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

Centers Without Walls for Collaborative Research in the Epilepsies: Sudden Unexpected Death in Epilepsy (SUDEP) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NS-14-004

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853   

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage linked cooperative agreement (U01) applications from multidisciplinary and multicenter PD(s)/PI(s) to accelerate the rate of progress in understanding the underlying mechanisms that contribute to sudden unexpected death in epilepsy (SUDEP), determine risk factors for SUDEP in individuals with epilepsy, and work toward intervention(s) that prevent SUDEP.  Linked applications must include an administrative core, scientific projects and may include other cores as needed to serve the scientific projects.  

Key Dates
Posted Date

September 20, 2013

Open Date (Earliest Submission Date)

February 10, 2014

Letter of Intent Due Date(s)

February 10, 2014

Application Due Date(s)

March 10, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2014

Advisory Council Review

August 2014

Earliest Start Date

September 2014

Expiration Date

March 11, 2014

Due Dates for E.O. 12372

Not Applicable

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.

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


Background

The NINDS supports research to better understand, treat, and ultimately prevent the diverse collection of seizure-related syndromes known as the epilepsies, as well as co-occurring conditions and mortality.  Seizures can be controlled by available therapies for approximately two-thirds of all individuals diagnosed with epilepsy, although difficult side effects and co-occurring conditions continue to affect quality of life for many.  In some cases, epilepsy can have devastating consequences, including sudden unexpected death in epilepsy (SUDEP). Deaths categorized as SUDEP encompass non-traumatic, non-drowning-related deaths in people with epilepsy that may or may not be associated with a recent seizure, but are not due to status epilepticus. 

SUDEP is the most common epilepsy-related cause of death.  The rate of sudden death in people with epilepsy is estimated to be 20-fold higher than in the general population. Current estimates suggest that the incidence of SUDEP is 0.1 to 2.3 per 1,000 person-years in community samples; 1.1. to 5.9 for individuals treated in epilepsy centers, many of whom have refractory epilepsy.  Two workshops on SUDEP were held in 2008 and 2010 to design methods to raise awareness of the risk of SUDEP, to identify possible risk factors and preventive strategies for SUDEP, to develop a research agenda, and to establish a SUDEP research consortium.  The "Epilepsy Research Benchmarks", milestone goals set by the community, include goals to "prevent or reduce other harmful conditions that occur in people with epilepsy."  SUDEP-specific goals include discovering the biological mechanisms that cause SUDEP, and developing and testing at least one prevention strategy to reduce SUDEP rates.  However, it is clear that a great deal of additional research is required to achieve those goals.

Research Objectives

This purpose of this Funding Opportunity Announcement (FOA) is to support a multicenter, multidisciplinary research team to accelerate the rate of progress in identifying the underlying mechanisms that cause SUDEP, identify risk factors of SUDEP for individuals with epilepsy, and/or develop prevention strategies to reduce SUDEP rates.  It is expected that advances in understanding the underlying mechanisms of SUDEP will enable more rapid translation of targeted clinical therapies and prevention strategies.

The Center Without Walls will be comprised of awardees under this FOA who submit linked U01 applications for either scientific projects or cores.  During the course of the funding period, technologies will improve and the rate of progress and scope of the research may change. It is expected that the PDs/PIs, in consultation with NINDS program staff, will make necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects funded through the Center Without Walls program, and to incorporate new technological advances.

The Center Without Walls is a collaborative effort that requires frequent interactions of awardees among themselves and with the NIH. Applicants must explicitly indicate their willingness to: participate in Executive and/or Steering Committee Meetings and regular telephone conference calls; cooperate with other awardees in the development and design of research priorities, especially regarding resources; and agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2. "Award Administration Information".

Specific Areas of Research Interest

The FOA will support a systematic and comprehensive multicenter investigation of the biologic basis of SUDEP.  Specific research areas of interest include, but are not limited to:

Individual U01 applications should include a proposal for a scientific project that is basic, translational and/or clinical in nature.  An overall Center Without Walls application must include at least two scientific projects (each submitted as individual U01 applications), but may include more as appropriate to the make-up of the overall Center.  The scientific projects cannot include clinical trials. 

Additional individual U01 applications may support core activities.  An Administrative Core application is required and the Center Without Walls Director(s) should serve as the PD/PIs of this U01 application.  Other cores may be proposed as appropriate to the goals of the Center in individual U01 applications and must support at least two of the scientific projects. 

Investigator(s) may serve as the PD/PI for both U01 applications to support scientific projects and U01 applications that support core activities.

Under the direction of NINDS, an independent scientific oversight committee will also be established in order to advance the general scientific goals of the Epilepsy Centers Without Walls Program.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NINDS intends to commit an estimated total of $3 million direct costs in FY2014 to fund one Center Without Walls comprised of linked U01s.

Award Budget

Budgets for individual U01 applications for either scientific projects or cores are not limited, but should reflect the actual needs of the proposed project or core.  Applicants should note that support for all projects and cores combined to form a Center Without Walls application (made up of linked U01 awards) will not exceed $3 million direct costs per year.

Award Project Period

The scope of the proposed scientific projects and cores should determine the project period.  The maximum project period for scientific projects and cores is 5 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

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The Epilepsy Center Without Walls Program is intended to support comprehensive collaborative projects conducted by multidisciplinary teams. It is expected that a Center project will be submitted as multiple linked U01 applications with each U01 application proposing a specific research project or a core.  This arrangement provides each PD/PI a unique cooperative agreement award with each component U01 clearly integrated as one part of the overall multidisciplinary Center Without Walls program.  It is strongly encouraged that the Center involve investigator(s) on one or more of the scientific projects whose primary field of expertise is outside of the epilepsies, but whose inclusion provides a significant and relevant contribution to the project to enrich the perspectives and methodologies brought to bear in addressing the challenge.  In addition, multidisciplinary teams are encouraged to consider having an early-stage or new investigator lead a component of the project.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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:

Vicky Whittemore, PhD
Channels, Synapses and Circuits Cluster
National Institutes of Health
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Blvd.
Rockville, MD 20852
Telephone: 301-496-1917
Email: vicky.whittemore@nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

Applicants must explicitly indicate their willingness to: participate in Executive and/or Steering Committee Meetings and regular telephone conference calls; cooperate with other awardees in the development and design of research priorities, especially regarding resources; and agree to the "Cooperative Agreement Terms and Conditions of Award".

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The budget for an individual U01 application is not limited, but support for the entire Center Without Walls (made up of the linked U01 awards) will not exceed $3 million direct costs per year for not more than 5 years.

Budgets for each individual U01 for both scientific projects and cores should cover travel expenses to attend in-person Center Without Walls meetings, collaborations between laboratories involved in the Center Without Walls, as well as scientific conferences not directly related to the Center activities.

May include a budget to support pilot and collaborative projects, but should be limited to not more than $50,000 total direct costs in any year of the proposed funding period. 

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:  Clearly state the contribution the scientific project or core makes to the overall composition of the Center Without Walls.

The Research Strategy should have a section entitled “Collaboration within the Center Without Walls”. In this section, the applicant should describe how he/she believes his/her unique expertise can contribute to the collective effort of the Center.  The applicant should also provide evidence of their intention to work together with other members of the Center to share ideas, develop future collaborations, and generate common tools and reagents.

NINDS believes that applications that propose preclinical research, or that are based on previous preclinical data, will be greatly strengthened if the design, execution, and interpretation of the proposed studies and supporting data are adequately described.  NINDS encourages investigators, whenever possible, to address these elements directly in their applications.  Investigators are urged to discuss these issues with program staff prior to submission of applications (see: NOT-NS-11-023 at http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-023.html).

The U01 application for support of the Administrative core for the Center Without Walls should include:

Letters of Support: Letters should be provided for all proposed collaborations with investigators who are not PDs/PIs for scientific projects or cores.

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.

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. Applicants may utilize the Appendix to include the Charter for the proposed Center Without Walls, and any policies (such as collaboration and publication policies).

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) 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 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.

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 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.

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

Applicant Information Webinar

An Applicant Information Webinar will be scheduled to provide information about the FOA to prospective applicants. NIH staff will provide an overview of the FOA and answer questions. The webinar is open to all prospective applicants. Participation in the teleconference is not a prerequisite for applying, and is not required for a successful application. Information about how to participate in the webinar will be posted at http://www.ninds.nih.gov. Potential applicants are encouraged to submit their questions or comments to vicky.whittemore@nih.gov prior to the meeting. Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site. NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, note the following:

Synergy: Each U01 application will be reviewed for the contribution the scientific project or core makes to the overall composition of the Center Without Walls, as well as the synergy between the scientific projects and core(s).

Overall Impact

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).

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?  

Investigator(s)    

Are the PD(s)/PI(s), 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?   

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?   

Review Criteria for Administrative Core

The following criteria will be used to review the Administrative Core, but will not receive individual criterion scores. The Administrative Core will receive a score that reflects the following criteria:

Review Criteria for Additional Core(s) (if applicable)

Each Core must provide essential functions or services for at least two projects. Each U01 Core application will be reviewed based on the criterion below, but will not receive individual criterion scores. The Core will be assessed based on the following criteria:

Is the environment for the Core adequate to support the program as proposed?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed 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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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 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 National Institute of Neurological Disorders and Stroke, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines 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:

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, SAM 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and other local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policy.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility with the awardees for the project as a whole, although tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD/PI is a member of the Center Without Walls and will have the primary responsibility for:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

An NINDS Program Director identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the administrative and financial aspects of the award and will serve as the NINDS Administrative Program Officer.

An NINDS Program Director identified in the Notice of Grant Award will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination.  The dominant role and primary responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NINDS Scientific Program Officer. 

The NINDS Scientific Program Officer will have substantial involvement in the project above and beyond normal stewardship and monitoring of the award, as described below:

Areas of Joint Responsibility include:

SUDEP Center Without Walls Executive Committee (EC)

Center Without Walls Steering Committee (SC)

Areas of Joint Responsibility include:

Dispute Resolution:

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Vicky Whittemore, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: vicky.whittemore@nih.gov

Peer Review Contact(s)

Chief Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: nindsreview.nih.gov@mail.nih

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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NIH Funding Opportunities and Notices



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