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; 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.

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) 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 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 receive a Center Core Grant, an institution or consortium must meet the following program requirements.

• Cores and Core services must be specifically targeted to neuroscience research. Resources 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)) who hold qualifying NINDS-funded research projects. Qualifying projects include R01 and other awards of similar scale, as specified in Section III.3. Additional Information on Eligibility.

• Support provided by the Cores to the qualifying projects must be for activities within the scope of the projects' funded Specific Aims.

• 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. 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 non-exclusive 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.

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)

• 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 of NIH IPF number) is allowed.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

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, R37, P01, P50 and U54 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.

Investigators holding smaller research projects (R21 and R03), fellowships, and career (K) awards are eligible for Center services, but these investigators/awards do not count toward the minimum required number of qualifying projects.

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. 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.

Applicants can access 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.

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 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:

Edmund Talley, Ph.D.
Neuroscience Center, Room 2132
6001 Executive Boulevard, MSC 9521
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-1917
Email (strongly preferred): [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core (Use for Scientific Core)	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 1

• Scientific Core: at least one required

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.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions. In addition, provide the following information:

Facilities and Other Resources:

Institutional Support: Describe commitment and support by the host institution, including provision of space, faculty position commitments, salary for staff, purchases of equipment, and/or financing for new construction/renovation.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

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.

• Qualifying investigators:

• Provide concise but complete information on the Qualifying Projects and their associated Investigators. Provide detail sufficient for verification that proposed core activities are within the scope of the funded aims of the projects. 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, which is to seek fundamental knowledge about the brain and nervous system, and to use that knowledge to reduce the burden of neurological disease. Describe how the proposed Center will meet current and future needs for their research.

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

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.

SF424 (R&R) Cover (Scientific 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 (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific 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.

Facilities and Other Resources: Describe the available resources for the Scientific Core. Describe commitment and support by the host institution, including provision of space, faculty position commitments, salary for Core staff, purchases of equipment, and/or financing for new construction/renovation. In addition, this section must provide comprehensive information on related facilities and services available at the host institution. These alternative resources must be clearly delineated from those proposed for the Center.

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) (Scientific 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 (Scientific 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 (Scientific Core)

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.

Co-Funding

Co-funding by the applicant organization or by outside sources is encouraged, but 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 and 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.

PHS 398 Research Plan (Scientific Core)

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

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

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

Planned Enrollment Report (Scientific Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Scientific Core)

When conducting clinical research, follow all instructions for completing Cumulative 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. 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, a plan for evaluation of pilot projects that are not within scope of funded research project aims should be provided. 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.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

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.

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

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.

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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? 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 (which is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease)? 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 to determine whether services offered by the Cores are within the scope of the funded awards?

Investigator(s)

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

Innovation

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

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?

Approach

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

If the 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 there a plan for evaluating pilot projects, and is it 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?

Environment

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

Is the host institution a premier locus for cutting edge neuroscience research? Are the primary users at the top of their respective fields? Is there a large 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 (which is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease)?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed Center 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

Renewals

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

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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.

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) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.

• Availability of funds.

• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or 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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Edmund Talley, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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 Parts 74 and 92.