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
Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Neuroprotection (U01 Clinical Trial Not Allowed)
Activity Code
U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-NS-18-033
Companion Funding Opportunity
RFA-NS-18-034, U24 Resource-Related Research Projects - Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.853
Funding Opportunity Purpose

Recent advances in endovascular thrombectomy and the extended time window for intervention in acute ischemic stroke patients that have salvageable brain tissue at the time of reperfusion, offer a new opportunity to reconsider neuroprotective agents as adjunctive therapies to extend the time window for reperfusion and to improve long-term functional outcome.

The purpose of this funding opportunity announcement (FOA) issued by NINDS is to invite applications for network sites for the NIH Stroke Preclinical Assessment Network (SPAN).  SPAN will facilitate testing of up to 6 promising neuroprotective drugs or interventions to be given prior to or at the time of reperfusion in experimental models of ischemic stroke (e.g., transient middle cerebral artery occlusion). The awarded network sites will become part of the network and will collaborate with the other awarded sites under the oversight and central coordination provided by the SPAN Coordinating Center (RFA-NS-18-034).  Applicants for the network sites must propose a promising neuroprotective intervention to be tested within SPAN; awarded sites will test up to 6 interventions in parallel, including their own. If successful, this network will accelerate the identification of the most promising neuroprotective therapies for future pivotal clinical trials and span the gap between preclinical and clinical testing, in a cost-and time-effective fashion.

Key Dates

Posted Date
August 6, 2018
Open Date (Earliest Submission Date)
November 13, 2018
Letter of Intent Due Date(s)
November 13, 2018
Application Due Date(s)
December 13, 2018, by 5:00PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.  Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

AIDS Application Due Date(s)
Not applicable.
Scientific Merit Review
February-March 2019
Advisory Council Review
May 2019
Earliest Start Date
July 2019
Expiration Date
December 14, 2018
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability. 
     
  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications of promising neuroprotective drugs/interventions for the Stroke Preclinical Assessment Network (SPAN).  SPAN will support late-stage preclinical studies of putative neuroprotectants to be given prior to or at the time of reperfusion, with clinically relevant long-term outcomes and comorbidities. Parallel testing of the most promising interventions will help to determine if an intervention can improve outcome as compared to reperfusion alone and/or extend the therapeutic window for reperfusion, and if so, guide the selection of the best agent(s) to transition to future Phase II clinical trials (to be conducted through StrokeNet).  SPAN will consist of one Coordinating Center (CC) and up to 6 network sites; this infrastructure is expected to test up to 6 compounds/interventions (one for each of the awarded sites) in animal models of transient cerebral ischemia. The SPAN program will not support any human subjects research.

Background

Until 2015, intravenous recombinant tissue-type plasminogen activator (rt-PA) was the only FDA-approved therapy for acute ischemic stroke. Despite its overall efficacy and safety, rt-PA presents some limitations, such as increased risk of hemorrhagic transformation, a narrow time window of few hours from stroke onset, and a low success rate in lysing large clots. Over the past few years, acute endovascular therapy (EVT) with stent-retriever devices and access to advanced imaging modalities have transformed the standard of care, offering the opportunity to improve outcome significantly in selected patients that have salvageable tissue treated as late as 16-24 hours after their stroke. Despite the success of EVT in clinical trials, many patients still experience neurological deficits following therapy; thus, there is a need to develop adjunctive approaches to improve long-term outcomes.  These recent advances offer a new and timely opportunity to further evaluate the potential benefit of neuroprotective agents in the context of mechanical revascularization.

The 2012 NINDS Stroke Research Priorities Meeting identified several priorities that are relevant to the proposed initiative:

  • Accelerating the Translation of Stroke Research in Preclinical Animal Models into Clinical Studies of Highly Promising Treatments;
  • Preclinical and Clinical Studies to Improve Early Reperfusion Therapy and Establish the Limitations of Late Reperfusion Therapy;
  • Preclinical and Clinical Studies to Achieve Robust Brain Protection.

Furthermore, this initiative builds on the recent NINDS-sponsored workshop "Translational Stroke Research: Vision and Opportunities", which recommended that preclinical multi-laboratory trials of a putative treatment may be valuable before investing in a clinical trial.

Research Objectives

The overall goal of this program is to create a virtual preclinical stroke network to support late stage preclinical studies of potential neuroprotective strategies to be given prior to or at the time of reperfusion to test their potential  ability to provide additional benefit to reperfusion alone, by either improving long-term functional outcome or extending the therapeutic window of intervention (e.g., by stabilizing the penumbra, improving collateral flow, etc.) in animal models (rodents and possibly larger species, if warranted) of transient cerebral ischemia. SPAN will test in parallel up to 6 compounds/interventions in animal models of transient cerebral ischemia following the same rigor and methodology characteristic of clinical trials. The parallel testing of multiple interventions, including an adaptive design approach that will eliminate compounds that do not demonstrate sufficient promise, will allow the identification of the most promising candidates to advance to clinical testing. Only drugs/ interventions that are supported by robust and rigorous preliminary data, have been shown to be safe in humans, and are likely to be ready for clinical testing by the end of the award will be eligible to be tested through the SPAN network. 

SPAN Organization

The Coordinating Center (CC) will provide scientific and organizational leadership to SPAN to achieve both efficiency and excellence in the implementation and performance of the neuroprotection protocols.  The CC will work collaboratively with the network sites and NINDS to provide overall study coordination, including oversight of study protocols, monitoring of the individual sites, data management, data sharing, and reporting. Additionally, the CC will be responsible for formulation of active and control compounds. The roles and responsibilities of the SPAN CC are described more fully in the companion FOA, RFA-NS-18-034. 

Each network site will propose a promising neuroprotectant to be tested in SPAN and will test, in a controlled, randomized, and blinded fashion, up to 6 interventions in parallel, including their own.

SPAN Network Committees

1. The governing body of the network will be a Steering Committee, appointed by the CC in conjunction with NINDS, that will consist of the PD/PI of the CC, the PD/PI of each of the network’s testing sites, NINDS Program staff and 3 representatives from the NIH Stroke Clinical Trials Network (StrokeNet) Steering Committee. The NINDS Director has the right to supersede any decision by the network at any time.

2. An independent External Advisory Board, appointed by and reporting to NINDS, will comprise basic and clinician scientists with expertise in neuroprotection, representatives from pharmaceutical and biotech industry, and experts in regulatory affairs, statistics, and clinical trial design.

Characteristics, Roles, and Responsibilities of SPAN Network Sites

It is expected that SPAN sites will be academic or other preclinical research laboratories with documented expertise in the transient middle cerebral occlusion (tMCAo) model of ischemic stroke and related relevant comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.). Applicant sites must propose a neuroprotective intervention to be tested in the network.  Each network site will conduct tests of the selected interventions (one from each of up to 6 network sites, including their own) following standard protocols and procedures to be developed by the network.

Applicants should consider the following factors:

  • Proposed interventions to be considered for SPAN need to be supported by extensive and rigorously obtained preliminary data (published and/or unpublished) in a relevant experimental stroke model (transient middle cerebral occlusion) demonstrating potential efficacy; in addition, rigorously obtained evidence of safety in humans is required. 
  • Sites must demonstrate expertise in assessing clinically-relevant long-term functional outcomes.
  • Sites must have access to advanced preclinical imaging facilities.
  • Applicants to this FOA will be required to incorporate the SPAN network infrastructure into their proposed study, including central coordination and data management through the CC.
  • All sites funded under this FOA must participate in and accept responsibility for driving the scientific objectives of the network. PIs of each network site must agree to become active members of the SPAN Steering Committee.
  • Applicants must agree to test up to 6 interventions in parallel, in collaboration with the other network sites, in a randomized and blinded fashion. Interventions that appear less efficacious will be removed from further testing; those that demonstrate stronger efficacy during the parallel testing will be prioritized and allocated more resources, as appropriate, with the use of an adaptive design. Sites will be blinded to treatment allocation throughout the study and all data will be analyzed by the CC. It is not required that all sites participate in every testing. Additional (ad hoc) performance sites may be proposed to fulfill specific study requirements.

Characteristics of Non-Responsive Applications

This FOA is limited to neuroprotective interventions for ischemic stroke in preclinical models of transient cerebral ischemia followed by reperfusion. No human subjects research will be supported through this FOA.   Preclinical studies that are not directly responsive to this FOA (such as, but not limited to, the pathophysiology of stroke, target validation/identification, biomarkers, or testing neuroprotective interventions in primary intracerebral hemorrhage, or in models of neonatal hypoxia-ischemia) are out of scope for this initiative. However, these topics are of great interest to NINDS, and applicants are encouraged to contact NINDS program staff to determine the most appropriate funding mechanism. Pilot studies of neuroprotection that are not supported by strong preliminary data and/or relevant publications and have not shown safety in humans will not be supported under this FOA. Studies not focused on transient cerebral ischemia models are out of scope.

Opportunities for Partnership

Projects involving partnerships with industry, small businesses or non-government organizations are encouraged under this FOA. The policy of the NIH is to make available to the public the results and accomplishments of the activities that it funds.

National Institute of Neurological Disorders and Stroke

The NINDS will be responsible for organizing and providing overall support for the SPAN network. NINDS Program Staff and the NINDS Grants management will be responsible for the overall management of the SPAN network. In addition to regular grant stewardship, an NINDS Project Scientist will be involved substantially with the awardees as an NINDs partner, consistent with the Cooperative Agreement mechanism.

Applicants are strongly encouraged to consult with NINDS Scientific/Program Staff early during the planning phase of their application (See Agency Contacts, Section VII).

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

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

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NINDS intends to commit up to $4,000,000 in direct costs to fund up to 6 awards for 3 years, pending availability of funds and a sufficient number of meritorious applications.

 
Award Budget

Application budgets are limited to $725,000 in direct costs for 3 years ($75,000 direct cost during year 1 to set up the network, then $325,000 in direct costs per year).

Award 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations
Higher Education Institutions
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 
Required Registrations
Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

 
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
 
The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:
  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)
However, to avoid conflict of interest, the Institution being awarded as a network site cannot be the SPAN CC.
 

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
 
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity
 
The letter of intent should be sent to:
 
Francesca Bosetti, Pharm.D., Ph.D.
Telephone: 301-496-1431
Fax: 301-402-2060
Email: frances@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.

The PI/PD(s) must demonstrate published expertise in the transient middle cerebral occlusion model of ischemic stroke, neuroprotection, rigorous experimental design, behavioral motor and cognitive outcomes, and preclinical modeling of stroke comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.).The PI must be willing to commit a minimum of 3 person months effort , have documented expertise in leading multiple complex projects in parallel. It is critical to the success of the SPAN network that the site/project PIs interact effectively and collaboratively with the CC and with the NINDS. Therefore, in addition to the required strong leadership and staff with highly specialized expertise, the project site must include a dedicated staff member as key personnel who will be the point of contact, is highly motivated, has excellent communication skills, has significant training and experience with information technology and the biological data management.

 
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

State the aims and hypotheses to be tested.

Investigator(s): Describe the experience of the PD/PI a nd the investigative team in rigorous preclinical modeling of transient cerebral ischemia, neuroprotection, advanced imaging, drug development, and clinically relevant short- and long-term outcome measures, modeling of stroke-related comorbid conditions (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.) in rodents and possibly other larger species. Describe the PD/PI’s experience in leading and participating in complex multi-site projects. If the project is collaborative or multi PI-PD, describe complementary and integrated expertise, leadership plan and organizational structure, and how it will benefit the project and the overall network.

Research Strategy

Organize the Research Strategy by Significance, Innovation, and Approach. A Milestone Plan, under separate heading, must be included in the Approach.

Significance: Describe the rationale and supporting data demonstrating the merit of the proposed neuroprotective intervention(s) to be given at the time of or prior to reperfusion. Describe the rationale and supporting data demonstrating the merit of the proposed interventions and existing safety data in humans. Discuss how results of the proposed study (positive or negative) may be explained based on the biological action of the proposed intervention and why the proposed intervention is promising among overall neuroprotective interventions that have been tested preclinically and clinically. Describe the path leading to a clinical trial.

Prior studies and rationale for development: Applicants should describe the full body of evidence being used to support the proposed intervention and should include a plausible biological mechanism, as well as clinical safety data, which would allow the proposed intervention, if successful in its preclinical testing, to potentially rapidly advance to future clinical trials. Preliminary data as well as published literature demonstrating the feasibility and efficacy of the proposed intervention should be included, and the applicant should specifically address the rigor of the animal studies being used as support (https://www.ninds.nih.gov/sites/default/files/transparency_in_reporting_guidance_508C.pdf). Applicants should also provide compelling evidence that the proposed intervention will reach /act upon the designated target or that its mechanism of action is such that it is expected to be of benefit in ameliorating a specific aspect of transient cerebral ischemia.

Innovation: Describe the cutting edge and clinically relevant and innovative attributes the application brings to the field of neuroprotection and in the context of the latest advances in endovascular therapy and acute ischemic stroke standard of care, as well as the overall technical advances and innovative strengths that the application has to offer the network.

Approach: Describe the overall strategy, methodology and analyses that will be used to accomplish the aims of the project. Detail the strengths and appropriateness of assays and methodologies used to test neuroprotection, and whether or not these measures are quantitative, robust, reproducible, clinically relevant and clearly linked to neuroprotection and functional/imaging outcomes in ischemic stroke. Describe potential problems, alternative strategies and benchmarks for success.  The experimental plan should address relevant biological variables, such as sex and age, and the use of ischemic stroke-related comorbidities, as well as how the proposed intervention can be blinded, sample size calculation, study power, and plans for training of site personnel. Although the CC will be responsible for drug acquisition and formulation, details on the source, acquisition and formulation criteria of the proposed compound will help accelerating the process.

Applicants should also describe the capacity of the site to run multiple studies in parallel and provide clear scientific, administrative, and institutional commitments to collaborate with other funded network project investigators/sites and the CC to maximize time- and cost-efficiency of testing in parallel up to 6 various neuroprotective interventions and respective controls.

Milestone Plan: The plan should include 1-year well-defined stage-appropriate milestones for the proposed intervention, with clear go/no-go criteria and a realistic timeline. Some examples are outlined below. Milestones should be unambiguous, quantifiable, and scientifically justified. The final milestone plan is subject to concurrence by the CC and NINDS.

  • Set up the required infrastructure and animal models to be ready for testing by the end of year 1
  • Agreement to test interventions from other sites, in addition to the one proposed in the application, according to the timeline established by the CC and NINDS
  • Participate in all scheduled SPAN teleconferences and annual meetings
  • Develop all resources and expertise required for data sharing with the CC and other sites? and provide all data to the CC, according to the established protocols.
     

Letters of Support: If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NINDS, other governmental or nongovernmental entities, letters of support detailing the terms of collaboration and data sharing must be included and must be from the appropriate authority/ies (e.g., institutional/foundation official, funding sponsor, and/or lead PI of the parent activity). This letter should also disclose the process of sharing for the parent activity and discuss if sharing of these specimens might extend beyond the individual project and involve collaborative activities within the network. Any conflicts in sharing with any known entities should be revealed and discussed. Review and approval for the use of samples and data must be completed and a letter of approval must be obtained prior to submission of an application under this FOA.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Applications must include a clear administrative and institutional commitment to data sharing, including strategies and ability to share raw data, images, and protocols both within the network as well as with other investigators. 
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicant Webinar

Applicants are strongly encouraged to consult with NINDS Scientific/Research staff early on during the planning stage of their application (see Agency contacts, Section VIII). This early contact will provide an opportunity to clarify the applicant's understanding of NINDS’ goals, policies and guidelines. These discussions also provide important information and guidance on how to develop an appropriate application. .  To facilitate this, an Applicant Webinar will be scheduled to provide an overview of the FOA and answer questions. The webinar is open to all prospective applicants. Participation in the teleconference is not a prerequisite for applying and is not required for a successful application. Information about how to participate in the webinar will be posted at http://www.ninds.nih.gov. Potential applicants are encouraged to submit their questions or comments to frances@mail.nih.gov prior to the meeting. Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site. NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.

Please notify the NINDS Program Officer by email at frances@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Are the supporting data (published and unpublished) rigorous and do they suggest feasibility and efficacy of the proposed neuroprotective intervention and superiority to other interventions that have been tested preclinically and clinically? Is there evidence of target engagement or is the mechanism of action plausible for neuroprotection in the context of brain ischemia/reperfusion? Is evidence of human safety provided? Is it likely that the proposed neuroprotective intervention will be ready for testing in clinical trials by the end of the award?

Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or thos?e 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?

Do the PD/PI and the investigative team have published experience in preclinical modeling of transient cerebral ischemia, neuroprotection, drug development, advanced imaging, clinically relevant short- and long-term functional outcomes and modeling of stroke-related comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.)?

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?

Are new long-term outcome measures or neuroimaging endpoints clinically relevant and/or novel? Is the proposed concept timely and does it have the potential to advance the field of neuroprotection in the context of the latest advances in endovascular therapy and overall standard of care for acute ischemic stroke patients?

Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are the techniques and assays proposed to test neuroprotective interventions appropriate and clinically relevant? Are the assays and outcome measures quantitative, robust, reproducible and clearly linked to neuroprotection? Is the interaction between the site and the CC clearly described? How appropriate are the outcome measures? How appropriate are the methods of blinding, sample size calculation, study power, data management plans, and plans for training of site personnel?

Are the 1-year milestones well defined, quantitative and with clear go/no-go criteria?  How likely is the study to be completed within the project period? How will the site collaborate with other funded network projects/investigators and with the CC in a time- and cost- effective manner?

Does the application include clear scientific, administrative, and institutional commitments to collaborate with other network sites and PIs and with the CC to test up to 6 neuroprotective drugs/interventions?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?

Is there evidence of Institutional concurrence and commitment to Data Sharing requirements of the SPAN network?

Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not applicable.
Renewals
Not applicable.
Revisions
Not applicable.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
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)  Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all application

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to NINDS on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Compliance with data and resource sharing policies and the collaborative structure of the network.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this 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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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:

  • Determining experimental approaches, designing protocols, and conducting experiments;
  • Establishing milestones for the project, in consultation with NINDS program staff;
  • Submitting annual progress reports during the funding period, in a format as agreed upon by NINDS program staff;
  • Accepting and implementing any other common guidelines and procedures developed for the network and approved by NINDS program staff;
  • Interacting collaboratively with the SPAN CC;
  • Attending network calls and participating actively in all SPAN network activities;
  • Serving as a member of the SPAN Steering Committee;
  • Attending in-person SPAN network meetings (including the initial Kickoff Meeting) once per year organized by the CC with input from the NINDS, the Steering Committee, and the External Advisory Board, and present up to date findings and protocols on ongoing projects.
  • Contributing study data in real time or as determined by the CC and network Steering Committee.
  • Awardees are expected to make new information and materials known to the research community not only in the annual network meeting but also in a timely manner through publications, web announcements, reports to NINDS program staff, and other mechanisms.
  • Timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NINDS support. Timely publication of major findings is required.

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

NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NINDS will be to facilitate and not to direct the activities. 

NINDS Program Staff will:

  • Contribute to the adjustment of research protocols or approaches as warranted;
  • Contribute to developing final milestones for the study;
  • Serve as a liaison between the awardees, the NINDS Advisory Council and the larger scientific community; 
  • Serve on committees of the SPAN network as appropriate;
  • Assist in promoting the availability of data and resources developed during this project to the scientific community at large;
  • Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action;
  • Retain the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to achieve its goals agreed to at the time of award, fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award including biospecimen and data sharing requirements.

Additionally, NINDS Program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. As with any award, even during the period recommended for support, continuation is conditional upon satisfactory progress and collaboration with the other network sites and with the CC.

Areas of Joint Responsibility include:

None. All responsibilities are divided between awardees and NIH staff as described above.

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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
 
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Scientific/Research Contact(s)

Francesca Bosetti, Pharm.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: frances@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)
Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: tijuanna.decoster@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 Part 75.


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