Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)

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)

Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)

Funding Opportunity Title

Biological
Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in
Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54
Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Funding Opportunity Announcement (FOA) Number

RFA-NS-19-022

Companion Funding Opportunity

None

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

93.853, 93.865

Key Dates

Posted Date

February 7, 2019

Open Date (Earliest Submission Date)

March 10, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

April 10, 2019, 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.

No late applications will be accepted for this Funding
Opportunity Announcement.

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

July 2019

Advisory Council Review

August 2019

Earliest Start Date

October 2019

Expiration Date

April 11, 2019

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Multi-Project (M)
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. Table of Contents

    Part 1. Overview Information

    Part 2. Full Text of the Announcement

    Section
    I. Funding Opportunity Description

    Section II. Award InformationSection III. Eligibility InformationSection IV. Application and Submission
    Information
    Section V. Application Review InformationSection VI. Award Administration InformationSection VII. Agency ContactsSection VIII. Other Information



    Part 2.
    Full Text of Announcement

    Section I. Funding Opportunity Description

    Data from the Centers for Disease Control and Prevention
    illustrate the high burden of pediatric brain injury with approximately 640,000
    traumatic brain injury (TBI)-related emergency department (ED) visits, 18,000
    TBI-related hospitalizations, and 1,500 TBI-related deaths reported among
    children 14 years of age and younger in 2013.  Since early adolescence is a
    critical period for several neurodevelopmental processes associated with
    cognition, emotion, and psychosocial behaviors, the pre-adolescent and
    adolescent age groups may be at increased risk for the effects of brain insult
    and injury that can cause negative long-term neurobiological and behavioral
    consequences. Therefore, this FOA will focus on Early (11-14 years old) and
    Middle (15-17 years old) adolescent stages as defined using the Bright Futures guidelines
    developed by the American Academy of Pediatrics.

    Both concussion itself and exposure to repeated head impacts
    can lead to a complex expression of concussive-type symptoms.  A concussion can
    present as a heterogeneous combination of symptoms across multiple domains,
    including but not limited to, the cognitive, behavioral, oculomotor,
    vestibular, disrupted sleep, psychosocial, and affective domains.  Usually, these
    symptoms are self-reported and resolve within 7 to 10 days after onset;
    however, a subset of patients experience prolonged, persistent concussive
    symptoms beyond the typical recovery period.  Further development of a
    clinically relevant risk-stratification algorithm for identification of the
    subset of patients that will experience persistent concussive symptoms would
    have utility both in clinical management and patient enrichment for future
    clinical trials.  Currently, clinical outcome assessment measures including
    balance, fatigue, migraine history, and mental health history coupled with
    demographics, such as sex, age and education, have been shown to improve
    prognostic risk-stratification for persistent symptoms. Nevertheless, in
    adolescents, there is a lack of information about the biological mechanisms
    that underlie outcome, and measures such as blood protein levels, neuroimaging,
    or ocular motor function, etc. that may improve prognostication for and
    monitoring of recovery from persistent concussion symptoms. Persistent
    concussive symptoms often result in decreased academic performance and can lead
    to reduced quality of life.  Because clinicians generally diagnose concussion
    and monitor recovery from concussion primarily based on self-reporting of symptoms,
    younger patients present a particular challenge in that they may lack proper
    insight and communication skills to reliably report their symptoms. This
    dilemma reinforces the need for objective biological measures that accurately
    reflect concussion symptoms and degrees of recovery.  Moreover, the lack of
    well-defined biologic mechanisms, and validated biological measures for
    prognosing and monitoring persistent concussive symptoms hampers the
    development and selection of appropriate therapies and treatment.  Current TBI
    research initiatives that focus on providing insight into the acute and
    subsequent course of recovery from concussion have not concentrated on peri-adolescent
    populations.  Consequently, little is known about the acute and persistent effects
    of concussion in this age group. 

    In October 2016, NIH convened TBI researchers, experts on
    brain development, clinicians who treat pediatric concussion, and patient
    advocates to discuss pediatric concussion. The deliberations focused on the
    state of the science, the adequacy of current diagnostic tools and treatments,
    ongoing research supported by the NIH and the Canadian Institutes of Health
    Research (CIHR), and feasible study designs to address major gaps in knowledge.
     Workshop attendees agreed that objective measures are needed to improve the
    prognosis and recovery monitoring of pediatric presenting with concussion
    and/or persistent concussive symptoms. Ultimately, these objective measures
    would be included in a risk stratification model for persistent concussive
    symptoms that will enhance clinical care and improve patient stratification for
    future clinical trials. To accomplish this goal, the Stakeholders recommended
    the collection of a dataset that will provide phenotypic, biological, and clinical
    data across the course of injury in an early adolescent population. Moreover, workshop
    participants suggested that this dataset should leverage the active NIH Adolescent Brain Cognitive Development (ABCD) study and other large TBI observational studies by harmonizing data collection
    protocols and implementing an accelerated data sharing plan when appropriate.

    Specific
    Research Objectives

    This FOA solicits multicenter applications from
    multidisciplinary groups who wish to (1) discover and validate a set of objective
    biological measures that underlie post-injury disability and will improve
    accuracy for prognosticating and monitoring persistent concussive symptoms that
    result from concussion and/or repetitive head impacts, (2) develop a clinically
    useful risk stratification algorithm that incorporates these biological
    measures with current clinical and self-report measures (e.g., The Rivermead
    Postconcussive Symptom Questionnaire, Pediatric Quality of Life Inventory, or
    Post-Concussion Symptom Inventory for Children), and (3) provide the broader
    scientific community with a data resource for hypothesis generation, test
    validation, and discovery related to pediatric concussion using data sharing
    through the Federal Interagency TBI Research
    (FITBIR)
    (https://fitbir.nih.gov/) database and the NINDS biomarker repository,
    BioSEND (https://www.biosend.org/).

    Specific
    Areas of Research Interest

    Applications to this FOA will be
    expected to work synergistically to discover, characterize, and validate a
    combination of biological measures for prognosis and/or monitoring recovery of
    persistent concussive symptoms with enrollment from multiple points of care
    (e.g., Emergency Departments, urgent care clinics, primary care,
    concussion/sports medicine clinics, or other specialty clinics) and
    participants with a variety of injury mechanisms (e.g., falls, sports, abusive
    head trauma, automobile accidents).  Biological measures that are responsive
    may include, but are not limited to, neuroimaging, electroencephalography,
    oculomotor control, vestibular function, measures of auditory processing and
    speech production, autonomic responses, metabolomics, proteomics and other
    biofluid-based assays.  Applications’ analysis plans are also expected to
    include potential mediating factors such as medication and the type and amount
    of post-injury treatment and rehabilitation provided to participants.

    Scientific projects must include
    both a discovery and external validation stage to their project whereby
    performance of the biological measures assessed during the discovery stage are
    externally validated.  Validated measures should then be incorporated into a
    clinical risk stratification algorithm for persistent concussive symptoms in
    early and middle adolescent (EMA) populations.

    Examples of clinical research designs that would be responsive
    under this FOA should include, but are not limited to:

  • A well-phenotyped prospective cohort study using EMA persons
    presenting with acute injury (< 3 days) and those presenting with persistent concussive symptoms (>3 months).
  • A Cross-Sequential study design using EMA persons presenting with
    acute injury (< 3 days) and those presenting with persistent concussive symptoms (>3 months).

Non-responsive studies include:

  • Use of pre-injury prospective designs that rely on concussion
    incidence rates as the source of recruiting acutely injured participants.
  • Studies limited to only one injury mechanism, e.g.,
    sports-related concussion, or limited to a single point of care, e.g.,
    recruitment only in emergency departments.
  • Clinical Efficacy trials assessing multiple post-injury treatment
    protocols.
  • Preclinical research studies using animal models of TBI and PCS.

As the research strategy is
prepared, it is important to note that NINDS believes applications will be
greatly strengthened if the rigorous design, execution, and interpretation of
the proposed studies and supporting data are adequately described. NINDS
encourages investigators, whenever possible, to address these elements directly
in their applications. Investigators are urged to discuss these issues with
Scientific/Research staff prior to submission of applications (see: NOT-NS-11-023 and NOT-OD-15-103).
The NINDS also expects that applications will conform to the principles
outlined in Landis
et al., 2012
 and show consideration for biological variables described
in NOT-OD-15-102.
Applications deemed not responsive to the FOA will be withdrawn.

Common
Data Element Use and Data Sharing

It is
expected that the PCS-EMA CWOW will incorporate the NINDS Core TBI pediatric common
data elements (CDEs) and appropriate Core CDEs in the NINDS TBI CDE set.

Additionally, studies are required to use NINDS CDEs for
both outcome and non-outcome measures (including, but not limited to
demographics, medical and injury history, history of abusive injury, family
history,  medications, neuroimaging, rehabilitation strategy, and standardized
outcome assessments) as described by the NINDS
CDE Project
.  

In order to advance the goal of widespread data sharing,
investigators funded under this FOA are expected to share all data collected in
this FOA via FITBIR, as appropriate and
consistent with achieving the goals of this program. FITBIR staff will
work with investigators to help them submit data types consistent with the FITBIR Data Dictionary and the NINDS CDE program. For answers to frequently asked questions and how to
contact FITBIR, please see: https://fitbir.nih.gov/content/contact-us.
To ensure maximal value of the project for the broader research community, the
PCS-EMA CWOW will be expected to share a “limited” clinical dataset (e.g.,
clinical assessment & outcome measures, symptom lists, mechanism of injury,
demographics, etc.), excluding biological measures, in a FITBIR limited-access
“public” state no more than 1-year after collection, as appropriate and
consistent with achieving the goals of this program.

Biological
Samples

All biological specimens are expected
to be banked at the NINDS BioSEND Biomarkers
Repository
.  When appropriate, biospecimens must be collected per NINDS
Biomarkers Repository protocols
and procedures, and all specimens collected
must come from individuals who have consented to banking and sharing broadly
with academia and industry.

Note that costs for collection are
NOT included as a component of the NINDS BioSEND Biomarkers Repository award.
Therefore, most costs for the biospecimen banking are borne by the grantees
utilizing this resource (see NOT-NS-15-046)
and should be budgeted for in the application. Applicants planning projects in
which biospecimens will be collected are strongly advised to consult the NINDS
Biomarkers Repository website for more information about samples banked at the
repository (https://www.biosend.org). In
addition, applicants are advised to consult with NINDS Biomarkers Repository
staff to obtain a quote for biospecimen banking costs (email: biosend@iu.edu).

Imaging
Based Studies

For applications proposing to include neuroimaging, the
NINDS neuroimaging CDEs and imaging protocols should, as much as possible,
align with existing large federally-funded TBI and/or adolescent cohort studies
(e.g., TRACK-TBI ; NCAA/DoD CARE Consortium, Chronic Effects of Neurotrauma Consortium,
NIH’s Adolescent Brain
Cognitive Development Study
(ABCD)).  Further, when incorporating
neuroimaging methods, consideration should be taken regarding the feasibility
of carrying out the proposed methods in a non-research environment (e.g.,
non-academic hospitals).

Special Consideration

Required
components:

Each application must have an Administrative Core, a Data
Coordinating Research Core, and at least three Research Projects. The Research
Projects must interact and synergize with other projects and cores within the PCS-EMA
CWOW. 

Administrative Core: The Program Director(s)/Principal
Investigators (PD/PIs) should serve as the lead(s) of this Core. The
Administrative Core should coordinate the integration and management of
activities within the Center including management of
reporting, establishing milestones, organizing communications among sites, and
resolving disputes.

Data Coordinating Core: The Data Coordinating Core (DCC) must
provide a data management plan capable of coordinating and curating data
collected across all PCS-EMA CWOW research projects. The DCC will be responsible for data submission to the FITBIR informatics platform and be able to coordinate
with the NINDS biomarker repository, BioSEND.  
The end goal of the data management plan should be to develop a resource of
clinical, neuroimaging, behavioral, and biological data for the broader
scientific community.

Research Projects: Any combination
of at least three research projects can be used to address the list of research
areas of interest.  In the discovery stage, each research project should focus
on discovery and determining the selectivity and sensitivity of a unique
individual or set of biological measures.  Where feasible, each project’s
biological measures should be collected across all research projects.  For
external validation, each of the research projects should collect the full set
of biological measures to be validated.  Following validation, a risk
stratification algorithm for prognosing or monitoring recovery of persistent
concussive symptoms in a pediatric population should be developed.

Milestones: Milestones are required for all studies and must
address data sharing progress as described in NOT-NS-17-029.
Applicants should propose annual milestones that provide clear go/no-go
decision points for evaluating a project’s continued success or emergent
difficulties and will be used to evaluate the application not only in peer
review but also in consideration of the awarded project for funding of
non-competing award years.  Achievement of milestones will be evaluated by
NINDS Program staff, and funding of non-competing award years will depend on
milestone accomplishments.  Milestones should also include clear
quantitative thresholds for determining whether specific or a combination of
biological measures will move on from the discovery to the validation stage.

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.

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit the
following amounts in FY 2019:

NINDS intends to commit, $2,000,000 direct costs, to fund
1 award.

NICHD intends to commit, $250,000 direct costs, to fund a
Core of 1 award.

Award Budget

Application budgets are limited to $2,250,000 direct costs
per year but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum project period is 5 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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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 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) – 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.
  • o   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. 
  • eRA Commons – Applicants
    must have an active DUNS number to register in eRA Commons. Organizations can
    register with the eRA Commons as they are working through their SAM or
    Grants.gov registration, but 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 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

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.  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).

Section IV. Application and Submission Information

1. Requesting an
Application Package

The application forms package specific to this opportunity
must be accessed through ASSIST or an institutional system-to-system solution. A
button to apply using ASSIST is 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 Multi-Project (M) Instructions
in the SF424
(R&R) Application Guide
, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. 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:

Patrick SF Bellgowan, PhD


Telephone: 301-496-1447


Fax: 301-480-1080


Email: psfb@mail.nih.gov

Page Limitations

Available
Component Types

Research
Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Data Coordinating Core

6

Research Projects

12

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits
must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required, maximum of 1
  • Data Coordinating Core: required, maximum 1
  • Research Projects: minimum of 3

Overall Component

When preparing your application, use Component Type
‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell
lines from other components should be repeated in cell line table in Overall
component.

Research & Related Other
Project Information (Overall)

Follow standard instructions.

Project/Performance Site
Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance
Sites in the Overall section of the assembled application image in eRA Commons
compiled from data collected in the other components will be generated upon
submission.

Research & Related
Senior/Key Person Profile (Overall)

Include only the Project
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
this FOA) for the entire application.

A summary of Senior/Key Persons
followed by their Biographical Sketches in the Overall section of the assembled
application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information
included in the Overall component is the Estimated Project Funding section of
the SF424 (R&R) Cover.

Budget considerations should include, but are not limited
to:

  • Estimated
    costs per year for clinical, neuroimaging, and physiological data curation and
    data sharing through FITBIR.
  • Estimated
    costs per year for biospecimen storage at the NINDS
    BioSEND biospecimen repository

A budget summary in the Overall
section of the assembled application image in eRA Commons compiled from
detailed budget data collected in the other components will be generated upon
submission.

PHS 398 Research Plan (Overall)

Specific Aims: The specific
aims should outline the overall vision of the PCS-EMA CWOW.  The Aims should be
overarching and at a high level distinct from the Aims of individual Cores and
Research Projects.  The Aims must address how the selected biological measures
reflect the pathophysiology of persistent concussive-symptoms in this EMA
population and how they would be integrated into a prognostic algorithm.    

Research Strategy: The
Overall Research Strategy should describe the PCS-EMA CWOW’s goals and
objectives, background information, and the overall importance of including
biological measures into the prognosis and monitoring of concussive symptoms in
a pediatric population. Describe the rationale for the proposed program.
Explain the strategy for achieving the goals defined for the overall Center,
how each research project and core relates to that strategy, and a transition
plan for moving from discovery and external validation of the biological
measures to a risk stratification algorithm. The risk stratification algorithm
should be practical, efficient, and easily implemented in diverse clinical
settings where patients present; e.g., emergency departments, urgent care
clinics, sports medicine clinics, and primary care offices.  A description of
the feasibility of the algorithm for clinical use must be provided.

Enrollment:

Enrollment must only include early and middle
adolescent (EMA; 11 – 17 years old) aged persons (as defined by the American
Academy of Pediatrics Bright Futures Guidelines) at initial enrollment with a
sampling strategy designed to establish a cohort that is broadly representative
of and generalizable to a North American general population, including males
and females, as well as major racial, ethnic, and sociodemographic subgroups of
the population.  Detailed plans for ensuring high rates of recruitment and
retention should be described.

Study
Leadership and Management
:

This may be either a single or multiple PD/PI
project.  Multiple PD/PI projects must provide a Study Leadership and
Management section that should include the overall study leadership structure.

A description of the research team and a plan to ensure
the maintenance of close collaboration and effective communication among
members of the research team.  The steps that will be taken to ensure
successful completion of the research proposed should be described, in the
event that a key member leaves the project prior to the end of the performance
period.

Data
Sharing Plan:

The development of policies, methods, and standards
for data sharing are critically important for this FOA. Applicants are required
to include a data sharing plan that describes inter-site data quality
assurance, including protocols for corrective actions when needed.  The
data sharing plan must also include a data management and curation plan, and
description of the “limited” clinical data set (e.g., clinical
assessment & outcome measures, symptom lists, mechanism of injury,
demographics, etc.) to be available in FITBIR in a limited access “public”
state no more than 1-year after collection.

Milestones:

A milestone plan, under separate
headings, must be included in the Research Strategy section of the application. Milestones
are goals that create go/no-go decision points in the project and must include
clear and quantitative criteria for success.  Milestones should include
details regarding timely subject recruitment, types of data to be collected,
clean and accurate data submission timelines, and the quality, collection and
submission of biospecimen samples.  The milestone plan must include a
timeline for recruitment and number of visits per year over the course of the
study and a data sharing schedule that is consistent
with NINDS’s TBI data submission policy NOT-NS-17-029.

Letters of Support: Include
letters of support/agreement for any collaborative/cooperative arrangements,
subcontracts, consultants, and / or BioSEND if biospecimens are being collected.
Letters of support for the Center overall should be included with the Overall
component. Letters of support for individual scientific projects or cores
should be included with those components of the application.

Collaboration
with NIH Intramural Researchers:

A letter from the Scientific Director of the
collaborating NIH Institute or Center must be submitted as part of the Center
application and must specify the amount of NIH Intramural resources to be
allocated to the proposed project. In addition, the letter should state that
the project will comply with the DHHS regulations for research involving human
subjects (if applicable) and with the PHS policy on vertebrate animal research
(if applicable).

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, with the modifications indicated in the Data Sharing Plan
section above.

Appendix:

Only limited items are allowed in the Appendix. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions.   

PHS Human Subjects and Clinical
Trials Information (Overall)

When involving NIH-defined human subjects research,
clinical research, and/or clinical trials 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, there must
be at least one human subjects study record using the Study Record: PHS Human Subjects and
Clinical Trials Information
form or a Delayed Onset Study record within the application. The study record(s) must be included in the
component(s) where the work is being done, unless the same study spans multiple
components. To avoid the creation of duplicate study records, a single study
record with sufficient information for all involved components must be included
in the Overall component when the same study spans multiple components.

Study
Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424
(R&R) Application Guide must be followed.

Delayed
Onset Study

Note: Delayed
onset
does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).

All instructions in the SF424
(R&R) Application Guide must be followed

PHS Assignment Request Form (Overall)

All instructions in the SF424
(R&R) Application Guide must be followed. 

Administrative Core

When preparing your application, use Component Type ‘Admin
Core.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative
Core)

Complete only the following fields:

  • Applicant
    Information
  • Type of
    Applicant (optional)
  • Descriptive
    Title of Applicant’s Project
  • Proposed
    Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative
Core)

Enter Human Embryonic Stem Cells in
each relevant component.

Research & Related Other
Project Information (Administrative Core)

Human Subjects: Answer only
the ‘Are Human Subjects Involved?’ and ‘Is the Project Exempt from Federal
regulations?’ questions.

Vertebrate Animals: Answer
only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.

Project /Performance Site
Location(s) (Administrative Core)

List all performance sites that
apply to the specific component.

Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.

Research & Related
Senior/Key Person Profile (Administrative Core)

  • In the
    Project Director/Principal Investigator section of the form, use Project Role
    of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in
    the Credential field.
  • In the
    additional Senior/Key Profiles section, list Senior/Key persons that are
    working in the component.
  • Include a
    single Biographical Sketch for each Senior/Key person listed in the application
    regardless of the number of components in which they participate. When a
    Senior/Key person is listed in multiple components, the Biographical Sketch can
    be included in any one component.
  • If more
    than 100 Senior/Key persons are included in a component, the Additional Senior
    Key Person attachments should be used.   

Budget (Administrative Core)

Budget forms appropriate for the
specific component will be included in the application package.

Note: The R&R Budget form
included in many of the component types allows for up to 100 Senior/Key Persons
in section A and 100 Equipment Items in section C prior to using attachments
for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative
Core)

Specific Aims: Describe the aims for
ensuring that the overall vision of the proposed Consortium is achieved.
Hypothesis-driven research aims are not appropriate.

Research Strategy:  The Administrative
Core lead should describe their research productivity, active research funding
(NIH R01-equivalent or greater) at time of submission, and capacity for
visionary leadership of an interdisciplinary team. Each application should
detail a plan for supervising and coordinating the entire range of proposed
activities.  Applicants must explain the roles and responsibilities of
Administrative Core personnel including scientific leadership, and administrative
management and coordination of the proposed activities.  Plans for holding
regular meetings and facilitating communication between projects and cores;
prioritizing core and resource usage/strategies; monitoring progress and
ensuring that milestones are completed in a timely fashion; and ensuring that
data/tissue/specimens collected by the center are shared in a timely fashion
must be clearly detailed.  Describe the plan to develop policies and procedures
for providing access to data from both key investigators and potential
collaborators from outside the Center.  The administrative core must
provide clear diagnostic criteria that will be used in all Research Projects
for clinical presentation including, but not limited to, diagnostic criteria
for concussion, mild TBI, and persistent concussive symptoms. The
administrative core should provide training across research sites for clinical
assessment batteries and biological sample collection. An annual in-person
center meeting is strongly encouraged. Clear and quantifiable milestones (e.g.,
for cross-site meetings and communications, establishing a “limited
dataset” to be shared annually, etc.) creating go/no-go decision points
for measuring the success of all this core’s specific aims should be proposed.   

Letters of Support: When
appropriate, a letter of support should be provided from BioSEND that
demonstrates the Administrative Core has contacted and received a cost estimate
for BioSEND’s services.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow
all instructions for the Appendix as described in the SF424 (R&R) Application
Guide; any instructions provided here are in addition to the SF424 (R&R)
Application Guide instructions.   

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research,
clinical research, and/or clinical trials 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 a 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

Note: Delayed
onset
does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
Application Guide must be followed

Data Coordinating Core

When preparing your application, use Component Type ‘Data
Coordinating Co ’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Data
Coordinating Core)

Complete only the following fields:

  • Applicant
    Information
  • Type of
    Applicant (optional)
  • Descriptive
    Title of Applicant’s Project
  • Proposed
    Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Coordinating Core)

Enter Human Embryonic Stem Cells in each relevant
component.

Research & Related Other Project Information
(Core or Project Name)

Human
Subjects:
Answer only the ‘Are Human Subjects Involved?’ and
‘Is the Project Exempt from Federal regulations?’ questions.

Vertebrate
Animals:
Answer only the ‘Are Vertebrate Animals Used?’
question.

Project
Narrative:
  Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data
Coordinating Core)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data
Coordinating Core)

  • In the
    Project Director/Principal Investigator section of the form, use Project Role
    of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID
    in the Credential field.
  • In the
    additional Senior/Key Profiles section, list Senior/Key persons that are
    working in the component.
  • Include a
    single Biographical Sketch for each Senior/Key person listed in the application
    regardless of the number of components in which they participate. When a
    Senior/Key person is listed in multiple components, the Biographical Sketch can
    be included in any one component.
  • If more
    than 100 Senior/Key persons are included in a component, the Additional Senior
    Key Person attachments should be used.   

Budget (Data Coordinating Core)

Budget forms appropriate for the specific component
will be included in the application package.

This level of effort is required whether or not
salary is requested.

Note: The R&R Budget form included in many of the
component types allows for up to 100 Senior/Key Persons in section A and 100
Equipment Items in section C prior to using attachments for additional entries.
All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Coordinating Core)

Specific
Aims:
 Describe
the aims for providing the necessary resources and technical expertise to
support the goals of the research projects and support both the coordination of
specimen collection and storage with BioSEND and data sharing requirements of
the PCS-EMAs CWOW related to FITBIR data submission, data curation, and data
quality assurance.  Hypothesis-driven
research aims are not appropriate.       

Research
Strategy:
Each application should detail the core service to be
provided, including all equipment, methods, or services involved. 
Describe all aspects of the core resource that are innovative, and any
technical or methodological innovations that will be developed during the
duration of the project.  Applicants should explain how this core will
interact with other projects and/or cores within the Center.  Cores must
support all projects, and percent usage of core resources per project should be
indicated.   If a project or core is collecting or providing
specimens, collection and storage protocols should be clearly described and
standardized across collection sites. The Data Coordinating Core should
demonstrate knowledge of and provide methods for complying with the data and
specimen submission policies of FITBIR and BioSEND. Data quality assurance of
data submitted to FITBIR is the responsibility of the DCC. Applications should
describe the data quality assurance procedures that will be implemented.

The Data Coordinating Core is responsible for
providing a thorough list of all CDEs and Unique Data Elements (UDEs) that will
be collected in all projects. Clear and quantifiable annual milestones creating
go/no-go decision points for measuring the success of all the core’s specific
aims should be proposed.

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. .

Appendix:

Limited items are allowed in the Appendix. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide; any instructions provided here are in addition to the SF424 (R&R)
Application Guide instructions.   

PHS Human Subjects and Clinical
Trials Information (Data Coordinating Core)

When involving NIH-defined human subjects research,
clinical research, and/or clinical trials 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 a 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.

Research Project

When preparing your application, use Component Type ‘Project.’

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research
Project)

Complete only the following fields:

  • Applicant
    Information
  • Type of
    Applicant (optional)
  • Descriptive
    Title of Applicant’s Project
  • Proposed
    Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research
Project)

Enter Human Embryonic Stem Cells in each relevant
component.

Research & Related Other Project
Information (Research Project)

Human
Subjects:
Answer only the ‘Are Human Subjects Involved?’ and
‘Is the Project Exempt from Federal regulations?’ questions.

Vertebrate
Animals:
Answer only the ‘Are Vertebrate Animals Used?’
question.

Project
Narrative:
  Do not complete. Note: ASSIST screens will show an
asterisk for this attachment indicating it is required. However, eRA systems
only enforce this requirement in the Overall component and applications will
not receive an error if omitted in other components.

Application guide states that Project Narrative is
required.  However it is only required for the Overall component. 

Project /Performance Site Location(s)
(Research Project)

List all performance sites that apply to the specific
component.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Research Project)

  • In the
    Project Director/Principal Investigator section of the form, use Project Role
    of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID
    in the Credential field.
  • In the
    additional Senior/Key Profiles section, list Senior/Key persons that are
    working in the component.
  • Include a
    single Biographical Sketch for each Senior/Key person listed in the application
    regardless of the number of components in which they participate. When a
    Senior/Key person is listed in multiple components, the Biographical Sketch can
    be included in any one component.
  • If more
    than 100 Senior/Key persons are included in a component, the Additional Senior
    Key Person attachments should be used.   

Budget (Research Project)

Budget forms appropriate for the specific component
will be included in the application package.  The amount of effort for the
PD(s)/PI(s) must be commensurate with the requirements of the position. 
This level of effort is required whether or not salary is requested.

Note: The R&R Budget form included in many of the
component types allows for up to 100 Senior/Key Persons in section A and 100
Equipment Items in section C prior to using attachments for additional entries.
All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research
Project)

Specific
Aims:
Provide
the overall goals or hypothesis of the entire research project and list separate
Specific Aims to be accomplished, briefly outline the methods proposed, and
summarize the expected outcomes.   

Research
Strategy:
Describe the research strategy for the project and
how the research will develop and then characterize the selectivity and
sensitivity of biological measures

for either prognosing and/or monitoring persistent
concussive symptoms in a pediatric population.  Provide a concise review
of the relevant literature and its rigor, detail available pilot data, and justify
the proposed aims and methods (applicants must discuss scientific premise,
scientific rigor, and biological variables).  Provide alternative
approaches to addressing the research aims if the proposed approaches
fail.  Applicants should explain how this research project will interact
and synergize with other projects and/or cores within the CWOW.  Projects
should focus on recruitment of EMA (11-17 years old) participants and must
provide strong justification for inclusion of ages outside this range. 

Use of standardized outcome and non-outcome measures and
instruments (e.g., NINDS
Common Data Elements (CDE
s)) that are compatible with existing natural
history and comparative effectiveness trials of TBI and/or neurodevelopment
studies (TRACK-TBI, ADAPT, and ABCD study) is highly recommended.
Justification must be provided for using measures and instruments that are not
CDEs.   When appropriate, clear operational definitions for independent and
dependent measures such as “repetitive head hits”,
“impacts” and “concussion” should be provided.

Description must include analytic plans for
determining the sensitivity and selectivity of each measure and any combination
of measures, interim analysis for biological measures including alternative
strategies, and for the selection of biological measures that will be advanced
to external validation.

As the research strategy is prepared, it is important
to note that NINDS believes applications will be greatly strengthened if the
rigorous design, execution, and interpretation of the proposed studies and supporting
data are adequately described. NINDS encourages investigators, whenever
possible, to address these elements directly in their applications.
Investigators are urged to discuss these issues with Scientific/Research staff
prior to submission of applications (see: NOT-NS-11-023 and NOT-OD-15-103).
The NINDS also expects that applications will conform to the principles
outlined in Landis
et al., 2012
 and show consideration for biological variables described
in NOT-OD-15-102.

Clear and quantifiable annual milestones creating
go/no-go decision points for measuring the success of all the project’s
specific aims should be proposed. 

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.

Appendix:

Limited items are allowed in the Appendix.Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide; any instructions provided here are in addition to the SF424 (R&R)
Application Guide instructions.   

PHS Human Subjects and Clinical
Trials Information (Research Project)

When involving NIH-defined human subjects research,
clinical research, and/or clinical trials 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 a 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

Note: Delayed
onset
does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).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) using ASSIST or other electronic submission
systems. 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.

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.

For information on how your application will be
automatically assembled for review and funding consideration after submission
go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component
Project Leads 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.

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 (SAM). 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. 

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

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 – Overall

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 – Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a Center that by its nature is not innovative
may be essential to advance a field.

Significance

Does the Center 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 Center
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?  Do the PCS-EMAs CWOW’s
selection of biological measures appropriately cover the diversity of symptom
clusters present in EMA patients with persistent concussive symptoms? Will
there be a tangible risk stratification algorithm for persistent concussive
symptoms that can be used clinically, in research, or for patient
stratification and/or in future clinical trials?

Are the data sharing plans
appropriate to accelerate knowledge in this area?  Does this Center
structure provide synergistic opportunities for scientific advancement that
would not be achieved by each project working alone?

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the DCC and Research Project(s)? If Early
Stage Investigators or those in the early stages of independent careers, do
they have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project? 

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?        

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the Center? Have investigators included plans to address
weaknesses in the rigor of prior research that serves as the key support for
the proposed project? Have the investigators presented strategies to ensure a
robust and unbiased approach, as appropriate for the work proposed?  Are
potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed? Have the
investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center 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?  

Is there a clear plan for coordinating data
collection among the research sites?  Is there a plan for demonstrating data
quality assessments for datasets that are collected across the multiple sites? 
Is there a test for the reproducibility of data collection across sites
provided?

Does the application provide clear diagnostic
criteria for concussion, mild TBI, moderate TBI? Does the PCS-EMA CWOW have
consistent definitions for head impact, repetitive head impacts and / or TBI
exposure? Is a timeline included which delineates clear feasibility to both
discover and validate the biological markers? Is there a clear and objective
plan for transitioning from biological measures from the discovery stage to the
external validation stage?  Is a feasible plan provided to recruit and retain
EMA pediatric participants for both the discovery and validation stages?

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?

Do the study environments provide a range of point of
care settings?

Will recruitment include patients with a range of
injury mechanisms (e.g. falls, sports, and automobile accidents)?

Scored Review Criteria – Research
Project(s)

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 Center project that by
its nature is not innovative may be essential to advance a field or the overall
goals of the Center. 

Significance

Do the project’s aims/hypotheses address an important
aspect of the Center’s overall strategy for incorporating biological measures to
address the pathophysiology of persistent concussive-symptoms in pediatric
populations and integrating those measures into a prognostic algorithm?

Is the prior research that serves as the key support
for the proposed project rigorous? 

How will the project contribute to the success of
other projects and to the overall success of the Center?

Is the project likely to result in major (rather than
incremental) scientific advances?

Investigator(s)

Is the expertise of the research project leader,
collaborators, and other researchers well suited to the project?

Is the research project leader an established
scientist with a history of innovative work in their area of research?

Do all members of the project team dedicate
sufficient effort to research activities?

Innovation

Does the research project utilize novel theoretical
concepts, methods, or technologies?

Does the project propose innovative use of human
tissues or biospecimens in its approach to addressing its hypotheses? 

Approach

Are the overall strategies, methodologies, and
analyses well-reasoned and appropriate to accomplish the specific aims of the
project?

Have investigators included plans to address weaknesses
in the rigor of prior research that serves as the key support for the proposed
project?

Have the investigators presented strategies to ensure
a robust and unbiased approach, as appropriate, for the work proposed?

Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early stages of
development, will the strategy establish feasibility, and will particularly
risky aspects be managed?

Have the investigators presented adequate plans to address
relevant biological variables, such as sex, for studies in vertebrate animals
or human subjects? 

Is there a clear description of how this research
project will interact and synergize with other projects and/or cores within the
Center?

Have the investigators provided a recruitment plan to
establish cohorts that are broadly representative of and generalizable to the
pre-adolescent and adolescent North American population? 

Have the investigators provided a plan to recruit
appropriate control groups?

Do the investigators incorporate the NINDS CDEs and
align with natural history and comparative effectiveness trials of TBI and/or
neurodevelopment studies when appropriate?

Does the project clearly detail the discovery and
external validation of one or more biological measures that will have a
significant impact on the prognostic and monitoring accuracy of persistent
concussive symptoms following either concussion and/or exposure to repetitive
head impacts? 

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? 

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed?

Will the project benefit from unique features of the
scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria – Overall

As applicable for the CWOW 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.

Review Criteria – Cores

Reviewers will provide overall numeric scores; individual
criterion scores are not provided.  The review criteria for the individual
cores are provided below.

Administrative Core

Does the Administrative Core provide support such
that overall vision of the proposed CWOW is achieved? Does the Administrative
Core Lead/Center Director have appropriate expertise and dedicate
sufficient time to administrative activities? If an Associate Director is
named, does that person have required expertise to effectively assist the
Center Director with scientific and administrative management? Is there an
appropriate plan for establishing and maintaining effective communications and
cooperation among Center investigators on a regular basis? Does the core
provide a clear strategy for supervising and coordinating the entire range of
proposed activities, including plans for monitoring progress and ensuring that
component plans are implemented, accomplished, and all milestones are met?  Are
plans included for prioritizing how core resources will be utilized?  Are there
appropriate plans for management of data, specimens, and other resources?  Is
the leadership approach, governance and organizational structure appropriate
for the project? Does the core provide clear and quantifiable milestones
creating go/no-go decision points for measuring the success of its
goals?  

Has the Core described the data that will be included
in the “limited dataset” that will be uploaded to FITBIR and shared
on an annual basis?  Has the administrative core developed a schedule and
provided logistical support for site meetings and teleconferences, including an
in-person meeting of the PDs / PIs at least one time per year and an all-site
meeting for the Center at least once a year?

Data Coordinating Core

Does the proposed data coordinating core have the
equipment, methods, and/or services appropriate for managing, curating data for
each project?

Are the data curation and validation methods
scientifically rigorous?

Are any technological or methodological innovations
proposed?

Does the core Leader/Director have
the appropriate expertise and enough dedicated time to direct and fulfill the core
activities? Does the administrative core provide a training plan to standardize
data collection across research sites for clinical assessment batteries and
biological sample collection? Has the core demonstrated an understanding of the
FITBIR and BioSEND data policies and procedures? Has the core provided an
estimate from BioSEND for sample collection and storage? Has the DCC provided a
list of all CDEs and UDEs used by the Research Projects and justified the use
of UDEs? Does the core provide methods for cross-mapping the Centers data
dictionary to the existing NINDS CDEs? 

Milestones

Are the milestones appropriate to the scientific aims
of the project? Do the milestones provide enough timeline details and
quantification of subject recruitment and retention?  Does the recruitment
timeline provide alternative strategies if recruitment and retention is lower
than expected? Do the milestones provide objective measures for go/no go
programmatic decisions? Are the milestones feasible within the timeline
presented?. Do the milestones provide timelines for uploading the “limited
dataset” into FITBIR? Do the milestones provide timelines and quantities
of the full data set to be uploaded into FITBIR as required by NOT-17-029?
Do the milestones include a timeline for recruitment and number of visits per
year over the course of the study and a data sharing schedule that is
consistent with NINDS’s TBI data submission policy NOT-NS-17-029 for all clinical, neuroimaging, behavioral, demographic, and biological data?

Interaction

Are there adequate plans for ensuring effective
intra-group communication, interaction, cohesiveness, and coordination among
the PD(s)/PI(s), Research Project Leaders, and NINDS Project Scientist? Are
there plans for scheduling group meetings, notifying group members (including
NINDS Scientific and Program Officers), and documenting and disseminating group
meeting proceedings?

Protections
for Human Subjects

For research that involves human
subjects but does not involve one of the 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 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 Individuals Across the Lifespan  

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 individuals of all ages (including children and older adults) 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
.

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
.

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.

Not Applicable.

Not Applicable.

Not Applicable.

Additional Review Considerations – Overall

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications
from Foreign Organizations

Not Applicable.

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).

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
.  .


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 the National
Institute of Neurological Disorders and Stroke 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 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.  

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.

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

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.

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 Part 75, and other HHS, PHS, and NIH
grant administration policies.

The administrative and funding instrument used for this
program will be the cooperative agreement, an “assistance” mechanism
(rather than an “acquisition” mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the NIH purpose
is to support and stimulate the recipients’ activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.

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

  • Determining experimental approaches, designing protocols, setting
    project milestones and conducting experiments;
  • Developing policies regarding data sharing, CDE usage and
    protocol alignment with existing TBI and neurodevelopmental consortia;
  • Reporting to NINDS Scientific Program staff regarding timeline
    and milestone achievement during the course of the project, as delineated in
    the terms and conditions of award;
  • Submitting annual progress reports during the funding period, in
    a format as agreed upon by NINDS program staff;
  • Awardees are expected to make new information and materials known
    to the research community not only in the annual meetings but also in a timely
    manner through publications, web announcements, reports to NINDS program staff,
    and other mechanisms.
  • Awardees will retain custody of and have primary rights to the
    data and software developed under these awards, subject to Government rights of
    access consistent with current DHHS, PHS, and NIH policies.

Publications:

  • The PD(s)/PI(s) will be responsible for the 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 Scientists 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:

  • An NINDS Scientific Program Official will
    be assigned and will have substantial scientific/programmatic involvement
    during the conduct of this activity through technical assistance, advice and
    coordination. However, the role of NINDS Scientific Program Officer will be to
    facilitate and not to direct the activities.
  • The NINDS Scientific Program Official will contribute to the
    adjustment of research protocols, project milestones or approaches as
    warranted;
  • NINDS Scientific Program Official may serve as a liaison between
    the awardees, the NINDS Advisory Council and the larger scientific community;
  • NINDS Scientific Program Official will assist in promoting the
    availability of data and resources developed in the course of this project to
    the scientific community at large;
  • NINDS Scientific Program Official will assist awardees in the
    development, if needed, of policies for dealing with situations that require
    coordinated action;
  • A separate NINDS Administrative Program Official will retain the
    option to recommend the withholding or reduction of support from any
    cooperative agreement that either substantially fails to achieve its goals
    according to the milestones 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.
  • Additionally, the NINDS Administrative Program Official will be
    responsible for the normal scientific and programmatic stewardship of the award
    and will be named in the award notice.

Areas
of Joint Responsibility include:

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

Opportunities for Partnership

Projects involving partnerships with industry, small
businesses or non-government organizations are encouraged under this FOA. 
The policy of the NIH is to make available to the public the results and
accomplishments of the activities that it funds. To ensure that research
resources are made accessible to the broader biomedical community, NIH expects
applicants who respond to this funding opportunity to submit a plan for: (1)
sharing the research resources generated through any grants awarded and (2)
addressing how they will exercise intellectual property rights, should any be
generated through an award, while making such research resources available to
the broader scientific community consistent with this initiative. Projects
existing studies in which databases already exist or have been created via
other resources may be maintained under those projects, but not funded via this
program.  However, it is expected that these databases will become
federated under the DMR.

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 Administrative Core chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee’s right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required
to submit the Research Performance Progress Report
(RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement
.

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

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

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

Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions
regarding ASSIST, eRA Commons, 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)

Patrick S Frost Bellgowan, PhD


National Institute of Neurological Disorders and Stroke (NINDS)


Telephone: 301-496-1447


Email: psfb@mail.nih.gov

Valerie Maholmes


Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)


Telephone: 301-496-1514


Email: valerie.malholmes@nih.gov

Peer Review Contact(s)

Natalia Strunnikova, Ph.D.


National Institute of Neurological Disorders and Stroke
(NINDS)


Telephone: 301-496-9223


Email: strunnikovan@mail.nih.gov

Financial/Grants Management Contact(s)

Tijuanna DeCoster, PhD


National Institute of Neurological Disorders and Stroke (NINDS)


Telephone: 301- 496-9231


Email: decostert@mail.nih.gov

Bryan Clark



Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)


Telephone: 301-435-9675


Email: bryan.clark@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.    

NIH… Turning Discovery Into Health®


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