RFA-DA-27-003-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

National Cancer Institute (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Limited Competition for the Adolescent Brain Cognitive Development -Extended (ABCD-E) Study Renewal - Data Analysis, Informatics and Resource Center, and Coordinating Center (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of

RFA-DA-20-003

Reissue of

RFA-DA-20-004

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-DA-27-003

Companion Funding Opportunity

RFA-DA-27-002

, U01 Research Project (Cooperative Agreements)

Number of Applications

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

Assistance Listing Number(s)

93.279, 93.865, 93.273, 93.399

Funding Opportunity Purpose

This is a notice of funding opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with the National Institutes of Health (NIH) standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding. Only current award recipients will be eligible to apply. This NOFO seeks two separate U24 applications to renew the Adolescent Brian Cognitive Development (ABCD) Research Coordinating Center (CC) and the Data Analysis Informatics and Resource Center (DAIRC) to extend study visits into young adulthood. This renewal called Adolescent Brain Cognitive Development – Extended (ABCD-E) study is critical to be able to follow these youth through their emerging adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest. The structure of the ABCD-E study Consortium shall consist of three highly integrated components: (1) a set of linked Research Project Sites, (2) a single central Data Analysis, Informatics, and Resource Center, and (3) a single overall Coordinating Center. As such, this NOFO runs in parallel with a companion NOFO that solicits applications for research project sites (RFA-DA-27-002). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

Funding Opportunity Goal(s)

To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS.

Key Dates

Posted Date

June 08, 2026

Open Date (Earliest Submission Date)

June 09, 2026

Not Applicable

July 09, 2026

Not Applicable

April 2027

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.

Expiration Date

July 10, 2026

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 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.

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

This is a notice of funding opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding. Only current award recipients will be eligible to apply. The purpose of the NOFO is to renew the current Adolescent Brain Cognitive Development (ABCD) Centers. This renewal, called Adolescent Brain Cognitive Development – Extended study (ABCD-E), is critical to be able to follow these children through their emerging adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest.

Background: This announcement proposes a renewal of the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study. The ABCD study(R) is the largest long-term study of brain development and child and adolescent health in the United States. It has been highly successful in recruiting and retaining a cohort of almost 12,000 participants beginning at ages 9-10 and assessing them through ages 19-20. This includes approximately 2,000 participants from multiple births (e.g., twins, triplets). The National Institute on Drug Abuse (NIDA) in collaboration with other NIH Institutes, Centers, and Offices (ICOs) established the ABCD Study Consortium that consists of three highly integrated components: 21 Research Sites, a Coordinating Center (CC), and a Data Analysis, Informatics, and Resource Center (DAIRC). Together, the consortium established a common protocol conducted semi-annually, annually, or biennially that includes brain scans, biospecimen collection, and assessments in neurocognition, substance use, physical and mental health, etc. Because of its open science model, nearly 1,600 papers have been published using ABCD data covering a wide array of topics including psychiatric symptoms (e.g., attention-deficit/hyperactivity disorder [ADHD], suicidality), substance use, technology use (e.g., videogames, social media), obesity/weight gain, genetics, and their interactions with brain structure and function. For additional background information regarding this study, applicants can review the website (https://abcdstudy.org/).

The ABCD study was launched over a decade ago to better understand how experiences during late childhood and early adolescence influence brain development, how they interact with each other, and with genetic and other biological factors to promote or interfere with later health outcomes. Its goal was to create a large and well characterized cohort of youth to provide knowledge about the normal variability in adolescent brain and cognitive development and to collect physical (e.g., hormonal, nutrition, brain injuries, sleep patterns), behavioral (e.g., physical activity, social media use, video game activity), and environmental (e.g., relationships, social support systems, adversity, toxic exposures, etc.) data to elucidate risk and resilience factors for substance use, mental health disorders, and other health outcomes. However, the impacts of these experiences have only just begun to emerge as ABCD participants are now in their late teens/early twenties. Mental health and substance use disorders, as well as physical health conditions such as diabetes, hypertension, and early onset cancers become more prevalent in the 20s. As health conditions become evident, data collected during the adolescent years will help to identify predictors of later adverse outcomes to inform the development and timing of early interventions.

Finally, while conventional wisdom is that the brain continues to develop into the mid-20s, advances in brain imaging technology are now showing that the brain continues to change across the lifespan, with the adolescent period potentially extending into the early 30s. As these changes continue, so do new experiences that may influence them. The transition from adolescence to adulthood brings new life events (e.g., entering college/workforce, romantic relationships, parenthood), financial independence, and changing social networks, among many other experiences, which may continue to impact brain, cognitive, social-emotional, and other health outcomes.

Objective and Organization of the Adolescent Brain Cognitive Development - Extended (ABCD-E) Study Consortium: The purpose of this NOFO is to renew both the ABCD Coordinating Center (CC), and Data Analysis, Informatics, and Resource Center (DAIRC). This renewal called Adolescent Brain Cognitive Development – Extended (ABCD-E) study, is critical to be able to follow the original pediatric cohort through their emerging adulthood when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest. Current primary recipients will be eligible to apply, and this new award period will be 5 years in duration.

The ABCD-E study will continue to collect and release data from current ABCD participants that will enable researchers from around the world to:

It is expected that the proposed study will be designed to rigorously address the overarching objective and research questions outlined above. To accomplish these objectives, the Adolescent Brain Cognitive Development – Extended (ABCD-E) Study Consortium will consist of three highly integrated components.

Consortium Coordinating Center (CC): This NOFO seeks one application for a single coordinating center led by the Coordinating Center Director(s) that will assemble, integrate, and coordinate consortium activities, and is directly responsible for the overall management, performance, and dissemination plans and policies across the consortium.

Data Analysis, Informatics, & Resource Center (DAIRC): This NOFO seeks one application for a single data analysis, informatics, and resource center that will coordinate, standardize, and integrate all core data-collection, including a centralized mobile application for survey administration and participant engagement, objective health measures, and linking external data including electronic health records, as well as processing, storage, and analytic activities of the consortium; facilitate data sharing through the NIH Brain Development Cohorts (NBDC) Data Hub; and serve as a resource to the scientific community to enable broad use of ABCD-E data.

Research Project Sites: A set of linked research project site applications that will be responsible for subject retention, phenotypic assessments, biospecimen collection, neurocognitive testing, and neuroimaging and electroencephalogram acquisition is also required. Each research project award will represent a different site for subject follow-up, test administration, and collection of data using a common protocol established by the consortium, so that the data collected across the research project sites can be merged for integrative data analyses. Additional information about this component can be found at: RFA-DA-27-002.

Purpose of the ABCD-E Study Consortium Coordinating Center The CC will provide the organizational framework for the management, direction, and overall coordination of the nationwide multisite ABCD-E Study consortium. The CC will also be responsible for the standardization of protocols, training of staff, and site monitoring to ensure phenotypic assessments, biospecimen collection, neurocognitive testing, and neuroimaging and electroencephalogram acquisition are consistent across research sites and implemented with fidelity.

The CC will work with the DAIRC to ensure standardization of neuroimaging and electroencephalogram data acquisition and assessment protocols and create a pilot technology and reserve fund to take advantage of improvements/changing technology as they occur during the longitudinal study. Because the neuroimaging field undergoes rapid technical advances, the CC and the DAIRC will need to plan for integrating technological advances into the longitudinal study and determine how changes in hardware and analytic approaches will be coordinated across multiple research sites.

Coordination of Protocol Development & Implementation: As ABCD-E study participants become young adults, we anticipate protocol modifications to capture dynamic changes during this time period, including but not limited to, developmentally appropriate measures, assessment timing, protocol duration, and survey administration, etc. The CC should include expertise in studying young adulthood (either as a member or consultant) to ensure the adequacy and appropriateness of the protocol for this age group. We request that the ABCD-E study consortium determines a core set of protocol features that remain standardized and collected throughout the duration of this study to capitalize on the longitudinal study design to answer the specific aims articulated in this NOFO. The protocol needs to include at least one brain scan session in conjunction with electroencephalogram acquisition, phenotypic assessments administered through a centralized mobile app (e.g., surveys, Ecological Momentary Assessment (EMA), wearables), where appropriate, as well as objective health measures (e.g., wearables, biospecimens, anthropometrics). Lastly, when appropriate, please consider using artificial intelligence tools to increase efficiency and innovate data collection and methodology. An example would be asking participants a brief narrative question and using large language models (LLM s) to analyze the text for linguistic pattern recognition.

The CC will implement an extensive array of administrative and project management plans and activities as described below. The CC, in conjunction with the DAIRC, will develop and monitor a set of metrics to ensure the robustness of the consortium activities so that the ABCD-E study collectively can meet its goals. The CC should include a director (or co-directors) and one or more associate directors to ensure that the wide scope of activities is seamlessly coordinated.

Central Institutional Review Board (IRB): The use of single Institutional Review Board (sIRB) is required for any multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site (please see the Single IRB Policy for Multi-Site Research). The sIRB will be established and managed by the CC including tracking/ensuring participation in reliance agreements.

Pilot Technology & Reserve Fund: The ABCD-E Study will want to take advantage of improvements/changing technology as they occur during the longitudinal study as well as maintain the ability to strengthen ongoing efforts or to pursue new and interesting research directions based on the results obtained to date. A reserve fund should be established to (a) conduct feasibility testing at several research sites for the identified technology and necessary transition activities to scale up the approach, if successful, throughout the consortium and (b) solve unanticipated challenges or opportunities not yet identified. For use of these funds, the NIH Scientific Director and the NIH Program Officer must be informed in writing for prior approval to be given in advance.

Purpose of the ABCD-E Study Data Analysis, Informatics, and Resource Center (DAIRC) The DAIRC will develop (and revise when necessary) the procedures for collection of the core phenotypic assessments, biospecimen collection, neurocognitive testing, and neuroimaging and electroencephalogram data in a manner that will maximize comparability across the individual research sites of the consortium for the longitudinal study. The center will work with the workgroups to perform quality control (including development of tools to facilitate QC) and data curation for the measures collected from the research sites, as well as providing data informatics tools to monitor consortium progress and performance. The center will facilitate cross-site pooling of data, create a database across assessment modalities, and harmonize with existing large-scale neurodevelopmental research efforts, where possible. The center will be expected to facilitate data sharing through the NIH Brain Development Cohorts (NBDC) Data Hub to support scientific collaboration that enables the effective communication of detailed research data, tools, and supporting documentation. For more information on the ABCD-E Study Data repository (hosted by NBDC), please see this link: https://www.nbdc-datahub.org/.

This renewal application should include Imaging, Informatics, Linked External Data, Biostatistics, and Data Release and Resource Plans. Because the neuroimaging field undergoes rapid technical advances, the CC and the DAIRC will need to plan for integrating technological advances into the longitudinal study and determine how changes in hardware and analytic approaches will be coordinated across multiple research sites. Workgroups within the Consortium will provide the DAIRC with recommendations, advice, and decisions in specific areas. At least five workgroups should be proposed, described below.

An Imaging workgroup will make decisions about any changes to the image acquisition and processing protocols. The DAIRC will provide an evaluation of how any such changes would affect the imaging processing pipeline and harmonization across sites and scanners and will oversee the implementation of any such MRI acquisition protocol changes. The DAIRC will work with the CC to ensure standardization of neuroimaging data acquisition protocols. The Imaging workgroup will also oversee image processing of the pooled data to provide post-processed data for analysis.

An electroencephalography (EEG) workgroup will need to be convened to develop the EEG protocol, including hardware/equipment, data collection software, acquisition protocols and tasks; ensure consistency of EEG data collected across research project sites; develop/implement processing pipelines; conduct quality control; and prepare data for release.

An Informatics workgroup(s) will continue to support data collection and reporting infrastructure, including the incorporation of new data collection and analysis domains that emerge from various assessment workgroups (e.g., passive data, mobile technology) over the course of the longitudinal study, ingestion of third-party data (e.g., biospecimen analyses), as well as any new metrics and/or tracking systems that are needed for monitoring progress.

A Data Release workgroup with participation from the DAIRC, CC, consortium workgroups (as needed), NBDC Data Hub staff, NBDC Data Science Strategist, and other NIH and Consortium members as necessary to ensure the efficient and timely transfer of data to NBDC. One annual data release, at a minimum, is expected for the duration of the study.

A Data Resources workgroup will coordinate a strategic approach to dissemination of ABCD-E data and informatics resources (e.g., processing pipelines) to the scientific field at large. They will create and execute a plan that will enable scientists from outside institutions (e.g., non-ABCD-E study research project sites) to utilize the data, specialized tools, techniques, software packages, etc. The Data Resources workgroup will leverage the ABCD-E Study Data repository (hosted by the NBDC Data Hub) and further enhance the Data Exploration and Analysis Portal (DEAP; https://abcd.deapscience.com/#/home) that provides an interactive user interface to allow users to explore and analyze ABCD-E Study data online, while providing appropriate statistical models and tools that take advantage of the study design.

In addition to these workgroups, this application should also include a plan for the identification of linked external data, including electronic health records, and how it will be integrated into the ABCD-E study dataset. Applicants should work with assessment workgroups to ensure that external data relevant to their scientific domains are included. This application should also include a plan to provide input and consultation on statistics and experimental design, recommend methods for integrating data from different levels of analysis from the neuroimaging to the behavioral levels, and for linking data from different time points so that data from each study participant can readily be grouped for analysis of neurodevelopmental trajectories.

The DAIRC should include a director (or co-directors) and one or more associate directors to ensure that the wide scope of activities--functions of supporting the ABCD-E Study consortium data collection, processing, informatics, data release enterprise and acting as a resource center to scientific community at large--are seamlessly coordinated.

Additional Information for Both Centers While current award recipients (from RFA-DA-20-002, RFA-DA-20-003, and RFA-DA-20-004) will be eligible to apply, Investigators are permitted to apply for only one component (CC, DAIRC, or research project site) as the PD/PI but may serve as co-investigator on more than one component. The Program Directors/Principal Investigators will have overall responsibility for the progress of the proposed studies.

This program also requires a Multiple PD/PI (MPI) structure with a maximum of four PD/PIs that will each bring expertise necessary to achieve the stated objectives outlined above. Each PD/PI is expected to bring unique, subject matter expertise and distinct contributions to the team. Therefore, applicants must include an MPI Leadership Plan as required by the NIH that describes the leadership structure, interactions, decision-making processes, and distribution of responsibilities across the PD/PIs, and how the leadership team plans to engage actively with the rest of the Consortium. A succession plan that supports continuity of leadership as described in the MPI leadership also needs to be included as "Other Project Information" as an attachment (see Section IV for instructions). Succession planning is a tool/process for the identification and development of new leaders that can replace current leaders if a vacancy occurs. Selection of successor MPIs for each PD/PI should reflect continuity in leadership structure and scientific expertise. We also encourage the identification of co-investigators that can grow into leadership roles at the center and support the center's succession plan structure during the duration of this award.

It is expected that the proposed study will be designed to rigorously address the overarching objectives and research questions outlined above. To support the consortium reaching its stated goals/outcomes, a results-based accountability (RBA) approach will continue to be used for all components. Additional information about the use of RBA for the ABCD-E Study can be found in Section VI. To support the RBA approach, the research project sites will work collaboratively with the CC, DAIRC, and NIH Scientific Director and Program Official. A review of consortium center metrics needs to be included as "Other Project Information" as an attachment (see Section IV for instructions).

Community-Engaged Research Methods in ABCD-E Study Consortium: Young adults have important insights that can improve meaningful outcomes and uptake of research findings across the continuum of research from basic through implementation studies. We strongly encourage the use of community-engaged research methods (e.g., the promotion of bi-directional communication between the researchers and young adults throughout the research project). Community-engaged research methods will vary with the focus and approach used in each consortium activity but should at minimum ensure that researchers are connected with young adults that reflect the characteristics of the cohort (e.g., people with ADHD) to incorporate their input throughout the planning, implementation, and dissemination of the research.

Special Considerations NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

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

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?

Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH intends to commit up to $223 million in FY27-FY31 to fund up to two awards for this NOFO (RFA-DA-27-003) and up to 21 awards for the companion NOFO (RFA-DA-27-002), contingent upon annual appropriations.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is five 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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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

Eligible Organizations: Only organizations previously funded under RFA-DA-20-003, or RFA-DA-20-004 are eligible to apply.

Foreign Organizations/Foreign Collaborations

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 allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

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.

Only PDs/PIs or Co-Investigators of the currently awarded ABCD Study through RFA-DA-20-002, RFA-DA-20-003 or RFA-DA-20-004 are eligible to apply for this limited competition NOFO, through the eligible organizations. Investigators are permitted to apply for only one component of the overall ABCD-E Study Consortium (CC, DAIRC or research site) as the PD/PI but may serve as co-investigator on more than one component.

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:

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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 How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

Other Attachments: The following four documents are required as individual PDF files:

Succession Plan: Please include a plan (up to 2 pages) that identifies new leaders that can replace current leaders if a vacancy occurs. Selection of successor MPIs for each PD/PI should reflect continuity in leadership structure and scientific expertise.

Consortium Center Metrics Review: Please include aggregate consortium center data under RFA-DA-20-003 and RFA-DA-20-004 from April 1, 2025 to April 1, 2026 to report consortium center performance (up to 3 pages). If any metrics are not within 10% of meeting the results-based metric, include 1 additional page to articulate an ABCD-E study consortium plan for metric improvement.

Center Organizational Structures (up to 4 pages): Provide a detailed description of the center's leadership team and organizational structure, outlining who holds leadership positions along with their effort, their reporting relationships, and chain of command. Please include Associate Director positions that have key decision-making authority and leadership responsibilities. Describe how decision-making authority is distributed across all levels of the CC and DAIRC leadership team. Provide a communication plan describing how input from the Consortium is obtained and how information and key decisions are shared between the center leadership teams, workgroups and committees, and the broader Consortium.

Community engagement and collaboration: (up to 2 pages): Describe how ABCD-E CC will solicit and incorporate input from relevant community members and organizations about the appropriateness of Consortium-wide policies and protocols in shaping study goals and inclusion of study participants. Please include how the community members or organizations are involved (e.g., as members of a National Liaison Board) and how they are collaboratively engaged in the research project (e.g., activities, frequency, and duration of involvement). It is expected that community partners are compensated for their time on the project and, when appropriate, incorporated into the study team at a level commensurate with their expertise and the role they are playing, potentially as Senior/Key personnel as consultant, co-Investigator, or MPI. Refer to the following for guidance: NIH's Community Engagement Alliance. Describe how the ABCD-E DAIRC will solicit and incorporate input from the scientific community about the ABCD-E data resource.

SF424(R&R) Senior/Key Person Profile

R&R Budget

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

As part of the Research Strategy, applicants must describe how they will carry out the following functions of the ABCD-E Study DAIRC:

Provide a data sharing policy with explicit plans, procedures, milestones, and timelines to make the data and biospecimens available for access and analysis by the research community, including working with the NIH on a plan to ensure the long-term archiving and distribution of datasets and resources developed by the ABCD-E Study beyond its funding period; Establish a plan to ensure predictable data releases with clear timelines leading up to each data release. The timeline should be as aggressive as possible to permit prompt access without compromising data quality, confidentiality, and security. At least one data release annually for the length of the award is mandatory;

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…