Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of The Director, National Institutes of Health (OD)

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

National Institute on Drug Abuse (NIDA)

National Institute of General Medical Sciences (NIGMS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
Clinical Sites for the Environmental influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network - 3 (UG1 Clinical Trial Required)
Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type
Reissue of RFA-OD-19-026
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-OD-24-008
Companion Funding Opportunity
RFA-OD-24-009 , U24 Resource-Related Research Project (Cooperative Agreements)
Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.310, 93.279, 93.859, 93.865
Funding Opportunity Purpose

This Notice of Funding opportunity (NOFO), issued by the Office of the Director (OD), National Institutes of Health (NIH), invites applications from entities/institutions in Institutional Development Award (IDeA)-eligible States to participate as Clinical Sites in the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN).

This NOFO runs in parallel with companion NOFO (RFA-OD-24-009) that will solicit applications for a Data Coordinating and Operations Center (DCOC) within the IDeA States. The ECHO ISPCTN Clinical Sites and DCOC together will form the ECHO ISPCTN. The ECHO ISPCTN is the intervention component of the ECHO program and supports its overall mission to enhance the health of children for generations to come.

Each ISPCTN Clinical Site will support site readiness to participate in approximately five ECHO ISPCTN multicenter pediatric clinical trials related to prevention or treatment of one or more of ECHO’s five outcome areas of interest: pre-, peri-, and postnatal outcomes; upper and lower airways; obesity; neurodevelopment; and positive health. Overall, the five trials should address at least two of the five areas. The Clinical Site will have responsibility to
 

  • Develop, conduct, and disseminate findings from multicenter clinical trials research, assuring the participation of children living in rural or underserved communities in IDeA states
  • Build pediatric clinical trial research capacity in IDeA states funded by the ECHO ISPCTN
  • Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility

Through the rigorous use of appropriate scientific methodology and by recruiting and retaining the numbers of participants that justify multicenter trials, the ECHO ISPCTN aims to provide valid and generalizable answers to intervention research questions relevant to the health of children from rural or underserved backgrounds. The ECHO ISPCTN awardees will be primarily responsible for initiating and conducting clinical trials, although they may collaborate with other NIH research networks or subject matter experts outside of the network.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Key Dates

Posted Date
January 19, 2024
Open Date (Earliest Submission Date)
March 15, 2024
Letter of Intent Due Date(s)

April 01, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
April 15, 2024 April 15, 2024 Not Applicable October 2024 January 2025 June 2025

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
April 16, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose/Research Objectives

The purpose of this Notice of Funding Opportunity, issued by the Office of the Director (OD), National Institutes of Health (NIH), is to invite applications from entities/institutions in Institutional Development Award (IDeA)-eligible states to participate in the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN) as a clinical site. This NOFO runs in parallel with companion NOFO (RFA-OD-24-009) that will solicit applications for a Data Coordinating and Operations Center (DCOC) within the IDeA states. The DCOC and the Clinical Sites together will form the ECHO ISPCTN, a research network that will conduct pediatric multicenter clinical trials as part of the ECHO Program and engage in team science to implement solution-oriented research.

The ECHO ISPCTN is the intervention component of the ECHO Program and supports its overall mission to enhance the health of children for generations to come. Through the rigorous use of appropriate scientific methodology, and by recruiting and retaining sufficient participants for studies that require a multicenter pediatric clinical trial design, the ECHO ISPCTN aims to provide answers to relevant research questions more robustly and rapidly than any one site could do alone. The ECHO ISPCTN itself will be primarily responsible for initiating and conducting pediatric clinical trials, although it may also collaborate with other NIH research networks or non-network subject matter experts. The award will support approximately five pediatric clinical trials related to prevention or treatment of conditions in at least two of the 5 outcome areas of the ECHO Program: pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.

The clinical sites of the ECHO ISPCTN will

  • Develop, conduct, and disseminate findings from pediatric multicenter clinical trials, assuring the participation of children living in rural or underserved communities located in Institutional Development Award (IDeA) states
  • Build pediatric clinical trial network capacity in IDeA states funded by the ECHO ISPCTN.
  • Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility

Background

Congress authorized the IDeA Program in 1993 to broaden the geographic distribution of NIH funding for biomedical and behavioral research. The program aims to enhance the competitiveness for research funding of institutions located in 23 states and the Commonwealth of Puerto Rico in which the aggregate success rate for grant applications to NIH has historically been relatively low. Hence, the NIH designed this program to serve the health research needs of the rural or underserved populations in these states and to expand and strengthen research teams to compete successfully for NIH funding.

In 2016, the NIH established the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN) to provide access to state-of-the-art clinical trials for rural or underserved children living in IDeA states. Through the IDeA Program, the NIH aimed to leverage the resources that it had developed in these states in clinical and translational research and bridge a gap by providing these children and families access to clinical trials to enhance their health.

The ECHO ISPCTN is the only NIH pediatric clinical trials network with a specific focus on rural or underserved populations, populations of great prevalence in IDeA states. Children living in rural or underserved communities experience worse outcomes on many health indicators than their counterparts. Health inequities in rural or underserved areas may result from suboptimal socioeconomic and ecological conditions, including limited access to health care and other community and familial resources.

Children in IDeA states are under-represented in clinical trials. Improved access to state-of-the-art clinical trials helps answer important questions that result in health benefits for this population. The ECHO ISPCTN is uniquely positioned to identify targeted solutions to address the health issues of rural or underserved children by conducting clinical trials and disseminating the findings that can enhance the health of children. Through this approach, the ECHO ISPCTN bridges an important gap in pediatric health research.

This Notice of Funding Opportunity builds on the success of the first two cycles of the ECHO ISPCTN (RFA-OD-16-001, RFA-16-OD-002, RFA-OD-19-025, and RFA-OD-19-026) which developed research infrastructure and pediatric clinical trials expertise in IDeA states and conducted clinical trials, assuring the participation of rural or underserved children in ECHO ISPCTN clinical trials.

Network Structure

The overall framework of the ECHO ISPCTN will consist of dedicated pediatric clinical trial teams at participating ECHO ISPCTN Clinical Sites and a central Data Coordinating and Operations Center (DCOC) to provide comprehensive support of the network.

Clinical Sites
Each ISPCTN Clinical Site will support a team of one to two principal investigators, one to two early stage investigators, and a full-time equivalent research coordinator. ECHO ISPCTN Clinical Sites will propose, develop, and conduct ECHO ISPCTN multicenter pediatric clinical trials; build capacity in their early stage investigators and research staff to engage in rigorous multicenter trials; and engage interested parties such as community members, nonprofit organizations, and professional societies to ensure that network trials are informed by their priorities, needs, and capacities. The multicenter trials proposed by clinical sites should be related to the prevention or treatment of conditions in the 5 ECHO outcome areas: pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.  Applicants are encouraged to leverage resources and facilities supported by other NIH programs, such as the IDeA Program-Infrastructure for Clinical and Translational Research (IDeA-CTR) and the Clinical and Translational Science Award (CTSA) Programs.

Partner Institutions
To enhance research expertise and potential to build capacity to include needed expertise on multicenter clinical trial proposals, ECHO ISPCTN Clinical Site and DCOC applicants may propose collaborations. Applicants may consider collaborating with other components or investigators within their own state or in other IDeA or non-IDeA states. The NIH will support a minimum of 75% of total costs to institutions within IDeA states.

Data Coordinating and Operations Center (for information only)
The ECHO ISPCTN Data Coordinating and Operations Center (DCOC) will provide support for research projects initiated by the ECHO ISPCTN Clinical Sites. Some examples of the services the DCOC will provide include but are not limited to the following.

A. Support for Clinical Trials Development, Implementation and Dissemination

The DCOC will assist writing teams in developing protocols for multicenter clinical trials that relate to the five ECHO child health focus areas among children from rural or underserved backgrounds. While the DCOC will advise investigators, all major study design and budgetary decisions will be determined by the protocol chair(s), the Leadership Committee, and the program office, facilitated by the DCOC. DCOC responsibilities include, but are not limited to

  • Protocol Development
    • Establishing processes for clinical site protocol development with Steering Committee review
    • Assisting investigators with performing study feasibility assessments
    • Developing sampling strategies and advising on study design
    • Performing biostatistical analyses including sample size estimates and trial data analysis
    • Developing statistical analysis plans
  • Regulatory
    • Providing regulatory sponsorship of clinical trials conducted under an investigational new drug (IND) or investigational device exemption (IDE) 
    • Establishing processes for tracking studies and changes/approvals by the ECHO ISPCTN Protocol Review Committee, Data and Safety Monitoring Board (DSMB) and single institutional review board (IRB)
    • Developing a well-defined reporting process for adverse events (AEs) and unanticipated problems (as defined by OHRP) in compliance with local IRB requirements, 21 CFR 312.32 for Investigational New Drugs (IND), and 21 CRF 812.150 for Investigational Device Exemptions (IDE)
    • Documenting and following procedures for handling protocol deviations/violations
    • Implementing a plan to report safety analyses and AEs to the Data and Safety Monitoring Board (DSMB) in a format that highlights trends or signals
  • Budgetary
    • Assisting investigators to develop study budgets
    • Overseeing and coordinating multicenter clinical trials including establishing subcontracts with participating clinical sites and disbursing trial-specific funds to sites
    • Monitoring and reporting study fund distributions and outstanding invoices to the program office
  • Data Management
    • Establishing systems for data management and quality assurance
    • Monitoring and reporting study progress, participant safety, and adverse events to the program office and regulatory bodies
    • Monitoring and reporting participant accrual, retention, and diversity in studies to the program office and Steering Committee
    • Ensuring data completeness and fidelity to each study protocol
    • Performing clinical site visits as needed upon pre-approval of the program office
  • Supporting investigators' dissemination of study results 

B. Clinical Trial Capacity Building

The DCOC is responsible for providing systematic, core curricula for ECHO ISPCTN investigators of all levels and for research coordinators. The curricula will be focused on pediatric, multicenter clinical trial design, implementation, and publication, as well as the principles of Good Clinical Practice consistent with Food and Drug Administration ICH GCP E6 standards, and not more broadly on general research skills or academic advancement. The DCOC may use a variety of formats to ensure broad access to the curricula including didactic lectures, workshops, enduring materials, or other interactive approaches to suit diverse learning styles. The DCOC will partner with existing, experienced clinical trial education providers to leverage expertise and resources whenever possible to reduce production costs and ensure network researchers are exposed to high quality content. The DCOC will monitor uptake of the curricula and adjust the dissemination strategy as necessary to ensure widespread participation among network investigators and research coordinators.

C. Engagement of Communities of Potential Participants and Other Interested Parties

The DCOC will support clinical sites in engaging interested parties such as community members, nonprofit organizations, and professional societies to strengthen and enhance ECHO ISPCTN clinical trials at the development, implementation, and dissemination phases. For instance, to assist investigators in identifying areas of research need, the DCOC may recommend foremost, external scientists to provide keynote addresses at ECHO ISPCTN investigator meetings. To help investigators identify participant-centered recruitment and retention plans, and preferences for return of individual study results, the DCOC may organize virtual or face-to-face engagement of individuals from the community of potential participants.

The DCOC will also support the dissemination of aggregate research products to lay, scientific, and medical communities by developing a communication plan for interested parties to learn of and access selected clinical trial-related information such as protocols, scientific publications, and lay study summaries. The communication plan will include press releases, newsletters, social media posts, and an ISPCTN-specific website linked to the existing ECHO Program website (echochildren.org). In support of scientific publications, the DCOC will establish, document, and follow processes for manuscripts and presentations tracking, preparation, review, communication, and submission that will apply to all network-funded studies. The DCOC will create reports and summaries for the ECHO ISPCTN Data and Safety Monitoring Board (DSMB), Protocol Review Committee (PRC), Steering Committee, Leadership Committee, and NIH.

As per NIH policy on public access (NIH Public Access Policy Details | Public Access), the DCOC will report clinical trial results, data analysis plans, and an English-language informed consent document to the ClinicalTrials.gov database for every ECHO ISPCTN-funded study. Also, to satisfy NIH policies on data sharing (NOT-OD-21-013: Final NIH Policy for Data Management and Sharing), the DCOC will prepare and provide de-identified research datasets and biological specimens, if appropriate, to data repositories for public and controlled access on behalf of the network.

D. Administrative and Operational Support for Governance and Oversight Bodies

ECHO ISPCTN clinical trial conduct and overall functioning relies on the work of committees, work groups, and task forces comprising network investigators and research coordinators, as well as external oversight bodies. (See Section VI. Award Administration Information, 2. Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions of Award for more details on network governance and oversight). The DCOC will provide logistical support to these groups to carry out their vital functions. Examples of logistical support that the DCOC will provide include scheduling and hosting virtual and in-person meetings, setting and distributing meeting agendas and minutes, preparing and submitting documents for review by regulatory and oversight bodies, and handling travel arrangements for oversight bodies to attend in-person meetings as needed.

The ECHO ISPCTN develops goals, objectives, indicators, and targets (GOIT) for the network in accordance with the overarching aims of the program. These GOIT are created, reviewed, and revised by the Steering Committee with input from the program office on an annual basis.  The program office will establish consortium-level operational objectives related to 1) clinical trial concept development, 2) study implementation (including project timelines to start of enrollment and study participant accrual and retention), 3) data collection, completeness, and usability, and 4) publication and dissemination of ECHO ISPCTN study results. The DCOC will provide a dashboard to report progress of the network overall and for each clinical site toward attainment of GOIT milestones so that the network can adjust as needed.

Governance and Oversight
The ECHO ISPCTN governance will include a Leadership Committee consisting of a DCOC representative, NIH representative, and approximately five clinical site representatives to bi-directionally engage with clinical sites via “pods.” It will also include a Steering Committee with a representative from each award and the NIH, as well as work groups, subgroups, and task forces, as needed. This governance structure will share accountability for establishing, monitoring, and evaluating the achievement of ECHO ISPCTN goals, which include

  • Developing, conducting, and disseminating results from multicenter clinical trials research for children living in rural or underserved communities in IDeA states
  • Building pediatric clinical trial capacity in IDeA states
  • Engaging interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility

For clinical trial oversight, the ECHO Program Office will convene an independent protocol review committee and an independent data and safety monitoring board for the network. For all study protocols, the ECHO ISPCTN will designate a single institutional review board (sIRB) for all study sites to streamline IRB protocol approval while maintaining participant safety and protection of human subjects oversight. (See Section VI. Award Administration Information, 2. Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions of Award for more details on network governance and oversight)

ECHO ISPCTN Clinical Trials

The ECHO ISPCTN will develop, complete, and disseminate findings from approximately five multicenter clinical trials during this funding period. Each multicenter clinical trial must be focused on one or more of the five ECHO outcome areas, and over all five multicenter trials, at least two of the five outcome areas should be represented. The five ECHO outcome areas are pre-, peri-, and postnatal outcomes; obesity; upper and lower airways; neurodevelopment; and positive health.

Ongoing or completed trials that the ECHO ISPCTN initiated in the prior funding cycle include

  • Improving Pediatric COVID-19 Vaccine Uptake Using an mHealth Tool (MoVeUP) (NCT05386355)
  • Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (BREATHE) (NCT05615870)

The following are examples of other research topics that demonstrate the breadth of possible study questions that could be suitable for the ECHO ISPCTN to investigate in future multicenter trials

  • To what extent can use of telehealth for subspecialist follow-up appointments improve neurodevelopmental outcomes among premature infants in rural areas?
  • To what extent can participation in culturally tailored, behavior-change programs for families reduce childhood obesity?
  • To what extent can participation in social media literacy programs enhance children’s mental health and well-being?
  • To what extent can melatonin improve toddlers’ sleep hygiene and self-regulation?
  • To what extent can use of devices to monitor airway obstruction in primary care offices improve the diagnosis of pediatric asthma?

The ECHO ISPCTN is particularly interested in studies conducted in the primary care setting.

Plan for Enhancing Diverse Perspectives

 The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. Many benefits flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in and benefit from research, and enhancing public trust.

To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to the following

  • Transdisciplinary research projects and collaborations among researchers, including those from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
  • Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Individual applications and partnerships that enhance geographic and regional heterogeneity
  • Investigators and teams composed of researchers at different career stages
  • Participation of individuals from diverse backgrounds, including groups historically  underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women
  • Opportunities to enhance the research environment to benefit early- and mid-career investigators This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV).

    Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.
     

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New
Renewal

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to fund an estimate of 15-20 awards, corresponding to a total of $7,000,000, for fiscal year 2025. Future year amounts will depend on annual appropriations.

Award Budget

Applicants may request direct cost budgets of up to $300,000 for each of the five years of the award. The application should include a detailed budget for each year of study.

Award Project Period

5 years

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • 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

Only institutions or organizations in the following IDeA states/commonwealth are eligible to respond to this NOFO

? Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.
 

Foreign Organizations

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

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

To be eligible for an award through this announcement, NIH invites any Program Director/Principal Investigator(s) (PD/PI(s)) from an IDeA-eligible state with the skills, knowledge, and resources necessary to carry out the proposed research to work with their organization to develop and submit an application for support.  

The primary institution must be in an IDeA state. PD/PI(s) from IDeA states may or may not have extensive experience with clinical trials or comparable track records of publications and funding as other investigators. However, the PD/PI(s) must be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

At least one PD/PI for the clinical site should be a board-certified pediatrician in an IDeA state.
PD/PI(s) will supervise the development and conduct of ECHO ISPCTN clinical research at their institution and any partnering performance site.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

An organization may participate as a lead organization in only one application submitted to this NOFO for the same due date.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Lisa Steele, PhD
Chief, Epidemiology and Population Health Branch
Division of Aids, Behavioral and Population Sciences (DABP)
Center for Scientific Review, NIH
Phone: 301-257-2638
Email: lisa.steele@nih.gov
 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the exception of the following additional instructions (see Other Attachments).

Other Attachments

Facilities and Other Resources
Use the following instructions for guidance on required headings and content for the "Facilities and Other Resources" attachment.

Infrastructure and Equipment
Describe the institutional infrastructure supporting pediatric clinical research.

Clinical Capabilities
Describe the inpatient and primary care clinical services available to support pediatric research including

  • Laboratory and pharmacy services, and the experience of these facilities in supporting clinical research.
  • Clinical staffing, including primary pediatric care providers, subspecialists and nurses, their experience in conducting or facilitating clinical research, and their capacity to support nighttime and weekend participant recruitment and assessment.
  • Availability of individuals (including general pediatricians) with research or clinical expertise within ECHO's five focus areas and their potential to be ECHO ISPCTN protocol chairs developing multicenter clinical trial protocols and serving as site investigators implementing network trials at the clinical site.

Populations Available for Clinical Studies/Trials
Describe access to potential study participants from at least one inpatient and oneprimary care setting that serve pediatric patient populations with at least 30% of the children from rural or underserved areas. It is preferable for applicants to propose recruitment from hospitals and primary care practices that are associated or have a pre-existing relationship with the applicant institution, for example being components of the same legal entity and reporting to the same institutional review board. Include the following information in tabular format for the year 2023:

  • Number of inpatient hospitalizations of children (0-17 years)
  • Number of inpatient hospitalizations of children who live in a rural home
  • Number of infants born at the hospital
  • Number of hospitalized children with the following ECHO-relevant diagnoses: preterm birth, asthma
  • Number of children who had at least 1 primary care visit
  • Number of children who live in a rural home and had at least 1 primary care visit
  • Number of children with at least 1 primary care visit billed with one the following ECHO-relevant diagnosis codes: routine child health exam, asthma, attention-deficit hyperactivity disorder, depression, obesity

Provide details about how you derived estimates, including the number of inpatient and primary care settings included. If you included more than one setting, report estimates separately for each setting, as well as overall. Describe how you defined rurality and the record retrieval strategy you used to calculate the estimates.

Experience with Clinical Trials and Clinical Trials Networks
Describe the clinical site's participation and success in conducting single and multicenter clinical trials (including in the first and second cycle of the ECHO ISPCTN, if applicable). Provide the total number of clinical trials in which the applicant site has participated over the last 5 years. For up to 10 selected trials within the last 5 years, list in tabular format the following: study title, National Clinical Trial (NCT) number, time from institutional review board approval of the protocol to clinical site activation, and total number of participants enrolled by the clinical site.

Data Systems
Describe the availability of computers, electronic medical records, and other electronic data and information systems, and how you will leverage these technologies for ECHO ISPCTN trials.

Other Pediatric Research Financial Support
List currently funded pediatric clinical research at the proposed clinical site. This research includes but is not limited to research funded by NIH and other federal and non-federal granting agencies.

Special Strengths
Describe special or unique strengths at the clinical site that may be relevant to ECHO ISPCTN research. These strengths can include expertise in engagement of rural or underserved participants, community-partnered research, practice-based research networks, research regulatory support, clinical trial study design, or other relevant knowledge or experience. They may also include having established partnerships or an institutional Center for Translational Research or Center for Translational Science Award, which the network could leverage to build capacity to develop or conduct multicenter clinical trials.

Plan for Enhancing Diverse Perspectives
In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The Plan for Enhancing Diverse Perspectives should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the  research strategy section. The Plan for Enhancing Diverse Perspectives will vary depending on the scientific aims, expertise required, the environment and performance sites of the clinical site, as well as how the project aims are structured. The Plan for Enhancing Diverse Perspectives may be no more than 1 page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the Plan for Enhancing Diverse Perspectives can include, but are not limited to

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, and community-based)
  • Description of any planned partnerships that may enhance geographic and regional diversity
  • Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce
  • Proposed monitoring activities to identify and measure Plan for Enhancing Diverse Perspectives progress benchmarks
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s)
  • Publication plan that enumerates planned manuscripts and proposed lead authorship
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from underrepresented backgrounds

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.
 

SF424(R&R) Senior/Key Person Profile

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

A biographical sketch should be included for all key personnel. The biographical sketch of the PD/PI(s) should reflect their strengths, leadership, administrative skills, and scientific expertise.

PD/PI(s) must make a substantial, long-term commitment of effort to ECHO ISPCTN responsibilities, which include

  • Serving as a co-chair for any ECHO ISPCTN trial protocol whose development is being led by an investigator at their clinical site to ensure protocols are consistent with ECHO ISPCTN policies and priorities
  • Maintaining responsibility for close oversight of all ECHO ISPCTN trials being conducted at the clinical site to ensure study quality, data integrity, and participant safety. This includes meeting with local investigators leading the site's participation in the trial on a frequent basis and periodically attending study-specific meetings convened by the ECHO ISPCTN Data Coordinating and Operations Center
  • Participating in a wide variety of network activities including but not limited to committees, work groups, task forces, protocol development teams, network trial proposal reviews, and network manuscript reviews
  • Leading the clinical site's quality improvement efforts and reporting the resolution of any deficiencies to the NIH program office if deficiencies in progress toward network goals are identified by the Data Coordinating and Operations Center or NIH through site monitoring and performance feedback
  • Mentoring early stage investigators named as key persons on the award in their progress toward completion of the ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan proposed in the application's research plan. PD/PI(s) may designate an additional senior faculty member to provide support to early stage investigators if the individual has expertise in both clinical trials research and in mentorship

At least one PD/PI must be a board-certified pediatrician. The PD/PI(s) (collectively if more than one) must have previous training and scientific expertise in pediatric medicine as well as experience in conducting pediatric clinical trials. In the PD/PI biosketch(es), provide a description of previous experience with clinical trials research detailing the nature of involvement (e.g., trial protocol development, implementation, oversight, and/or results dissemination). List publications of prior trial research results. Clearly state clinical, academic, administrative, and other research time commitments and how they will affect the PD/PI's availability to engage in ECHO ISPCTN activities.

One or two early stage investigators (as defined by the NIH Early Stage Investigator Policy) must be designated as key persons for at least the first award year. The goal should be to maintain one or two early stage investigators on the award throughout all 5 years of funding. Early stage investigators' primary award responsibilities will be contributing to the design, implementation, and dissemination of ECHO ISPCTN trials. In addition, each named early stage investigator must complete an ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan as proposed in the application's research plan and overseen by the clinical site PD/PI(s). Early stage investigators need not have prior clinical trial experience when they start receiving ECHO ISPCTN support but must be willing to complete fundamental clinical trials coursework, contribute to the development of network protocols, and serve as trial site investigators under the supervision of the clinical site PD/PI(s).

If at any point during the award cycle, early stage investigators, other key persons, or other personnel included in the budget are no longer contributing effort toward the key ECHO ISPCTN goals of developing, conducting, disseminating, or overseeing network trials commensurate with their level of funding, the PD/PI(s) must adjust the award budget to reflect those individuals' actual efforts and request pre-approval for a change in key personnel from the ECHO ISPCTN program official.
 

R&R Budget

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

The award provides allowances for each of the following costs:

  • Salary and fringe benefits for the time and effort for PD/PI(s)' commitment to the network—minimum of 1.8 person months overall for PD/PI(s) for each of the five award years. 
  • Salary and fringe benefits for co-investigators while they are actively developing ECHO ISPCTN clinical trials, serving as site investigators on network trials, and/or mentoring early stage investigators completing the ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan.
  • Salary and fringe benefits for the time and effort for one or two early stage investigators' commitment to the network—minimum of 1.8 person months for each early stage investigator for at least the first year of the award and for every subsequent year that the early stage investigator is actively developing clinical trials for the network or serving as a site investigator on an ongoing network trial. To build a clinical trial workforce, the goal should be to maintain one or two early stage investigators directly involved in ECHO ISPCTN activities throughout all 5 years of the award.
  • Salary and fringe benefits for the time and effort for at least one research nurse coordinator to focus solely on ISPCTN projects—minimum of 12 person months for each of the five years of the award, total effort as needed based on the number of ongoing ECHO ISPCTN trials. This award will not support time devoted to non-ECHO ISPCTN research. In the budget justification, it is appropriate to describe the experience and skillset of an individual who may not have prior clinical trial experience but demonstrates the potential to become a strong ECHO ISPCTN research nurse coordinator. As an alternative to supporting a single research nurse coordinator at 12 person months per year, the applicant may propose to support one research nurse coordinator at a minimum of 6 person months per year plus an experienced, non-nurse research coordinator at a minimum of 6 months per year, for each of the five award years. Applicants may also include in the budget request additional part-time research coordinators as needed to develop or implement ECHO ISPCTN trials.
  • Travel to Network Face-to-Face Meetings (up to three per year) and Trial Kickoff Meetings (at the start of every new ECHO ISPCTN trial). At least one PD/PI, one research nurse coordinator, and one early stage investigator per clinical site should plan to attend each Network Face-to-Face Meeting in its entirety. At least one site investigator and one research nurse coordinator should attend Trial Kickoff Meetings. Face-to-face meetings allow research teams to develop new research protocols, share experiences with protocol implementation, and discuss ECHO ISPCTN research results with other site teams across the network. 
  • Coursework or other training in the development or conduct of clinical trials, especially regulatory compliance, including any associated travel costs. Allocation of funds for professional development in these specific areas are encouraged for all key persons and research coordinators, especially early stage investigators as part of their ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan.
  • Allowable costs associated with implementing the Plan for Enhancing Diverse Perspectives (as outlined in the Grants Policy Statement section 7).
  • Administrative support services that are directly associated with and necessary for ECHO ISPCTN programmatic work.
  • Consultant costs that are directly associated with and necessary for ECHO ISPCTN programmatic work.

The ECHO ISPCTN Data Coordinating and Operations Center will provide additional study implementation reimbursements using a capitated fee schedule per study that is approved by NIH.

Items that may NOT be supported with award funds include

  • Direct support of laboratories and other facilities, salaries, fringe benefits, travel, and research projects that are not directly associated with or necessary for ECHO ISPCTN programmatic work.
  • Patient care costs such as inpatient hospitalizations, outpatient visits, and laboratory or radiographic tests, unless exclusively for the purposes of implementing an NIH-approved ECHO ISPCTN protocol.
  • Salary and support for central institutional administrative personnel (e.g. budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges unless the conditions in Section 7.4 of the NIH Grants Policy Statement are met.
  • Salary and support for administrative activities such as institutional public relations or health and educational services.
     

R&R Subaward Budget

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

NIH encourages partnerships with NIH-funded research programs (e.g., Centers for Translational Research and Centers for Translational Science Award) or other clinical trial-support programs within the site's own state, another IDeA state, or a non-IDeA state for the following purposes: enhancing subject-matter or scientific expertise for clinical trial development, implementation, dissemination, or skills building, or improving capacity to recruit and retain rural or underserved participants into ECHO ISPCTN trials. All partnerships must be well justified. Recruitment of research participants for clinical trials must take place in IDeA states. If partnerships with institutions outside IDeA states are part of the proposed budget, a minimum of 75% of total costs must be awarded to institutions within IDeA states.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

If this is a renewal, a progress report is required within the research plan (suggested length: 1 page or less). In the progress report, provide a summary of the applicant's accomplishments during the prior funding cycle of the ECHO ISPCTN. In terms of research productivity, list for the clinical site overall:

  1. Number of ECHO ISPCTN trial concept proposals submitted
  2. Number of trial protocols cochaired
  3. Number of ECHO ISPCTN studies in which the site participated
  4. Time to site activation for each study as reported by the Data Coordinating and Operations Center
  5. Number of participants enrolled for each study
  6. Number of participants retained for the primary outcome for each study.

In terms of capacity building, describe growth in the institution's clinical trial workforce including gains in workforce size and skills, as well as any new research financial support obtained by key personnel in the prior ECHO ISPCTN funding cycle, including by the early stage investigators named as key personnel on the award. In terms of engagement, describe activities undertaken by the clinical site in the prior funding cycle to incorporate input from interested parties, such as community members, nonprofit organizations, and professional societies, for the development, implementation, or dissemination of findings from ECHO ISPCTN clinical trials.

Specific Aims
Use the following three specific aims to ensure that the application includes all requested information and to streamline the review process. 1) Develop, conduct, and disseminate findings from multicenter clinical trials research, assuring the participation of children living in rural or underserved communities in IDeA states; 2) Build pediatric clinical trial research capacity at the clinical site; and 3) Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility.

Research Strategy
Please follow the headings and subheadings outlined in this section, to ensure that all requested information is included and to streamline the study section review process.

Subsection 1. Develop, conduct, and disseminate findings from multicenter clinical trials research, assuring the participation of children living in rural or underserved communities in IDeA states. 
Note that in Subsection 1, applicants must accomplish two tasks: A) describe the clinical site's readiness to engage in clinical trials research, and B) briefly propose a multicenter clinical trial that the network could conduct.

Subsection 1A. Readiness to engage in ECHO ISPCTN clinical trials. (Suggested length 1-2 pages.)
Describe readiness to engage in ECHO ISPCTN clinical trials research, including ability to propose, develop, implement, and publish findings from multicenter trial protocols within the five ECHO focus areas. The ECHO ISPCTN Program Office expects each clinical site to propose at least three multicenter clinical trial concepts over the course of the funding cycle. The network will ultimately select at least five concept proposals submitted by clinical sites to develop into protocols to implement. With rare exception (e.g., lack of sufficient recruitment population), NIH expects all clinical sites to be available to participate in all five network trials. Explain how the applicant will contribute to meeting these expectations for proposing and implementing network clinical trials. Describe anticipated difficulties with meeting trial proposal and implementation goals and offer possible solutions. Include plans for identifying and hiring appropriate personnel and any flexibility to adjust the staffing plan depending on the foci of the trials that the network selects. For instance, a neonatologist may be needed to lead the site in conducting the first network-approved trial if it targets perinatal morbidity, but a general pediatrician may be needed to lead the site in the next approved study if it targets teenage obesity.

Provide a plan for how the PD/PI(s) will solicit trial proposals from faculty at their clinical site throughout the funding cycle and help faculty to develop successful trial proposals into protocols. Describe how the PD/PI(s) will orient faculty new to the network to the ECHO ISPCTN's priorities, policies, processes, and practices. Also provide a plan for how the PD/PI(s) will maintain close oversight of study activities while network trials are being developed and conducted at their site.

Applicants with access to NIH-funded research programs (e.g., Center for Translational Research or Center for Translational Science Award) or other clinical trial support programs should describe how they will leverage these resources to augment efforts to develop and conduct ECHO ISPCTN trials, such as by accessing their pilot study funding, community advisory boards, or study design experts.

Subsection 1B. Briefly propose a multicenter clinical research trial that the ECHO ISPCTN could conduct during this funding cycle. (Suggested length 4-5 pages.)
If NIH awards this application, the trial proposal herein will count toward the minimum three total proposals that the ECHO ISPCTN program office expects each clinical site to submit over the funding cycle, regardless of whether the network ultimately decides to develop and implement the proposed trial.

The trial proposal should focus on one of the five ECHO focus areas and be solution-oriented, i.e., generate results that could inform child health policy, public health programs, or clinical practice. Studies may test interventions designed to promote health or prevent or treat disease using experimental drugs, devices, health care delivery methods, or behavioral interventions. The ECHO ISPCTN is particularly interested in trials conducted in the primary care setting. Because the ECHO ISPCTN focuses on large scale, multicenter trials, all proposed study interventions should have already demonstrated "proof of concept" in prior studies. Consider building trial proposals upon the expertise developed and results generated from past ECHO ISPCTN clinical trials or from other clinical trials listed in ClinicalTrials.gov.

Include the following elements in your brief clinical trial proposal: background/rationale, research question and any associated hypotheses, study design, and study timeline.

In describing the background/rationale for the trial, explain the potential policy, public health, or clinical impact of study findings, particularly among rural or underserved pediatric populations. Explain why the ECHO ISPCTN is an appropriate network to conduct the trial. Describe the knowledge gap in the literature that the proposed trial would fill. Include evidence from published research, particularly "proof of concept" clinical trials, demonstrating the readiness of the intervention to be tested in the multicenter context of the ECHO ISPCTN.

Pose a research question that is specific and actionable. In stating the research question, include the intervention conditions to be compared, duration of intervention, and primary outcome measure.

In the study design paragraphs, describe the study setting, eligibility criteria, and desired number of participants per intervention condition. Briefly describe community-engaged recruitment and retention strategies that you would use to enhance participation of rural or underserved children. Given that a primary mission of the ECHO ISPCTN is to build capacity to conduct clinical trials in IDeA states, describe a plan to maximize the number of clinical sites that can participate in the trial, with a minimum requirement of 9 sites. Describe the main features of the intervention conditions, how you would assess the primary outcome, and a general strategy for statistical analysis.

Provide an overall timeline for all study activities to demonstrate that the network could complete the trial within the five-year funding cycle. Describe contingency plans if the trial does not meet study timeline milestones, such as if there are enrollment shortfalls.

All clinical trial proposals submitted by ECHO ISPCTN Clinical Site awardees will be evaluated by the ECHO ISPCTN Steering Committee, Protocol Review Committee, and Data and Safety Monitoring Board during the course of proposal and protocol development to determine which five trials the network will conduct. The network will select trials to implement based on how well they excel on four criteria: public health or clinical impact, relatedness to the ECHO ISPCTN, scientific merit, and feasibility.

Subsection 2. Build pediatric clinical trial research capacity. (Suggested length: 3-4 pages.)
Propose a capacity-building ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan for mentoring the early stage investigator(s) named as key personnel on the award. Focus the plan on enhancing skills in multicenter clinical trial design, implementation, and publication, as well as the principles of Good Clinical Practice consistent with Food and Drug Administration ICH GCP E6 standards, and not on other study designs or on academic advancement. Describe what training materials you propose to leverage, which may include existing national, regional, or local resources.  Include frequency and focus of meetings between early stage investigators and the PD/PI(s), anticipated timeline for completing proposed coursework, and method for tracking and documenting progress toward completion. Because experiential learning is the priority, participation in the development, implementation, and dissemination of ECHO ISPCTN trial protocols will be the primary metric of success of the Onboarding and Clinical Trials Skills Development Plan. NIH encourages applicants to partner with other NIH-funded centers (e.g., Center for Translational Research and Center for Translational Science Award) to provide supplemental expertise in clinical trials skills development if indicated.

Subsection 3. Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility. (Suggested length: 2-3 pages.)
Propose a plan to engage broader communities to enhance clinical trial impact, transferability, rigor, and feasibility. Specifically, applicants should propose to seek and incorporate input from a) pediatric professional organizations, such as by accessing their position papers and evidence reports, to generate potentially impactful ECHO ISPCTN trial ideas; b) pediatric-focused community organizations, such as state agencies or nonprofit organizations, to optimize the relevance of ECHO ISPCTN studies to children in IDeA states; and c) individuals from potential future study populations to enhance research accessibility and meaningfulness to participants, such as to understand their preferences for how the network could return individual research results to participants, or approaches to enroll and retain participants from rural or underserved communities in network trials. Applicants may propose to solicit community members' input by engaging existing community advisory boards, convening study-specific focus groups, performing key informant interviews, or through other methods.

Letters of Support 
Applicants must provide letter(s) from the appropriate senior institutional officials (at or above the level of dean, vice president for research, or equivalent) from the primary applicant institution and from any partner trial performance site institutions, that

  • Commit the institution to the ECHO ISPCTN goals, indicating that the program will be integral to its broad vision of clinical research.
  • Define the position, authority, and reporting responsibility of the PD/PI(s) on their institution's organizational chart.
  • Define the authority of the PD/PI(s) will have over use of facilities and space to conduct ECHO ISPCTN research, as well as over hiring and approving of new faculty and support personnel.
  • Guarantee the release time for faculty and salary support for research coordinators and ancillary personnel, as specified in the application budget.
  • Define the financial and other resource support the applicant institution will provide if NIH awards the grant. There are no dollar requirements, but specific commitment is required. Some examples include financial support and provision of research space and equipment. The letter writer can summarize specifics commitments in a table. NIH encourages co-funding or matching funds from other sources (including industry) if these funds do not limit faculty research, communications, and implementation of ECHO ISPCTN studies, and if there are methods in place to ensure transparency, management of conflicts of interest, and prevent misuse of federal funds, and PD/PI(s) can ensure that there will be no violation of NIH policies with respect to sharing of data and resources, academic freedom, and publication rights.

Include letters of support from partnering institutions or outside collaborators with statement of roles and responsibilities. If the PD/PI(s) intend to leverage the research support of another NIH-funded center (e.g., Center for Translational Research and Center for Translational Science Award), include a letter of support from the center indicating the center's role in supporting the applicant's goals for clinical trial activities and/or capacity building activities.
 

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
  • In addressing a Data Management and Sharing Plan, all applicants should state their agreement with the following centralized process. On behalf of the network, for each ECHO ISPCTN study, the Data Coordinating and Operations Center will upload the de-identified data to the NICHD Data and Specimen Hub (DASH), a controlled-access, public use database, in accordance with the NIH Data Management Sharing Policy.

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

See Section 2 - Study Population Characteristics

2.9 Inclusion Enrollment Report(s)

The ECHO ISPCTN Data Coordinating and Operations Center will provide Inclusion Enrollment Reports to the NIH and reports to ClinicalTrials.gov for network studies on behalf of all participating clinical sites.

Delayed Onset Study

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

Applicants should note a Justification for Delayed Onset Studies such as “The ECHO ISPCTN has not yet determined which clinical trials it will conduct during the funding period that begins in June 2025. Therefore, human subjects study information is not available at this time.”

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

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

In order to expedite review, applicants are requested to notify the Center for Scientific Review by email at lisa.steele@nih.gov when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application.

Pre-application Information Session
NIH anticipates hosting an informational pre-application session, addressing the scientific and administrative issues associated with this initiative, around one month prior to the Letter of Intent due date. The purpose of this information session is to (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NIH programmatic emphasis, and (3) facilitate the submission of a well-organized application.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular NOFO, note the following:

The ECHO ISPCTN aims to build capacity of research teams located in IDeA states to develop, conduct, and disseminate results from pediatric multicenter clinical trials, thereby enhancing access to state-of-the-art clinical trials for children from rural or underserved areas living in IDeA states. By engaging in ECHO ISPCTN trials, research teams will gain experience to augment and strengthen the clinical research capacity of IDeA states overall. While some prior investigator experience in clinical trials research is important, investigators from IDeA states may or may not have extensive prior clinical trial experience or track records of publications and funding comparable to more experienced investigators.  Clinical trial concepts proposed will be further developed and evaluated by the ISPCTN Steering Committee before advancing to implementation.

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

 

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

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

Specific for this NOFO
As demonstrated in the biosketch(es), how experienced are the PD/PI(s) specifically in the conduct of pediatric, multicenter clinical trials? How experienced are they in developing the research skills of junior investigators?  Are the research interests of the early stage investigator(s), as stated in biosketch(es), aligned with at least one of the five ECHO focus areas? If this is a renewal application, how productive was the applicant in proposing or developing ECHO ISPCTN trial protocols? Did the applicant recruit and retain participants well and contribute to ECHO ISPCTN manuscripts in prior cycles, as demonstrated in the Facilities and Other Resources attachment?
 

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project? 

 

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

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

Specific for this NOFO
If the clinical trial proposed in the Research Plan includes study design, methods, and intervention that are not by themselves innovative, does the trial address important questions or unmet needs?
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

 

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific for this NOFO
In the Research Plan, how sufficient is the applicant's readiness to propose, develop, conduct, and disseminate ECHO ISPCTN trials? How systematic, appropriate, and specific to multicenter clinical trials is the ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan? To what degree will plans to engage interested parties such as community members, nonprofit organizations, or professional societies enhance network trials' impact, transferability, rigor, or feasibility?
Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?  

 

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?

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

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

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

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

Specific for this NOFO
In the Facilities and Other Resources, does the applicant demonstrate 1) adequate access to rural or underserved participant populations in ECHO's 5 outcome areas, including in the primary care setting; and 2) a history of successful implementation of clinical trials?

In the letters of support, does the institutional leadership demonstrate institutional commitment to support the proposed program?
To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 

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

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

 

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

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

 

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

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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

 

For Renewals, the committee will consider the progress made in the last funding period.

 

Not applicable

Additional Review Considerations

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

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

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.

2. Review and Selection Process

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 policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

  • Identifying priority areas for research.
  • Developing and implementing ECHO ISPCTN protocols.
  • Projecting participant enrollment at their site for approved protocols and meeting recruitment and retention targets. For specific studies, NIH may require recipients, either individually or collectively as a network, who do not accomplish negotiated milestones to submit a milestone report which will discuss why the milestones were not met in the agreed upon timeframe and propose a corrective action plan. The corrective action plan shall include amended milestones, plans to achieve the amended milestones, and any additional items required by ECHO ISPCTN Program staff. The plan must be approved and signed by the institutional officials and the PD/PI(s) listed on the awards prior to submission to NIH.
  • Collecting and transmitting data to the ECHO ISPCTN Data Coordinating and Operations Center. 
  • Maintaining quality control measures to ensure protocol adherence and collection and transmission of accurate data within required timeframes to the ECHO ISCPTN Data Coordinating and Operations Center and/or other coordinating centers identified in protocol awards.
  • Analyzing ECHO ISPCTN data in collaboration with the Data Coordinating and Operations Center and publishing study results.
  • Embracing the collaborative nature of ECHO ISPCTN research and the role of team science in accomplishing network goals.
  • Mentoring early stage investigator(s) in their progress with the ECHO ISPCTN Onboarding and Clinical Trials Skills Development Plan. Providing input and oversight to early stage investigators who propose or implement ISPCTN protocols.
  • Proposing, designing, and conducting ECHO ISPCTN studies, supervising clinical site personnel, including local investigators leading the clinical site's participation in network trials.
  • Interacting with local IRBs and local grants management officials and collaborating with the other clinical site PD/PI(s), the ECHO ISPCTN Leadership Committee, the Steering Committee, the Data Coordinating and Operations Center, and the ECHO ISPCTN program office.
  • Designating one representative to serve as the clinical site's voting member of the ECHO ISPCTN Steering Committee. 
  • Publishing or assisting in publishing and publicly disseminating study results in accordance with ECHO ISPCTN and NIH policies, including submitting manuscripts to the National Library of Medicine's PubMed Central within timeframes specified by the NIH Public Access Policy.
  • Complying with Data Sharing and Management plan as outlined in Section IV - Research Plan - Other Plan(s) of this RFA, including ensuring the appropriate language regarding sharing plans is included in study informed consent forms.
  • Acknowledging NIH funding support in all relevant publications and presentations of work performed under this agreement.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

NIH assistance to ECHO ISPCTN operations will be provided by the ECHO ISPCTN program official and project scientists. NIH staff will have substantial scientific/programmatic involvement during the conduct of this activity through the provision of technical assistance, advice, and coordination above and beyond the normal program stewardship role for grants. An ECHO ISPCTN program designate will serve as executive secretary to the ECHO ISPCTN Protocol Review Committee and Data and Safety Monitoring Board and provide minutes and findings to the ECHO Program Director for approval. In addition, in various matters related to study approval and oversight, the NIH staff will have final decision authority, as described below.

NIH Program Official
An ECHO ISPCTN Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This program official's role is distinct from that of the project scientists, and will include the following

  • Study and Budget Approval: Provide final approval of ECHO ISPCTN clinical trial protocols and their budgets, prior to initiation of any ECHO ISPCTN study, as well as assist in the development and review of study budgets including consideration of special institutional needs regarding study-specific capitated payment schedules.
  • Investigational New Drug (IND)/Investigational Device Exemption (IDE) Application Decisions: Determine on a case-by-case basis whether ECHO ISPCTN trials require Food and Drug Administration review, and if the regulatory sponsor for a clinical trial conducted under IND/IDE will be an ECHO ISPCTN clinical site or the Data Coordinating and Operations Center. The Data Coordinating and Operations Center will provide NIH staff with timely reports of serious adverse events (SAE) and protocol deviations. The NIH program official will work with the Data Coordinating and Operations Center and the Data and Safety Monitoring Board to determine the final disposition of SAE Reports for all ECHO ISPCTN IND/IDE studies.
  • NIH Public Access Policy Compliance Oversight: Ensure that all ECHO ISPCTN trials are registering and submitting trial information to the ClinicalTrials.gov registry and depositing de-identified study datasets to a central repository (e.g., NICHD Data and Specimen Hub (DASH)).  
  • Clinical Site Monitoring: Carry out continuous review activities, including regularly scheduled and ad hoc meetings with individual clinical sites to ensure that they are meeting objectives and handling all regulatory, fiscal, human subjects oversight, and administrative matters according to NIH policies and guidelines. In consultation with the ECHO ISPCTN project scientists, the NIH program official may initiate a decision to withhold funding support to a clinical site if the site does not meet technical performance requirements, such as by committing a critical protocol deviation or breach of participant safety, missing enrollment/retention targets by a wide margin, or submitting data of poor quality.
  • Study Monitoring: With assistance from the ECHO ISPCTN Data Coordinating and Operations Center, monitor studies' human subjects' enrollment and safety, ensuring compliance with Office for Human Research Protections and NIH requirements for human subject research, as well as adherence to federal standards for data integrity. The ECHO ISPCTN program official may initiate a decision to modify, terminate, curtail, or suspend a study based on the advice of the Data Coordinating and Operations Center, Steering Committee, Leadership Committee, Protocol Review Committee, Data and Safety Monitoring Board, and/or NIH Project Scientists. 
  • For-Cause Clinical Site Visits Oversight: Initiate a for-cause clinical site visit or preapprove and participate in one initiated by the Data Coordinating and Operations Center. Afterwards, the program official will review, approve, and submit the resultant corrective and preventive action plan developed by the Data Coordinating and Operations Center to the visited clinical site.
  • Committee Work: Participate as a non-voting member of the ECHO ISPCTN Steering and Leadership Committees, and other relevant committees.

NIH Project Scientists

The NIH Project Scientists will have substantial scientific involvement as described below

  • Trial Concept Development: Assist the Steering Committee with the identification of important areas of study and provide scientific support to investigators developing trial proposals to ensure they build upon existing literature and are feasible and appropriate to test in the ECHO ISPCTN.
  • Protocol Drafting: Assist writing teams in the development of study protocols. The project scientists will also assist in the review and evaluation of clinical trial development at each stage of the process in conjunction with the Steering and Leadership Committees and make recommendations to enhance the scientific quality of the work. Specifically, the project scientists will identify scientific issues in implementation of the research and provide recommendations to improve rigor, applicability to the network, feasibility, or impact.
  • Study Materials Development: Be integral members of the teams developing all study materials including manuals of procedures, scripted interactions with participants, informed consent and assent forms, recruitment advertisements, data capture forms, and data and safety monitoring plans. Project scientists will contribute to the development, review, and approval of all study materials.
  • Dissemination of Study Results: Assist in the reporting of results to the community of investigators, study participants, and other interested parties. Project scientists will participate in proposing, coauthoring, and reviewing manuscripts prior to their final approval from the ECHO Director for submission to peer-reviewed journals for publication.  
  • Scientific productivity reporting: Recommend administrative actions to enhance scientific productivity in protocol development, study start-up activities, trial conduct, and results dissemination.
  • Committee Work: Participate as non-voting members of the ECHO ISPCTN Steering and Leadership Committees, and other relevant committees.
     

Areas of Joint Responsibility include:

Steering Committee 
The ECHO ISPCTN Steering Committee will be the main governing body of the ECHO ISPCTN and will have the primary responsibility for developing research policies by consensus, vetting studies for the network to consider for conduct, supervising the conduct of the studies, and reporting results.

The Steering Committee will consist of one PD/PI from each clinical site, the PD/PI(s) of the Data Coordinating and Operations Center, and one NIH ECHO Project Scientist. The Steering Committee will determine all major scientific decisions by majority vote. Each clinical site will have one vote, as will the Data Coordinating and Operations Center and the NIH ECHO Project Scientist. The Steering Committee will establish subcommittees, work groups, and task forces as appropriate. The ISPCTN PD/PIs will elect a Steering Committee chair--either from a clinical site or external to ISPCTN--to create agendas for and facilitate Steering Committee meetings. The NIH ECHO Director can advise the ISPCTN PI/PDs on the expected qualifications or conflicts of interest of a potential internal or external chair. The NIH ECHO Program Office expects the Steering Committee chair to demonstrate outstanding skills in leadership, teamwork, and cooperation. If the Steering Committee has an external chair, that person would serve as a non-voting member except in instances requiring a casting vote, when the votes on each side of a decision are equal.

The ECHO ISPCTN program office will appoint an executive secretary and external scientists to the ECHO ISPCTN Protocol Review Committee and Data and Safety Monitoring Board, both of which will report to the ECHO director. The Data Coordinating and Operations Center will provide logistical support to these groups.

The Steering Committee, with the assistance of the Data Coordinating and Operations Center, is responsible for coordinating protocol development, study design, protocol submission, study conduct, quality control and study monitoring, trial endpoint adjudication, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug, device, and other product management, compliance with federally mandated regulations, and protocol and performance reporting.

The ECHO ISPCTN will establish policies and procedures through the Data Coordinating and Operations Center, the Steering Committee, the Leadership Committee, and the NIH that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the ECHO program office. ECHO ISPCTN members must accept and implement policies and procedures approved by the Steering Committee.

Leadership Committee 
The ECHO ISPCTN Leadership Committee will be a subgroup of the Steering Committee with added representation of one early stage investigator and one research nurse coordinator. The Leadership Committee will have representatives from the clinical sites, the Data Coordinating and Operations Center, and the NIH. The Steering Committee chair will also serve as Leadership Committee chair. One representative from each clinical site, the Data Coordinating and Operations Center, and the NIH will each have one Leadership Committee vote. In the case of ties, the ECHO ISPCTN program office reserves the right to allot the chairperson a tie-breaking vote.

The Leadership Committee will provide executive leadership for the ECHO ISPCTN by providing programmatic and budgetary oversight of strategic issues and resource use. It will prioritize research activities, develop governance policies for ratification by the Steering Committee, establish ad hoc committees, help to develop Steering Committee meeting agendas, and assist in the resolution of disputes within the network.

External Scientific Board
Five or more external experts will serve as the ECHO External Scientific Board and will be selected and appointed by the ECHO director. The external scientific board may review and offer input on ECHO ISPCTN structure, function, and studies during all phases of their lifecycle. External scientific board members will provide input, based on their individual areas of expertise, as needed over the course of the program. They will assist the program office regarding processes and substantive issues that arise during the funding cycle and will help ensure that the resources and research findings of the ECHO ISPCTN are as useful as possible to the public. The program office may invite external scientific board members to attend some ECHO ISPCTN Steering Committee or other network meetings.

Protocol Review Committee
The ECHO ISPCTN Protocol Review Committee will serve as a scientific oversight committee for the network. The Protocol Review Committee will review proposed protocols that the network is considering for implementation. The purpose of the protocol review committee is to assess the scientific merit of each proposed ECHO ISPCTN protocol. The committee will be appointed by and responsible to the ECHO ISPCTN program office to provide peer review of the protocols developed by network investigators.  All protocols will be reviewed and approved by the ECHO ISPCTN Steering Committee prior to submission to the Protocol Review Committee.

Membership of the ECHO ISPCTN Protocol Review Committee will include a chair, medical experts, scientists, statisticians, and other clinical research or trial experts. Membership will expand to include additional expertise as needed for any given protocol. The ECHO ISPCTN Protocol Review Committee Executive Secretary will be responsible for scheduling and attending committee meetings, taking minutes, and assisting the committee chair in drafting a report of recommendations for the ECHO director’s review.

Data and Safety Monitoring Board
The program office will establish an independent ECHO ISPCTN Data and Safety Monitoring Board to monitor and provide recommendations to the ECHO director regarding network studies' participant enrollment, retention, and safety, as well as data quality, and other issues as appropriate. The ECHO ISPCTN Protocol Review Committee and the Data and Safety Monitoring Board are separate bodies which may overlap in membership. The Data and Safety Monitoring Board will review Protocol Review Committee-approved protocols, informed consent forms, and data and safety monitoring plans prior to the start of participant recruitment. The program office will share the ECHO director-approved recommendations of the Data and Safety Monitoring Board with study teams and the Data Coordinating and Operations Center to add to their single institutional review board protocol submissions.

Single Institutional Review Board (IRB)
The ECHO ISPCTN will use a single institutional review board to streamline the protocol approval process and standardize the monitoring of human subjects' protections in network trials. The ECHO ISPCTN program office will respect the sovereignty of tribal nations to additionally include a tribal IRB.
 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

For each ECHO ISPCTN study, the Data Coordinating and Operations Center will upload all network-generated data to an NIH-sponsored, controlled-access, public use database on behalf of all participating clinical sites, in accordance with the NIH Data Management Sharing Policy.

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

Tonse N.K. Raju, MD
Program Officer
Environmental influences on Child Health Outcomes (ECHO)
Office of the Director, National Institutes of Health
Three White Flint North, Room 03D17
11601 Landsdown Street
North Bethesda, MD 20852
Mobile: 202-302-3984 
ECHO Phone: 301-435-5236
tonse.raju@nih.gov
 

Michele McGuirl, Ph.D.
Email: michele.mcguirl@nih.gov
 



 



Janani Prabhakar
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-1321
E-mail: janani.prabhakar@nih.gov



The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the NOFO and the IC's research portfolio.



Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Bonnie J. Jackson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5482
Email: bonnie.jackson@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov



Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov



Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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