Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) In the Epilepsies (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-NS-11-003

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NS-12-005

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853

FOA Purpose

This FOA solicits Research Project Grant (R01) applications from institutions/organizations proposing exceptionally innovative research on novel hypotheses or difficult problems, solutions to which would have an extremely high impact on biomedical or biobehavioral research in the epilepsies. This FOA is for support of new projects, not continuation of projects that have already been initiated. It does not support pilot projects, i.e., projects of limited scope that are designed primarily to generate data that will enable the PD/PI to seek other funding opportunities.  Interventional clinical trials are also not appropriate for this FOA.

Key Dates
Posted Date

June 22, 2011

Open Date (Earliest Submission Date)

August 15, 2011

Letter of Intent Due Date

August 15, 2011

Application Due Date(s)

September 15, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

November-December, 2011

Advisory Council Review

January, 2012

Earliest Start Date(s)

April, 2012

Expiration Date

September 16, 2011

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

Epilepsy is one of the most common neurological disorders, representing a significant source of public health burden.  The number of people currently living with epilepsy in the population is estimated at 3 million Americans and 50 million people worldwide.  The lifetime risk of epilepsy to age 80 is 3%.  Seizures can be controlled by available therapies for approximately two-thirds of all patients diagnosed with epilepsy, although difficult side-effects and comorbid conditions continue to affect quality of life for many.  The remaining one-third of patients continues to suffer from seizures that are not adequately controlled by available therapies and, in some cases, can have devastating consequences. 

NINDS has engaged in two planning efforts for epilepsy. In partnership with epilepsy voluntary organizations, professional groups, and other Federal agencies, the NINDS supported “Curing Epilepsy” conferences in 2000 and 2007 to summarize the state of the field and to highlight new research needed to identify causes, improve treatments and find cures for the epilepsies.  As an outcome of these conferences, the NINDS published “Epilepsy Research Benchmarks,” (http://www.ninds.nih.gov/research/epilepsyweb/2007_benchmarks.htm), milestone goals set by the community.  Since then, many investigators have focused on research topics related to the Benchmarks and have made many important discoveries (for more information about the NINDS Epilepsy research program see http://www.ninds.nih.gov/research/epilepsyweb/researchers/epilepsy_researchers.htm), but it is clear that new ideas, new approaches, and new teams are also needed to accelerate progress.  NINDS recognizes the need to encourage innovative research approaches to move toward real cures for epilepsy, defined as “no seizures, no side effects, and prevention in those at risk”.

Epilepsy is a disorder that involves disruption of basic neurobiological functions at all levels, including cellular/molecular biology and genetics, cognitive/behavioral and systems neuroscience, neuroplasticity, and neurodevelopment.  Investigators from outside the field of epilepsy are strongly encouraged to submit applications to this FOA that apply knowledge from these areas to bring potentially paradigm-shifting approaches to the study and/or treatment of the epilepsies.  Investigators who are currently working in epilepsy research are encouraged to submit applications on highly innovative concepts that cannot be supported through other research mechanisms.  Applications from new collaborative teams are particularly encouraged.

For examples of grants funded through the general EUREKA program or the prior Epilepsies EUREKA announcements, please search the NIH Reporter http://projectreporter.nih.gov/reporter.cfm using FOA numbers: RFA-GM-09-008, RFA-GM-08-002, or RFA-NS-11-003.

The Epilepsies EUREKA Program

The rationale for the Epilepsies EUREKA (Exceptional Unconventional Research Enabling Knowledge Acceleration) initiative is to move epilepsy research forward in leaps rather than in incremental steps.  To do this, investigators must have opportunities to test unconventional, potentially paradigm-shifting hypotheses, and to attempt to use novel, innovative approaches to solve difficult technical and conceptual problems that severely impede progress in the epilepsy field. However, applications proposing such research are difficult to evaluate in comparison to more typical investigator-initiated R01 research grant applications, in which appraisals of novelty and/or impact tend to be offset by considerations of feasibility and risk. 

To encourage exceptionally innovative epilepsy research, the Epilepsies EUREKA initiative solicits applications from investigators who want to test novel, unconventional hypotheses or pursue major methodological or technical challenges. The purpose of this FOA is to foster exceptionally innovative research that, if successful, will have an unusually high impact on research in the epilepsies. In addition, a goal of this initiative is to draw new investigators to the field of epilepsy research and to foster new collaborations.

The investigator should anticipate starting and completing the project during the term of the award, since this FOA is not for support of ongoing research or for pilot projects. In addition, clinical intervention trials are outside the scope of this FOA, given the limits on the duration and funds for this award. If it is the hypothesis that is novel, then the investigator should be able to prove or disprove that hypothesis by the end of the funding period. If it is the methodology or technology that is exceptionally innovative, then the investigator should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.

Several key features of the EUREKA FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s. The application format (see Section IV-6, Other Submission Requirements), through its page limitations and requirements for explicitly addressing specific application aspects, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on the experimental details. The applications will be evaluated by a separate review panel, and reviewers will be instructed to emphasize significance and innovation in their evaluations, and these criteria will be the primary basis for funding decisions. Reviewers will be asked to assess the logic of the experimental plan to determine whether the project has some (non-zero) likelihood of success, but they will be reminded that risk is a hallmark of exceptionally innovative research and, in most cases should not detract from the merit of an application.  A PD/PI’s record of overcoming difficult scientific hurdles, appropriate to his/her career stage, may also be useful in assessing the likelihood of success, although the focus of this initiative is on the project rather than the investigator.  These features are intended to steer applicants and reviewers, at each step of the process, toward the goals of the EUREKA initiative, which are to solicit and fund unusually bold and potentially transformative research.

Before submitting an application, it is extremely important to verify that the proposed research is of interest to the NINDS.  Responses to commonly asked questions about the general EUREKA program may be found at http://www.nigms.nih.gov/Research/Application/EurekaFAQs.htm. Applicants are encouraged to review the challenges described in the NINDS Epilepsy Research Benchmarks (http://www.ninds.nih.gov/research/epilepsyweb/2007_benchmarks.htm) prior to preparing an application.  For example, the NINDS welcomes applications focused on, but not limited to, highly novel approaches to:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NINDS intends to commit up to $2,000,000 in total costs in FY2012 to fund 4-6 awards.

Award Budget

Support may be requested for up to $800,000 in direct costs (excluding consortium Facilities and Administrative [F&A] costs) over a four year period, prorated for shorter terms ($600,000 for three years, $400,000 for two years). Regardless of the term of support, direct costs (excluding consortium Facilities and Administrative [F&A] costs) may not exceed $250,000 in any one year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Award Project Period

2 to 4 years

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.    

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent

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:

The letter of intent should be sent to:

Brandy Fureman, Ph.D.
Channels, Synapses and Circuits Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.  
Rockville, MD 20852
Telephone: 301-496-1917
Email: furemanb@ninds.nih.gov (preferred method for submitting letters of intent) 

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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:

Bibliography and References Cited

Bibliography & References Cited: limited to 20 references. Note that the six page limit for the Research Strategy section of the Research Plan does not include the Literature Cited section. 

SF 424(R&R) Senior/Key Person Profile Expanded Component

Biographical Sketches: Key personnel other than PDs/PIs should submit standard Biographical Sketches (as described in the SF424 (R&R) Application Guide instructions). PDs/PIs must submit EUREKA-specific biographical sketches. For this FOA, the number of publications, patents, and/or meeting abstracts cited in each PD/PI’s biosketch is limited to 15 or fewer items. In particular, PDs/PIs should cite their most relevant publications and/or other items and those that illustrate their exceptional innovativeness and the significance of their past accomplishments.

PHS 398 Research Plan Component

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

Research Strategy

Research Strategy: The Research Strategy section, which is limited to six pages, should be self-contained, since appendices and updates are not allowed for this FOA. Except in unusual circumstances, multiple aims are inappropriate, since the research plan should be focused on verifying a hypothesis or solving a problem.  The Research Strategy section should be uploaded separately from the one-page Specific Aims section. Applications will be reviewed by panels that encompass diverse scientific interests, therefore jargon should be avoided. The challenge, potential impact, and approach should be explained in language that scientists in other fields can understand.  The applicant should address the following six points within the six page Research Strategy, using headings that correspond to each point (e.g., the heading for the response to point 1 should be “The Challenge”).

1. The Challenge: What is the hypothesis or problem that will be addressed? If you are testing an exceptionally novel hypothesis, how does it challenge the standard paradigm?  If you are addressing a technological or methodological problem, what makes the problem especially challenging?

2. The Potential Impact on Epilepsy: Why is testing the hypothesis or solving the problem important to understanding, treating, or preventing epilepsy? How broad is the potential impact? Will the potential impact on the epilepsy community be major or incremental?

3. The Approach (recommended limit, three pages): How will you attempt to verify the novel hypothesis or solve the problem? Provide enough information so that reviewers can determine what, in general, you are proposing to do, but do not include a detailed experimental plan. If it is your methodology that is novel, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other epilepsy investigators have attempted to do?

4. The Appropriateness of EUREKA: Why is the proposed research uniquely suited to the stated goals of the Epilepsies EUREKA initiative, rather than a conventional research grant application? How does the proposed research differ from what you are already funded to do?

5. The Likelihood of Success: Briefly describe the past achievements that best illustrate your exceptional innovativeness, your ability to make paradigm-shifting discoveries or solve very difficult problems, and the impact of your past discoveries or solutions. The achievements that you highlight need not be conceptually related to the hypothesis or problem that you are addressing in this application. If your previous research was not unusually innovative, and you have not yet made a paradigm-shifting discovery or solved a very difficult problem, which aspect of the logic of the experimental approach suggests that there is some probability that the proposed research will be successful?  

6. Timeline (recommended limit, half a page): Provide a timeline for the proposed research. To facilitate evaluation of progress reports, indicate when you anticipate that essential components of the project (e.g., optimization of protocols, generation of reagents, critical experiments to verify the hypothesis, validation of novel tools or techniques) will be completed. 

Resource Sharing Plan

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

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, with the following modifications:

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NINDS. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at nindsreview.nih.gov@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How important is it for the community to address the problem or test the hypothesis? If the effort is successful, how significant will the outcome be?

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How innovative or novel is the hypothesis or methodology? Is it significantly different from hypotheses or methodologies already being pursued in the epilepsy field?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 appropriate National Advisory Neurological Disorders and Stroke Councill. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Brandy Fureman, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: furemanb@ninds.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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