Required Application Instructions

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

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

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

Most grant awards are relatively short in duration (i.e., 2-5 years) and 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 fraction of their time writing grant applications, rather than performing and overseeing research. In addition, many investigators feel pressured to engage in short-term research that generates publishable data quickly, rather than undertaking more ambitious, creative, and longer-term projects.

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. As described above, the award is intended to increase funding stability, reduce the time investigators spend writing grant applications, and promote ambitious, creative research.

Investigators receiving RPAs must relinquish their other NINDS research grants, with a limited number of exceptions (see below). PDs/PIs can retain grant support from other funding sources, as long as they can dedicate sufficient research effort to the RPA (see below). Since the RPA is intended to support the research program of a single 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 be incorporated into the RPA and continue for its duration.

The research supported by an RPA, by replacing NINDS funding previously obtained through individual grant awards, should become a major focus of the PD/PI’s laboratory or research group. Therefore, the PD/PI must devote at least 50% of his/her research effort to the RPA (i.e., not including effort involving teaching, administration, and/or clinical duties) throughout the duration of the award period. PDs/PIs will be expected to renegotiate their time and effort on other (non-NINDS) NIH grants in order to accommodate the RPA level of effort. The amount of an RPA will be determined by NINDS, based on the recommendations of the study section, the National Advisory Neurological Disorders and Stroke (NANDS) Council, and evaluation of the needs, expected productivity, and impact of the proposed research program. NINDS will continue to implement the NIH $1,000,000 total direct cost Special Council Review policy in considering all sources of investigator support (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html).

For investigators with multiple NINDS grants, the amount of the RPA will generally be slightly less than the sum of recent NINDS support being folded into the award. However, it is important to note that this level of support will remain stable for up to eight years, unlike the often fluctuating level of support provided by a collection of individual grants. For investigators with single NINDS grants, exceptions will be considered and, in well-justified cases, RPA support may exceed the level provided by the previous or current award. Investigators should balance a potential reduction in funding against the benefits of the RPA, which include:

• RPAs support will be for up to eight years, thereby providing increased funding stability. The initial budget period will be five years, with an additional three years granted contingent upon an administrative review (see 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, since the award is not tied to specific aims or predicated on completing specific, pre-defined projects;
• Reduction in the administrative burden associated with writing multiple grant applications and managing multiple grant awards.

Since an RPA is intended to provide the entirety of an investigator’s NINDS research support, most existing grants (e.g., NINDS R01s, R21s, P01s) will be incorporated into the award. However, the PD/PI will remain eligible for the following separate sources of NINDS funding:

• Grants that exclusively support research resources (e.g. P30, R 24, or U24 awards);
• Contracts;
• Selected cooperative agreements;
• Grants supporting training, workforce development or diversity building (Note: individual career development grants are not permitted except for the NINDS K24 award [http://www.ninds.nih.gov/funding/areas/training_and_career_development/independent-scientist-awards.htm#k24]);
• Funding for clinical trials;
• SBIR/STTR grants;
• Conference grants;
• Administrative Supplements;
• Grants submitted in response to selected targeted research programs (eligible FOAs to be determined by NINDS in consultation with the NANDS Council).

To clarify which FOAs are exempted from this policy, applicants are strongly encouraged to contact NINDS staff.

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 is likely to continue to progress. 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 may apply for other research project funding from NINDS and the level of RPA funding may be reduced. If the investigator chooses to accept another 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. If an application to renew an RPA is unsuccessful, NINDS intends to provide a ramp-down of funding rather than an abrupt termination of support.

Eligibility: The RPA is intended to facilitate ambitious, creative research programs led by PDs/PIs with track records of productive, high-quality, and high-impact research. 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 here as R01, R37, DP1, or DP2 awards) due to expire in FY16 or FY17. Applicants must also have received continuous R01 or R01 equivalent grant support from NINDS for at least the past 5 years. NINDS investigators with additional non-NINDS support are welcome to apply, but funds cannot be requested through the RPA for activities supported by another NIH Institute or Center, federal or state agency, or private foundation. The RPA is not appropriate to support clinical trials (see http://www.ninds.nih.gov/funding/funding_announcements/clinicalall.htm for a listing of NINDS clinical trial support mechanisms).

Note: It is anticipated that the RPA mechanism will be highly competitive. To prevent a lapse in funding, a PD/PI can submit a competitive renewal R01 application and an RPA application in parallel. Should both applications be selected for funding, the PD/PI will be required to relinquish one of the awards.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

PD/PIs applying for an RPA must have one or more NINDS R01 or R01 equivalent awards due to expire in FY16 or FY17.

Applicants must also have received continuous R01 or R01 equivalent grant support from NINDS for at least the past 5 years.

The PD/PI must devote at least 50% of his/her research effort to the RPA (i.e., not including effort involving teaching, administration, and/or clinical duties) throughout the duration of the award period. PD/PIs will be expected to renegotiate their time and effort on other (non-NINDS) NIH grants in order to accommodate the RPA level of effort.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

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

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

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

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

The letter of intent should be sent to:

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, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

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

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

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

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

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

The RPA is intended for investigators with track records of creativity, consistent productivity, and significant scientific impact. The PD/PI should, in the Biographical Sketch, address these considerations and demonstrate that he/she has a history of conducting rigorous and reproducible research and reporting it in a transparent fashion. In addition, the PD/PI should demonstrate their suitability for funding through the RPA mechanism, including flexibility and adaptability to new research opportunities. The PD/PI should also have a record (commensurate with career stage) of professional service, including successful mentoring of undergraduate, graduate, or medical students, postdoctoral or clinical fellows, or junior faculty. If the PD/PI has trained individuals from diverse, underrepresented populations, it should be mentioned in the application.

Include biosketches for any subcontracted independent investigators and include the same information that is requested for the PD/PI of the parent grant award.

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 and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications. Show the total award amount for the entire award period (including indirect costs) as well as the number of person-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 its 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.

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 are not required and 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;

2) Description of recent research achievements of the PD/PI. This description should focus primarily on progress during the previous five years. Do not repeat material adequately 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. Explain how the research program you are proposing will leverage your previous contributions (e.g., novel ideas, accomplishments, experience, sustained productivity, etc.). Explain how the proposed research program is in an area that will continue to be important and generate significant new discoveries. Applicants should also describe the rigor and reproducibility of their previous research.

3) Overview of proposed research program. This should be a description of the key questions or challenges you plan to address in your research program and the general strategies and tools that might be used to approach 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.. The proposed research can be either a continuation of the investigator's previous or current work, or involve a new line of investigation. If the planned research 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. Preliminary data are not required, but limited information may be included 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. 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. Explain how your research program 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, and providing a statement that if chosen to receive an award, the PD/PI will commit a minimum of 50% of his/her research effort throughout the duration of the RPA.

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 modifications:

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

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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). 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

For this FOA:

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; however, RPA grant funds may not be used to support this component.

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. 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;
• Contracts;
• Selected cooperative agreements;
• 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]);
• Funding for clinical trials;
• 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. 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.

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.

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 NINDS, 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 NOT-OD-13-030.

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

For this particular announcement, note the following:

The RPA is intended to fund all the NINDS-related research in an investigator’s laboratory. The RPA should promote ambitious, creative research by giving the investigator more freedom to pursue his/her research goals. For this FOA, applicants are expected to provide an overview of the research program, the scientific questions they currently plan to address and a general description of possible strategies. Experimental details and preliminary data are not expected, but limited information may be included 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.

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

Significance

Does the research program address an important problem or a critical barrier to progress in the field? 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? Will achievement of the proposed goals significantly affect the field of study?

Are the PD/PI, collaborators, and other researchers well suited to the research program? Has the PD/PI demonstrated an ongoing record of accomplishments that have advanced his/her 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 been 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 a high level? 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 and reproducible research and reporting it transparently? 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 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 use of the RPA mechanism enable more innovative and adventurous approaches to the scientific issues described in the application?

Is the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish overall goals of the research program? If the project is in the early stages of development, will the strategy establish feasibility?

Specific to this FOA: Is the proposed research program suited to the use of the RPA mechanism? Will it allow the PD/PI to pursue ground-breaking, longer-term research that would be more difficult to pursue through other grant mechanisms? Is there a sound basis for the proposed level of research 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 proposed research program? 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 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.

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

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

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.

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

• Carryover of an unobligated balance from one budget period to another budget period will require Grants Management Officer prior approval.
• The first and 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 RPA will replace current NINDS funding from other grants. Renegotiation of current NINDS funds will be expected.
• It is expected that the PD/PI will renegotiate effort on other non-NINDS NIH grants, if necessary, to permit at least 50% effort to be devoted to the RPA.
• Future grant support will not be folded into this award.

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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

The instructions are hereby modified as follows:

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. 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.

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [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]

Ernest Lyons, Ph.D.
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 Part 75.