NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

The objective of this FOA is to support a Coordinating Center for the Environmental Influences on Child Health Outcomes (ECHO) program. The ECHO Coordinating Center will provide the organizational framework for the management, direction, and overall coordination of all common ECHO activities.

Following the closure of the National Children’s Study (NCS) in fiscal year (FY) 2015, Dr. Francis Collins, the NIH Director, emphasized the importance of and need for research addressing the links between the environment and child health and development. To make the best use of the NCS-appropriated funds for FY 2015, NIH established new programs and enhanced existing programs focusing primarily on the development of tools to enhance measurement of environmental exposures (e.g., physical, chemical, biological, psychosocial), and the study of environmental influences on placental and in utero development to identify the seeds of future diseases and conditions.

The new ECHO program for FY 2016 continues to leverage investments made in extant programs while providing the flexibility to investigate key questions of interest at the intersection of environmental health and pediatric research. NIH will support multiple synergistic, longitudinal studies using extant cohorts that represent a broad range of environmental exposures (e.g., physical, chemical, biological, behavioral, social). All longitudinal studies will test the hypothesis of how environmental exposures impact childhood health outcomes. Studies will include a strategy for collection of a targeted set of data (Core Elements) as a component of the project and will agree to collaboration on standardization through Steering Committee participation. These Core Elements will include:

• Demographics [e.g., race, gender, ethnicity, socioeconomic status, geographic location/diversity]
• Typical Early Development [e.g., growth, milestones, sleep, nutrition, activity level]
• Optional Sub-Element: Microbiome
• Genetic Influences on Early Childhood Development
• Optional Sub-Element: Epigenetics [e.g., maternal exposome ]
• Environmental Factors [e.g., physical, chemical, biological (in utero), psychosocial, natural and built environments]
• Patient Reported Outcomes (PROs) [e.g., PROMIS Adult and Pediatric Self- and Proxy-Reported Health representing Physical, Mental and Social Health Domains]

The cohort studies will focus on one to four key pediatric outcomes to assess range of functioning over time. These Focus Areas are:

• Upper and Lower Airway [e.g., asthma, allergies, sleep disordered breathing]
• Obesity [e.g., nutrition, diabetes, metabolic risk factors]
• Pre-, Peri-, and Postnatal Outcomes [e.g., birth defects, childhood outcomes]
• Neurodevelopment [e.g., autism, ADHD, depression, social/behavioral development, cognition]

The FY 2016 plan aims to provide the flexibility and opportunity to investigate key questions of interest at the intersection of environmental health and pediatric research, while also leveraging additional features and capabilities of the studies. For example, the studies could:

• Take maximal advantage of existing tissue banks collected across pregnancy (e.g., cervicovaginal secretions, maternal DNA, cord blood, placenta) and data sets by funding additional analyses
• Serve as a test bed for validating new technologies, tools, and approaches for efficient and effective environmental and pediatric monitoring
• Use systems approaches to develop multi-variable models to predict disease development
• Recruit participating women with subsequent pregnancies to investigate outcomes of second children to serve as a comparison cohort to first pregnancy children

An additional opportunity for creating an IDeA States National Pediatric Clinical Research Network also will be supported. This national network for pediatric research will help address access gaps for rural children through a national network for pediatric research embedded at IDeA locations and link existing IDeA state centers with experts in clinical trials.

This set of companion FOAs aims to create a consortium of sites and investigators to conduct longitudinal studies of the effects that early environmental exposures (including in utero exposures) have on later child development and health outcomes. The consortium will consist of:

• Pediatric Cohort: extant cohorts will be followed prospectively, with assessments of exposures and outcomes. Pediatric cohorts will each conduct individual prospective longitudinal studies targeting at least one focus area and will participate with the other awardee clinical sites to conduct mutually agreed upon collaborative studies of a synthetic cohort of pooled sites. [RFA-OD-16-004]
• Coordinating Center: a central site responsible for organizing and managing activities and logistics for collaborative components of the consortium, including oversight and coordination of all ECHO programs, multi-cohort study design and protocol and informed consent development, administrative management of multiple-site/-project studies, evaluation of progress, data quality and completeness, and sample storage. The ECHO Coordinating Center will include an Opportunities and Infrastructure Fund to support pilot projects and to introduce new tools and technologies in the context of the ECHO program. [this FOA]
• Data Analysis Center: responsible for managing data from ECHO pediatric cohorts, developing and applying novel analytic methods for combining and analyzing existing and new longitudinal data from disparate extant cohorts, and for conducting multi-level analyses on pooled consortium data to address the impact of early life exposures on childhood health outcomes. [RFA-OD-16-005]
• CHEAR Core: serve as a resource for analyzing personal environmental exposures from existing and prospective collections [PA-16-046]
• PRO Core: responsible for maintaining and providing PROs, assisting with the incorporation of PROs into study design, coordinating the mode of administration, and updating existing and validating emerging child PROs [RFA-OD-16-003]
• Data Coordinating and Operations Center for the IDeA States Pediatric Clinical Trials Network: a central site within the IDeA program that provides data coordination functions for pediatric clinical trials, technical instruction, adherence to state-of-the-art data standards, quality assurance, and an operational interface between the IDeA system and other entities. [RFA-OD-16-002]
• Clinical Sites for the IDeA States Pediatric Clinical Trials Network: sites at which teams of dedicated pediatric research staff will be established to augment geographic diversity of clinical trials [RFA-OD-16-001]

The ECHO Coordinating Center (CC) will provide the organizational framework for the management, direction, and overall coordination of all ECHO activities. Applicants for the ECHO CC are strongly encouraged to also apply to the ECHO Data Analysis Center FOA. Note that each application to these two FOAs should be self-contained.

Specifically, the ECHO CC will have the following responsibilities:

• Under direction from the ECHO Steering Committee, develop, standardize and provide quality control for the core outcomes to be collected by all ECHO Pediatric Cohorts. This includes developing the protocols and the standard operating procedures for the collection of core outcomes; organizing and maintaining protocol-specific Study Management Teams, organizing training of ECHO Pediatric Cohort staff for the collection of these outcomes; monitoring outcome collection and ensuring through specific Quality Assurance and Quality Control measures that administration of outcome tools and acquisition of biospecimens is appropriate and consistent across all research sites; coordinating data transfer to the ECHO Data Analysis Center; coordinating biospecimen transfer to the appropriate analytic facilities; utilizing existing biorepositories for long term biospecimen storage.
• Establish and support communication pathways and interactions between ECHO Pediatric Cohorts that address each of the four scientific focus areas with the goal to facilitate the exchange of information, the harmonization of research activities and the development and implementation of within-scientific-focus-area research protocols.
• Establish and support communication pathways and interactions between all ECHO Pediatric Cohorts aiming at increasing the collaborative nature of the program and the support of young investigators.
• Coordinate the functions of the ECHO Steering Committee including organization of yearly face-to-face scientific and administrative meetings (4 face-to-face meetings will take place during the first year of the ECHO program) and monthly teleconferences, maintenance of Steering Committee minutes and coordination of ECHO subcommittees and workgroups.
• Coordinate the functions of the ECHO External Scientific Board including organization of face-to-face meetings and teleconferences, maintenance of Scientific Board minutes and communications between the External Scientific Board, the ECHO Steering Committee and the NIH Program Director and NIH ECHO team.
• Develop and implement, under the guidance of the ECHO Steering Committee, ECHO policies including, but not limited to data sharing policy, publications policy, and external collaborations policy.
• Design and maintain the ECHO website to function both as an internal resource for the storage and exchange of all ECHO documents and as the interface between ECHO and the broader scientific community and between ECHO and the public.
• Administer the ECHO Opportunities and Infrastructure Fund under the guidance of the ECHO Steering Committee and establish agreements for support of pilot projects, and for the introduction of new tools and technologies.

This FOA will not support:

• Data analyses.
• Administrative or technical management or support of independent projects conducted within each ECHO Pediatric Cohort.
• Administrative or technical management or support of clinical trials conducted under the ECHO-associated IDeA pediatric clinical trials network.
• Coordination of research conducted in animals.

The ECHO CC will consist of the following components:

1. ECHO Steering Committee Support and Communications Component

This component will have the overall responsibility for the coordination of ECHO activities through the Steering Committee and will conduct the following tasks:

• Coordinate all functions of the ECHO Steering and Executive Committees, the ECHO External Scientific Board and their interactions with the ECHO Pediatric Cohorts and the ECHO Cores.
• Develop and implement ECHO operating policies and procedures under the guidance of the ECHO Steering Committee.
• Develop and maintain effective communications between ECHO investigators and all ECHO elements (Steering and Executive Committees, External Scientific Board, NIH ECHO Team, ECHO Cores, Data Analysis Center, biorepositories).
• Develop and maintain effective communications between ECHO and the public, including the participants in the ECHO-supported studies.
• Develop and maintain the ECHO Website to function both as an internal resource for the storage and exchange of all ECHO documents and as the interface between ECHO and the broader scientific community and between ECHO and the public.

2. Core Elements and Scientific Focus Areas Coordination Component

This component will have the responsibility of developing common ECHO protocols and procedures for assessing the Core Element outcomes across all ECHO Pediatric Cohorts, as determined by the ECHO Steering Committee. In addition, this component will have the responsibility to coordinate common research activities within each of the four ECHO focus areas and harmonize aspects of the work conducted within each focus area with the goal to improve synergy and the robustness of scientific findings. The activities of this component include:

• Develop protocols and procedures for presentation and approval by the ECHO Steering Committee.
• Establish and maintain protocol-specific Study Monitoring Teams.
• Ensure that appropriate local IRB approvals are obtained and appropriate consent is obtained from study participants at each participating ECHO Pediatric Cohort for the acquisition of all core elements and the transfer and utilization of data to the Data Analysis Center and of biospecimens to central ECHO analytic sites.
• Train the ECHO Pediatric Cohort staff for these protocols.
• Monitor the ECHO Pediatric Cohorts execution of the protocols and applying Quality Assurance and Quality Control methods for output optimization.
• Coordinate data transfer from the Pediatric Cohort sites to the ECHO Data Analysis Center.
• Coordinate biospecimen transfer to analytic facilities and establish collaborations with existing biorepositories for long-term biospecimen storage and availability for future research.
• Facilitate interaction of ECHO cohorts within each focus area through teleconferences and meetings and by building focus area-specific domains within the ECHO website.
• Catalyze the harmonization of focus area-specific outcomes and outcome collection.
• If needed, facilitate the development of new common research protocols within each focus area, support IRB applications, train staff, monitor protocol execution and coordinate data and biospecimen transfer to the ECHO Data Analysis Center and Core facilities, as appropriate.

3. Opportunities and Infrastructure Fund Component

ECHO will include an Opportunities and Infrastructure Fund (OIF) that will be managed by this CC. The OIF will support pilot research projects led by young investigators within the ECHO Pediatric Cohorts and the introduction of new tools and technologies in the ECHO program. Recommendations regarding the distribution of opportunities and infrastructure funds will be made yearly by the ECHO Steering Committee, which will assess ECHO’s needs and will request applications for pilot projects within the ECHO community.

Management of the OIF will include:

• Support the ECHO Steering Committee in its yearly assessment of infrastructure and resource needs.
• Develop, on behalf of the ECHO Steering Committee, requests for opportunities funds applications, manage acceptance of such applications, and organize application reviews utilizing external reviewers.
• Establish an administrative structure to disburse and track opportunities and infrastructure funds, and monitor the projects progress.
• Establish procedures, formats, and timelines for reporting on the status of OIF projects and expenditures to the ECHO Steering Committee and the NIH ECHO Team.

4. Coordinating Center Administration Core

This Core is responsible for internal management of the ECHO Coordinating Center activities.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Alkis Togias, MD
Telephone: 240-627-3587
Fax: 301-480-4258
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall Component	6
Core: use for ECHO Steering Committee Support and Communications Component; Core Elements and Scientific Focus Areas Coordination Component; and Opportunities and Infrastructure Fund Component	12 pages for each Component
Admin Core: use for ECHO Coordinating Center Administration Core	6

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

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
• ECHO Steering Committee Support and Communications Component: required
• Core Elements and Scientific Focus Areas Coordination Component: required
• Opportunities and Infrastructure Fund Component: required
• ECHO Coordinating Center Administration Core: required

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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

If multiple PDs/PIs are proposed, identify the contact PD/PI who will also serve as the representative of the Coordinating Center at the ECHO Steering Committee. For this individual, as well as for any other PDs/PIs, utilize sections A (Personal Statement), B (Positions and Honors) and C (Contributions to Science) of the SF424 Biographical Sketch form to indicate the relevant education, training, expertise and experience.

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.

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.

Specific Aims: Briefly describe the overall Specific Aims of the proposed Coordinating Center.

Research Strategy: The Overall section of the application should describe proposed plans for the organization and staffing of the Coordinating Center, how the components of the organization, including key personnel, will interact and ensure efficient cooperation, communication and coordination, and how the proposed organization of Center components will create an integrated entity capable of effectively providing support for ECHO s functions.

Include the following:

(i) An overall organizational chart showing the three required Center Group Components and the Administration Core, as well as any additional organizational entities, identifying the proposed PD(s)/PI(s), the Component Leaders, and staff serving in a senior role.

(ii) An overall discussion of governance, and internal and external communication and coordination concepts that are of importance for the success of a large, multi-center project and its coordinating center.

(iii) An overall discussion of considerations of particular relevance and importance for the protocol design and development and for study initiation and monitoring for the collection of ECHO Core Element data and for other studies conducted within the ECHO scientific focus areas or under the ECHO OIF support, including the applicability of current and new innovative strategies, methodologies and approaches to overcome common problems and difficulties in human subjects research.

(iv) A detailed description of the relevant expertise, experience and accomplishments of the applicant organization in the planning, direction, coordination, management and provision of the full scope of organizational and research support provided for in this application. If the applicant organization also submits an application for the ECHO Data Analysis Center FOA, include a discussion of specific advantages offered to ECHO if the applicant organization was to support both the Coordinating Center and the Data Analysis Center.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core'.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Component 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 forms appropriate for the specific component will be included in the application package.

Applicants must include funding in the budget for the following:

• Travel and other expenses for Senior/Key Personnel to attend four ECHO Steering Committee meetings in Year 1, in the Bethesda, Maryland area and 1-2 meetings per year in Years 2-7.

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.

Specific Aims: Briefly describe the overall Specific Aims of the proposed Component.

Research Strategy: This section of the application should describe proposed plans for support of the functions of the ECHO Steering and Executive Committees and plans for support of all communications between all ECHO elements, between ECHO and the broader scientific community and between ECHO and the public.

Include the following:

i) An organizational chart listing the tasks that this Component will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities. Discuss the applicant organization’s prior experience in coordinating research networks and present examples of challenges that were encountered and solutions offered.

(ii) A description of how the Center will coordinate the functions of the ECHO Steering and Executive Committees, the ECHO External Advisory Board and their interactions with the ECHO Pediatric Cohorts and the ECHO Cores. Discuss potential problems and offer alternative approaches.

(iii) A description of the methods that the Center will employ to develop and implement ECHO operating policies and procedures under the guidance of the ECHO Steering and Executive Committees. Discuss how the Coordinating Center will ensure expeditious processes while being inclusive and thorough. Present timelines for policy development.

(iv) A description of how the Coordinating Center will establish and maintain effective communications between ECHO investigators and all ECHO elements (Steering and Executive Committees, External Advisory Board, NIH ECHO Team, ECHO Cores, Data Analysis Center, biorepositories). Discuss potential problems and offer alternative approaches.

(v) Plans and procedures for the development and maintenance of effective communications between ECHO and the public, including the participants in the ECHO-supported studies.

(vi) Plans and procedures for the development and maintenance of the ECHO Website to function both as an internal resource for the storage and exchange of all ECHO documents and as the interface between ECHO and the broader scientific community and between ECHO and the public. Describe in general terms the expertise of the group as a whole in developing such websites, the elements and services that the ECHO website will include, and special characteristics that will enhance its functionality. Discuss website testing. Present a specific, staged timeline for website development and testing.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

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 (Core Elements and Scientific Focus Areas Coordination Component)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core Elements and Scientific Focus Areas Coordination Component)

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) (Core Elements and Scientific Focus Areas Coordination Component)

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 (Core Elements and Scientific Focus Areas Coordination Component)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Component 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 (Core Elements and Scientific Focus Areas Coordination Component)

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

Applicants should consider budgeting for support of 2-3 ECHO-wide clinical protocols that will collect Core Elements data from approximately 50,000 ECHO pediatric cohort participants from up to 30 pediatric cohort awardees, over the entire period of the Cooperative Agreement. In addition to protocol development, this includes:

• Support for central IRB functions.
• Training of clinical site personnel in data collection.
• Site monitoring and quality control.
• Support of biospecimen transfer to central bioreporsitories and long-term biospecimen storage.

Applicants should also consider budgeting for the support of 1-2 clinical protocols within each of the Scientific Focus Areas (up to 10 clinical sites per Scientific Focus Area) over the entire period of the Cooperative Agreement to include the same items as those listed above.

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 (Core Elements and Scientific Focus Areas Coordination Component)

Specific Aims: Briefly describe the overall Specific Aims of the proposed Component.

Research Strategy: This section of the application should describe proposed plans for the support of the ECHO studies that will collect Core Elements data from all the ECHO cohorts, as well as plans to coordinate and support interactions and work that will be conducted within each specific ECHO focus area.

Include the following:

(i) An organizational chart listing the tasks that this Component will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities.

(ii) A description of the processes that the Coordinating Center will follow in the development of clinical protocols and ancillary documents (e.g. manuals of operation, case report forms) ensuring that all ECHO elements will be included in the process. Incorporate the establishment and operation of Study Monitoring Teams. Discuss timelines from initiation to completion of protocol development.

(iii) A description of the Coordinating Center s involvement in the development of study informed consent forms and IRB applications under central versus local IRB models. Discuss important aspects of the consent process as it pertains to the transfer and utilization of data to the ECHO Data Analysis Center and of biospecimens to central ECHO analytic sites and central biorepository sites.

(iv) A plan for training ECHO Pediatric Cohort site staff prior to study initiation.

(v) Plans and procedures to monitor the ECHO Pediatric Cohorts execution of ECHO protocols and to apply Quality Assurance and Quality Control methods for output optimization.

(vi) Plans for the Coordinating Center to collaborate with the ECHO Data Analysis Center and support the process of data transfer to the Data Analysis Center.

(vii) Plans to coordinate biospecimen transfer to ECHO analytic facilities (e.g. CHEAR Core) for protocol-specified testing and plans to establish collaboration with existing biorepositories and to coordinate biospecimen transfer for long-term storage and availability for future research.

(viii) Processes for establishing and facilitating interactions of ECHO cohorts within each scientific Focus Area including teleconferences, Steering Committee satellite meetings, Focus Area-specific ECHO website domains etc. Discuss how the proposed Coordinating Center will harmonize Focus Area-specific outcomes and outcome collection.

(ix) A description of the role that the proposed ECHO Coordinating Center will play in supporting the development of new common research protocols within each Focus Area, including support of IRB applications, staff training, monitoring of protocol execution and coordinating data and biospecimen transfer to the ECHO Data Analysis Center and Core facilities, as appropriate.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Core Elements and Scientific Focus Areas Coordination Component)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Core Elements and Scientific Focus Areas Coordination Component)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Opportunities and Infrastructure Fund Component)

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 (Opportunities and Infrastructure Fund Component)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Opportunities and Infrastructure Fund Component)

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) (Opportunities and Infrastructure Fund Component)

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 (Opportunities and Infrastructure Fund Component)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Component 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 (Opportunities and Infrastructure Fund Component)

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

Applicants should budget $3M total costs per year for the OIF starting in Year 2 of the ECHO Coordinating Center award. Note that no OIF moneys will be available in Year 5 of the award.

In addition, applicants should budget for costs associated with the administration of the OIF, support of the OIF award process and for Coordinating Center support of studies that will be funded by the OIF. It is anticipated that, every year, with the exception of Year 1 and Year 5 of the Coordinating Center award, the OIF will support up to 10 pilot studies (probably no more than 100 participants per study) of up to 2 years duration. Approximately 50% of those studies will require ECHO Coordinating Center support.

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 (Opportunities and Infrastructure Fund Component)

Specific Aims: Briefly describe the overall Specific Aims of the proposed Component.

Research Strategy: This section of the application should describe proposed plans for the management of the ECHO Opportunities and Infrastructure Fund (OIF), a fund that is meant to allow the ECHO program to conduct pilot projects and to introduce new tools and technologies. The ECHO Coordinating Center will manage this fund with advice from the ECHO Steering Committee.

Include the following:

(i) An organizational chart listing the tasks that this Component will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities.

(ii) A description of the support that the proposed Coordinating Center will offer to the ECHO Steering Committee in setting up policies for the OIF, assisting the Steering Committee with yearly assessment of infrastructure and resource needs and development of OIF requests for applications, distribution of these requests within the ECHO community, receipt of applications, and assisting the Steering Committee in setting up application reviews utilizing external reviewers, award making decisions and announcement of those decisions.

(iii) Proposed policies and procedures for distribution of OIF awards and monitoring their progress.

(iv) A description of the role that the proposed ECHO Coordinating Center will play in supporting the final development of OIF research protocols, including support of IRB applications, staff training, monitoring of protocol execution and coordinating data and biospecimen transfer to the ECHO Data Analysis Center and Core facilities, as appropriate.

(v) Proposed procedures, formats, and timelines for reporting on the status of OIF projects and expenditures to the ECHO Steering Committee and the NIH ECHO Program Director.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Opportunities and Infrastructure Fund Component)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Opportunities and Infrastructure Fund Component)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core

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

SF424 (R&R) Cover (ECHO Coordinating Center Administration 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 (ECHO Coordinating Center Administration Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (ECHO Coordinating Center Administration 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) (ECHO Coordinating Center Administration 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 (ECHO Coordinating Center Administration 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 (ECHO Coordinating Center Administration Core)

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

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

PHS 398 Research Plan (ECHO Coordinating Center Administration Core)

Specific Aims: Briefly describe the overall Specific Aims of the proposed Core.

Research Strategy: This section of the application should describe the internal administrative structure of the proposed ECHO Coordinating Center and should identify lines of authority, personnel with specific responsibilities for internal function quality assurance and control, and personnel with financial responsibilities for the management of the ECHO Coordinating Center Award. In addition, this Core should describe processes and procedures that will ensure effective operations and communications among the Coordinating Center staff in all domains including the financial management of the Coordinating Center award.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (ECHO Coordinating Center Administration Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (ECHO Coordinating Center Administration Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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.

This initiative is not subject to intergovernmental review.

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

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

In addition:

• Grants funded under this FOA will not be awarded with the Streamlined Noncompeting Award Process (SNAP) authorities (NIH Grants Policy Statement 8.4.1.2 Streamlined Non-Competing Award Process).
• Grantees will not be able to submit a modified progress report.
• Grantees will not be provided the authority outlined in the NIH Standard Terms of Award to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Award. All extensions, including the first extension, will require NIH prior approval.
• Grantees will not have authority to automatically carryover funds. All carryover actions require NIH prior approval.
• Grantees must submit annual Federal Financial Reports (FFRs).
• All grant funds must be expended within the approved project period on a first-in, first-out basis. Unobligated funds reported on the FFR must be returned to NIH.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the ECHO Coordinating 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 ECHO Coordinating Center proposed).

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 ECHO Coordinating Center that by its nature is not innovative may be essential to advance a field.

Does the proposed Center address the needs of the research that the ECHO program will need to conduct? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the ECHO research program?"

Does the project facilitate success of the overall ECHO goals to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact? Are the proposed plans for strategic oversight and coordination effort between the various elements of ECHO appropriate? Does the Coordinating Center provide special synergies that will enhance the field? Will successful completion of the proposed aims bring unique advantages to the ECHO program?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the ECHO Coordinating Center? If Early Stage Investigators or New Investigators, or 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 investigators have experience and/or skills required for directing a large, multi-component, collaborative program?

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

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Is the proposed plan for establishment and support of communication among all participants in the ECHO program appropriate? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the ECHO program? Are appropriate plans for work-flow, program integration and a well-established and realistic timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the ECHO Coordinating 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.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed ECHO Coordinating Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the ECHO Coordinating 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.

Not Applicable

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

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

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

As applicable for the component 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.

Significance

Does the proposed component address the committee support and communication needs of the ECHO Coordinating Center? Is the scope of activities proposed for the core appropriate to meet those needs? How will the core contribute to achieving the overall goals of the ECHO program?

Investigators

Are the component Lead(s), collaborators, and other researchers well suited to the component? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the component? Are the leadership and administrative staff of the component qualified to provide ECHO committee support and communications to support the ECHO program?

Innovation

Does the application propose novel organizational concepts or management strategies in providing committee support and communications for the ECHO Coordinating Center? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the committee support and communication goals of the ECHO Coordinating Center? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the ECHO Coordinating Center? Are an appropriate plan for work-flow and a well-established timeline proposed?

Environment

Will the institutional environment in which the component will operate contribute to the probability of success in facilitating committee support and communications aspects of the ECHO Coordinating Center? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed component? Will the core benefit from unique features of the institutional environment, infrastructure, or personnel?

As applicable for the component 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.

Significance

Does the proposed component address the needs of the ECHO Coordinating Center to coordinate development and implementation of core elements and coordinate activities of the four scientific focus areas? How will the core contribute to achieving the overall goals of the ECHO program to investigate the longitudinal impact of prenatal, perinatal, and postnatal environmental exposures on pediatric health outcomes with high public health impact?

Investigators

Are the component Lead(s), collaborators, and other researchers well suited to the component? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the component? Are the leadership and administrative staff of the component qualified to coordinate development and implementation of component elements and coordinating activities of the four scientific focus areas? Do they have experience: training staff to follow clinical protocols, and monitoring execution of clinical protocols; coordinating research activities across multiple research projects or a research consortium; coordinating or managing biospecimen resources?

Innovation

Does the application propose novel organizational concepts or management strategies in supporting the ECHO program? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the ECHO Coordinating Center to coordinate development and implementation of core elements and coordinate activities of the four scientific focus areas? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the ECHO program? Are an appropriate plan for work-flow and a well-established timeline proposed?

Environment

Will the institutional environment in which the component will operate contribute to the probability of success in facilitating the ECHO Coordinating Center to coordinate development and implementation of core elements and coordinate activities of the four scientific focus areas, and the probability of success of the ECHO program? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed component? Will the component benefit from unique features of the institutional environment, infrastructure, or personnel?

As applicable for the component 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.

Significance

Does the proposed component address the needs of the ECHO Coordinating Center to manage the ECHO Operational and Infrastructure Fund? How will the component contribute to achieving the overall goals of the ECHO program?

Investigators

Are the component Lead(s), collaborators, and other researchers well suited to the component? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the component? Do they have experience managing a request and selection process for using internal funds for pilot work? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in managing the ECHO Operational and Infrastructure Fund? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to manage the ECHO Operational and Infrastructure Fund? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the ECHO Coordinating Center? Are an appropriate plan for work-flow and a well-established timeline proposed?

Environment

Will the institutional environment in which the component will operate contribute to the probability of success in managing the ECHO Operational and Infrastructure Fund? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed component? Will the core benefit from unique features of the institutional environment, infrastructure, or personnel?

As applicable for the core 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.

Significance

Does the proposed Core address the needs of the ECHO Coordinating Center? How will the core contribute to achieving the overall goals of the ECHO program?

Investigators

Are the Core Lead(s), collaborators, and other researchers well suited to the core? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core? Are the leadership and administrative staff of the core qualified in coordinating ECHO Coordinating Center operations? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in supporting the ECHO Coordinating Center? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the ECHO Coordinating Center? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the ECHO Coordinating Center? Are an appropriate plan for work-flow and a well-established timeline proposed?

Environment

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Potential for coordination with the ECHO Data Analysis Center.

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.

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.

Awardee-selected projects supported by the ECHO Opportunity and Infrastructure Fund that involve human subjects research require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other DHHS, PHS, and NIH grant administration policies.

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

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

• Directing the activities of the ECHO Coordinating Center, including: (i) establishing and implementing processes for decision-making, communication and collaboration; (ii) establishing and implementing processes and systems for tracking the implementation of Center support functions, identifying problems/deficiencies, and determining the need for and implementing corrective actions; (iii) assessing and allocating resources, reviewing their adequacy, and determining needed adjustments; (iv) establishing and implementing financial management capacity and systems to track and project Center resources and expenditures; (v) implementing and managing an information system to support day-to-day Center activities; (vi) establishing and managing portals for study-specific documents/materials; (vii) reporting to and obtaining input from the ECHO Steering Committee (including the Executive Committee), the External Scientific Board, the ECHO Data Analysis Center PD/PI, the ECHO Genetics Core PD/PI, the ECHO PRO Core PD/PI, the ECHO CHEAR Core PD/PI, the ECHO Pediatric Cohort site PDs/PIs, and the IDeA States Pediatric Clinical Trials Network DCOC PD/PI; and (viii) establishing procedures and metrics for assessing Center progress and productivity.
• Providing the full scope of ECHO coordination support including standardization, quality assurance and quality control for the collection of core outcomes by all ECHO Pediatric Cohort sites; ensuring appropriate handling and tabulation for biospecimens to be transferred to central ECHO laboratories and for biospecimens to be stored in biorepositories; ensuring appropriate and effective coordination and collaboration with the NIH ECHO Program Director and the NIH ECHO Team, the ECHO Steering Committee, the ECHO Data Analysis Center PD/PI, the ECHO Genetics Core PD/PI, the ECHO PRO Core PD/PI, the ECHO CHEAR Core PD/PI, and the ECHO Pediatric Cohorts PDs/PIs (across all ECHO cohorts and within ECHO scientific focus areas); and ensuring that the performance of support functions complies with all Federal and, where appropriate, country-specific regulatory requirements and guidelines for the conduct of human subjects research, as well as NIH policies and procedures.
• Providing reports to the NIH ECHO Program Director and the NIH ECHO Team regarding Coordinating Center and overall ECHO activities (e.g. tabular summaries of study progress, protocol deviation and site monitoring reports), as well as budgetary summaries as requested.
• Ensuring the appropriate training/certification of Coordinating Center staff designated to provide coordination support, and including a list of all training programs and written assessments in the Annual Progress Report.

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

NIH assistance to the ECHO operations will be provided by the ECHO Project Director and the NIH ECHO Team, as well as by NIH Project Scientists or other NIH staff that may be assigned to across-ECHO studies or studies within one of the four ECHO scientific focus areas. NIH staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the normal program stewardship role for grants. It is anticipated that decisions regarding the Coordinating Center activities will be reached by consensus and that the NIH staff members will participate in this process. In various matters related to study approval and oversight, the NIH staff will have final decision authority, as described below.

• Concept Proposals and Study Protocols: NIH Project Scientists will: (i) participate in the development, review and approval of the concept proposals and research protocols of all across-ECHO studies and of ECHO-supported studies that will entail a particular ECHO scientific focus area; (ii) provide final approval prior to initiation for across-ECHO studies as well as for ECHO-supported studies within each ECHO scientific focus area; (iii) approve timelines for protocol development, implementation and completion; (iv) participate in the data analysis process and the development of manuscripts resulting from ECHO-supported studies.
• Study Monitoring and Management: (i) The NIH ECHO Team and NIH Project Scientists, through the ECHO Coordinating Center, will monitor compliance with OHRP and NIH requirements for human subject research, accurate protocol implementation and internal quality assurance across all ECHO-supported studies. This includes: participating in the development of and approving Data and Safety Monitoring Plans prior to study initiation; determining the need to conduct for-cause clinical site visits, participating in such visits, and approving recommendations for remedial actions. (ii) NIH staff will participate in ECHO Study Management Teams to manage the day-to-day implementation of ECHO-supported studies that will be conducted across all ECHO Pediatric Cohorts or across-Cohort studies that address an ECHO scientific focus area.
• IND/IDE Sponsorship: Aside from the IDeA States Pediatric Clinical Trials Network, the ECHO Pediatric Cohort sites are not likely to conduct clinical trials requiring IND/IDE sponsorship. However, in the rare event that this becomes a necessity, the ECHO NIH Program Director will determine on a case by case basis whether the regulatory sponsor for a clinical trial conducted under IND/IDE will be an NIH IC or an ECHO Pediatric Cohort Investigator. If the regulatory sponsorship responsibility is assigned to a NIH IC, NIH Project Scientists/Medical Monitors will obtain, through the ECHO Coordinating Center and the ECHO Data Analysis Center, regular reports on serious adverse events and protocol deviations, and will decide on the final disposition of SAE Reports for all IND/IDE studies.
• Study Termination: NIH reserves the right to terminate, curtail or suspend an ECHO-supported study for any reason, including but not limited to risks to subject safety, occurrence of unforeseen safety or ethical issues, scientific question is no longer relevant or the objectives will not be met, failure to comply with Federal regulations or Terms and Conditions of Award, and reaching a major study endpoint before schedule with persuasive statistical significance.
• Access to Data: The NIH ECHO Team and NIH Project Scientists will have the right of access to all data (raw and analyzed) generated under this cooperative agreement and may periodically review these data.
• Grant Stewardship: Additionally, a NIH program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• The ECHO NIH Program Director, with approval by the NIH Director, will establish an ECHO External Scientific Board. The External Scientific Board will submit its recommendations to the ECHO NIH Program Director, who will then inform the members of the ECHO Steering Committee. Recommendations by the External Scientific Board are consultative.

Areas of Joint Responsibility include:

• The NIH ECHO Program Director and the NIH ECHO Team, in collaboration with the PDs/PIs of all ECHO awards, will participate in deliberations and decision-making regarding the multiple substantive, operational, financial and administrative responsibilities of this NIH initiative.
• NIH Project Scientists and/or their designees will collaborate with ECHO Coordinating Center staff to ensure the provision of appropriate information, materials and training regarding NIH policies and procedures for the conduct of human subject research.
• Close interactions amongst the awardee, awardees from the companion FOAs, and NIH will be required. Shortly after the award, the PDs/PIs and NIH program staff will form the ECHO Steering Committee, which ultimately will report to the NIH Director.

ECHO Steering Committee

• The ECHO Steering Committee will be co-chaired by the NIH ECHO Program Director, the PI/PD of the Coordinating Center, and the PI/PD of the Data Analysis Center. It also will be composed of the PIs/PDs of the PRO Core, CHEAR Core, the Genetics Core, the IDeA States Pediatric Clinical Trials Network DCOC, and each of the cohort sites, who all will have 1 vote. The NIH ECHO Program Director and the NIH ECHO Team will serve as non-voting members of the ECHO Steering Committee.
• An Executive Committee of the Steering Committee also will be established, and will be composed of the three co-chairs and a representative from each of the funded elements one each from the PRO Core, the Genetics Core, CHEAR Core, and the IDeA States Pediatric Clinical Trials Network DCOC, as well as one PI/PD collectively representing the cohort sites.
• The Executive Committee will invite expert consultants as needed, coordinate with the External Scientific Board, assist as necessary with annual progress reports, and appoint and charge members of subcommittees.
• These subcommittees will facilitate development, implementation, and monitoring of specific ECHO functions as needed. Suggested subcommittees include:
• Data Measurement and Sharing: members from each cohort site, the CC, the DAC, and the PRO Core; responsible for selecting core measures and establishing protocols for data collection, quality control (QC), and sharing; CC and DAC would implement the protocols, conduct training and QC, etc.
• Biostatistics and Design: members from each cohort site, the CC, the DAC, and the PRO Core; responsible for (1) developing analysis plans for each of the core measures, including biospecimens and environmental samples, (2) reviewing and providing advice on the analysis plans for each of the participating cohorts, (3) conducting methods research based on issues that arise during the course of the project, (4) serve as a consulting body for any of the PDs/PIs seeking input on analysis issues
• Publications: members from each cohort site, CC, DAC, and the PRO Core; responsible for developing publication policies and procedures, review of abstract and manuscript proposals for cross-project papers and presentations, review of proposed ancillary studies, and review of proposed pilot studies
• Focus Areas: members from the cohorts in each Focus Area and the CC; separate subcommittees for each of the 4 Focus Areas to support regular interactions among investigators interested in the same Focus Areas
• Project Coordinators: members would include the coordinators from the cohort sites and a CC representative; meet regularly for exchange of information about their studies, and help each other identify best practices for a variety of logistical issues including retention, training, data collection, etc.
• IDeA States Network: members from the participating IDeA states sites, IDeA states DCOC, and the CC; meeting regularly for exchange of information about their projects, best practices, etc.
• Key personnel will be expected to serve on subcommittees, as appropriate, according to their expertise.
• The Steering Committee will meet in person quarterly during the first year and at least annually thereafter. Monthly teleconferences will be held for the Steering Committee and its subcommittees, and these may be more frequent at times to facilitate planning, etc. The Coordinating Center (CC) will be responsible for arranging and facilitating the meeting and teleconferences. Applicants should plan to attend an initial planning meeting of the Steering Committee in Bethesda, Maryland in fall 2016.
• The Steering Committee will have responsibility for developing the overall scientific direction of the program; assuring compliance with program policies and procedures; designing study protocols; implementing studies; ensuring data quality and completeness; planning for analysis and interpretation of data; and reporting results in presentations and publications.
• The Steering Committee must work cooperatively and interactively during the first year to develop the final protocols and all of the materials necessary to begin the prospective human studies within 12-18 months after award. The final plan, with a study timeline and milestones, will be submitted and must be approved by the NIH ECHO Program Director and the NIH Director, with involvement of the NIH ECHO Team and relevant IC program staff, before the second year of funds will be awarded.
• First year planning activities include, but are not limited to:
• Developing clinical and laboratory protocols and plans for data collection and management
• Standardizing collection of core data elements
• Overseeing plans to address the various bio-ethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings) that are likely to arise during the conduct of the research
• Obtaining approvals as needed at the ECHO Pediatric Cohort site institutions, such as IRB approvals
• Preparing a Manual of Operations with primary responsibility residing with the CC
• Developing a detailed plan for storage and shipping of all biospecimens
• Developing detailed plans for the thorough analysis of data
• Agreeing to abide by a common data sharing plan
• Developing a detailed timeline with concrete milestones for the entire study

External Scientific Board

• Five to seven external experts will serve as the External Scientific Board (ESB), and will be selected and appointed by the NIH ECHO Program Director and NIH Director.
• The ESB will review and offer input on ECHO structure, function, and studies, both during protocol development and during the analysis of results. Members of the Board will provide input based on their individual areas of expertise, as needed over the course of the program. They will assist the NIH regarding processes and substantive issues that arise during the project and will help ensure that the resources to be delivered by the program are as useful as possible for the end users.
• External Scientific Board members may be invited to attend some ECHO Steering Committee meetings.

Data and Safety Monitoring Board

• In the event the ECHO activities include clinical trials, an independent DSMB will be established to monitor and provide recommendations to the NIH regarding participant recruitment/enrollment, safety, data quality, and other issues, as appropriate. The DSMB will also review the Steering Committee-approved common protocol, informed consent templates, milestones, and monitoring plans prior to the start of recruitment. It is recommended that, if possible, a single central Institutional Review Board (IRB) is used to streamline the protocol approval process and to standardize the monitoring of human subjects protection in the ECHO program.

Development of Milestones

• Because this Consortium will require specific achievable goals (e.g., timely recruitment of participants, expected annual throughput), milestones should be proposed by the applicant. Milestones are goals that are quantifiable for measuring success, and include associated annual or semi-annual quantitative criteria.
• Final milestones will be designed during the first year in the planning phase. After review and approval by the NIH, the final set of approved milestones will be specified in the Notice of Award.
• Progress towards achieving the final set of milestones will be evaluated by NIH program staff on an annual basis. If justified, future year milestones may be revised based on data and information obtained during the previous year. If, based on the progress report, the project does not meet the milestones, funding for the project may be either restricted or discontinued.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the ECHO awards) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The panel members will be a designee of the ECHO Steering Committee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 progress report, 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.

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

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Alkis Togias, MD
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Telephone: 240-627-3587
Email: [email protected]

Valerie Durrant
Center for Scientific Review (CSR)
Telephone: 301-827-6390
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Donna Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]

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.

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.