Collaborative Centers in Children’s Environmental Health Research and Translation Centers (P2C Clinical Trial Optional)

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 Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Collaborative Centers in Children’s
Environmental Health Research and Translation (P2C  Clinical Trial Optional)

Activity Code

P2C Resource-Related Research Multi-Component Projects and Centers

Funding Opportunity Announcement (FOA) Number

RFA-ES-20-001

Companion Funding Opportunity

None

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

93.113

Funding Opportunity Purpose

To accelerate the movement of research findings to action,
NIEHS invites grant applications from institutions/organizations that propose
to build a Collaborative Center in Children’s
Environmental Health Research and Translation (CEHRT Center). Centers are
charged with developing effective strategies to translate key children’s
environmental health (CEH) research findings to relevant stakeholders in the
community, academia and practice.

The overall goal of this FOA is the creation of a national
network of children’s environmental health translation centers. Through
external collaboration with the children’s environmental health community,
Centers will protect and improve children’s health by developing and testing new
scientific questions and public health interventions/strategies with an eye
towards translation; and mentoring a pipeline of new investigators interested
in translational CEH.

CEHRT centers will serve as leaders in CEH translational research
and research methodology development, with a focus on creating actionable steps
to move evidence-informed biomedical, behavioral, psychosocial, environmental
research findings in children’s environmental health to the wider community. The
collective collaborative center program will also serve as a national research
resource to support response efforts to emerging environmental exposures affecting
children.

Key Dates

Open Date (Earliest Submission Date)

October 23, 2020

Letter of Intent Due Date(s)

October 23, 2020

Application Due Date(s)

November 23, 2020

All applications are due by 5: 00 PM local time of
applicant organization. All types of non-AIDS
applications
allowed for this funding opportunity announcement are due on
the listed date.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2021

Advisory Council Review

October 2021

Earliest Start Date

December 1 2021

Expiration Date

November 24, 2020

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 Information


    Section III. Eligibility Information


    Section IV. Application and Submission
    Information



    Section V. Application Review Information


    Section VI. Award Administration Information


    Section VII. Agency Contacts


    Section VIII. Other Information




    Part 2.
    Full Text of Announcement

    Section I. Funding Opportunity Description

    For more than 20 years, the NIEHS has developed and
    sustained a strong base of Children’s Environmental Health (CEH) research
    projects through both its unsolicited program and the NIEHS and EPA Children’s
    Environmental Health Centers (CEHC). The CEHC provided demonstrable evidence
    that supporting transdisciplinary research teams and science addressed major
    CEH challenges and contributed to the protection of our children at the local, regional,
    and national levels.  The 2017 Impact Report provides many specific examples.   https://www.epa.gov/sites/production/files/2017-10/documents/niehs_epa_childrens_centers_impact_report_2017_0.pdf.

    Capitalizing on this strong base of fundamental knowledge, active
    research opportunities and programs about the effects of a variety of environmental
    exposures on children’s health, NIEHS is establishing a new CEH Center program (infrastructure
    grant) that will facilitate translation of the research results into tangible
    tools, interventions, strategies, methods, messages, and activities to protect
    and improve children’s health from environmental exposures and to promote environmental
    health equity. The Centers will also maintain a robust pipeline for new
    investigators, stimulate new science and mobilize prompt responses to emerging issues.
    These Centers will serve as resource to the scientific community and stakeholder
    partners and prioritize and incorporate their concerns, for example, develop solutions
    to protect children, provide opportunities for collaborations and access to Center
    expertise.

    For purposes of this FOA, translational research encompasses
    the evolution of an idea as it moves through the various phases of research with
    the goal of creating an impact on human health. The NIEHS Translational
    Research Framework (TRF) describes five major translational research categories:
    fundamental questions, integration and synthesis, application and adjustment,
    practice, and impact. We invite potential applicants to read more about this
    concept of translational research and familiarize themselves with the various
    activities conducted in each translational research category at www.niehs.nih.gov/translation.

    The objective of this FOA is to create and nurture a
    national network of Children’s Environmental Health Research Translation Centers
    (CEHRT Centers) that will (1) provide the scientific community and stakeholders
    (broadly defined) access to state-of -the art collateral expertise in CEH as
    well as expertise in health communication, environmental health literacy and
    dissemination and implementation science  to enhance and accelerate the reach and
    adoption of CEH knowledge and science, (2) promote external collaborations with
    the children’s environmental health community of researchers and stakeholders,
    and (3) provide assistance in response to national, regional, state or local
    CEH issues or emergencies.  To achieve this, the CEHRT center program will adopt
    dissemination and implementation strategies that can evolve quickly with the
    state of the science as well as create actionable steps to best implement, disseminate
    and sustain CEH knowledge, intervention and programs in the most vulnerable communities.

    The Program Goals are to:

    1. Support collaborations among recognized children’s
    environmental health scientists along with partners from scientific fields not
    traditionally associated with environmental health science (EHS) research. These
    fields might include health and risk communication, dissemination and implementation
    science, behavioral and social sciences, engineering, economics, medicine,
    policy, computer science, and more.  These partners will be expected to provide
    new ideas, strategies, and approaches for moving the CEH science into applied
    public health and clinical practice in order to expand the impact of CEH research
    findings.

    2. Synthesize and use existing CEH research findings to create
    new messages, tools, methods/approaches, risk management strategies, public
    health interventions and practices, curriculums and other educational
    activities, clinical guidelines, policies and products that translate CEH research
    findings to applied products and impacts. These products can then be used and/or
    adapted by stakeholders, at-risk populations, affected communities, and the
    clinical or public health community to improve children’s health.

    3. Establish two distinct pilot programs.  Within the Translation
    Core, the pilot project program will test, implement, adapt and evaluate new CEH
    research translational products (curriculum, messages, tools, methods, practices,
    etc.). In the Developmental Core, the catalyst program will consist of small
    pilot projects that can address time sensitive environmental health concerns in
    children or test new emerging areas concepts, tools or approaches in CEH
    science.

    4. Nurture and mentor early stage investigators in CEH
    research with an emphasis on translation research strategies and approaches.

    Specific
    Areas of Research Interest:

    The theme or vision of the center program
    must be within the scientific mission of NIEHS with a focus on Children’s Environmental
    Health to be responsive to this initiative.  NIEHS is interested in research
    that focuses on environmental exposures, which influence the healthy
    development of children from early conception through adolescence and young
    adulthood.

    Organization
    of a Collaborative Center CEHRT in the Context of this FOA:

    The CEHRT center is to provide researchers, stakeholder and
    community organizations access to specialized expertise and resources not
    typically available through their departments, institutions, and/or professional
    associations.  This includes access to cutting-edge technologies and approaches
    that are particularly timely for understanding CEH outcomes or exposures.  The
    emphasis of the Centers infrastructure should be on developing approaches to facilitate
    the movement of CEH research findings into practice through a concerted program
    of didactic, interactive and mentored collaborative interaction.  Applicants
    should propose a cogent program of outreach, research resources, and mentored collaborative
    opportunities in the specific content area through the following core activities:

    Administrative
    Core
    : The applicant should present a clear model of managerial oversight,
    responsibilities, and commitment to this center, which includes the role of key
    personnel and their expertise. The research center must develop formal plans for
    prioritization of resources, access guidelines, quality control to enhance responsiveness
    to the scientific community and stakeholders. The core will be responsible for documentation
    of overall-effectiveness and impact of the center. In addition, the center will
    be expected to collaborate with other funded translation centers in the network
    as appropriate to eliminate duplicate efforts and leverage efforts among common
    themes. 

    Developmental
    Core:
    The Developmental Core (DC) supports a catalyst program
    of translational research projects directed at emerging and time-sensitive issues
    relevant to CEH. These projects could generate preliminary data, and develop, test,
    implement and evaluate new intervention/prevention/communication strategies (Goal
    3). The DC would also provide professional development and career advancement
    for the next generation of CEH scientists by engaging them in translational pilot
    projects and mentorship through interdisciplinary collaborations and
    intellectual exchange (Goal 4). The DC will be expected to foster an innovative
    space for developing new science and creating a robust pipeline for the next
    generation of CEH scientists that support the translation of research.

    Translation
    Core:
    The Translation Core (TC) is the focal point for these centers.
    Effective translation of research findings must draw on the collective expertise
    from communication, education and dissemination and implementation sciences to
    achieve this aim.  To this end, the Core will support collaborations with
    partners from fields not traditionally associated with EHS research. These fields
    might include health and risk communication, behavioral and social sciences,
    engineering, economics, medicine, policy, computer science, and more. These partners
    will be expected to provide new ideas, strategies, and approaches for moving
    CEH science into applied practice in order to expand the impact of CEH research
    findings (Goal 1). The Core will also focus on developing specific strategies
    to expedite the bridging of research findings into translational products where
    the adoption of products will be measured and shared with key stakeholders and
    affected communities to improve CEH.

    Examples of translational products might include: new
    messages, tools, methods/approaches, risk management strategies, public health
    interventions and practices, curriculums and educational activities, clinical guidelines,
    policies, and other products that translate CEH findings to applied products
    and impacts (Goal 2).  The NIEHS Translational Research Framework values the
    need for research that focuses on replicating and adapting existing ideas and
    strategies. As such, the Translational Core will also support the implementation
    and dissemination of existing CEH interventions and/or practices to varied
    contexts and communities.  The TC will work with subject matter experts within
    their program to develop a translation plan that draws on the NIEHS
    Translational Research Framework or other related frameworks or theories. Access
    to pilot funds to assist in these efforts and respond to outside stakeholders will
    be dedicated to this Core and managed by Core Leader.

    Coordinating
    Center (optional):
    In addition to proposing a CEHRT Center, the
    applicant may propose to take on the additional role of serving as the coordinating
    center across all the RFA-funded CEHRT Centers. Responsibilities for the coordinating
    center include: developing and maintaining a central web portal, coordinating the
    promotion of the overall infrastructure program to the research community in various
    settings, coordinating trans-center activities, hosting and archiving periodic
    teleconferences and web-based interactions among the infrastructure PIs and senior
    staff, and documenting overall infrastructure outcome data with respect to how
    the centers are advancing the goals of this program. Up to $100,000 per year
    (direct costs) may be requested to take on the additional responsibility of
    serving as the Coordinating Center.

    Workforce
    Diversity:
    While not a specific core activity, the NIH continues
    to encourage institutions to increase the participation of individuals currently
    underrepresented in the biomedical, behavioral, clinical and social sciences;
    this includes: individuals from underrepresented racial and ethnic groups,
    individuals with disabilities, and individuals from disadvantaged backgrounds
    that have inhibited their ability to pursue a career in health-related
    research.  For more information on NIH’s interest in diversity, see “NOT-OD-20-031.”Within
    the context of the P2C application, applicants should describe how they will
    identify and facilitate approaches that would encourage the participation of
    underrepresented racial and ethnic minorities, persons with disabilities, and
    women.

    Special
    Considerations:
    To be responsive to this initiative, the
    applicant institution must have a strong base of ongoing, independently
    supported, peer-reviewed research projects clearly dedicated to the study of
    environmental health sciences in children’s health.  Research focusing
    mainly of female or reproductive health will not be responsive to this
    initiative.  The research base must exist prior to the submission of an application
    and will be considered by program staff to determine eligibility.  See
    Section III.1 Eligible Applicants for more detailed description of CEH base support
    calculation.

    A special interactive webinar will be scheduled and later
    archived for potential applicants. In addition, a webpage of frequently asked
    questions (FAQs) will be posted. Updates on both the webinar and the FAQs will
    be available at  https://www.niehs.nih.gov/research/supported/centers/prevention/index.cfm

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

    Section II. Award Information

    Funding Instrument

    Grant: A support mechanism providing money, property, or both
    to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application
    types. Only those application types listed here are allowed for this FOA.

    Funds Available and Anticipated Number of Awards

    NIEHS intends to fund an estimate of 5 – 6 awards,
    corresponding to a total of $5M, for fiscal year 2021. Future year amounts will
    depend on annual appropriations.

    Award Budget

    Applicants may request direct costs up to $500,000 per
    year. Because the nature and scope of the proposed infrastructure will vary,
    it is anticipated that the size of the awards will vary to reflect the actual
    needs of the proposed center.

    In addition to proposing an infrastructure center, the
    applicant may propose to take on the additional role of serving as the
    coordinating center across all the funded infrastructure centers and may
    request up to $100,000 in additional direct costs for this optional role.
    Only one coordinating center will be chosen from among the funded P2C
    networks.

    Award Project Period

    The total project period for an application submitted in
    response to this FOA may not exceed 5 years of support.

    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.

Additional
Eligibility Criteria

There are additional eligibility criteria for applications
responding to this FOA:

Multi-PD/PI required: One recognized and established research
investigator in CEH (Director), and an expert (referred to as Deputy Director)
with a track record in health communication with translation of science to lay
audience, scientific community and public health and or medical professionals.

Active Scientists.  Applicants must have active scientists working
in children’s environmental health that is within the scientific mission of
NIEHS.  Active CEH scientists must hold their primary affiliation with
applicant institution or other institutions and this position (tenured or
nontenured) must be permanent; Applicants need to have a strong record in
scientific publications and competitiveness for peer-reviewed external funding
for research within the science mission of NIEHS in CEH. Active scientists must
meet the following criteria:

(1) PD/PIs must have externally-funded active CEH grants or
contracts within the three most recently completed fiscal years: 2017, 2018,
2019.  Grant awarded in FY 2020 may be included.  Federal fiscal year runs from
October 1 to September 30.

(2) PD/PIs must have strong CEH research publications in
peer-reviewed journals during the three most recently completed Federal fiscal
years, including FY2019.

Funding
by the NIEHS. 

(1) Each application must have and identify at least three
active PD/PIs  who have received a research grant or other significant funding
from NIEHS within the three most recently completed Federal fiscal years in the
area of children’s environmental health at the time of submission (FY 2017,
2018, and 2019.  The mechanisms that qualify are research projects (R01, R21,
R00, R15), research program projects (P01, P50, P42), and individual research career
development awards for faculty (K24, K08, K23).

(2) Mechanisms that do not qualify are individual pre-doctoral
and/or post-doctoral fellowships (e.g., F31, F32, K99), T awards, U45, Conference
grants (e.g., R13, U13) and R24, U24, P30 or U2C grants funded by NIEHS.  Furthermore,
grants and cooperative agreements in extension periods, either with or without
additional funds, as well as supplements of any kind, do not count toward this
requirement.   

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

Only one application per institution (normally identified by
a unique DUNS number or NIH IPF number) is allowed

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:

Linda Bass, PhD


Telephone: 984-287-3236


Fax: 919-541-2503


Email: [email protected]

Page Limitations

Available
Component Types

Research
Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

12 pages

Developmental Core

12 pages

Translation Core

12 pages

Coordinating Center (optional)

6 pages

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, 1 maximum
  • Administrative Core: required, 1 maximum
  • Development Core: required, 1 maximum
  • Translation Core: required, 1 maximum
  • Coordinating Center; optional, 1 maximum

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
Summary/Abstract.
 Provide a Project Summary/Abstract of a Strategic
Vision for the Center. Also describe the Translational Research Vision, Children’s
Environmental Health Identity, and the Impact of the Research Base in CEH on
the goals of the CEHRT Center in how it advances the NIEHS Strategic Plan

Project
Narrative.
 In the project narrative (i.e., the “public
health relevance” statement), briefly state the relevance of the Center’s
research to public health and the protection of children from environmental
exposures. 

Facilities
& Other Resources:
Explain the center’s administrative
position within the larger institution, including formal departments and other
scientifically related centers. Explain how the scientific and institutional environments
at the applicant institution contribute to the probability of success for
achieving the specific aims described in the application.

Describe the organizational resources available to
the center. Identify the facilities to be used, including, but not limited to,
dedicated space, computer facilities and resources, laboratories, and other facilities.
If appropriate, indicate their capacities, pertinent capabilities, relative
proximity and extent of availability to the project. Relative proximity of resources
and size and shape of dedicated space may be presented in either graphic or
narrative form. Describe only those resources that are directly related to achieving
the specific aims described in the application or that complement the proposed research
resource cores. Provide any information describing the Other Resources available
to the project (e.g., secure data room) and the extent to which they would be
available to the project. 

Describe institutional investment in the success of
the center’s Early Stage Investigators (ESI), e.g., resources for classes,
travel, and training; collegial support such as career enrichment programs,
assistance and guidance in the supervision of trainees involved with the ESI’s
projects, and availability of organized peer groups; logistical support such as
administrative management and oversight and best practices training; and financial
support such as protected time for research with salary support and coverage of
supplies, equipment and technical personnel.

List types and amount of committed
funding the center receives from the applicant institution. Examples include but
are not limited to dedicated equipment, dedicated space, salary support for
investigators or core staff, faculty appointments in subject areas relevant to
the goals of the program, operating budgets, financial support for new space or
equipment, and arrangements the center has to recover indirect costs. Include
salaries only if the support is provided for a center-related function such as
directing a center, managing a core, or similar activities. Institutional support
for center and core personnel and research faculty should be reflected in the
budget request. This information may be presented in tabular form.

Other
attachments:
Include an attachment titled “Active Research
Support”. The information presented in this section constitutes the center’s
“externally funded annual support for children’s environmental health research
and training” (see Award Budget in Section II).

Provide information about the proposed CEHRT Center’s
external funding for children’s environmental health research, research training,
and data collection that is within the mission of NIEHS and was received in
either FY 2017 or FY 2018 or FY 2019; select one fiscal year, do not present
information for all. This information may be presented in tabular form.
Comparable grants awarded in FY 2020 may be listed in a separate table. Report
only direct costs; do not report total costs. Report only on funding for activities
that are related to CEH research; do not report all funding to all center affiliates.

Center Members (i.e. Center affiliates): Title this
attachment “Center Members” and list all the Center members, including
highest educational degree, institutional title, and affiliations, including department
 

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.  

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:  Briefly state
the proposed research domain(s), expertise, key resources as well as specific
strategies for promoting opportunities in CEH to the larger scientific
community and relevant stakeholders.

Applicants are required to identify
their center’s primary research area(s) in CEH to be supported through this
program, the areas in which the center expects to make its most significant
contributions to CEH in the next five years.  The centers should include a translation
plan that describes how the Center will increase the scientific impacts, innovation,
productivity and translation of CEH research in their primary research area(s)
and expertise. Applicant centers are required to provide evidence that the support
they request through this initiative will contribute to the center achieving
its specific aims.     

Research Strategy:  Thoroughly
and clearly address the main objective of the Children’s Environmental Health Translation
Center (CEHRT) which is to create a research resource that will provide research
expertise and opportunities in current CEH research while focusing on translation
of extant CEH research to relevant partners and stakeholders.

Discuss the vision, theme and objectives
and the potential impact of the proposed infrastructure center on CEH. Within
this section, describe the research capacity and clearly identifiable major
scientific focus areas in CEH.

Describe how the center will leverage
and build on resources and expertise of the applicant and collaborative
institutions. Make clear why this unique expertise and collaborations would be
appropriate and timely for the field of CEH.

Describe the scope of the research and
translation activities that the center proposes including the techniques, approaches,
resources and opportunities that it will provide to the CEH community and stakeholders. 
Explain the primary target audience(s) utilizing the center research and
translation resources. Describe the vulnerable populations or affected communities
that will benefit from Centers translational efforts and access to resources.

Describe how support from this FOA
will be leveraged to increase the center’s ability to make major contributions
in the primary research area over and above what could be done without this
support. Describe how the experience, training, and ongoing record of accomplishments
of the center’s leadership and affiliates will contribute to the center’s
ability to make major contributions in CEH.

Describe how the research resources
from this FOA will be used over and above what is already provided by the applicant’s
institution through other funding mechanisms.

Describe the Center members. List
the center affiliates in alphabetical order, indicating whether they are active
CEH scientists; other center affiliates; or technical/administrative contributors.
 Other pertinent information, such as disciplines (e.g., behavior science,
epidemiology, sociology, anthropology, economics, public health, medicine,
toxicology), academic department, or institutional affiliation (for
collaborations across institutions) may be included but is not required.
Information may be presented in tabular form. Include biographical sketches for
all center affiliates in the appropriate component of the application.

Describe how the infrastructure center
will complement or leverage existing resources and expertise provided by other funding
sources.  If resources are to be supported by this FOA and other sources (like
EHS Core Center), describe the financial arrangements.  Describe the steps taken
to ensure that the resources are not duplicative of existing activities.

Briefly describe the applicant
center’s governance and organizational structure, providing an organizational
chart; the responsibilities and authority of the Center Director (PD/PI) and
Deputy Director; and the role of advisory or user committees. 

Letters of Support: Include
letters of support for the proposed center as a whole; letters of support specific
to individual cores should be included with the appropriate component. Letters may
be from collaborators or communities that would benefit from the Centers resources
such as knowledge, skills and products.

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 following modification:

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.

Generally, Resource Sharing Plans are expected.  All
applications, regardless of the amount of direct costs requested for any one
year, should address the following essential elements of a Data Sharing Plan:

Any software, tools or protocols that are developed
under this program should be shared broadly and at least referenced on home
page under resources and tools.

Any resources developed to implement broad dissemination
sharing of research results should be made publicly available through a simple
web interface

All CEHRT Centers produced materials should be submitted
to NIEHS’ Partnerships for Environmental Public Health (PEPH) Resource Center.

https://connect.niehs.nih.gov/peph/index.cfm?directTo=peph.landing.

Appendix:

Only limited items are allowed in the Appendix. Follow
all instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Human Subjects and Clinical Trials
Information (Overall)

When involving human subjects research, clinical
research, and/or NIH-defined 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 ‘Administrative
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)

 Applicants
must provide a detailed budget, including justification for all expenditures for
the Administrative Core. 

Budget forms appropriate for the specific
component will be included in the application package.  direct costs for the Administrative
Core may not exceed $100,000 annually.

The budget for the Administrative
Core must include travel for the Director and Deputy Director and core leads ,
and  one member of the Internal  Advisory Board to attend one annual CEHRT
center meeting.  The budget should also include costs associated with external
communications as needed.

A Center should expect to host the
annual CEHRT center meeting once within the project period and may want to set
funds aside for this event.  Please consult with program staff for details.

Items Not
Allowed Under this Component of the CEHRT Center Grant Include:

1. Direct support of individual research except for
Pilot Projects.


2. Salary for Director, Deputy Director, Core leaders, Collaborators, or individuals
unless clearly defined roles are documented in the operation of the CEHRT
Center.


3. Travel to workshops or scientific meetings, except for junior, mid-level and
recruited investigators for cultivating career enhancements.  


4. Page and publication charges.


5. Director’s Funds or Discretionary Fund.

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:
 Identify
general objectives planned for the Administrative Core (AC) along with the main
benchmarks that would indicate the accomplishment of these objectives.    

Research
Strategy:
 The Administrative Core will provide overall administrative
and organizational oversight and management of the Center.  

As part of this section, the application
should address the following:

(1) Overall leadership and personnel capacity that
may include but is not limited to the following;

(2) Administrative, operations and meeting support
staff;

(3) Business and or legal expert staff

(4) Other staff required to support the Center as
a whole 

 


Detailed plans to support the activities of the
Center including at minimum:

(1) Coordinate and integrate the CEHRT center components
and activities such as workshops, retreats, and meetings.

(2) Attract early and mid-level investigators to
enhance research and translation efforts in CEH from inside and outside the
institution.

Provide the following information for the Administrative
Core (AC):

(1) Describe how the support from this FOA will be
used over and above what is already provided by the applicant’s institution. 
Describe how the services complement or leverage administrative services provided
by other sources.  If administrative services are to be supported by this FOA
and other sources like the NIEHS Environmental Health Core Center, please the
describe the financial arrangements.  Describe the steps taken to ensure that
the core does not duplicate existing activities.

(2) Explain how the types of administrative
services to be provided from this FOA advance the overall application’s specific
aims.

(3) Explain how the applicant plans to assess
whether the administrative support services provided by this FOA are advancing
the overall application’s specific aims.  Explain the procedures the applicant
is planning to use to maximize efficiency of administrative services supported
by this FOA.

(4) Explain eligibility and priorities for accessing
core services provided by this FOA and the procedures to be used to ensure that
junior scientists and outside collaborators and public use or access to core
services.

(5) Describe the core’s governance and organizational
structure.

Leaderships Qualifications: Describe the responsibilities
of the Director and Deputy Director of the Center of the Multi-PD/PI plan. The
Center Director is expected to be a well-recognized and respected leader in the
field of CEH with the authority to oversee the organization and operation of
the CEHRT Center and to provide scientific and administrative leadership for
the total program. A Deputy Director is expected to play an active role in the
organization and operation as well with specific function to serve as the lead
of the Translation Core to prioritize, expedite research results into practice.

Describe how the Center would make its activities,
resources, and opportunities known to basic and children’s environmental health
scientific communities, partners and stakeholders. Highlight innovative strategies
for promoting research opportunities to diverse communities for example, this
may include some combination of advertisements in professional journals, newsletters,
and websites; contacts with relevant research departments and funded researchers;
presentations at professional meetings; and other means, as appropriate.

Also, describe how the Center would develop a web portal
to promote outreach, with connection to archived research resources (e.g., research
protocols, background information, reference articles, databases, and contact
information, as appropriate).

Include plans for an independent advisory board to
provide guidance on resources being developed and access to materials and
translational activities. Indicate the types of expertise or perspectives that
would be appropriate for the board.  Potential board members must not be
contacted until after the review of the application has been completed.

CEHRT Centers would be expected to collaborate with
other Centers funded under this FOA, as appropriate; however, the level of collaboration
would depend on the actual research domains that get funded under this FOA and
their potential synergy. 

Letters of Support: Include
any letters of support from colleagues at secondary institutions including
appropriate administrative officials.

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 following modification:

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.

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 human subjects research, clinical research,
and/or NIH-defined 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

Development Core

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

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

SF424 (R&R) Cover (Development
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 (Development
Core)

Enter Human Embryonic Stem Cells in each relevant
component.  

Research & Related Other Project Information
(Development 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.

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

Project /Performance Site Location(s)
(Development 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 (Development 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.

Research & Related Senior/Key Person Profile (Core or
Project Name)

  • 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 (Development Core)

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

Annual direct costs for this core may not exceed $150,000.00
per year.

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 (Development Core)

Specific
Aims:
Describe the Development Core’s objectives and the current
and planned support and services to be provided. The specific aims for the Development
Core should explicitly address how the core will focus on supporting translational
CEH research to increase the scientific impact, innovation, productivity of children’s
environmental health researchers; increase the Center scientists’ and users competitiveness
for peer-reviewed external funding in children’s environmental health research;
and support experiences for junior scientists that will contribute to their research
independence.

Research
Strategy:
The research strategy should address how the applicant
plans to use support from this FOA to provide development activities and service
beyond services and activities provided by the applicant institution including
other center awards.

All applicants requesting support for a Development
Core must propose a catalyst program supporting small-scale and innovative pilot
projects, especially those that will provide preliminary data leading to larger
research efforts improving children’s environmental health, respond to emerging
environmental threats, or test innovative technology to break new ground or extend
into new directions.  Each catalyst program application should include a
translation plan. The catalyst program may provide funding for research, but
may also, in addition to or instead of, provide other types of support, such as
research assistant(s) or dedicated consulting or mentorship.

Researchers associated with the CEHTR Center
(infrastructure grant) may be considered for pilot funding, but first- priority
should be researchers who come to the infrastructure network from outside locations.
The distribution of pilot funds through the catalyst program will require strategies
for negotiating with secondary institutions to transfer grant funds in the most
fiscally and administratively efficient manner.

The Development Core may also support other types of
development activities, including but not limited to, application preparation
workshops/boot camp; seminar or brown bag series; working groups; and other
internal workshops and conferences. The Developmental Core will create a collaborative
innovation and discovery space for Center affiliates and outside scientific
community and stakeholders to engage in activities with a goal to find
solutions to protect our children from environmental exposures.

Provide
the following information for the Development Core:

Describe how the support from this FOA will be used
to provide development services and activities above and beyond services and
activities provided by the applicant institution and center, including those
from NIH-funded R, P, T, F, K, or R25 programs, if applicable to the applicant
center and/or its affiliates.

Describe what services and activities will be provided
and how they will be provided as well as how the resource will be evaluated.

Describe how the development services and activities provided
by this FOA complement and/or leverage development services and activities
provided by other sources.

If development services and activities are to be
supported both by this FOA and other sources, describe the financial arrangements.
Describe the steps taken to ensure that the core does not duplicate existing
activities.

Explain how the types of development services and activities
to be provided through support from this FOA advance the overall application’s
specific aims.

Explain how the applicant plans to assess whether the
development services and activities supported by this FOA are advancing the
overall application’s specific aims. Explain the procedures the applicant is
planning to use, and, if applicable, has used, to maximize the efficiency of
development services and activities supported by this FOA.

Explain eligibility and priorities for accessing Development
Core services supported by this FOA and the procedures to be used to ensure
that junior scientists and outside collaborators have access to core services.

Describe procedures for soliciting, reviewing, and
selecting applications or proposed activities, including who will be involved in
the review.

Describe the core’s governance and organizational structure.

For the catalyst program, address all the items above
and, in addition, include the following:

  • Procedures
    for soliciting and reviewing seed grant applications from junior researchers
    and outside collaborators.
  • How the core
    will prioritize the funding of applications from junior researchers and outside
    collaborators.
  • Requirements
    for preparing research applications to continue or expand the research project.
  • Size of
    awards.
  • Length of
    award periods.
  • Number of
    awards permitted to an individual researcher.
  • Mentoring
    arrangements.
  • Describe
    the core’s governance and organizational structure.

Explain the institutional plans and procedures that
assure compliance with applicable federal regulations and NIH policies for the
protection of human research participants, including the evaluation of risks
and protections in project proposals, appropriate ethical oversight of funded
projects, and plans for monitoring data and safety in clinical research
projects. Information in other sections may be referenced and not repeated.

Letters
of Support:
Include any letters of support from colleagues at
secondary institutions including appropriate administrative officials.

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.

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.

Appendix:  Only limited items are allowed in the Appendix. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Development
Core)

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

Translation Core

When preparing your application, use Component Type ‘Translation
Core.

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

SF424 (R&R) Cover (Translation
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 (Translation
Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project
Information (Translation 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)
(Translation 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 (Translation 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 (Translation Core)

Budget forms appropriate for the specific component
will be included in the application package. Annual direct costs for this core is
a minimum of $250,000.00 per year.

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 (Translation
Core)

Specific
Aims:   
Identify general objectives planned for the Translation
Core along with the main benchmarks that would indicate the accomplishment of
these objectives. This core will promote the translation of research
results in the field of CEH through a variety of approaches, methods and
strategies drawn from the communication, education and dissemination and
implementation sciences.  This core will engage researchers, clinicians and communities
to work together and share knowledge and expertise to ensure the improvement of
CEH through the uptake, sustainment and spread of evidence-based interventions
and/or practices into real-world practices.

Research
Strategy:
The Translation Core will provide overall support to
the success of the CEHR Translation Center.

A significant component for this Center program will
be the Translation Core (TC). The Core should build upon recognized theories,
strategies, or frameworks such as the NIEHS Translational Research Framework to
guide their planning.  The Core should focus on opportunities to expand the reach
of existing CEH research results through such efforts as CEH communication and messaging,
implementation and adaptation and sustainment of effective interventions and/or
practices to meet contextual needs, and to widely disseminate (i.e., spread) of
these messages, interventions and/or practices. Educational curriculum development
is key, and the learning process has changed dramatically over the past decade
with the integration of new internet-based technologies.  Thus courses,
workshops, and demonstrations are encouraged and may occur at the applicant
institution, at national meetings, and other public venues or through virtual
meeting technologies as appropriate. When possible, activities should be made
available for remote viewing and archived for possible screening at later date.
Importantly, there is a need from more multi-directional communication that
allows for input so the learning experience may be tailored, accessible and culturally
appropriate.

The Translation Core may also consider the following
research areas in their applications (if applicable) such as:

  • Studies of
    multi-level contextual factors (e.g., local, organizational, system-levels)
    that may influence the success of dissemination or implementation efforts. Studies
    of effective implementation and/or dissemination strategies to improve uptake and
    spread of CEH practices and/or interventions.
  • Understand
    how effective interventions work, particularly multi-level or multi-component
    interventions, to inform how CEH interventions can be adapted and/or delivered with
    fidelity when implemented in various settings.
  • Consider
    extant literature on barriers to and facilitators of CEH practices to improve
    health.

As part of this section, the applicant should address
the following:

Describe how the support from this FOA will be used
to provide scientific and technical services and resources above and beyond
services and resources provided by the applicant institution and center as well
as existing NIH grants to advance the field of CEH through translational approaches
and methods.

Describe how these services and resources will be provided.

Describe how the translational services and activities
provided by this FOA complement and/or leverage translation services and
activities provided by other sources. If translation services and activities
are to be supported both by this FOA and other sources, describe the financial
arrangements. Describe the steps taken to ensure that the core does not
duplicate existing activities.

Explain how the types of scientific and technical services
and resources to be provided through support from this core will advance the
overall application’s specific aims. Explain the procedures the applicant is
planning to use, and, if applicable, has used, to maximize the efficiency of
scientific and technical services and resources supported by this FOA.

Explain eligibility and priorities for accessing translation
core services supported by this FOA and the procedures to be used to ensure
that junior scientists have access to core services as well as collaborators outside
of your organization.

Describe the Core’s governance and organizational
structure.

This Core may also develop a pilot grant program to focus
on methods, strategies and approaches used to improve and expedite the
translation of the research results to targeted stakeholders with an emphasis on
medical and public health communities. Procedures for soliciting, reviewing,
selecting and awarding seed grant applications to help facilitate translation
efforts need to be addressed.

  • How the
    core will prioritize the funding of applications from junior researchers? 
  • Describe
    the process for reviewing and who will be selecting the awards.
  • Requirements
    for preparing research applications to continue or expand the research  project.
  • Size of
    awards.
  • Length of
    award periods.
  • Number of
    awards permitted to an individual researcher.
  • Mentoring
    arrangements.

Letters
of Support:
Include any letters of support from colleagues at
secondary institutions including appropriate administrative officials.

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.

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.

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 (Translation
Core)

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

Coordinating Center

When preparing your application, use Component Type ‘Coordinating
Center’

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

SF424 (R&R) Cover (Coordinating Center)

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 (Coordinating
Center)

Enter Human Embryonic Stem Cells in each relevant
component.

Research & Related Other Project Information
(Coordinating Center)

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)
(Coordinating Center)

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 (Coordinating Center)

  • 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 (Coordinating Center)

Budget forms appropriate for the specific component
will be included in the application package.  Annual direct costs for the
Coordinating Center may not exceed $100,000.00 per year.

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 (Coordinating Center)

Specific
Aims:
In addition to proposing the CEHRT center, an applicant
may propose to take on the additional role as serving as the coordinating center
across all the funded P2C CEHRT

       Centers. However, this responsibility is optional and is not a necessary part of a P2C application.

 If interested in assuming this additional responsibility of coordinating activities across awarded Centers, briefly discuss how you would meet the specific goals of developing and maintaining a central web portal, promoting the overall infrastructure of the program to the research community and stakeholders in a variety of settings.
 

 How would you promote and coordinate trans-center activities, host and document periodic web-based conferences and teleconferences among the centers PI and staff, and document the overall outcome products and deliverables with respect to supporting the research community and stakeholders as well as the goals of NIH?

 How would you collect, organize, and disseminate information relevant to the CEHRT Center program as needed for program evaluation, planning and reporting?

Research Strategy:  Provide details on the operation of a centralized
web portal that will provide the research community and stakeholders with access to the overall collaborating centers and direct them to the appropriate centers and resources. 

Discuss how you would promote the overall program to appropriate research and stakeholder communities and individual investigators especially through presentations, and booths at national research meetings. 

Provide strategies to coordinate and integrate activities and promote best practices across the Centers.  Discuss a model for hosting and archiving periodic virtual meetings, teleconferences, and occasional direct face-to-face meetings among the funded Centers (PIs and their senior staff). 

Provide a framework for gathering outcomes data on the role of the program to meet its four priority goals including supporting mentored research collaborations and the potential value added of the infrastructure center program. Work with NIEHS program staff to establish milestones and metrics.

All CEHRT Centers produced materials should be submitted to NIEHS’ Partnerships for Environmental Public Health (PEPH) Resource Center.

https://connect.niehs.nih.gov/peph/index.cfm?directTo=peph.landing.

Letters of Support: Include any letters of support from colleagues at
secondary institutions including appropriate administrative officials.

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 (Coordinating
Center)

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

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement
.

Pre-award costs are allowable only as described in the NIH Grants Policy
Statement
.

7. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide.  Paper applications
will not be accepted.

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 the NIEHS, NIH.
Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the NIEHS Scientific Review Officer by email at [email protected] when the application
has been submitted. Please include the FOA number and title, PD/PI name, and title
of the application.

Select
Pilot Project Pre-Approval

While Foreign Components are acceptable in the CEHRT Center,
select catalyst and pilot projects partly performed in a foreign country must be
approved by NIEHS before an award can be made.  The catalyst or pilot project must
demonstrate a highly competitive justification both to the CEHRT Center through
its selection process and NIEHS.  All foreign catalyst and pilot projects are
subject to NIH and Federal regulations and guidelines governing the approval of
such activities and will be considered case-by-case.

Post Submission Materials

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

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review
system.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study
design, methods, and intervention that are not by themselves innovative but address
important questions or unmet needs. Additionally, the results of the clinical
trial may indicate that further clinical development of the intervention is
unwarranted or lead to new avenues of scientific investigation.

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 Core 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? 

Evaluate how access by the relevant
stakeholders to the proposed center’s research domains, translational efforts,
and expertise transform the field of children’s environmental health and lead
to improve public health and clinical practice?

In
addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical
trial to test the proposed hypothesis or intervention well supported by
preliminary data, clinical and/or preclinical studies, or information in the literature
or knowledge of biological mechanisms? For trials focusing on clinical or
public health endpoints, is this clinical trial necessary for testing the safety,
efficacy or effectiveness of an intervention that could lead to a change in
clinical practice, community behaviors or health care policy?  For trials
focusing on mechanistic, behavioral, physiological, biochemical, or other
biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the center? 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?

Do the Center Director and Deputy
Director, and Core Leaders demonstrate the ability to provide scientific and
administrative leadership and direction?

Do the named investigators have the
qualifications/background to assist in the Center efforts towards implementing
the translational research vision of the Center?

Is there balance of expertise
proposed with expertise in CEH along with other appropriate disciplines such
as, but not limited to, Sociology, Behavioral Science, Communication Research,
and Dissemination and Implementation Science?

In
addition, for applications involving clinical trials

With regard to the proposed
leadership for the Center, do the PD/PI(s) and key personnel have the expertise,
experience, and ability to organize, manage and implement the proposed clinical
trial and meet milestones and timelines? Do they have appropriate expertise in
study coordination, data management and statistics? For a multicenter trial, is
the organizational structure appropriate and does the application identify a
core of potential center investigators and staffing for a coordinating center?

Innovation

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

In
addition, for applications involving clinical trials

Does the design/research plan
include innovative elements, as appropriate, that enhance its sensitivity, potential
for information or potential to advance scientific knowledge or clinical practice?

Assess whether the applicants provide
sufficient information or approaches to evaluate the potential for involvement in
 clinical and public health practices?

Approach

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 Center? 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 Center 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?
 

In
addition, for applications involving clinical trials

Does the application adequately address the following,
if applicable:

Study
Design

Is the study design justified and appropriate to address
primary and secondary outcome variable(s)/endpoints that will be clear, informative
and relevant to the hypothesis being tested? Is the scientific rationale/premise
of the study based on previously well-designed preclinical and/or clinical
research? Given the methods used to assign participants and deliver interventions,
is the study design adequately powered to answer the research question(s), test
the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial
appropriately designed to conduct the research efficiently? Are the study populations
(size, gender, age, demographic group), proposed intervention arms/dose, and
duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is
the process for obtaining informed consent or assent appropriate? Is the
eligible population available? Are the plans for recruitment outreach,
enrollment, retention, handling dropouts, missed visits, and losses to follow-up
appropriate to ensure robust data collection? Are the planned recruitment timelines
feasible and is the plan to monitor accrual adequate? Has the need for randomization
(or not), masking (if appropriate), controls, and inclusion/exclusion criteria been
addressed? Are differences addressed, if applicable, in the intervention effect
due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and
monitor adherence to, the trial protocol and data collection or distribution guidelines
appropriate? Is there a plan to obtain required study agent(s)? Does the application
propose to use existing available resources, as applicable?

Data
Management and Statistical Analysis

Are planned analyses and statistical
approach appropriate for the proposed study design and methods used to assign participants
and deliver interventions? Are the procedures for data management and quality
control of data adequate at clinical site(s) or at Center laboratories, as
applicable? Have the methods for standardization of procedures for data management
to assess the effect of the intervention and quality control been addressed? Is
there a plan to complete data analysis within the proposed period of the award?  

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

In
addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating,
enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the
capability and ability to conduct the trial at the proposed site(s) or centers?
Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the
application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence
of the ability of the individual site or center to: (1) enroll the proposed
numbers; (2) adhere to the protocol; (3) collect and transmit data in an
accurate and timely fashion; and, (4) operate within the proposed organizational
structure? 

Additional Review Criteria Cores

For components types: Admin Core, Development Core, Translation Core and Coordinating Center (optional), reviewers will consider the following review criteria in assessing and providing a score to each component.

Administrative Core

  • Will the
    services provided by the core enable the program to achieve its specific aims
    and make advances in research and translation of CEH?
  • Are the
    qualifications, experience, and commitment of core leader and other personnel
    appropriate?
  • Will the
    CEHTC be able to establish itself as a recognizable entity in the field of children’s
    environmental health?
  • How appropriate
    are the plans describing  the obtention of membership and/or  how to access resources
    and utilize services?
  • Are the
    plans to develop  and administer the Internal Advisory Committee appropriate
    and are the expertise of the committee members a good fit for the Center’s proposed
    research and translational efforts?
  • Is there enough
    expertise and administrative support for the proposed activities?
  • Does the
    applicant have a strong understanding of their audiences need?
  • Have they
    proposed an appropriate strategy to promote expertise to the broader CEH research
    community?
  • Would the
    proposed center web portal provide a good indication of the breadth of opportunities
    and resources?
  • Would the
    website provide access to a useful array of materials and/or references?
  • Did the
    applicant make an effort to promote opportunities to individuals currently
    underrepresented in the biomedical, behavioral, clinical and social sciences?
  • Did the applicant
    describe approaches for active engagement with their identified stakeholders?
  • Would the
    proposed center seek opportunities to interact with other centers funded under
    this FOA?

Development Core

  • Does the
    applicant have an appropriate strategy for advertising the catalyst program and
    for reviewing and prioritizing requests?
  • Has the
    applicant laid out appropriate criteria for prioritizing the outlay of catalyst
    funding?
  • Are there
    sufficient expertise and administrative support for the proposed activities?
  • Does the
    applicant have a strategy for following up and evaluating investments?
  • Does the applicant have a
    plan to create a collaborative space to encourage collaboration and mentoring
    opportunities?
  • Catalyst
    program- how feasible and practical are the plans to operationalize the program? 
  • Have they provided details
    on how they will advertise and encourage outside institution applications?  
  • Has the applicant laid
    out appropriate criteria for prioritizing the outlay of pilot funding?
  • Is the selection process transparent
    and fair and equitable?
  • Does the applicant have a
    strategy for following up and evaluating the pilot funding investments?

Translation Core

(a) Translating research information into
environmental public health and clinical practice:

  • Will the
    different type of activities in this core increase awareness and understanding
    of children’s environmental health research?  
  • For the
    products being proposed, are they relevant to the scientific focus or the expertise
    of the collective center?
  • Has the
    applicant identified the needs of its target audience and described appropriate
    activities to engage and reach their target audience?
  • Is there
    adequate integration of the Translation Core within the center and its overall proposed
    activities?
  • Is there
    communication between core functions and structure in place to assure integration
    with other funded centers?

(b) Ensuring transparency to the Children’s
environmental health community and deep understanding of community and other
stakeholder needs

  • Are the
    plans appropriate to increasing awareness of children’s environmental health
    research results and concerns both regarding (re)emerging and legacy compounds
    that impact children’s health?
  • Do the
    plans adequately describe a process for maintaining transparent communications
    between the identified audience and the academic partners throughout the entire
    process of the activity? 
  • Evaluate
    the plan and approaches described that will build and sustain  multi-directional
    communication within the center, between centers and most importantly with
    their targeted stakeholders and the broader CEH scientific community?

(c) Leadership and staff expertise

  • Is the Core
    leader qualified for the position? Does he or she demonstrate appropriate education
    and expertise in public health, behavioral and social science research,
    outreach, health communication, or other relevant disciplines?
  • Are his
    or her education and expertise aligned to the vision and objectives of the CEC?
    Does the investigator provide previous experience/evidence for conducting
    community engagement activities/projects? 

(d) Pilot Project Program

  • Does the
    applicant have an appropriate strategy for advertising the pilot program and
    reviewing and prioritizing requests?
  • How
    feasible and practical are the plans to review and distribute funds for pilot
    projects?
  • Does the applicant
    have a strategy for following up and evaluating the pilot funding investments?
  • Does the
    Core plan to use pilot project funds in a manner that encourages innovative methods,
    tools and approaches to convey CEH research results of importance to stakeholders?

(e) Evaluation of deliverables and outcomes

  • Are milestones
    in place to achieve the TC goals?
  • Are the materials
    and activities that are described in the application culturally appropriate or
    do they acknowledge the need to address this as a primary concern for their
    success?

Coordinating Center (optional)

  • Do the
    applicants have significant knowledge of the activities proposed in the Collaborative
    Centers of CEHRT program? 
  • Do they
    have sufficient understanding of the current status of the field of children’s
    environmental health? 
  • Do the
    applicants have sufficient expertise in coordinating scientific endeavors and evaluating
    outcomes and deliverables?
  • Have they
    proposed an outward focus of the program as opposed to an inward organizational
    strategy for coordination?
  • Will the
    proposed team willing to work cooperatively with the NIEHS and the NIEHS CEHRT
    Centers Program to further the overall goals of the Program?

Additional Review Criteria

As applicable for the Center 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.

Study Timeline

Specific
to applications involving clinical trials

Is the study timeline described in detail, taking
into account start-up activities, the anticipated rate of enrollment, and
planned follow-up assessment? Is the projected timeline feasible and well
justified? Does the project incorporate efficiencies and utilize existing
resources (e.g., CTSAs, practice-based research networks, electronic medical records,
administrative database, or patient registries) to increase the efficiency of
participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions
discussed (e.g., strategies that can be implemented in the event of enrollment
shortfalls)?

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 core 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
.

Vertebrate
Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures involving
animals, including species, strains, ages, sex, and total number to be used;
(2) justifications for the use of animals versus alternative models and for the
appropriateness of the species proposed; (3) interventions to minimize discomfort,
distress, pain and injury; and (4) justification for euthanasia method if NOT consistent
with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess
the use of chimpanzees as they would any other application proposing the use of
vertebrate animals. For additional information on review of the Vertebrate
Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section
.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research personnel
and/or the environment, and if needed, determine whether adequate protection is
proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations – Overall

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

Applications
from Foreign Organizations

Not applicable.

Select Agent
Research

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

Resource Sharing
Plans

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


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) by NIEHS 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 National Advisory Environmental Health
Sciences Councill. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed Center as determined
    by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed Center 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.

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

Individual awards are based on the application submitted to,
and as approved by, the NIH and are subject to the IC-specific terms and conditions
identified in the NoA. 

ClinicalTrials.gov: If an award provides for one or more clinical
trials. By law (Title VIII, Section 801 of Public Law 110-85), the “responsible
party” must register and submit results information for certain “applicable
clinical trials” on the ClinicalTrials.gov Protocol Registration and Results
System Information Website (https://register.clinicaltrials.gov).
NIH expects registration and results reporting of all trials whether required
under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Monitoring Requirements: The NIH policy for data and safety
monitoring requires oversight and monitoring of all NIH-conducted or -supported
human biomedical and behavioral intervention studies (clinical trials) to
ensure the safety of participants and the validity and integrity of the data. Further
information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm
and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects involving
the use of investigational therapeutics, vaccines, or other medical interventions
(including licensed products and devices for a purpose other than that for
which they were licensed) in humans under a research protocol must be performed
under a Food and Drug Administration (FDA) investigational new drug (IND) or
investigational device exemption (IDE). 

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or
studies involving greater than minimal risk to human subjects require prior
approval by NIH prior to initiation. 

  • The awardee institution will comply with the NIH Guidance
    on Changes That Involve Human Subjects in Active Awards and That Will Require
    Prior NIH Approval
    .
  • The awardee institution will provide NIH with specific plans for
    data and safety monitoring, and will notify the IRB and NIH of serious adverse events
    and unanticipated problems, consistent with NIH DSMP policies.
  • While Foreign Components are acceptable in the CEHRT Center,
    select catalyst and pilot projects partly performed in a foreign country must be
    approved by NIEHS before an award can be made.  The catalyst or pilot project must
    demonstrate a highly competitive justification both to the CEHRT Center through
    its selection process and NIEHS.  All foreign catalyst and pilot projects are subject
    to NIH and Federal regulations and guidelines governing the approval of such
    activities and will be considered case-by-case.

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 laws that
prohibit discrimination on the basis of race, color, national origin, disability,
age and, in some circumstances, religion, conscience, and sex.  This includes
ensuring programs are accessible to persons with limited English proficiency.  The
HHS Office for Civil Rights provides guidance on complying with civil rights laws
enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in
scope for many reasons that are nondiscriminatory, such as the principal investigator’s
scientific interest, funding limitations, recruitment requirements, and other
considerations. Thus, criteria in research protocols that target or exclude certain
populations are warranted where nondiscriminatory justifications establish that
such criteria are appropriate with respect to the health or safety of the subjects,
the scientific study design, or the purpose of the research.  For additional
guidance regarding how the provisions apply to NIH grant programs, please
contact the Scientific/Research Contact that is identified in Section VII under
Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information
about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.    

In accordance with the statutory provisions contained in Section
872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009
(Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance
and Integrity Information System (FAPIIS) requirements.  FAPIIS requires
Federal award making officials to review and consider information about an applicant
in the designated integrity and performance system (currently FAPIIS) prior to
making an award.  An applicant, at its option, may review information in the
designated integrity and performance systems accessible through FAPIIS and comment
on any information about itself that a Federal agency previously entered and is
currently in FAPIIS.  The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a judgement
about the applicant’s integrity, business ethics, and record of performance
under Federal awards when completing the review of risk posed by applicants as
described in 45 CFR Part 75.205 “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

Not Applicable

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: [email protected] (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: [email protected]

Scientific/Research Contact(s)

Kimberly Gray, PhD


National Institutes of Environmental Health Sciences (NIEHS)


Telephone: 984-287-3262


Email: [email protected]

Peer Review Contact(s)

Linda Bass, PhD


National Institutes of Environmental Health Sciences (NIEHS)


Telephone: 984-287-3236


Email: [email protected]

Financial/Grants Management Contact(s)

Barbara Gittleman


National Institutes of Environmental Health Sciences (NIEHS)


Telephone: 984-287-3261


Email: [email protected]

Section VIII. Other
Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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