Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Testing Laboratories (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
Reissue of RFA-NS-18-033
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-NS-22-003
Companion Funding Opportunity
RFA-NS-22-004 , U24 Resource-Related Research Project (Cooperative Agreements)
RFA-NS-22-032 , U01 Research Project (Cooperative Agreements)
RFA-NS-22-033 , U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
Assistance Listing Number(s)
93.853
Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications for testing laboratories to take part in the NINDS Stroke Preclinical Assessment Network (SPAN).SPAN will facilitate the testing of up to 8 promising cerebroprotective 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 (tMCAO)). Awarded testing laboratories will compose the main infrastructure of the network and will be expected to work with the SPAN Coordinating Center and intervention contributors to facilitate the parallel testing of multiple cerebroprotective interventions in experimental models of ischemic stroke. 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.

This FOA only solicits applications for SPAN testing laboratories. As such, applications should solely focus on the expertise and infrastructure that each prospective testing site can bring to SPAN. Separate FOAs are issued to solicit applications for specific cerebroprotective intervention research projects to be tested in SPAN (RFA-NS-22-032, RFA-NS-22-033) and for the Coordinating Center (RFA-NS-22-004).

Key Dates

Posted Date
January 06, 2022
Open Date (Earliest Submission Date)
February 14, 2022
Letter of Intent Due Date(s)

30 days prior to application due date.

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 14, 2022 Not Applicable Not Applicable July 2022 October 2022 December 2022

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
March 15, 2022
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 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.

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 testing laboratories to take part in the NINDS Stroke Preclinical Assessment Network (SPAN).SPAN will support late-stage preclinical studies of putative cerebroprotectants to be given prior to or at the time of reperfusion in models of transient middle cerebral artery occlusion (tMCAo), with clinically relevant long-term outcomes and in models of comorbidities. Each testing laboratory will be responsible for the parallel testing of up to 8 selected cerebroprotective interventions that will be chosen from among well-scoring applications submitted under the companion SPAN intervention FOA (RFA-NS-22-032). The overall goal is to determine whether such interventions can significantly improve outcome compared to reperfusion alone and/or extend the therapeutic window for reperfusion, in the hopes of guiding 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 8 testing laboratories, which will assess up to 8 interventions. 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 a 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 for ischemic stroke, offering the opportunity to significantly improve clinical outcome in selected patients that have salvageable tissue treated as late as 24 hours after their stroke. Unfortunately, despite the success of EVT in clinical trials, many patients still experience neurological deficits following therapy. Thus, there is a critical need to develop adjunctive approaches to improve long-term outcomes after ischemic stroke. These recent advances in stroke treatment such as EVT now offer a new and timely opportunity to further evaluate the potential benefit of cerebrovascular protective agents in the context of mechanical revascularization. Indeed, a cerebroprotectant that can stabilize the stroke penumbra or reduce the rate of infarct core expansion may offer significant benefit if administered as early as possible in a stroke’s evolution.

In 2018, the NINDS launched the Stroke Preclinical Assessment Network (SPAN), the first iteration of which consisted of one coordinating center (CC) and six study sites, each of which proposed a promising neuroprotective modality, all selected through rigorous NIH peer review. The network was designed to perform highly rigorous and reliable preclinical testing with a timeline and resources that would not be possible for a single laboratory, while at the same time allowing a blinded head-to-head comparison of each putative neuroprotective therapy. It also developed a rigorous data analysis pipeline that involves deposition of all raw experimental data from each site into a centralized, secure database followed by randomized assignment of the de-identified data to blinded reviewers at each of the six sites for analysis. During the first funding cycle, the SPAN network successfully demonstrated its ability to test interventions in a time and cost-effective manner. As a result, the NINDS now wishes to build on this momentum by further expanding the network to include more testing sites and promising cerebroprotective interventions.

Research Objectives

The overall goal of this program is to support a preclinical stroke network to conduct late-stage preclinical studies of potential cerebrovascular protective strategies to be given prior to or at the time of reperfusion. SPAN will test in parallel up to 8 compounds/interventions in animal models of tMCAo following the same rigor and methodology characteristic of clinical trials. The parallel testing of multiple interventions, including an adaptive experimental design that will eliminate compounds that do not demonstrate significant efficacy compared to the others, 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 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.

Selected testing laboratories will contribute to these objectives by collaborating with the SPAN Coordinating Center (RFA-NS-22-004) and intervention contributors (RFA-NS-22-032, RFA-NS-22-033) to conduct rigorous preclinical testing of SPAN cerebroprotective interventions in the rodent tMCAo model of experimental stroke. Testing laboratories will be expected to: perform all stroke surgeries; treat stroked animals with cerebroprotective interventions or vehicle control; monitor clinically relevant outcome measures such as small animal neuroimaging and behavioral testing at selected timepoints; and participate in the analysis of blinded data from other testing sites.

SPAN Organization

The Coordinating Center (CC) provides scientific and organizational leadership to SPAN to achieve both efficiency and excellence in the implementation and performance of cerebroprotective intervention testing protocols. The CC will work collaboratively with the testing sites, intervention contributors, and the NINDS to provide overall study coordination, including animal enrollment, oversight of study protocols, monitoring of the individual sites, data analysis, data management, data sharing, and reporting. Additionally, the CC will be responsible for the acquisition, formulation, and distribution of active and control compounds.Limited competition for the CC will be proposed through the companion FOA RFA-NS-22-004.

Up to 8 selected cerebroprotective interventions will be tested in parallel in SPAN in a controlled, randomized, and blinded fashion. Such interventions may be proposed by academic, small business, or industry investigators. The proposed interventions should be mature to potentially rapidly advance to a clinical trial at the end of the testing phase. All selected interventions will be assessed by the testing laboratories following standard protocols and procedures, under the direction and leadership of the CC. Candidate compounds/interventions for the network will be proposed through the companion FOAs RFA-NS-22-032 and RFA-NS-22-033 (SBIR) and selected following peer review.

SPAN testing laboratories will conduct tests of selected cerebroprotective interventions that will be chosen from well-scoring applications submitted under the companion intervention RFAs. Testing laboratory applications should focus solely on the expertise and infrastructure that each prospective site can bring to SPAN. It is expected that SPAN sites will be academic or other preclinical research laboratories with documented expertise in the rodent tMCAo model of ischemic stroke and relevant comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.). In addition, laboratories must demonstrate expertise in the assessment of clinically relevant, long-term functional outcome measures, with a particular emphasis on small rodent neuroimaging and behavioral testing. It is an absolute requirement that laboratories have extensive access to animal MRI facilities. All applicants must also agree to test multiple interventions in collaboration with the other testing laboratories in a randomized and blinded fashion, as directed by the SPAN CC.

The governing body of the network is the SPAN Steering Committee, which will consist of the PD/PI of the CC, the PD/PI of each of the network’s testing laboratories, the PD/PI of each selected intervention, and NINDS Program staff. 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. The NINDS Director has the right to supersede any decision by the network at any time.

Finally, there is also an independent External Advisory Board, appointed by and reporting to NINDS, which includes basic and clinician scientists with expertise in cerebroprotection, representatives from pharmaceutical and biotech industry, experts in regulatory affairs, statistics, and clinical trial design, and representatives from the NINDS 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).

Characteristics, Roles, and Responsibilities of SPAN Testing Laboratory PIs

It is expected that SPAN testing laboratories will be academic or other preclinical research laboratories with documented expertise in the rodent tMCAo model of ischemic stroke and related relevant comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.). Each testing lab will be required to conduct tests of the selected interventions (up to 8 selected through peer review) following standard protocols and procedures that have been developed by the CC.

Please note that the dissociation of SPAN testing laboratories from intervention research projects is a significant change from the prior SPAN funding period. In the prior cycle, the testing laboratories were also required to propose the interventions that would be tested. In contrast, for this current FOA, applications should not propose an intervention-related research project- rather, they should solely focus on the expertise and infrastructure that each prospective testing laboratory can bring to the network. For applicants who are instead interested in proposing an intervention research project, please see RFA-NS-22-032 and RFA-NS-22-033.

Applicants should consider the following factors:

  • Applications to this FOA should be solely focused on the expertise and infrastructure that each prospective testing laboratory can bring to SPAN. Applications will be required to incorporate other SPAN network infrastructure into their proposed study, including central coordination and data management through the CC.
  • Sites must demonstrate proven expertise in the successful performance of the rodent filament model of tMCAo, including in animal models of relevant comorbidities (i.e., aging, hypertension, diabetes, obesity, etc.). They must also demonstrate their ability to administer drug agents via the IP and/or IV route. While SPAN is currently solely focused on rodent models of tMCAo, expertise with non-rodent experimental stroke models is also desirable and can be mentioned in the application.
  • In addition, testing laboratories must be highly experienced with the assessment of clinically relevant, long-term functional outcomes after experimental stroke, with a specific emphasis on neuroimaging and behavioral testing. Assurances that prospective testing laboratories have sufficient, repeated access to small rodent neuroimaging facilities is a requirement of the application.
  • PDs/PIs of SPAN testing laboratories are required to commit a minimum of 2 calendar months effort per year to the network. They must also incorporate a minimum of two full time technicians or post-docs into the application budget, who will be responsible for the timely performance of MCAo surgeries, drug treatments, assessment of outcome measures, and analysis of data. SPAN’s current weekly throughput for tMCAo surgeries is approximately 8 surgeries per week for the past 48 weeks, so PDs/PIs must explicitly state that their lab will have available bandwidth to accommodate at least this number of experiments.
  • Applicants must agree that the selected interventions will be tested in parallel, in collaboration with the other testing laboratories, in a randomized and blinded fashion. Interventions that appear less efficacious will be removed from further testing; those that demonstrate stronger efficacy will be prioritized, as appropriate, with the use of an adaptive design. Laboratories will be blinded to treatment allocation throughout the study and all primary data will be submitted to the CC, which will further distribute it among the sites for blinded analysis. While it is not required that every site participate in the testing of all 8 cerebroprotective interventions, PDs/PIs should be prepared to test multiple interventions at the same time.
  • All applicants funded under this FOA must participate in and accept responsibility for driving the scientific objectives of the network and agree to become active members of the SPAN Steering Committee.

Responsive Applications to this FOA

All applications to this FOA must at a minimum incorporate the following features:

  • Applications are limited to testing laboratories that will perform blinded preclinical trials of up to 8 cerebroprotective interventions for acute ischemic stroke in preclinical rodent models of tMCAo.
  • Proposed laboratories must have substantial expertise in each of the following: the rodent filament model of tMCAo; animal models of relevant stroke comorbidities; and the assessment of clinically relevant neuroimaging and behavioral outcome measures after experimental stroke.
  • Repeated access to small rodent neuroimaging facilities is an absolute requirement.
  • Testing laboratory PIs must agree to test up to 8 blinded cerebroprotective interventions, as directed by the CC.
  • All applications must include a clear statement of PI/institutional commitment to the SPAN network and their willingness to participate in SPAN scientific planning (via the SPAN Steering Committee)

Applications Not Responsive to this FOA

Applications that do not meet the stated scope and requirements of this FOA will be considered non-responsive and may not be reviewed for this FOA. Characteristics of non-responsive applications that are considered outside the scope of this FOA include, but are not limited to, the following:

  • Applications that propose a research project for a particular cerebroprotective intervention will be considered out of scope for this FOA, which is instead limited to applications for SPAN testing laboratory infrastructure. Cerebroprotective intervention research projects should be submitted under the companion FOAs for SPAN interventions (RFA-NS-22-032, RFA-NS-22-033). While applications can be submitted to both the SPAN testing laboratory and intervention FOAs, an award would only be made to one or the other to avoid a conflict of interest (i.e., a PD/PI can serve as either a testing laboratory or an intervention contributor, but not both).
  • Applications that propose infrastructure/expertise involving experimental stroke models other than transient cerebral ischemia will be considered out of scope. Out of scope experimental models would include: hemorrhagic stroke, neonatal hypoxia-ischemia/pediatric stroke, cardiac arrest-induced global ischemia models, among others.
  • Applications that do not describe the testing laboratory's ability to assess experimental stroke via advanced neuroimaging and long-term behavioral outcomes will be out of scope.

Opportunities for Partnership

Projects involving partnerships with industry, small businesses or non-government organizations are encouraged under this FOA. Small businesses with potential promising cerebroprotective interventions that are responsive to this RFA could refer to the companion RFA-NS-22-033. 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, a NINDS Project Scientist will be involved substantially with the awardees as a 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. Only those application types listed here are allowed for this FOA.

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 $3,200,000 in direct costs per year to fund up to 8 awards for 3 years, pending the availability of funds and a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $400,000 in direct costs per year for 3 years.

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)

Local 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)

Federal Government

  • 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.

  • System for Award Management (SAM) – 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. 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 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.

It is preferable that only one PD/PI be identified on each testing laboratory application.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

While applications from the same institution can be submitted to both the SPAN testing laboratory and intervention FOAs, an award would only be made for one or the other to avoid a conflict of interest (i.e., an institution can serve as either a testing laboratory or an intervention contributor, but not both). Likewise, the recipient of a CC U24 is ineligible for a second SPAN award under either the testing lab or interventions FOAs.

To diversify the network, only one testing laboratory award per institution is allowed. A testing laboratory application must be from a single institution, which may include geographically or organizationally linked partners or sites, though this is not required.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

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:
 span@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 investigative team of the SPAN testing laboratory must demonstrate published expertise in the rodent tMCAo model of ischemic stroke, neuroprotection, rigorous experimental design, behavioral assessments including motor and cognitive outcomes, small animal neuroimaging, and the preclinical modeling of relevant stroke comorbidities (i.e., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.). The PI must be willing to commit a minimum of 2 person months effort and have documented expertise in leading multiple complex projects in parallel. It is critical to the success of the SPAN network that the testing laboratory PIs interact effectively and collaboratively with the CC, intervention contributors, and the NINDS. Therefore, in addition to the required strong leadership and staff with highly specialized expertise, the testing laboratory must include a dedicated staff member as key personnel who will be the point of contact for the CC and NINDS, is highly motivated, has excellent communication skills, and has significant training and experience in rodent tMCAo surgeries and behavioral testing.

R&R or Modular Budget

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 investigative team in rigorous preclinical modeling of transient cerebral ischemia, neuroprotection, advanced neuroimaging, drug testing, 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.

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

Significance: Describe the overall motivation of the team to participate as a SPAN testing laboratory. In addition, this section of the application should include rigorous preliminary data demonstrating the team’s expertise in the preclinical modeling of transient cerebral ischemia, implementing rigor’s guidelines, cerebroprotective treatments, advanced neuroimaging, and clinically relevant behavioral outcome measures.

Innovation: Describe the cutting edge, innovative, and clinically relevant attributes that the testing laboratory brings to SPAN, 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 site 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 potential assays and methodologies that will be used to test cerebroprotection, and whether or not these measures are quantitative, robust, reproducible, clinically relevant and clearly linked to cerebroprotection 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. It should also describe how the testing laboratory would perform the following: blinding of a proposed intervention, sample size calculation/power analysis, and training of site personnel. Finally, applicants should also describe the capacity of the site to access rodent MRI facilities, run multiple studies in parallel, and provide clear scientific, administrative, and institutional commitments to collaborate with other funded network investigators/sites and the CC to maximize time- and cost-efficiency of testing in parallel up to 8 various cerebroprotective interventions and respective controls.

Milestone Plan: The plan should include a yearly, well-defined, stage-appropriate milestone plan that describes how the testing site will be incorporated into the SPAN network. This should include 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 one.
  • Agreement to test multiple interventions from other sites, 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.
  • Establish any and all reliance agreements, MTAs, and/or subcontracts that will facilitate the transfer of cerebroprotective agents between the testing laboratories and CC, as appropriate.

Letters of Support: If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NINDS or other governmental and 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 resources 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, must 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
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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.

Please notify the NINDS Program Officer by email at span@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.  Applications submitted to the NIH in support of the NIH mission 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 the prior research that serves as the key support for the proposed project rigorous? 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 the feasibility of the laboratory and investigative team to successfully participate in SPAN?

Investigator(s)

Does the investigative team have published experience in preclinical modeling of transient cerebral ischemia, cerebroprotection, 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.)?

Is the PI/PD’s and investigative team’s proposed level of effort adequate for the testing requirements of the network?

Innovation

Are new long-term outcome measures or neuroimaging endpoints clinically relevant and/or novel?

Are the proposed methods and techniques state of the art and do they have the potential to advance the field of cerebroprotection in the context of the latest advances in endovascular therapy and overall standard of care for acute ischemic stroke patients?

Approach

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the techniques and assays proposed to test cerebroprotective interventions appropriate and clinically relevant?

Are the assays and outcome measures quantitative, robust, reproducible and clearly linked to cerebroprotection?

Is the interaction between the testing laboratory and the CC clearly described?

How appropriate are the plans for training of site personnel?

Are the yearly milestones well defined, quantitative and with clear go/no-go criteria? How likely is the lab to be incorporated into the network within the first year of the project period? How will the site collaborate with other funded network sites/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 8 neuroprotective drugs/interventions?

How well does the Data Sharing Plan provide a summary of the shared data, a description of the data standards, a plan for the data archiving, and a timeline for data submission to the archive and sharing data with the research community?

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?

Does the laboratory have access to a rodent MRI facility with dedicated time?

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

.Generally not applicble. Reviewers will bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.

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) Sharing Model Organisms; and (2)  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 will receive a written critique.

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.

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 recipient's business official.

Recipients 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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. 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.

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.

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 75.205and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 75, 2 CFR Part 200 , 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 recipientsis 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 recipientsfor 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.
  • Recipientsare 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 Project Scientist 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 Project Scientist 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 recipients, 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 recipients in the development, if needed, of policies for dealing with situations that require coordinated action.

Additionally, NINDS Program Officer 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.

  • 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: 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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)


National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431

Email: span@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)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email:ChiefGrantsManagementOfficer@ninds.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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