. Describe how large the base of investigators is, beyond those holding the minimum Qualifying Projects, who will derive benefits from the Center. Describe tangible commitments by the host institution in the support of the Center and/or in support of research towards the goals of the NINDS mission.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Provide an overview of the goals for the Center.

Research Strategy: The Research Strategy should include the following items:

Goals for the Center: Include unique features of services and/or administration, and how the Cores fulfill the requirements of NINDS-supported research. When appropriate, the Center is expected to incorporate innovative information management methods for enhancing data sharing and handling of large data sets

Provide concise but complete information on the Qualifying Projects (see Section III.3, Qualifying Research Projects) and their associated Program Director(s)/Principal Investigator(s).  Provide detail sufficient for verification that proposed core activities are within the scope of the funded aims of the projects.  In addition, provide a table of qualifying investigators, projects and other information.  The following information is required: PD/PI name, Institution, Qualifying Project Grant Number, Title of Grant, Project End Date, and Future Years left on grant (exclude grants in no-cost extension).  For qualifying project requirements, see Section III.3. Additional Information on Eligibility.

Describe the long-term research goals of the investigators holding Qualifying Projects.  Provide sufficient detail to indicate how these interests align with the NINDS mission. Describe how the proposed Center will meet current and future needs of its qualifying research investigators.

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.

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.

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

When preparing your application in ASSIST, use Component Type Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Salary support for the Scientific Core Director may be requested for up to 0.6 calendar months per year.

Salary may not be requested for investigators of qualifying projects.

Salary may be requested for technical support personnel and consultants.

Requests for shared equipment are allowed.

Consumable supplies may be requested to the extent they directly contribute to the operation of the cores and are not project specific.  Unique research reagents and supplies that are specific to the support of individual projects, including experimental animals, may not be requested.

Costs for animal purchase and care are only allowed in limited circumstances when required for core operations, and are not allowed for furtherance of specific projects.

Travel costs are not allowed.

Patient care and recruitment costs are not allowed.

Costs for seminars and workshops are not allowed.

Alteration and renovation costs are not allowed.

The host institution's existing facilities and available services should be clearly delineated from the facilities and services that are proposed for funding via this FOA in the Facilities & Other Resources section of the application.  There should be no overlap between the requested NINDS-funded core facilities and other pre-existing core facilities at the host institution.  The specific value of the requested funding from NINDS should be clearly described and distinguished from existing sources of funding.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide an overview of the Aims for the Scientific Core.

Research Strategy: Include the following information:

Services: Describe essential Core functions and their research value.

Research Core Suitability: Include information on expected economies and synergies, cost comparisons to comparable services, and the added value both to investigators and to the NINDS mission.

Describe how the services provided by the Cores will contribute to and enhance the funded specific aims of the qualifying research projects.

The Center/Core is expected to incorporate innovative information management methods for enhancing data sharing and handling of large data sets.

It is expected that Cores will generate revenue via fee-for-service arrangements whenever possible, in order to optimize efficient resource usage and enhance resource sustainability. These arrangements must be explicitly described in the application.

A Core proposing to disseminate induced pluripotent stem cell (iPSC) lines or related resources may be allowable, but as stated in NOT-NS-14-032 (NINDS Requirements for Induced Pluripotent Stem Cell Development and Resource Sharing), NINDS expects iPSC lines to be developed in the context of funded research project aims, to ensure that the value of each line is established from the perspective of specific research outcomes.  Investigators proposing such resources are expected to provide strong justification as to why their unique circumstances warrant a Core resource. In addition, investigators proposing iPSC development must explicitly describe, in detail, how they will follow NINDS guidelines described in NOT-NS-14-032 for non-redundant development, quality control, Freedom to Operate conditions, and cell line dissemination.

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.

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.

PHS Inclusion Enrollment Report (Scientific Core)

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

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Salary support for the Center Director may not exceed 0.6 calendar months.

Support for secretarial and administrative staff may be requested to the extent that it contributes substantially to the management of the Center and meets the requirements in SEC. 8.1.1.6 in the NIH grants policy statement. Such salaries may only be appropriate if all of the following conditions are met: (1) Administrative or clerical services are integral to a project or activity;(2) Individuals involved can be specifically identified with the project or activity; (3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) The costs are not also recovered as indirect costs. Together, salary support for the Center Director and secretarial and administrative staff may not exceed 10% of the direct costs for the Center in any year.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed but not required for each component.

Specific Aims: Describe the specific aims for Administration of the Center.

Research Strategy: Include the following information:

Administration: Description of the strategies and processes used to manage the Center to achieve the overall goals.

Steering Committee: The steering committee should be chaired by the PD/PI, and should include the directors of the individual Cores, at least two investigators holding Qualifying Projects, and a Department Chair or Vice President/Provost for Research or equivalent from the applicant organization. The Steering Committee will implement the Project Prioritization plan for project evaluation and access to Core facilities and services, and will advise the Center Director on strategic and operational issues.

Project Prioritization Plan: A plan for project evaluation and/or resource allocation is required. Prioritization may be established by virtue of a fee structure or by a formal project evaluation mechanism, or by other appropriate considerations. Where appropriate to the Project Prioritization Plan (e.g., instances where a limited number of projects can have access to Core resources at any one time), a process for evaluating pilot research should be described. In all cases, the relevance of the research to the NINDS mission should be a primary consideration.

Dissemination and Access Plan: Applications should propose or have in place a mechanism for thorough dissemination and advertisement of available services and resources to the full community of neuroscience investigators at the host institution.

Activity Reports: Detail the exact format for annual quantitative reporting of Core usage at the level of Projects and Investigators. The format should be sufficient for the Steering Committee to ensure compliance with Center usage requirements, and to assess the ongoing value of Core services. The format for reporting must be explicitly described in the application, and must include quantitative information on usage by individual project and their respective investigators. Competing renewal applications must include activity reports/usage tables for each core.

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:

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.

PHS Inclusion Enrollment Report (Administrative Core)

Not Applicable

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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 our Post Submission Application Materials 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 Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center 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 Center 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?

Will the Center and each of the Cores enhance research output in ways that would not be practical for individual research projects? Do the Cores convincingly add value over comparable facilities and services, either on- or off-site?  Are the cores and their services specifically targeted to neuroscience research, and not general to biomedical science?  Does the Center provide special synergies or influence the host research environment in tangible ways?  Are the long term research goals of the investigators holding Qualifying Projects described in sufficient detail to determine whether they align with the NINDS mission?  Is the proposed Center well-situated to meet the current and future needs of these investigators' research? Are the funded Specific Aims of the Qualifying Projects described in sufficient detail so that it can be determined if the services, facilities and/or reagents provided by the Cores to the Qualifying Projects are directed to activities that are consistent with the Qualifying Projects Specific Aims?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Is/are the Center and Core Directors well qualified to effectively administer the Center?  Are each of the Core Directors and personnel appropriately trained and suitably positioned for their respective roles?  Are they able to devote adequate time and effort to Core activities?  Do they have a history of performing services for their colleagues, outside the needs of their own research?  Is the steering committee appropriate for effective oversight of the Center?

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 features of the Center organization or its services unique? Are the technologies especially forward-ranging in their implementation? Do the Center and/or individual Cores have potential to serve as exemplars for outstanding research service?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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?

Do the Cores provide advanced techniques and services? Are they maximally appropriate for the anticipated research needs of the investigators? Are the facilities and equipment optimal? Are plans for Center administration, including procurement and personnel management, appropriate? Does the Dissemination and Access Plan ensure that facilities and services will be widely used, with easy and fair access to the appropriate users? Is the Project Prioritization Plan sufficient to ensure optimal allocation of Center resources? Is the plan for evaluating pilot projects appropriate to assess the range of research projects utilizing the Cores? For each of the Cores, is the format for the annual Activity Report appropriate for ensuring compliance with Center usage guidelines, and for assessing the ongoing value of Core services?

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?

Is the host institution a locus for neuroscience research?  Are the primary users established investigators of their respective fields?  Is there a base of investigators, outside those holding the minimum Qualifying Projects, who will derive benefits from the Center?  Has the host institution demonstrated tangible commitments in the support of the Center and/or in support of research towards the goals of the NINDS mission?

As applicable for the Center 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period. Do the activity reports for the scientific cores demonstrate appropriate bookkeeping and broad usage?

Not Applicable

As applicable for the Center 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 . Does the Center include information management methods that enhance data sharing and handling of large data sets as appropriate?

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 NINDS 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 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 Neurological Disorders and Stroke (NANDS). 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.

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.

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

Not Applicable

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. For general instructions please see the RPPR Instruction Guide, including Sec. 7.6 at http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf

In addition the RPPR should include:

• An accounting of service activities provided in an activity table. The table(s) should include users of the cores, their associated grants (with qualifying projects clearly indicated), and core usage (in hours and percent usage) by PI/grant.

Add the following text to the end of the prior paragraph if this FOA does allow for awardee-selected projects: Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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.

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
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: 301-945-7573

Randall R. Stewart, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: stewartr@ninds.nih.gov

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

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