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: Genetics and Genomics of Human Epilepsies (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NS-11-007

Companion FOA
  
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)
93.853
FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage linked cooperative agreement (U01) applications from large, multidisciplinary groups of investigators to accelerate the rate of progress in identifying the genetic factors that contribute to epilepsy syndromes. Linked applications may include an administrative core, a genetics core, and specific scientific projects proposed for the initial performance period of the Center without Walls.

Key Dates
Posted Date

November 23, 2010

Open Date (Earliest Submission Date)

Not Applicable

Letter of Intent Due Date

February 11, 2011

Application Due Date(s)

March 11, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011

Expiration Date

March 12, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

Purpose

The NINDS supports research to better understand, treat, and ultimately prevent the diverse collection of seizure-related syndromes known as the epilepsies.  These disorders have a wide range of severities, precipitating causes, comorbidities, and treatment outcomes.  In many cases, it is believed that genetic factors play a role in the risk and causes of a number of types of epilepsy.

Genetic influences on the development of epilepsy may be monogenic or polygenic, and may also involve environmental factors.  Of those genetic factors that have been discovered thus far, mutations in ion channels or neurotransmitter receptors, or in associated proteins, appear to play a prominent role.  While progress has been made in identifying genetic causes for selected Mendelian disorders, in large part the genetic contributions to epilepsy continue to be elusive.  This FOA solicits applications for an Epilepsy Center without Walls on Human Genetics.  The successful Center will be composed of a multidisciplinary team of investigators working together to address a shared challenge; to discover genetic factors that contribute to Mendelian and complex epilepsies.  A better understanding of these factors will accelerate progress in translating genomics to allow biologically based diagnoses, individualized treatments and target identification for the development of truly novel therapeutic agents.

Research Objectives

The NINDS held a workshop on human genetics of the epilepsies from August 30 to September 1, 2010.  The goals of the workshop were to 1) assess whether collaborative efforts to conduct a large-scale genome wide association study (GWAS) for idiopathic generalized epilepsy (hereafter referred to as “genetic generalized epilepsy” or GGE) would be scientifically useful and feasible, and 2) to seek expert opinion on how new genetic technologies could be most effectively used to identify and validate genetic contributions to specific epilepsy syndromes.  An effort to organize such a GWAS is now underway under the auspices of the International League Against Epilepsy (ILAE) Commission on Genetics and is not a component of this FOA. 

Discussion of the second workshop goal, evaluating how new genetic technologies can be most effectively used in the epilepsies, revealed that there are significant opportunities to discover genetic influences in both rare and common epilepsy syndromes. Technologies which are likely to be useful include whole exome sequencing, whole genome sequencing, and copy number variation analysis.  Workshop participants suggested that priority should be given to those epilepsy syndromes with a clear heritable component; these include both rare Mendelian disorders as well as more common conditions, for example, Juvenile Myoclonic Epilepsy (JME) or Childhood Absence Epilepsy (CAE) for which linkage studies suggest a genetic contribution.  Studying families was also encouraged, which may be useful not only for identifying variants, but also for gene discovery in related phenotypes (such as co-occurrence of epilepsy and episodic movement disorders).  Family studies could also enable better detection of epigenetic effects.  In all approaches discussed, it was agreed that appropriately matched control samples in consideration of population or other forms of stratification bias are required.  It was clear that the success of next generation sequencing depends on the quality of associated phenotypic data, as well as on the informatics systems available to support both deep sequencing and deep phenotyping.  The epilepsies are highly genetically and phenotypically heterogeneous, and massive parallel sequencing is likely to be a successful approach for DNA variant discovery. 

The purpose of this Funding Opportunity Announcement (FOA) is to encourage linked applications from large, multidisciplinary groups of investigators to accelerate the rate of progress in identifying the genetic factors that contribute to rare and common epilepsy syndromes.  It is expected that advances in understanding the genetic underpinnings of the epilepsies will enable more rapid translation of targeted clinical therapies and prevention strategies. 

Specific Areas of Research Interest

Linked applications may include U01 proposals for scientific projects as well as core support.  Examples of possible core support include but are not limited to administrative and genotyping cores.  For example, among the collection of linked U01 applications, one U01 application in particular may be identified as the overall administrative core and another as the overall genetics core for the Center without Walls.  Other cores may be proposed if appropriate to the projects and goals of the proposed Center.  The remaining U01 applications comprising the Center without Walls should propose specific scientific projects to identify genetic variation in selected syndromes or families.  Uniform criteria for phenotyping and standards for quality of phenotypic data to be applied to existing collections of patients should be developed as a component of a Center, utilizing individual projects or cores, as appropriate. The leadership plan should clarify the roles of the cores as essential to integration of the Center without Walls and the accomplishment of the Center's goals.     

A Steering Committee for the Center without Walls will be comprised of all participating U01 Principal Investigators and the associated NINDS Program Scientist.  Under the direction of NINDS, an independent scientific oversight board will also be established in order to advance the general scientific goals of the Epilepsy Centers without Walls Program. 

Before submitting an application, it is extremely important for potential applicants to verify that the proposed research is of interest to the NINDS and appropriate to this announcement.  Note that this FOA is not intended for Genome Wide Association Studies (GWAS), or for functional validation studies of putative genetic factors.  If desired, studies of these topic areas should be proposed using investigator-initiated mechanisms.  This FOA is also not intended to support applications for the recruitment of new subjects.  Study designs should consider including parallel efforts to sequence sporadic cases with an emphasis on Genetic Generalized Epilepsies and multiplex families.  Analysis of existing samples and those from subjects who can be re-contacted for longitudinal follow up should be given priority whenever possible. Applicants are encouraged to review the topic areas described herein prior to preparing an application.  However, applications are not limited to topics listed here if the proposed research project is germane to collaborative research on human epilepsy genetics. 

The NINDS welcomes linked U01 applications on collaborative approaches to accomplish the following goals:

Propose specific scientific projects to evaluate genetic variation in the epilepsies. These approaches can include, but are not limited to, projects to:

Provide administrative core support for the Center without Walls:

Provide genetics core support for the Center without Walls:

Applications for scientific project U01s should plan a project period of two to three years.  Additional scientific projects for the Centers without Walls are expected to be solicited through subsequent FOAs.

Applications for an administrative core U01 should plan a project period of five years.  During this time, the administrative core will provide administrative support to all scientific projects awarded via linked U01s through this FOA, as well as to additional scientific projects that will be solicited through subsequent FOAs.

Applications for a genetics core U01 should plan a project period of five years.  During this time, the genetics core will support scientific projects awarded as linked U01s through this FOA, as well as additional scientific projects that will be solicited through subsequent FOAs.

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS398 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 FY2011 for one Center without Walls comprised of linked U01s.

Award Budget

Individual linked U01 application budgets are not limited, but should reflect the actual needs of the proposed project.  Applicants should note that support for the entire Center without Walls (made up of linked U01 awards) will not exceed $3 million direct costs per year.  

Award Project Period

 The scope of the proposed project should determine the project period.  The maximum project period for administrative or genetic cores is 5 years.  The maximum period for specific scientific projects is 3 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 (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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 PHS398 Application Guide.

Because the Epilepsy Center without Walls Program is intended to support collaborative projects conducted by multidisciplinary teams, it is expected that the Center project will be submitted as linked U01 applications. This arrangement provides each principal investigator a unique cooperative agreement award, but the component U01 is a clearly integrated part of the overall multidisciplinary Center program.  The Center must include at least one principal investigator whose primary field of expertise is outside of the epilepsies but whose inclusion provides a significant, relevant contribution to the project.  This requirement is intended 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 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. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

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:

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

The letter of intent should be sent to:

Randall Stewart, PhD
Channels, Synapses and Circuits Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.
Rockville, MD 20852
Telephone: 301-496-1917
Email: stewartr@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: nindsreview.nih.gov@mail.nih.gov

Page Limitations
Face Page (PHS 398 Form Page 1)

The title of the Center without Walls (Item 1) should be the same for all linked applications. The title should be unique to a specific Center without Walls (do not repeat the title of this FOA) and should include the suffix “(1 of n, with n equaling the total number of linked applications)” or “(2 of n)” or “(3 of n)” to allow for the identification of the linked applications from each institution.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy

The following may be included in the application as deemed appropriate by the applicant:

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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

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?   

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?   

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?  Is there integration of the linked components, including a feasible management plan?

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  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 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

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 local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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 resides with the awardees for the project as a whole, although specific 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:

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

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

Applicants are encouraged to contact the NINDS institute representatives named below in Section VII to ensure that the proposed research will be responsive to this FOA.   

Application Submission Contacts

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)

Randall Stewart, PhD or Katrina Gwinn, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917 or 301-496-5745
Email: stewartr@ninds.nih.gov or katrina.gwinn@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke Center(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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.