and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Neurological Disorders and Stroke (NINDS) |
|
Funding Opportunity Title |
Exploratory Grant Program in Disease Modification and Prevention in the Epilepsies (P20) |
Activity Code |
P20 Exploratory Grants |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-NS-12-006 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.853 |
FOA Purpose |
This Funding Opportunity Announcement (FOA) solicits Research Program Project Grant (P20) applications from institutions/organizations proposing exploratory collaborative research on disease modification or prevention in an epilepsy syndrome. Successful exploratory studies may lead to subsequent applications for support of a collaborative, multidisciplinary Epilepsy Center without Walls on Disease Modification and Prevention. Depending on the topic area, however, exploratory studies may alternatively lead to applications for the NINDS Translational Program for Resistant Epilepsy and Epileptogenesis, the NINDS Clinical Trials Program, or additional investigator initiated research programs. This FOA is for support of new projects, not continuation of projects that have already been initiated. Interventional clinical trials are also not appropriate for this FOA. |
Posted Date |
August 18, 2011 |
Letter of Intent Due Date |
October 17, 2011 |
Application Due Date(s) |
November 17, 2011 |
AIDS Application Due Date(s) |
Not Applicable. |
Scientific Merit Review |
February/March, 2012 |
Advisory Council Review |
May, 2012 |
Earliest Start Date(s) |
July, 2012 |
Expiration Date |
November 18, 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.
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
Purpose
The seizure-related syndromes known collectively as the epilepsies represent one of the most common neurological disorders, and are a source of significant public health burden. These disorders have a wide range of severities, precipitating causes, comorbidities, and treatment outcomes. Approximately 3 million Americans and 50 million people worldwide live with epilepsy, and the risk of developing epilepsy over a lifetime (up to age 80) is 3%. Seizures can be controlled using available therapies in roughly two thirds of epilepsy patients, although side effects and various comorbid conditions remain problematic for many. Seizures are inadequately controlled in the remaining one third of patients, often with devastating consequences.
Preventive treatments are not yet available for epilepsy. Aside from resective brain surgery, no currently available therapy appears to cure or alter the course of the disease. In some epilepsy syndromes, however, it is possible to identify a population of individuals at significant risk for developing epilepsy before seizures begin. In other cases, it may be possible to modify the severity of the disorder even after spontaneous seizures have become recurrent.
The Epilepsy Research Benchmarks (http://www.ninds.nih.gov/research/epilepsyweb/2007_benchmarks.htm#benchmarks) identify the development of interventions that prevent, interrupt or reverse the epileptogenic process as a high priority. In this FOA, the NINDS seeks to accelerate the translation of antiepileptogenesis mechanisms into a targeted clinical prevention strategy or disease-modifying therapy in an epilepsy syndrome. Success in this area will require a rich understanding of the clinical syndromes themselves and a rigorous preclinical evidence base in order to move a promising intervention on to the next phase (e.g. translation and early phase clinical research). It is expected that an NIH-initiated, "proof-of-concept" effort to develop an epilepsy prevention or disease modifying therapy will encourage additional public and private sector research.
Research Objectives
The purpose of this Funding Opportunity Announcement (FOA) for Exploratory Grant (P20) applications is to support exploratory collaborative research to evaluate the translational potential of a disease modification or prevention therapy in an epilepsy syndrome. In this FOA, the NINDS seeks to develop a proof-of-concept experimental framework to identify and organize research efforts on syndromes in which significant progress can be made most quickly. The goal is to encourage formation of multidisciplinary preclinical/clinical collaborations and collection of preliminary data for the clinical population, intervention(s), model(s), and/or protocol(s) that may be tested in subsequent full-scale applications. Applicants may also request support for development of administrative structures for future basic, translational and clinical efforts.
This funding opportunity is broad in terms of syndrome of interest and is open to either prevention or disease modification efforts. Please note that this FOA is not for support of clinical trials, but does permit non-interventional clinical studies.
There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website (http://www.ninds.nih.gov/funding/grant_policy.htm). NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.
Specific Areas of Research Interest
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. Applicants are encouraged to review the topic areas described below and to contact the NINDS institute representative named in Section VII to ensure that the proposed research will be responsive to this FOA. The NINDS specifically encourages applications to evaluate the translational potential of one or more disease modifying or prevention therapies for a particular epilepsy syndrome (or group of syndromes), and to plan for an Epilepsy Center without Walls in which pre-clinical and clinical scientists collaborate to develop the rigorous evidence base needed to justify IND/IDE enabling studies for a promising intervention. However, the Institute recognizes that different epilepsy syndrome areas are at different stages of translational development. In some cases, an exploratory project may demonstrate that a rigorous evidence base does exist, and a subsequent application to the NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (PAR-11-154) or the NINDS Clinical Trials Program (PAR-11-173 or PAR-10-199) is appropriate. In other cases, an exploratory project will reveal that further collaborative basic or clinical research is needed to identify the appropriate intervention(s), at-risk populations, disease mechanisms, etc, and these studies may be more appropriately conducted in additional investigator-initiated applications. Therefore, this FOA is open to a broad range of exploratory projects in different syndrome areas, including, but not limited to the topics listed below.
The NINDS welcomes exploratory P20 applications on collaborative approaches to:
Applications for exploratory projects may include combinations of clinical, translational, and/or basic components as needed but should be tightly focused on a single unifying theme. Examples of a unifying theme include, but are not limited to, development of prevention or intervention therapy in a single epilepsy syndrome (e.g., controlling inflammation after febrile status epilepticus, mTOR pathway inhibition in tuberous sclerosis complex, or pre-clinical efficacy studies of existing AEDs, such as levetiracetam, for epilepsy prevention after head injury), development of a targeted interventional approach with potential application in multiple syndromes (e.g., targeted ion channel modulation in channelopathy disorders), or developing a better understanding of a potentially common epileptogenic mechanism involved in multiple syndromes (e.g., mTOR signaling or immune mechanisms in acquired epilepsies).
Applications may also request support to plan administrative core activities for subsequent collaborative applications (such as a Center without Walls, Translational U01, or Clinical Trial application). These activities may include (but are not limited to): designing common protocols and outcome adjudication processes, ensuring regulatory compliance and protection of data confidentiality and intellectual property (if applicable), and establishing consortium policies for data sharing and publication. Where appropriate, the use of NINDS Common Data Elements (http://www.nindscommondataelements.org/default.aspx) is strongly encouraged.
Funding Instrument |
Grant |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
NINDS intends to commit an estimated $1.2 million dollars in direct costs in FY 2012 to support up to 4 exploratory grants. |
Award Budget |
Application budgets are limited to $300K direct costs. Budget requests should reflect actual needs of the proposed project. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period 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.
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
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.
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.
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 PHS398 Application Guide.
Because the projects supported by this FOA are intended to be collaborative projects conducted by multidisciplinary teams, applicants are strongly encouraged to include at least one investigator (either a co-investigator or multiple PD/PI) whose primary field of expertise is outside of the epilepsies, but whose inclusion provides a significant, relevant contribution to the project. This program feature is intended to enrich the perspectives and methodologies brought to bear on the problems of antiepileptogenesis and disease modification.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
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.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
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.
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.Pre-Application Meeting: The NINDS anticipates holding a technical assistance meeting in August/September 2011 through a teleconference to which all interested prospective applicants are invited. Program and review staff will make presentations that explain their goals and objectives for the initiative and answer questions from the attendees. Prospective applicants are urged to monitor the NIH Guide for Grants and Contracts regarding a Notice for the date and time of the meeting (http://grants.nih.gov/grants/guide/index.html).
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 9259
6001 Executive Boulevard
Bethesda, MD 20892-9259
(Rockville, MD 20852 for express/courier service)
Telephone: 301-496-9223
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirement:
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
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 (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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).
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?
Is the proposed project focused on a syndrome or area in which there is potential to make significant progress quickly?
If successful, does the exploratory project establish a proof-of-concept experimental framework that could be generalized to organize subsequent translational research efforts in other syndromes or for other interventions?
How significant would the reduction in disease burden be if subsequent full-scale efforts are sucessful?
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? Is the proposed collaborative team comprised of investigators who would be the most appropriate participants in a full-scale project on this topic? Does the investigative team include at least one individual with expertise from outside the field of epilepsy?
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?
If the aims of the project are successfully completed, will investigators have an adequate plan for an Epilepsy Center without Walls application to develop the rigorous evidence base needed to justify subsequent IND/IDE enabling studies?
Alternatively, if the rigorous evidence base is successfully developed in the exploratory project, will the investigative team be well-positioned to launch a full-scale effort in the NINDS Translational Program, or the NINDS Clinical Trials Program?
Do the applicants provide appropriate justification for the particular stage of translational development chosen for this project, particularly if the project is focused on basic science questions?
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?
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
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.
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 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
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.
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.
Not Applicable
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Before submitting an application it is extremely important to verify that the
proposed research meets the goals and mission of the NINDS. Applicants are
encouraged to contact the NINDS Institute representatives listed below to
ensure that the proposed research will be responsive to this FOA.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Brandy Fureman, PhD
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-1917
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9223
Email: [email protected]
Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9231
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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