Part 1. Overview Information

Key Dates

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.

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access limited identifiable data or biospecimens from the ECHO Cohort to study high-priority areas of maternal and child health. Obtaining an award from this opportunity is necessary to participate in the ECHO Cohort ancillary studies process. The ECHO Program defines an ECHO Cohort Ancillary Study as a study that derives funding from a non-ECHO source and uses the ECHO Cohort’s non-publicly available data or biospecimens.

ECHO Cohort Ancillary Studies are open to the broad scientific community and require investigators who are not a part of the ECHO Cohort Consortium to apply for and receive an X01 award under this announcement. Investigators who are currently part of the ECHO Cohort Consortium who are requesting access to biospecimens as part of an ancillary study must also apply for and receive an X01 award under this announcement. While no funds are associated with awards from this announcement, these X01s allow the NIH ECHO Program Office to oversee awardees’ adherence to NIH and ECHO-specific policies and procedures during performance of ECHO Cohort Ancillary Studies.

This opportunity allows individuals across the scientific community to propose projects that leverage non-ECHO funding to conduct ancillary studies involving

• Analysis of limited identifiable data on the ECHO Cohort Data Platform
• Access to biospecimens from the ECHO Cohort Biorepository to generate new assay data for subsequent analysis and to return these data to the ECHO Cohort Data Platform 

To learn more details about the ECHO Cohort ancillary studies process, go to https://echochildren.org/-echo-ancillary-studies/.

Background

In 2016 NIH launched the nationwide ECHO Program with the mission to enhance the health of children for generations to come. The Program established an observational “ECHO Cohort” study by funding a consortium (the ECHO Cohort Consortium) of cores, centers, and performance sites to combine data and biospecimens from multiple pre-existing and ongoing maternal-child cohort studies and begin collecting new data and biospecimens under a standardized data and biospecimen collection protocol.

The ECHO Program provides access to the ECHO Cohort data and biospecimens in three ways:

1. To conduct their research, investigators funded through the ECHO Cohort Consortium contribute and access identifiable data and biospecimens on the ECHO Cohort Data Platform and Biorepository.
2. ECHO makes de-identified, controlled access data available to the broader scientific community through an NIH data repository. Learn more about how to access the ECHO Cohort’s de-identified, controlled access data here: de-identified, controlled access data.
3. By proposing an Ancillary Study, which requires non-ECHO funding, investigators from the ECHO Cohort Consortium or from the broader scientific community can now request access to limited identifiable data on the ECHO Cohort Data Platform with or without biospecimens  from the ECHO Biorepository . Awards from this announcement will facilitate access to these data and biospecimen resources for ECHO Cohort Ancillary Studies.

With access to ECHO’s data and biospecimens, investigators can explore how a broad range of early environmental exposures from society to biology influence health outcomes in children. ECHO research often focuses on relationships among

1. Exposures like the natural and built environments, and physical, chemical, social, behavioral, and biological factors, focused mostly in the periods from preconception to age 5 years; and
2. Outcomes like pre-, peri- and postnatal; upper and lower airways; obesity; neurodevelopment; and positive health, or well-being, that occur from birth through adolescence.

At the publication of this announcement, the ECHO Cohort has data on approximately 130,000 maternal and child participants, representing births in all 50 states, D.C., and Puerto Rico, and more than 123,000 biospecimens in its biorepository. Because of the ECHO Cohort’s nationwide coverage, analyzing data from ECHO participants takes advantage of ample statistical power for addressing many important child health research questions and may very well yield generalizable findings.

To learn more about the data and biospecimens that are available for ECHO Cohort Ancillary Studies, request access to https://echoportal.org/.

Research Scope

Applications to this announcement should consist of well-conceived projects that leverage limited identifiable data on the ECHO Cohort Data Platform, with or without assays of biospecimens, to study high-priority areas of maternal and child health.

Applicants may propose any scientific question appropriate to the use of ECHO Cohort data. Specific areas of interest include, but are not limited to

• Detecting modifiable early developmental exposures that, if addressed by programs, policies, and practices, could enhance child health outcomes across the life course
• Exploring pathways to child health outcomes that incorporate state-of-the-art analytic biochemical or statistical methods
• Examining resilience or susceptibility factors that buffer or amplify the effects of adverse early exposures on child health outcomes
• Identifying periods of development most sensitive to specific beneficial or detrimental exposures to inform new strategies to promote child health.
• Measuring the effects of natural experiments or new health innovations or paradigms on child health outcomes.

Scientific questions may benefit from assays of ECHO Cohort biospecimens to characterize exposures, pathways, or outcomes. Ideal projects would include assays that generate results that are usable in multiple future analyses.

Specific Application Requirements and Expectations

Letter of Support for ECHO Ancillary Studies

To be responsive, applications to this announcement must include as an attachment a Letter of Support from the ECHO Cohort Steering Committee. NIH will not review applications without a Letter of Support from the ECHO Cohort Steering Committee. Find instructions on how to request a Steering Committee Letter of Support at https://echochildren.org/echo-ancillary-studies/.

For applications submissions to the first due date listed in this announcement, applicants must request a Letter of Support in early June 2025. Find specific dates for requesting Letters of Support from the ECHO Cohort Steering Committee at https://echochildren.org/echo-ancillary-studies/.

Evidence of Funding

ECHO Cohort Ancillary Studies require support from non-ECHO funding sources. This announcement does not provide funds for the research project. Applicants are responsible for providing their own funding to cover all costs associated with conducting the research, including accessing data and biospecimens.

Applications to this announcement must include evidence of adequate funding in-hand or having applied for funding sufficient for the study. Applicants must provide evidence that funding will cover:

• Investigators and staff time
• Establishment of material transfer agreements and data transfer agreements with the ECHO Cohort Consortium, including with the ECHO Laboratory Core and Data Analysis Center
• Costs for the ECHO Cohort Cores and Centers—ECHO Data Analysis Center, Coordinating Center, Laboratory Core, and/or Measurement Core—for the duration of the study period, including but not limited to
  • Training and certification by the ECHO Data Analysis Center so applicants can access and conduct data analysis on the ECHO Cohort Data Platform analysis workbench
  • Set up of a limited identifiable dataset by the ECHO Data Analysis Center
  • If the applicant proposes biospecimen assays, retrieving, aliquoting, packing, and shipping of biospecimens from the ECHO Laboratory Core to the assay laboratory, and return of biospecimens to the Laboratory Core, if required by the ECHO Cohort Biospecimens Policy
  • Consultation with the ECHO Measurement Core about data elements collected in the ECHO Cohort, including the meaning, complexity, and best use of specific measurements
  • Project management and support from the ECHO Coordinating Center for navigating the ECHO Cohort analysis proposal and publications processes

Find more information at https://echochildren.org/echo-ancillary-studies/ about how to prepare appropriate budgets for ECHO Cores and Centers to support the proposed ancillary study.

Biospecimen and Assay Data Quality and Security Measures

If proposals include the use of ECHO Cohort biospecimens, applications must include detailed information about the analytical laboratory, planned assays, and plans for implementing biospecimen and assay data quality and security measures. See Section IV below for more details.

Plans should include protection of ECHO Cohort research participants’ privacy and against risk of re-identification. Learn more about NIH expectations for protecting participant privacy at https://sharing.nih.gov/data-management-and-sharing-policy/protecting-participant-privacy-when-sharing-scientific-data.

Expectation of Returning Biospecimen Assay Data to ECHO

Project proposals should include plans to return biospecimen assay data to the ECHO Data Analysis Center. Applicants should acknowledge in their proposals that the ECHO Cohort Consortium does not release biospecimens to assay laboratories until official material transfer agreements and data transfer agreements are in place.

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

Section II. Award Information

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

Higher Education Institutions - Includes all types

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

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

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. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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.

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. 

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 How to Apply - Application Guide.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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).

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 How to Apply - 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 announcement

The letter of intent should be sent to:

Melissa Zajdel, Ph.D.
Program Officer
Office of the Director, NIH
Environmental influences on Child Health Outcomes
Email: [email protected]

Page Limitations

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

For this specific announcement, the Research Strategy section is limited to 6 pages.

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 How to Apply - Application Guide must be followed.

Total Federal Funds Requested: Enter $0.

Total Federal & Non-Federal Funds: Enter $0.

Estimated Program Income: Enter $0.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

Applicants should propose innovative projects that take advantage of the nature of the ECHO Cohort. This section should address the project's?

Significance

• Explain the importance of the research question that the proposed project addresses.
• Explain how the proposed project will improve scientific knowledge, technical capability, and/or health practices in one or more broad fields related to children’s health.
• Describe how the aims if achieved would advance the maternal-child health objectives of the ECHO Program.
• If proposing the use of biospecimens, explain how their use would advance maternal-child health.

Investigator(s)

• The application should demonstrate that the study team is familiar with the design of the ECHO Cohort, including the information about data that can be found in its Data Platform and biospecimens in its Biorepository.
• The study team should include an analyst dedicated to the project and qualified to undergo the training and certification process the the ECHO Data Analysis Center provides for accessing the ECHO Cohort Data Platform. 

Approach

• Provide relevant details on the proposed study design, including how and to what extent the study design capitalizes on the nature of the ECHO Cohort. These details should be consistent with information in the Letter of Support from the ECHO Cohort Steering Committee included in the application; more details on the Letter of Support below.
• Provide a justification for the choice of proposed data elements and, if requested proposed biospecimen assays, and how the study team will analyze them to address the proposed research questions. A directed acyclic graph can be useful.
• Include a discussion of potential harms the study could cause to individuals, groups, or communities and the proposed strategies the study team will employ to mitigate such harms
• Provide justification for collection time points of requested data and biospecimens
• For biospecimens, provide justification for types, numbers, and volumes
• Applicants may propose to use ECHO Cohort biospecimens to validate previous studies or in combination with biospecimens from other studies to increase sample size for sufficient statistical power. If applicable, describe how the biospecimens from the ECHO Cohort and other studies are compatible for use in the same analysis.
• Describe the laboratory facilities where assays will be performed and laboratory management systems such as the use of a Laboratory Information Management System (LIMS)
• Describe any proposed laboratory assays. Provide the following information for each assay:
  • Description of the analytical method and reference(s), such as the URL for a standard method or publication(s) that describes the assay(s) and QC methods, including the volume required for both dead and assay volumes; approaches that minimize volume requirements are preferred, especially for samples with low total volumes such as child blood or urine;
  • Methodologies and instrumentation, including the assay kit name if using a commercial kit;
  • Analyte stability and assay validation;
  • Assay performance metrics (precision, specificity, accuracy, linearity of range, limits of detection);
  • Pre- and post- analytical quality control (QC) plan, e.g., proportion of QC samples, estimated batch size, use of a pooled sample or individual replicates, reference materials, plan for evaluating assay performance, and the source of QC samples;
  • Shipping and storage processes to ensure integrity for each biospecimen;
  • Competency of laboratories conducting the assay using pediatric biospecimens and volumes including accreditations;
  • Relevant preliminary data or proficiency testing demonstrating experience with the assay, and accuracy and robustness of the proposed assays, including use with pediatric biospecimens and volumes.
• Provide sample-size and power calculations, including the anticipated size of a detectable meaningful effect. Based upon these calculations, demonstrate how the requested sample size is adequate to detect meaningful effects in the study or if additional samples are required from other sources.
• Provide a detailed statistical analysis plan(s) and the intended strata germane to the study. When appropriate, note how the study team will address sex as a biological variable, in accordance with NOT-OD-15-102
• Describe how the study team will analyze the study data and the statistical methods they will employ
• Address epidemiological and statistical issues germane to the research such as approaches to minimize effects of measurement error, missing data, confounding, and other sources of bias, and approaches to characterize interactions (effect modification) and mediation
• Include a summary of the team’s expertise and experience, and evidence that the team has the required expertise to perform the proposed analyses. Include information about the analyst(s) who will undertake training and certification by the ECHO Data Analysis Center to conduct the analysis on the ECHO Cohort Data Platform, including their qualifications to conduct the analysis successfully.
• Include a timeline of the study activities to justify the project period
• Address plans for protection of ECHO Cohort research participants’ privacy and against risk of re-identification. Learn more about NIH expectations for protecting participant privacy at https://sharing.nih.gov/data-management-and-sharing-policy/protecting-participant-privacy-when-sharing-scientific-data.

Applications should also address the following requirements of the announcement.

Letters of Support

To be responsive, applications to this announcement must include a Letter of Support from the ECHO Cohort Steering Committee as an attachment. NIH will not review applications without a Letter of Support from the ECHO Cohort Steering Committee. Find instructions on how to request a Steering Committee Letter of Support at https://echochildren.org/echo-ancillary-studies/.

For applications submissions to the first due date listed in this announcement, applicants must request a Letter of Support in early June 2025.

Evidence of Funding

Since this announcement does not provide funds for the research project, provide evidence of funding in hand or having applied for funding that is adequate to budget for:

• Supporting the study team during the analysis project, including funding for a dedicated analyst who will complete certification from the ECHO Data Analysis Center to access the ECHO Cohort Data Platform to complete all data analysis associated with the project
• Establishing material transfer agreements and data transfer agreements with the ECHO Cohort Consortium, including with the ECHO Laboratory Core and Data Analysis Center
• Covering costs associated with biospecimen assays and related data security and management, and
• Supporting the ECHO Cohort Cores and Centers—ECHO Data Analysis Center, Coordinating Center, Laboratory Core, and/or Measurement Core—for the duration of the study period, including but not limited to
  • Training and certification by the ECHO Data Analysis Center so applicants can access and conduct data analysis on the ECHO Cohort Data Platform analysis workbench
  • Set up of a limited identifiable dataset by the ECHO Data Analysis Center
  • If the applicant proposes biospecimen assays, retrieving, aliquoting, packing, and shipping of biospecimens from the ECHO Laboratory Core to the assay laboratory, and return of biospecimens to the Laboratory Core, if required by ECHO Cohort Biospecimens Policy
  • Consultation with the ECHO Measurement Core about data elements collected in the ECHO Cohort, including the meaning, complexity, and best use of specific measurements 
  • Project management and support from the ECHO Coordinating Center for navigating the ECHO Cohort analysis and publications processes

Biospecimen and Assay Data Security and Return

If proposals include use of ECHO Cohort biospecimens?

• Provide acknowledgment that the ECHO Cohort Consortium will not release biospecimens to assay laboratories until official material transfer agreements and data transfer agreements are in place
• Describe plans to establish material transfer agreements and data transfer agreements with the ECHO Cohort Consortium, including with the ECHO Laboratory Core and Data Analysis Center
• Describe plans for implementing biospecimen and assay data security measures
  • Include plans for protecting ECHO Cohort research participants’ privacy and mitigating risk of re-identification; learn more about NIH expectations for protecting participant privacy at https://sharing.nih.gov/data-management-and-sharing-policy/protecting-participant-privacy-when-sharing-scientific-data.
  • Include plans for the use of a Laboratory Information Management System (LIMS)
  • Include assurances that biospecimen shipping will avoid issues that result in specimen degradation, like delivery on weekends and other potential pitfalls.
  • Include evidence that proposed assay laboratories have freezer backups and redundant systems for storage of biospecimens during the assay period
• Describe plans for returning biospecimen assay data to the ECHO Data Analysis Center
• Describe plans for returning biospecimens to the ECHO Laboratory Core, if required by ECHO Cohort Biospecimens Policy

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form

All instructions in the How to Apply - 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the ECHO Program Office by email at [email protected] when the application has been submitted. Please include the FON number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

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 X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 NOFO.  This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research.  Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.

The NIH awarding component will convene a federal review panel who will evaluate applications for scientific and technical merit. The panel will consider the review criteria described below in the review process.

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).

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.

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.

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.

2. Review and Selection Process

X01 applications will undergo an internal administrative evaluation by NIH staff. Applications submitted for this funding opportunity will be administratively evaluated using the criteria shown above.

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.

As these X01 applications are reviewed by a federal review panel, they will not undergo Advisory Council review. The following will be considered in making award decisions:

• Scientific and technical merit of the proposed project, with consideration for the impact to the resource, as determined by a federal review panel convened by the NIH awarding component.
• Relevance of the proposed project to program priorities.

If the application is under consideration for award, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible award.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 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. 

An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources described in this NOFO. Successful applicants will receive instructions for next steps.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that projects 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 projects.

2. Administrative and National Policy Requirements

An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Not Applicable

3. Data Management and Sharing

Not Applicable

4. Reporting

Not applicable. An X01 does not results in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Section VII. Agency Contacts

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

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Melissa Zajdel, Ph.D.
Program Officer
Office of the Director, NIH
Environmental influences on Child Health Outcomes
Email: [email protected]

The NIH awarding component is responsible for review. Please contact the Scientific/Research Contact above for questions.

Not Applicable

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.

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.