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

NINDS Cooperative Program in Translational Research Multi-Component Research Projects (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of PAR-08-234  

Related Notices

  • April 10, 2012 - See Notice NOT-NS-12-012, Extension of Expiration Date.

Funding Opportunity Announcement (FOA) Number

PAR-11-295

Companion FOA

PAR-11-293, R21, NINDS Exploratory/Developmental Projects in Translational Research; PAR-11-294, U01, NINDS Cooperative Program in Translational Research Single-Component Projects; and PAR-11-296, U44, NINDS Cooperative Program in Translational Research Small Business Awards

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853

FOA Purpose

The goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitateencouragement, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. To be eligible for support, projects must include therapeutic leads and in vivo proof of concept on efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of the project period. The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, basic research, and studies of disease mechanism. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS staff in the development of the project plan and monitoring of research progress. 

Key Dates
Posted Date

August 8, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(New Date January 8, 2013 per NOT-NS-12-012) , Original Date September 8, 2012

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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

Research Objectives

Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for treatment of neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the translation of these discoveries into new treatments. The goal of this FOA is to support milestone-driven projects focused on the optimization and preclinical testing of candidate therapeutics. The program will facilitate theencouragement, development, and review of therapy-directed projects and will accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing.

This FOA is one of four coordinated programs being released by NINDS to promote translational research, including NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-11-293), NINDS Cooperative Program in Translational Research Single-Component Projects (U01) (PAR-11-294), and NINDS Cooperative Program in Translational Research Small Business Awards (SBIR [U44]) (PAR-11-296). The extramural research community may use these translational research initiatives in whatever combinations are necessary to achieve the most rapid and effective development of investigational interventions for neurological disorders.

Definition of Translational Research:

Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.

Background:

Opportunities for discovery and progress in the treatment of neurological diseases have never been greater. Remarkable advances have been made recently in our understanding of the molecular and genetic bases of disease, and the potential therapeutic opportunities offered by these scientific findings create an opportunity for basic, applied, and clinical scientists to combine and coordinate their efforts. The realization of the potential for translating accumulated new knowledge 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 and device companies and academic institutions will be needed, with a spirit of sharing in the risks and rewards of the effort being inherent to the relationships.

The NINDS Cooperative Program in Translational Research is intended to catalyze the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in neuroscience can flourish as a cooperative, iterative process leading to new and effective interventions for neurological disorders.

Scope of the Program:

The NINDS Translational Research Program is specifically focused on the preclinical therapy development necessary to begin clinical testing of therapeutic candidates for neurological disorders. The program supports the preclinical development of drugs, biologics, and devices leading to IND or IDE applications to the FDA. 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. The program supports only preclinical development, so production of therapeutics for clinical trials is outside the scope. Screening assay and animal model development are outside the scope, so all screening assays and animal models that will be used during preclinical development must be available and working.  Primary screens for identifying candidate therapeutics are outside the program scope.

For entry to the program, projects must have one or more identified therapeutic leads and there must be available in vivo proof of concept data on efficacy, which is normally preliminary efficacy data in an animal model of the disease. When projects do not include an animal model of disease for efficacy testing, an acceptable alternative for entry to the program is in vitro efficacy data and in vivo proof of concept in normal animals that the therapeutic lead is available via the intended route of administration. Preliminary data should demonstrate rigor in the preliminary evaluation of candidate therapeutics entering the program, including, when possible, preliminary assessments of drug-like characteristics.

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. 

Applications must include proposed annual milestones for each project to be within program scope. Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project and include quantitative success criteria (see http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm). Achievement of milestones will be evaluated by NINDS, and funding of non-competing award years will depend on milestone accomplishment.

Research activities explicitly within program scope include preclinical efficacy testing, predictive ADME (absorption, distribution, metabolism, and excretion) and toxicology testing, optimization of candidate therapeutics, formulation and stability studies, process development and manufacturing of candidate therapeutics, IND- or IDE-enabling pharmacology and toxicology, regulatory affairs, and IND or IDE submission. An IND or IDE must be achieved in each project during the project period.

Applicants are strongly encouraged to consult with NINDS as plans for an application are being developed. Early contact provides an opportunity for NINDS to discuss the program scope and goals, and to provide information and guidance on how to develop an appropriate milestone plan. Other aspects of an application that are unique to the program are also discussed. Consultations may include both an introductory call and a conference call with NINDS staff. 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.

Implementation:

The NINDS Cooperative Program in Translational Research Multi-Component Research Projects provides funding through the U54 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NINDS program staff in the planning and execution of the therapy-directed projects. The U54 cooperative agreements support translational research projects and core resources that are focused on multidimensional approaches to therapy development for a neurological disorder or a group of closely related neurological disorders. A U54 project plan leads to the submission of more than one IND or IDE and supports the planning for more than one clinical trial.

Each U54 cooperative agreement must include at least three components, which can be research projects or cores, to be within program scope.

A U54 cooperative agreement must include a Steering Committee composed of the PDs/PIs, project leaders, and NINDS Project Scientists to be within program scope. An External Advisory Committee composed of experts not otherwise associated with the activity is optional and should be included when appropriate.

Collaboration among awardees will be encouraged and facilitated by NINDS. Investigators will have the opportunity to share data, materials, and expertise. It is expected that lessons learned and techniques developed within one disease community will be relevant to the efforts of other communities.

Section II. Award Information
Funding Instrument

Cooperative Agreement.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

A project duration of up to five years may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign Institutions

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

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

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 (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.    

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.   

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.

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 (NINDS)
Telephone: (301) 496-9223
E-mail: nindsreview.nih.gov@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

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

Research Strategy

Overall Plan for Therapy Development:

Projects submitted to the NINDS Cooperative Program in Translational Research must include, within the 12 page Research Strategy, a description of an overall plan for therapy development to be within program scope. The plan must be based on a clearly stated project timeline that includes practical, achievable goals, project milestones, and IND or IDE submission. The plan should also include, when appropriate, a Target Product Profile. Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the research activity the proposed interaction occurs. When a U54 cooperative agreement includes multiple projects, each project must include an overall plan for therapy development.

Team building is an essential step in the development of the overall plan for therapy development. Because translational research is intrinsically interdisciplinary, the plan will often involve cooperation among basic researchers, experts in preclinical development, and clinicians, and may include the participation of private-sector companies and voluntary organizations.

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, with the following modification:

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.

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 postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Research Strategy Page Limitations

Special Instructions U54 cooperative agreement applications:

Since the PHS 398 application form is designed primarily for the traditional research project grant (R01) application, several sections have to be modified and expanded so that the form can be used to provide the information needed for a U54 cooperative agreement application.

Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the cores last. Identify each component by title, and assign each project a number and each core a capital letter that reflects the order in which the projects and cores are presented in the application, and provide the name of the investigator responsible for each component.

Applicants should prepare only a single face page for the entire application, not one for each component. The title should be followed by "(U54)".

In the Key Personnel table provided, list the PDs/PIs for the overall U54 cooperative agreement and the investigator responsible for each component project or core. List the investigators in the same order in which their individual components are presented. Under "Role on Project" state the investigator's role (e.g., "Investigator, Project 1", "Co-investigator, Core B", or "Consultant, Project 3").

For the entire U54 cooperative agreement, as well as for each project and core, prepare the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." Identify each budget page (e.g., "Composite", "Project 1", etc.). Place the composite budget pages first, followed by the projects and cores. All budgets (composite, projects, and cores) will be in this one section. Individual project budgets should not be included with the project research plans.

Put the biographical sketches for the PDs/PIs of the U54 cooperative agreement first, followed by the other biographical sketches in alphabetical order. Put all of the biographical sketches together in one section immediately after the budget section. Biographical sketches are required for all key personnel and consultants who participate in the research projects and cores.

Present all Resources pages in one section.

The Research Plan may begin with an Overall Research Strategy describing the overall plan of the U54 cooperative agreement, including proposed therapeutic development approaches, the intent and impact of proposed core resources, and the anticipated IND or IDE submissions. This overview section, if included, should be summary in nature and inform the reviewers of the vision for the proposed U54 cooperative agreement, but not address the details of specific development plans. The overview section should be as brief as possible, but should not in any case exceed 12 pages.

The Research Plan of each research project or core should consist of a title page (to include Title of Project, Name, Title, and Affiliation of Research Project Director/Principal Investigator, and then names titles, and affiliations of other investigators), Description (use form page 2 of form PHS 398 for this), and sections on Specific Aims, Research Strategy, Human Subjects Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements (as appropriate), and Consultants, as described in the PHS 398 instructions. The Specific Aims should not exceed 1 page, and the Research Strategy should not exceed 12 pages for each research project and should not exceed 6 pages for each research core.

Requests of $500,000 or more for direct costs in any year

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 PHS398 Application Guide.

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 - Overall

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 - Overall

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?   

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 - Overall

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.

Individual Projects:

 Core Resources:

Overall Program Organization:

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

Not applicable.

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 for recommended 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.

Additional Review Considerations - Overall

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

Not applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned 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 . 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:

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.

Milestones toward therapeutic intervention are included in each project and have quantitative success criteria (see http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm). Achievement of milestones will be reported in the PHS 2590 and evaluated by NINDS. Funding of non-competing award years will depend on milestone accomplishment.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)

Linda McGavern, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-1779
Email: mcgavernlm@ninds.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 (NINDS)
Telephone:  301-496-9231
Email: decostert@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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


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NIH Funding Opportunities and Notices


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