and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Neurological Disorders and Stroke (NINDS) |
|
Funding Opportunity Title |
NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
Reissue of PAR-10-144 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
PAR-11-154 |
Companion FOA |
PAR-10-143, R21, NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.853 |
FOA Purpose |
The goal of this funding opportunity announcement (FOA), from the National Institute of Neurological Disorders and Stroke (NINDS) is to support preclinical development of new therapies to cure epilepsy, prevent the emergence of epilepsy following brain injury (including status epilepticus, traumatic brain injury, stroke, encephalitis, or other injury) or in other high-risk groups, or to better treat individuals with intractable epilepsy. The program will facilitate solicitation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. This program is specifically directed at projects that include therapeutic leads with demonstrated activity against the intended disease target. The program supports preclinical optimization and testing of these leads and projects must be sufficiently advanced that an IND or IDE application to the FDA can be submitted by the end of the project period. The program does not support early-stage therapeutic discovery activities such as high throughput screening. The program also excludes clinical research, basic research, and studies of disease mechanism. This is a milestone-driven cooperative agreement program involving participation of NIH staff in the development of the project plan and monitoring of research progress. |
Posted Date |
March 15, 2011 |
Open Date (Earliest Submission Date) |
May 5, 2011 |
Letter of Intent Due Date |
One month prior to application due date. |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
May 8, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
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
Research Objectives
Epilepsy is one of the most common neurological disorders affecting both
American and international populations, representing a significant source of
public health burden. The number of people currently living with epilepsy
in the population is estimated at 2.5 million Americans, and 50 million people
worldwide. The lifetime risk of epilepsy to age 80 is 3%. Seizures
can be controlled by available therapies for approximately two-thirds of all
patients diagnosed with epilepsy, but difficult side-effects and comorbid
conditions continue to affect quality of life for many. The remaining
one-third of patients continues to suffer from seizures that are not adequately
controlled by available therapies and in some cases, can have devastating
consequences. To date, no available interventions have been shown to be
clinically effective for prevention of epilepsy in those at
risk.
NINDS recognizes the need to encourage innovative research approaches to move toward real cures for epilepsy, defined as no seizures, no side effects, and prevention in those at risk . The goal of this FOA is to support milestone-driven projects focused on the identification, optimization and preclinical testing of candidate therapeutics for resistant epilepsy and prevention of epileptogenesis. The program will: (a) develop novel drugs, biologics, and devices to enter clinical trials and (b) leverage the resulting expertise, resources, lessons learned, and partnerships to exploit commonalities of disease mechanism and downstream pathogenesis across epilepsies and thereby accelerate development of novel therapeutics for this devastating spectrum of diseases.
This FOA and its companion NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis (R21) (PAR-10-143) make up NINDS coordinated program to promote translational research in the epilepsies. The extramural research community may use these translational research initiatives flexibly and creatively, and in whatever combinations are necessary, to achieve the most rapid and effective development of investigational interventions for these spectrum of epilepsy diseases.
NINDS Anticonvulsant Screening Program
Applicants with compounds that have been screened as part of the NINDS Anticonvulsant Screening Program (ASP) contract may be suitable for this initiative. Although not required, applicants are encouraged to consult with the ASP before they submit an application in response to this initiative. In some cases, the ASP program may be appropriate for investigators who have a compound resulting from the NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis (R21) (PAR-10-143). Compounds sent to the ASP are tested for preclinical efficacy in a battery of complementary disease-specific and mechanistic models. Compounds submitted to the ASP can benefit by being compared to the ASP database of over 30,000 compounds. Initial hits are optimized by generating basic toxicological and biological activity profiles and comparative analysis. Intellectual property is held by the researchers who come to the ASP with a promising compound. The data generated by the ASP and other proprietary information are protected under confidentiality agreements.
Definition of Translational Research:
Translational research (see general NINDS program http://www.ninds.nih.gov/funding/areas/technology_development/index.htm) is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.
As described below, this program supports preclinical translational research focused on the development of novel candidate therapies for clinical testing.
Background:
Basic and clinical research in epilepsy and the availability of the Anticonvulsant Screening Program (ASP) have been responsible for dramatic advances resulting in the:
Recent advances have created opportunities for preclinical therapy development programs in the epilepsies to produce viable products for clinical testing. This FOA is designed to increase the number of preclinical therapeutic candidates for resistant epilepsy or prevention of epileptogenesis that reach the IND/IDE stage. Further enhancement of potential therapeutic interventions will depend on the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies. Collaborative arrangements between drug, biologics and device companies, academic medical centers, and private and public funders of translational research will be needed and are strongly encouraged, with a spirit of sharing in the risks and rewards of the effort being inherent to the relationships.
The Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis is intended to foster the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in the epilepsies can flourish as a cooperative, iterative process leading to new and effective interventions. The most successful therapy development efforts frequently are those that establish a clearly defined goal (often using a candidate therapeutic profile or label-based design plan), and bring together the appropriate expertise and experience, at the program launch stage.
In 2007, the Curing Epilepsy: Translating Discoveries into Therapies Conference took place to discuss potential targets and technologies for new therapies, with the goal of moving the field toward a cure. A new set of NINDS Epilepsy Research Benchmarks resulted from the conference to guide future research directions with the ultimate goal of developing new treatments that eliminate seizures without side effects, and preventing epilepsy in those at risk. In preparing applications, applicants may wish to consult the NINDS Epilepsy Research Benchmarks and prior NIH reports that identify specific opportunities and needs in epilepsy research found here: http://www.ninds.nih.gov/research/epilepsyweb/researchers/epilepsy_researchers.htm
Scope of the Program:
The Translational Research Program in Resistant Epilepsy and Epileptogenesis is specifically focused on the preclinical development of drugs, biologics, and devices including activities that lead to Investigational New Drug (IND) or Investigational Device Exemptions (IDE) applications to the Food and Drug Administration (FDA). For entry to the program, projects must have one or more identified therapeutic leads and convincing proof-of-principle on efficacy demonstrated in credible models of resistant epilepsy, epileptogenesis, or against defined disease targets in vitro.
When appropriate, projects must include lead optimization for disease-related activity and for pharmacological and toxicological properties consistent with the intended use of the therapy, which is the subject of a special review criterion. In cases where no lead optimization is proposed, there must be a demonstration that sufficient optimization for the disease target and intended use have been conducted previously.
In addition to optimization, projects may include preclinical efficacy testing, predictive ADMET (absorption, distribution, metabolism, excretion, and toxicology) testing, formulation, manufacture, pharmacology, toxicology, and IND or IDE submission. Applications must include feasible plans for achieving a complete IND or IDE application for submission to the FDA within the project period. Because the project must be sufficiently advanced at entry to achieve regulatory submission by the end of the project period, the program does not support early-stage therapeutic discovery activities such as high throughput screening.
All proposed studies must be directed at the most efficient route to regulatory submission, and therefore this program excludes basic research and studies of disease mechanism. Also outside the scope of the program are development of diagnostics or biomarkers, rehabilitation strategies, and non-exempt human studies.
Implementation:
The Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis provides funding through the U01 cooperative agreements mechanism. As a cooperative agreement, implementation will involve participation of NIH program staff in the planning and execution of these therapy-directed, milestone-driven projects. The U01 cooperative agreements support translational research projects that are focused on a single problem or approach. Consortium agreements are permitted.
Milestones: Applications must include proposed yearly go/no-go milestones that are the subject of a special review criterion. During the execution of the project, NIH staff will assess progress toward and achievement of milestones. Achievement of these milestones will be evaluated by NINDS prior to releasing funding for each year of the award. Guidance for preparation of milestone plans will be provided by NIH in a pre-application teleconference. Additional advice and examples of milestones can be found here http://www.ninds.nih.gov/research/translational/Coop_Tran_Res.htm.
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 SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The NINDS funding plan for this FOA will support up to $3.6 million total costs, which is sufficient for at least one new application per year for 3 years. |
Award Budget |
The estimated amount of funds available for support of 1 project awarded as a result of this announcement is $1 million direct costs for fiscal year 2011. Future year amounts will depend on annual appropriations. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received. |
Award Project Period |
The scope of the proposed translational project should determine the project period. The maximum period 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.
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.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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:
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
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Room 2135
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-1917
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Overall Plan for Therapy Development and Milestones:
Projects submitted under the U01 award mechanism must include an overall plan for preclinical and clinical therapy development. This plan must be based on a clearly stated project timeline that includes practical, achievable goals, and project milestones. Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project, including quantitative success criteria (see Example Milestones for NINDS Cooperative Program in Translational Research). All screening assays and animal models that will be used during preclinical development must be available and working; assay and animal model development are outside the scope of the Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis. Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the activity the proposed interaction occurs. An IND or IDE must be achieved during the project period. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations. The overall plan for therapy development should be included in the Significance section of the Research Strategy.
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.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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 submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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 translational research objective important to the research progress on resistant epilepsy or epileptogenesis?
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?
Are there adequate plans to optimize the candidate therapeutics, or is there evidence that proposed candidate therapeutics are sufficiently optimized to progress in the development plan?
Is the overall plan for therapy development through IND or IDE submission practical, achievable, and of high quality?
Are the proposed project milestones adequate and feasible?
Are there appropriate plans for the rigorous management and quality control of research data or materials from human subjects (if any)?
Are the experimental design and methods adequate to achieve the research objectives, including the involvement of basic and clinical scientists in the conception, design, and proposed implementation of the project as necessary?
Is the translational research objective likely to be completed within the project period?
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/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 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 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.
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.
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Consultation with NIH Program Staff:
Due to the unique requirements of the cooperative agreement program in Translational Research for Resistant Epilepsy and Epileptogenesis, applicants are strongly encouraged to consult with NIH Program Staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone-driven. These discussions also provide important information and guidance on how to develop an appropriate milestone plan. Pre-application consultation includes both an introductory call to discuss the scope and goals of the program and a conference call with NIH staff. Pre-application consultation on translational research cooperative agreements require adequate lead time before an application receipt date in order for applicants to have sufficient time to consider advice and perspective from NIH program staff. For this reason, the introductory call should be completed at least 10 weeks before a receipt date and the conference call at least 8 weeks before a receipt date.
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Email: [email protected]
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]
Randall Stewart, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-1917
E-mail: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9223
E-mail: [email protected] .
Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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