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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Most grant awards are relatively short in duration (i.e., 2-5 years) and are intended to support individual projects, rather than the overall research program of an investigator's laboratory or research group. Because of these constraints, many PDs/PIs spend a considerable portion of their time writing grant applications, rather than performing and overseeing research. The NINDS RPA is a different approach to supporting outstanding scientists. An RPA will support all the NINDS-related research in an investigator’s laboratory or research group for a sustained period of time. The award is intended to increase funding stability, reduce the time investigators spend writing grant applications, and facilitate a more flexible research environment enabling more ambitious, creative and/or long term research goals.

Investigators receiving an RPA must relinquish their other NINDS research grants, with a limited number of exceptions (see Part 2, Section I). PDs/PIs can retain other non-overlapping grant support, provided they remain able to dedicate sufficient effort to the RPA (see below). Since the RPA is intended to support most, if not all, of the NINDS related research in an investigator’s laboratory, the funding that PDs/PIs receive from leading or participating in NINDS multiple-PD/PI research grants, program project grants and/or Center grants will also be incorporated into the RPA.

By replacing all or most of an investigator’s NINDS funding, the research supported by an RPA should be the major focus of the PD/PI s laboratory or research group. Therefore, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RPA throughout the duration of the award period. Applications from PD/PIs committing less than 6 person months will not be accepted. When applicable, PDs/PIs will be expected to renegotiate their time and effort on other non-NINDS awards in order to accommodate the level of effort required by the RPA. The final budget awarded for an RPA will be determined by NINDS, based on the recommendations of the study section.

It is important to note that the RPA mechanism is not intended to support the expansion of an investigator’s current level of NINDS funding. RPAs will be awarded for no less than $350K DC, and RPA awards for PDs/PIs earlier in their career (= 15 years from their terminal degree) may be somewhat larger than the investigator’s recent level of support, as it is anticipated that these individuals are still in the growth phase of their careers. Barring these exceptions, only in very rare and extremely well-justified circumstances will awards exceed the most recent 4 year funded average of NINDS grants subject to be folded in (i.e. 2013 2016, see below). Applications with budgets more than 20% over the 4 year average described above will be considered non-compliant to this FOA and will be withdrawn prior to their review. Investigators should balance this funding limitation against the benefits of the RPA, which include:

• Funding stability for up to eight years. The initial budget period will be five years, with an additional three years granted contingent upon an administrative review (see Duration, below);
• Support for an investigator’s other currently funded NINDS research grants will in effect be extended through the RPA, without requiring submission of separate renewal applications;
• Increased flexibility to pursue new ideas and scientific opportunities as they arise during the course of research, as the award is not tied to specific aims or predicated on completing specific, pre-defined research objectives;
• Reduced administrative burden associated with writing multiple grant applications and managing multiple grant awards.

It is anticipated that the RPA will be highly competitive. To prevent a lapse in funding, a PD/PI may submit a competitive renewal R01 application and an RPA application in parallel. Should both applications be meritorious and considered for funding, the PD/PI will be permitted to accept only one of the awards.

As an RPA is intended to be the primary source of support for an investigator’s NINDS research, it is expected that it will replace most of the NINDS funding of the PD/PI’s laboratory. Institutions will be required to relinquish their interests in current NINDS-funded research grants where the applicant investigator is listed as the PD/PI (e.g. research project grants(RPGs), P01s, P50 and other Center awards) except for the following which would not be subject to consolidation into the R35 and the PD/PI would remain eligible to apply for:

• Grants that exclusively support research resources (e.g. P30, R24 or U24 awards);
• Contracts;
• Grants supporting training, workforce development or promoting diversity (Note: individual career development grants are not permitted with the exception of the NINDS K24 award [http://www.ninds.nih.gov/funding/areas/training_and_career_development/independent-scientist-awards.htm#k24]);
• Clinical trials;
• Grants submitted in response to the NINDS IGNITE or CREATE Programs;
• Grants submitted in response to the BRAIN Initiative;
• SBIR/STTR grants;
• Conference grants

In addition to those listed above, the PD/PI will remain eligible to apply for the additional sources of

NINDS funding listed below; however, applicants should contact NINDS with questions or for further clarification regarding excepted programs.

• Administrative Supplements;
• Grants submitted in response to selected targeted research programs. Eligible FOAs to be determined by NINDS in consultation with the NANDS Council.

RPA investigators will be permitted to accept a limited amount of support from other NINDS-supported investigators as a collaborator or consultant; however the level of support should not significantly exceed the current level of subcontracted support. R35 awardees are strongly encouraged to contact NINDS staff prior to submitting a new application for NINDS support.

Duration: The initial budget period of the RPA will be five years. The award will be extended for three additional years contingent upon an administrative review by NINDS staff and approval of the NANDS Council. This review will assess whether the investigator’s research program is progressing appropriately and will continue to do so. In this review, staff and Council members will take into account the fact that the RPA is intended to support projects that may involve higher risk and longer-term research. NINDS anticipates that most RPA awards will be extended; however, if the year five administrative review determines that a research program is not progressing adequately, the investigator will be encouraged to apply for other competitive research project funding from the NIH and the level of RPA funding will be reduced. If the investigator chooses to accept another NINDS grant award, he/she will be required to relinquish the remaining time and funds from the RPA.

Renewals: NINDS will perform a preliminary analysis of the effectiveness of the RPA program. Although NINDS is currently planning to continue this program, the decision to do so will depend on the outcome of this analysis. If the program is continued, renewal RPA applications will be permitted through future R35 FOAs.

Eligibility: The RPA is intended to provide a more stable funding environment to PDs/PIs with track records of productive, high-quality, and high-impact research, enabling them to operate their research programs more flexibly, unrestrained by specific project aims. It is important to note, however, that the RPA is not intended only for investigators with long track records of research. PDs/PIs who have made significant scientific contributions after one cycle of grant support are also eligible to apply. Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, , DP1 or DP2 awards) due to expire in FY17 or FY18. Applicants must also have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years, with no more than one of those years in a no cost extension.

Research not supported through an NINDS RPA:

• Research outside of the NINDS mission, or traditionally supported by another NIH Institute or Center
• Activities supported by another NIH Institute or Center, federal or state agency, or private foundation;
• Research that meets the NIH Clinical Trial definition (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html)

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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applications that do not meet eligibility requirements will not be reviewed.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

Additional Individual Eligibility Requirements:

Eligibility to apply to this FOA is limited to PDs/PIs who meet all of the following criteria:

• Are currently PD/PI on at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, DP1 or DP2 awards) due to expire in FY17 or FY18;
• Have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years, with no more than one of those years in a no cost extension;

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. To prevent a lapse in funding, a PD/PI may submit a competitive renewal R01 application and an RPA application in parallel. Should both applications be meritorious and considered for funding, the PD/PI will be permitted to accept only one of the awards.

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

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

David Owens, Ph.D.
Telephone: 301-496-9248
Fax: 301-402-4370
Email: [email protected]

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

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

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

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

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

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

Biographical Sketch: The RPA is intended for investigators with track records of research achievement, consistent productivity, and significant scientific impact. The PD/PI should address these considerations as well as the other RPA-specific elements of the Investigator Review Criterion, including the PD/PI’s record of professional service, including successful mentoring of undergraduate, graduate, and/or medical students, postdoctoral or clinical fellows, or junior faculty and training of individuals from diverse, underrepresented populations.

The R35 application should include standard biosketches for any subcontracted independent investigators.

Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NINDS grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current (FY17) and pending (FY18) support (including subcontracted support) for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications. This information should include project number and title, start and end dates, role on grant, the total award amount for the most recent award period (including direct and indirect costs) as well as the number of calendar-months per year to be devoted to the project by the senior/key person, regardless of source of support. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice the review.

All instructions in the SF424 (R&R) Application Guide must be followed. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 8 years of support. Include in the budget justification, the NINDS grant numbers and awarded dollars used as the basis for the proposed budget. Applicants must commit at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the RPA period. Applications from PD/PIs committing less than 6 person months will not be accepted.

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

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

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

Specific Aims: Specific Aims should not be submitted.

Research Strategy: Upload the Research Strategy as a single attachment containing the following information:

1) Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed. Describe in broad terms the scientific question (s) that you will address and why it is important.

2) Description of leveraging of your recent research achievements. This description should describe progress during the previous five years and should include evidence and examples of your conduct of rigorous research and transparent reporting in order to explain how you will leverage the contributions (e.g., novel ideas, accomplishments, experience, sustained productivity, etc.) made by your research group into the new approaches proposed in your research program. Discuss the reasons and likelihood that the proposed research program will continue to be important and generate significant new discoveries. Do not repeat material covered in the Biosketch. Do NOT include a Publication List. Instead, include references as necessary in the Bibliography & References Cited section in the Other Project Information Form

3) Overview of proposed research program. Describe the overall vision, conceptual framework and general strategies for furthering and sustaining the proposed research program for the next eight years. Identify the key questions or challenges you plan to address and the general approaches and tools that might be used to address them. Discuss the importance of the research question, and how the research, if successful, would affect current understanding of the problem being addressed and/or advance the field of study. Include in your overview a description of how your goals will leverage your previous contributions, your existing program, and/or the current state of the science. Include plans for transparent reporting, resource/data sharing as appropriate, and consideration of sex and other biological variables in the research program

The proposed research can be either a continuation of your previous or current work, or involve a new line of investigation. If the planned research program diverges significantly from your past/current work, explain your rationale for the changes and describe your ability to undertake this new direction. A detailed experimental plan is not expected and preliminary data should be included only if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which you have not yet published. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, you will have the flexibility to change course and pursue them. Whether the program is an extension of current work or a new line of investigation, reviewers will consider how the proposed RPA research program and resultant impact on the field will benefit from the flexibility, level of effort and the longer term funding offered by the RPA.

Letters of Support: The application must include a letter from the institution’s Authorized Organizational Official (AOR) indicating that they are aware of and accept the condition that other NINDS research awards must be relinquished as a condition of receiving a RPA (as described in Part 2, Section I), and providing a statement that if chosen to receive an award, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RFA throughout the duration of the award period.

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 include a Data Sharing Plan.

Appendix:

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

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

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

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

It is anticipated that the terms of award will include, but not be limited to, the following:

A permanent change of PD/PI will not be allowed under the RPA. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations such as child or eldercare.

Transfer of a RPA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval.

It is expected that the RPA will replace current NINDS funding of the laboratory. Institutions will be required to relinquish their interests in current NINDS-funded research grants where the applicant investigator is listed as the PD/PI (e.g. RPGs, P01s, P50s) or proportional interest in awards where the applicant is one of a multiple PI team (MPI), with the exceptions of those indicated below. The initial budget period of the RPA and timing of the award will be negotiated so that a smooth transition of support takes place. Exceptions include:

• Grants that exclusively support research resources (e.g. P30, R24 or U24 awards);
• Contracts;
• Grants supporting training, workforce development or diversity building (Note: individual career development grants are not permitted with the exception of the NINDS K24 award [http://www.ninds.nih.gov/funding/areas/training_and_career_development/independent-scientist-awards.htm#k24]);
• Clinical trials;
• Grants submitted in response to the NINDS IGNITE or CREATE Programs;
• Grants submitted in response to the BRAIN Initiative;
• SBIR/STTR grants;
• Conference grants

It is expected that the PD/PI will renegotiate effort on other grants, if necessary, to permit required effort on the RPA. Note that a change in effort of more than 25% may require programmatic approval from other NIH ICs. A temporary reduction in effort may be approved under circumstances such as medical conditions, disability, or personal or family situations such as child or eldercare.

NINDS will not consider funding future individual PD/PI or multiple PD/PI research grants from an RPA investigator during the RPA project period, except for applications included under the list of exempted awards in Part 2, Section I. PDs/PIs are strongly advised to consult with NINDS Program staff prior to the submission of a new application during the RPA project period.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

In an RPA application, applicants should not propose research which is currently funded by, and that fits appropriately within the mission of other NIH Institutes and Centers (ICs). PDs/PIs are encouraged to contact NINDS Scientific/Research staff prior to submission of an RPA application to discuss whether their application is relevant to the NINDS mission and does not overlap with grants from other NIH ICs or independent funding entities.

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

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

For this particular announcement, note the following:

An RPA is intended to support most all of the NINDS-related research in an investigator’s laboratory or research group for a sustained period of time, facilitating increased funding stability, reduced administrative burden, and a more flexible research environment enabling more ambitious, creative and/or long term research. RPA applicants are expected to provide an overview of their proposed research program, the scientific questions or challenges they intend to address and a general description of approaches and tools that might be used to address them. A detailed experimental plan is not expected and preliminary data should be included only if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.

Accordingly, reviewers will emphasize the following:

• Evidence of important previous contributions made by the PD/PI, particularly within the past 5 years
• Potential for the PD/PI’s research impact to continue at the same high level over the course of the RPA

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

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

Does the research program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the research program? If the overall goals of the research program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will obtaining answers to the scientific questions posed change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the proposed research program address a problem that is sufficiently comprehensive and substantial to be appropriate for long-term pursuit? Is the proposed research program adequately broad and ambitious? Will achievement of the proposed goals significantly affect the field of study?

Are the PD/PI, collaborators, and other researchers well suited to the project? If the PD/PI is in the early stages of an independent career, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Specific to this FOA: Does the PD/PI have a track record of productivity and of having substantial impact in the proposed field of study? Has the PD/PI shown evidence of being creative and adaptable, able to recognize new opportunities and explore new areas of scientific inquiry, and open to the use of new systems and strategies, as appropriate? What is the potential for the PD/PI’s research productivity and influence to continue at the same high caliber? Has the PD/PI proposed an appropriate commitment of time and effort for the proposed work? Does the PD/PI have a record of conducting rigorous, reproducible, and transparent research? Does the PD/PI have a record of professional service, including successful mentoring of undergraduate, graduate, or medical students, postdoctoral or clinical fellows, or junior faculty? Does the PD/PI have a record of training individuals from diverse, underrepresented populations?

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?

Specific to this FOA: Does the PD/PI have a track record of creativity and innovation? Will the increased stability and flexibility of the RPA mechanism enable continued high innovation or more innovative and adventurous approaches to the scientific issues described in the application?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the overall goals of the research program? 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?

Specific to this FOA: Is the proposed research program suited to the use of the RPA mechanism? Does the PD/PI provide strong evidence that the research program will evolve appropriately as the work is performed? Will the funding stability and flexibility of the RPA allow the PD/PI to pursue highly impactful, longer-term research that may be more difficult to pursue through other grant mechanisms? Is there a sound basis for the proposed level of effort?

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

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

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable.

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

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

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 both the proposed research program

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Scientific Review Branch, 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 Council. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

It is anticipated that the terms of award will include, but not be limited to, the following:

• Relinquishment and/or deobligation of funds from NINDS grants awarded to the PI as described in Part 2, Section I and prorated proportional financial deobligation of the PIs contribution to MPI grants according to the initial distribution of committed effort.
• Carryover of an unobligated balance for budgets greater than 25% from one budget period to another budget period will require Grants Management Officer prior approval.
• The initial no-cost extension can be done by the grantee in eRA Commons. Any subsequent no-cost extension will require Grants Management Officer approval.
• Change of PD/PI will not be allowed.
• Change of grantee institution (with NIH approval) will be allowable if the receiving institution agrees to all of the required terms.
• It is expected that the PD/PI will renegotiate effort on non-NINDS NIH grants, if necessary, to permit a minimum of 6 person months to be devoted to the RPA.
• The initial budget period of the RPA will be five years. The award may be extended for three additional years contingent upon an administrative review by NINDS staff and approval of the NANDS Council.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

Cooperative Agreement Terms and Conditions of Award

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.

a) Under Section 6.2 B.1 What are the major goals of the project? Note that the goals of the program of research supported by the RPA are broader than the specific aims of a single project and should be appropriately described. In addition to the scientific goals, describe the goals of enhanced mentoring of trainees and other research personnel that this award facilitates. If the goals of the RPA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NINDS mission interests.

b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.

c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the RPA.

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

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-710-0267

David Owens, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9248
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: 301-496-9223
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 Part 75.