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 - Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code
U24 Resource-Related Research Projects – Cooperative Agreements
Announcement Type
New
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-NS-18-034
Companion Funding Opportunity

RFA-NS-18-033, U01 Research Project - Cooperative Agreements

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

Recent advances in endovascular thrombectomy 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 the Coordinating Center (CC) 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 CC will work with the awarded network sites (RFA-NS-18-033) and will provide centralized administrative oversight and coordination of all aspects of the network. 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 5:00 PM 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 2019
Advisory Council Review
May 2019
Earliest Start Date
July 1, 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 for the Coordinating Center (CC) 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 CC and up to 6 network sites; this infrastructure is expected to test up to 6 compounds/interventions 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 during reperfusion.   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. 

The SPAN CC will contribute to these objectives by providing scientific and organizational leadership for implementation of preclinical protocols to be conducted within the network sites. The CC will promote high quality and efficiency in study execution and provide a central resource for protocol development, drug acquisition, formulation and distribution, study administration, data management, and statistical analysis. The CC additionally organizes the SPAN governance committees and oversees quality assurance for network performance.  The CC is encouraged to be innovative in improving research efficiency and quality.  

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 acquisition, formulation, and distribution of active and control compounds.  Candidate compounds/interventions for the network will be proposed through the companion FOA RFA-18-033 and selected following peer review.

Each Network site will propose one 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. The roles and responsibilities of the network sites are described more fully in the companion FOA, RFA-NS-18-033.

Expectations of the SPAN Coordinating Center

The CC provides scientific and organizational leadership to facilitate the conduct of preclinical studies within SPAN.  The CC is the administrative center of the network, with responsibility for maintaining the network’s infrastructure relevant to best practices consistent with those routinely used in clinical trials. Expertise in preclinical models of transient cerebral ischemia is not a requirement for the CC. However, the CC is required to have strong expertise in data management; statistical analysis, including adaptive trial design; drug formulation; complex project coordination; randomization; and blinding. Expertise in stroke research is desirable, but not required. In addition, the CC leads and manages the key SPAN governance committees: SPAN Steering Committee and the External Advisory Board (described below).  Specific activities could be performed through subcontracts, but the activities and the facilities need to be clearly described in the application.

Examples of responsibilities of the CC include the following:

  • Providing scientific leadership and regular communication to SPAN sites regarding protocols and study progression
  • Overseeing multiple concurrent protocols
  • Managing ongoing operational issues, such as subcontracts, protocol-specific site training, and site monitoring
  • Developing and implementing investigator and staff training programs
  • Organizing and implementing investigator meetings, including an annual in-person meeting to enable exchange of data and enhance synergy across the network
  • Overseeing drug/intervention and placebo control acquisition and distribution as needed
  • Developing operational guidelines and assuring compliance with protocols and reporting
  • Developing a plan for conflict resolution
  • Coordinating editorial and manuscript preparation
  • Managing data and resource sharing activities
  • Analyzing data and adjust protocols and interventions to be performed at each site, based on the adaptive design approach
  • Monitoring compliance with milestones to be determined at the time of the award.

The CC is expected to coordinate with the network sites to ensure that testing of the selected drugs/ intervention will start no later than 1 year after the award and will be completed in the remaining 2 years of the award.

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 (to facilitate a potential transition to clinical trials to be conducted in the future, if the intervention is successful in SPAN). 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.

.

The CC will be responsible for managing the logistics of committee activities, such as scheduling, soliciting agenda items, finalizing and distributing agendas, arranging and leading monthly teleconferences, preparing minutes, and making logistic and financial arrangements for annual in person SPAN meetings, including meeting space, accommodation, travel, per diem reimbursement, etc.

National Institute of Neurological Disorders and Stroke

The NINDS will be responsible for organizing and providing overall support for the SPAN network. NINDS Program and Grants Management staff 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 $500,000 in direct costs per year to fund one award for up to three years.

Award Budget

Application budgets may not exceed $500,000 in direct costs per year but need to reflect the actual needs of the proposed project.

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 the CC cannot be a SPAN network testing site.

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 PD/PI(s) should have documented experience and technical resources to manage a multi-site geographically dispersed consortium or network, in statistical analysis and adaptive trial design, drug formulation, data monitoring, data sharing, randomization, blinding and other rigorous procedures that are routinely used in clinical trials and that will be adopted in the SPAN preclinical network.

The PD/PI should be willing to commit a minimum of 3 personmonths effort, have documented expertise in leading multiple complex projects in parallel. It is critical to the success of the SPAN Network that the CC interacts effectively with the network project sites/PIs 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 biological data management.

The qualifications and experience of key personnel must be described, specifically documenting their respective abilities to organize and manage a CC.

 
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 specific aims to outline a clear strategy for implementing the goals of this FOA.

Research Strategy: Organize the Research Strategy by Significance, Innovation, and Approach. A milestone plan, under separate heading, must be included in the approach.

Significance: The Significance section should describe how the proposed CC infrastructure and organization will address primary goal of rapid identification of neuroprotective interventions as adjunctive therapies to recanalization. This section should provide justification and rationale indicating that the proposed team and plan can fulfill the role of the CC as the network’s information, data, and administrative hub, and will work closely, collaboratively and effectively with the individual projects’ PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board.

Innovation: Describe the leading and innovative tools and approaches that the proposed CC offers to the network in terms of data management, communication strategies, information technology, approaches to organization of meetings and conference calls, drug development and distribution, and other activities under the purview of the CC.

Approach: The approach should address administrative commitment, resources and ability to carry out the duties of the CC. The application must describe the current and/or planned organizational structure under which it proposes to operate. If the CC has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CC. Include the distance between these institutions (including administrative offices and shared resources) and location of proposed personnel.

Relevant Accomplishments: describe the group’s accomplishments relative to implementing procedures routinely used in clinical trials, such as randomization, blinding, monitoring of the sites, that would be applicable to the SPAN network. Describe relevant experience in drug procurement and formulation.

Describe the overall management plan, organizational hierarchy of the CC, its administrative structure, the communication plan, and the conflict resolution plan. Describe how the CC will organize, coordinate and administratively drive network-specific activities including: establishing the Steering Committee (the External Advisory Board will be established by the NINDS); organizing the  logistical components of all committee activities including, for example, scheduling, soliciting agenda items, finalizing and distributing agendas, arranging calls including conference calls, minutes (drafting, editing based on input, and finalizing); all logistic and financial requirements for in person network meetings including meeting space, accommodation, travel, per diem reimbursement, etc.; required sharing activities. The application should describe how the CC will work with multiple and de-centralized investigators and schedule large (dozens of participants) interactive conference calls including visual support. Indicate how members will be selected for Committees by nomination and vote. All Committees will be formed by 3 months after Notice of Grant Award.  SPAN Committees will include members from both the individual sites/projects of the network and the CC, as well as representation from the NINDS/NIH.

Describe how the CC will establish infrastructure, including processes for real-time data entry, data management, including quality assurance (e.g. accuracy, completeness, and internal consistency), and sharing (within the network and with external scientists after appropriate publication). Indicate how the CC will facilitate efficient and accurate incorporation of new and/or extant data via electronic data entry from remote locations. Indicate how the CC will assist in developing and build into its infrastructure the core set of data elements agreed upon by the network. Detail how the CC will harmonize compatible but not identically coded extant data across platforms for sharing and metanalyses. The application should explain the CC’s statistical expertise to help inform adaptive design and analyses. A plan for how the CC will monitor performance across the individual network sites should be described.

Milestone Plan: The application must include a 1-year well-defined Milestone Plan in the approach section with a timeline for establishing the CC to full functionality within the expectations indicated below. Milestones should be unambiguous, quantifiable, and justified. The final milestone plan is subject to concurrence by the CC and NINDS. The timeline and milestones will be used to evaluate applications both in peer review and also in consideration of the awarded CC for funding of non-competing award years. See the section below on Cooperative Agreement Terms and Conditions of Award for specific guidance on content and timing of Milestones. The final Milestone plan is subject to approval by NINDS.

  • Initiate calls to organize the Steering Committee by 1 month after Notice of Grant Award.
  • Organize the SPAN Kickoff Meeting to be held within 4 months of receiving a Notice of Grant Award.
  • Organize Annual meetings (1 per year within a month of annual date of original Notice of Grant Award).
  • Develop and test the CC’s information technology infrastructure for receiving real-time data entry from multiple remote locations (including imaging data) by the end of year 1.

    The application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility and how the responsibility is delegated among key/senior individuals. The qualifications, experience, and proposed duties of all proposed support personnel should be described.

    Applicants should provide clear scientific, administrative, and institutional commitments to collaborate with other funded network project investigators/sites to maximize time- and cost-efficiency of testing in parallel up to 6 various neuroprotective interventions.

Letters of Support: If the application includes subcontracts or subawards for particular components of the CC’s operational structure, it should include letters of support from consultants and/or sub awardees detailing the required expertise and available infrastructure. 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). Any conflicts 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. The sharing infrastructure and protocols must be able to facilitate sharing within the network and with scientists outside of the network (after projects are completed).
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 NINDS, 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 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 webinar 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 tofrances@mail.nih.gov prior to the webinar. 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.



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 center 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 center 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 proposed Center address the needs of the research projects/network that it will coordinate/administer/serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects/network? Is there evidence that the proposed team and plan can fulfill the role of the CC as the network's information, data, and administrative hub? Does the CC demonstrate clear understanding of the SPAN goals and the commitment to work closely, collaboratively and effectively with the individual projects' PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board?

Is there evidence that the proposed team and plan can fulfill the role of the CC as the network?s information, data, and administrative hub? Does the CC demonstrate clear understanding of the SPAN goals and the commitment to work closely, collaboratively and effectively with the individual projects? PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board?

Investigator(s)

Are the PD(s)/PI(s)/Directors and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing complex multi-site network or consortium projects? Do the PD(s)/PI(s), collaborators, and the overall research team have expertise in drug acquisition, formulation, and distribution? Do the PD(s)/PI(s) have the required expertise in implementing procedures routinely used in clinical trials, such as randomization, blinding, inclusion/exclusion criteria, pre-registration, monitoring of the sites, that would be applicable to the SPAN network? Do the PD(s)/PI(s) have adequate expertise in statistical analysis, including sample size determination and adaptive trial design? Is the PD/PI committing a minimum of 3 person months effort to the project? Does the application identify a dedicated staff member as key personnel to be the point of contact who has high motivation, excellent communication skills, significant training and experience with information technology and biological data management?

Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed? 

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects/network/ the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Does the CC offer innovative tools and approaches for data management, communication, information technology, organization of meetings and conference calls, and other activities under its purview? Does the application describe how an innovative preclinical adaptive design would be implemented?

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 and age, for studies in vertebrate animals?

Are the current and/or planned organizational structure, administrative structure and commitment and resources of the CC clearly described and well-suited to accomplish the aims of the project? If the CC has more than one component/affiliate institution, are the relationship and distance of component(s)/affiliate(s) to each other and to the CC reasonable to allow efficient communication and operation? Does the CC have the required expertise in implementing procedures routinely used in clinical trials, such as randomization, blinding, inclusion/exclusion criteria, pre-registration, monitoring of the sites, that would be applicable to the SPAN network? Is the plan for drug formulation and distribution appropriate?

Does the application include well described and appropriate communication and conflict resolution plans? Does it include a feasible and appropriate description of how the CC will organize, coordinate and administratively drive network-specific activities including: establishing the Steering Committee; logistical components of committee activities including, for example, scheduling, soliciting agenda items, finalizing and distributing agendas, arranging calls including conference calls, minutes (drafting, editing based on input, and finalizing); all logistic and financial requirements for in person network meetings including meeting space, accommodation, travel, per diem reimbursement, etc.; required sharing activities? Is it indicated how SPAN network members will be selected for Committees by nomination and vote?

Is the description of how the CC will work with multiple and de-centralized investigators and schedule large (dozens of participants) interactive conference calls including with visual support feasible and appropriate?

Is it described how the CC will establish infrastructure, including for real time electronic data entry, to collect, curate for quality (e.g. accuracy, completeness, and internal consistency), display, house, and distribute data, including all relevant control data (within the network and with external scientists after appropriate publication) and how the CC will facilitate efficient and accurate incorporation of new and/or extant data via electronic data entry from remote locations? Is it described how the CC will assist in developing and build into its infrastructure the core set of de-identified data elements agreed upon by the network and how the CC will receive in real time, and by remote electronic submission, data from up to 6 sites, and distribute data to approximately the same number of sites? Does the application explain how the CC will harmonize compatible but not identically coded extant data across platforms for sharing and meta-analyses? Is the plan to monitor performance and collect data from the individual project sites included and appropriate?

Does the application include a description of appropriate procedures for data collection and study monitoring, as well as internal quality assurance plan and procedures of the CC? Assurance of quality is a joint responsibility of the CC and the individual project sites.

Is there a clear scientific, administrative, and institutional commitment to collaborate with other funded network project investigators/sites to maximize time- and cost-efficiency of testing in parallel up to 6 various neuroprotective interventions?

Does the project include an appropriate and feasible Milestone Plan, with a timeline for establishing the CC to full functionality?

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 institutional environment in which the Center will operate contribute to the probability of success in facilitating the research projects/network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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 applications:

  • 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:

The SPAN Network CC PD/PI(s) will have the primary responsibility for:

  • Designing, leading and implementing all aspects of the SPAN CC as described in this FOA;
  • Setting milestones, subject to concurrence of the CC Program Director;
  • Ensuring adherence to all applicable NIH/NINDS policies including for data sharing and reporting and assisting sites with development of standard protocols involving vertebrate animals;
  • Analyzing and publishing results, interpretations and conclusions of the studies, in collaboration with the network PIs, and providing overall scientific and administrative leadership for the research projects;
  • Establishing and overseeing the SPAN Steering Committee;
  • Reporting to NINDS regarding timeline and milestone achievement and annual progress reports;
  • Coordinating and monitoring all projects within the SPAN Network;
  • Scheduling and participating in all network teleconferences and investigator meetings, including Kickoff and Annual in-person SPAN network meetings;
  • Coordinating and facilitating development and implementation of network-specific protocols and policies (e.g. regarding pre-registration, randomization, blinding, publication, sharing, etc., as applicable);
  • Providing appropriate guidance to network sites/PIs;
  • Providing quality assurance monitoring.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in typical research 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 Project Scientists will be to facilitate and not to direct or drive the activities.  The NINDS will establish a Steering Committee to assist in determining, in conjunction with the External Advisory Board Committee, the broad direction of the network.

NINDS Program staff will:

  • Contribute to the adjustment of research protocols or approaches as warranted;
  • Contribute to develop final milestones for the study;
  • Serve as a liaison between the awardees, the NINDS Advisory Council and the larger scientific community; 
  • Establish the External Advisory Board Committee;
  • Serve on committees of the SPAN network as appropriate;
  • Assist in promoting the availability of data and resources developed during the 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.

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: (1) a designee of the Advisory Committee chosen without NIH staff voting, (2) one NIH designee, and (3) a third designee with expertise in the relevant area who is chosen by the first two members; in the case of disagreement between the first two members, the third member will be chosen by the Consortium-elected Chair of the Steering Committee. This 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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