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.

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 Development^SM (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:

• Describe individual developmental trajectories (e.g., brain, cognitive, mental health, substance use), and the factors that affect them (e.g., physical activity, nutrition, sleep, screen use).
• Identify biomarkers, risk and resilience factors, mediators, and moderators (including brain and cognition, genetics, environmental exposures, and experiences), of:
  • Physical health conditions or their precursors (e.g., chronic illnesses such as cardiovascular disease, obesity, asthma)
  • Mental illnesses (e.g., ADHD, anxiety, depression), including comorbidities
  • Substance use and substance use disorders (e.g., nicotine, alcohol, cannabis)
• Understand the interactions among mental, physical, and social health and their impact on educational and vocational outcomes, interpersonal relationships, and general well-being.
• Develop novel approaches to predictive modeling of outcomes related to physical and mental health to inform strategies to improve the health of the nation's youth.

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

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

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.

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.
• 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.

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.

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:

• 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 (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.

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

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.

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

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

R&R Budget

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

R&R Subaward Budget

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:

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

• Provide scientific leadership, overall management, and primary oversight of the activities of the consortium. Besides a director (or co-directors), one or more associate directors also need to be included in the developed structure of the CC;
• Provide operational support for the communications within the consortium such as conference calls, email listservs, an internal document sharing website, workgroup support; formation of additional workgroups, subcommittees as needed; 
• Produce and maintain documentation of consortium policies (e.g., publication policies), standard operating procedures, and training manuals/videos;
• Oversee the Study Enhancement review process and tracking of progress and impact on core study;
• Provide logistical and administrative assistance for meetings of the Steering Committee, Expert Scientific Board, Observational Study Monitoring Board, and ABCD-E Annual Meeting;
• Provide for dedicated expertise and plans to address the various bioethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings, early substance use or substance use problems in study participants) that are likely to arise during the conduct of the research with young adults;
• Coordinate the activities of the assessment workgroups to develop the standardized core protocol;
• Conduct site visits to ensure reliability and consistency of data collected across research sites;
• In conjunction with DAIRC, provide for a detailed system for regular tracking and reporting of study progress, including a description of results-based accountability metrics, milestones, timelines, related to:
  • Subject retention, subject withdrawal/dropout and linked missing data longitudinally; 
  • The acquisition of neuroimaging, EEG, neurocognitive, and survey data; and 
  • Biospecimen collection, tracking, and analysis;
• Develop a system to identify and mitigate problems as they arise, including:
  • Procedures to ensure retention of participants who change geographic locations within this study period; 
  • Support to sites to resolve participant retention challenges that they have been unable to resolve locally; 
  • Procedures for remediation if a research site consistently lags in data acquisition and biospecimen collection benchmarks;
• Maintain a biorepository that will store residual saliva, teeth, and hair and will work with the NBDC Biobank to provide specimens to researchers via the NBDC Biospecimen Access Program.
• Develop procedures for participant engagement, including but not limited to a centralized mobile application;
• In conjunction with the DAIRC, develop policies and procedures for returning individual results to participants, where appropriate, including providing counseling as needed;
• Provide for communications support (e.g., graphics development, design/layout, writing for scientific and general audiences, copy editing) and administrative activities necessary for ABCD-E Study related retention and dissemination activities which include scientific infographics and webinars, newsletters, postcard/card type items as well as updating and printing of existing materials. Targeted analysis of various audience needs and formative research to inform the development of specific materials with graphic design may also be required. 
• Develop and maintain a website to publicize consortium activities and provide a venue, for public access to available consortium resources;
• Maintain and regularly update ABCD-E social media accounts to support public access to study information and resources;
• Provide additional communications support such as public relations and media interviews in coordination with the participating NIH Institutes, Centers, and Offices and developing and implementing crisis communication plans;
• Provide plans for including scientists and junior investigators at various levels of their research career (e.g., pre-doctoral, post-doctoral, junior faculty) to ensure the long-term sustainability of the consortium. 

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

• Provide leadership, overall management, and primary oversight of data management and analytics activities. Besides a director (or co-directors), one or more associate directors also need to be included in the developed structure of the DAIRC;
• Develop and validate MR imaging and EEG neurophysiology protocols and ensure standardization across all research sites, develop and execute plan for measurement and reduction of inter-site variability and test-retest reliability for each site;
• Standardized plan for dealing with MR imaging concerns specific to young adult participants (e.g., contraindications due to use of dental braces);
• Develop standardized plans and procedures for:
  • Capture of objective health measures (e.g., wearables, biospecimens, anthropometrics) and their integration into the ABCD-E Study dataset;
  • Centralized data collection of phenotypic assessments (e.g., surveys, EMA, wearables) through a mobile app, where appropriate;
  • Identification of linked external data and how it will integrate into the ABCD-E study database. This plan needs to include electronic health record capture;
  • Ingestion, quality control, and analysis of genomics data;
• Establish and maintain the methodology and tools for secure capture, storage, retrieval, quality control, and analysis of data collected by the consortium, including maintaining documentation of standard operating procedures and training;
• Work with the CC and consortium workgroups to develop protocols for identifying and addressing errors in the data; 
• Ensure all data workflows, pipelines, and infrastructure align with NIH security requirements, including appropriate controls for data protection and secure data access;
• Along with the CC, conduct a review of how to use artificial intelligence tools to increase efficiency and innovate data collection and methodology and develop a plan and procedures for using large language models (LLMs) to analyze the text of at least one narrative question for linguistic pattern recognition;
• Work with the CC to develop metrics to ensure that the ABCD-E study collectively can meet its goals;
• Develop and maintain dashboards to monitor participant retention, data collection completeness, biospecimen tracking, and return of results, where appropriate;
• Develop a plan, including an automated system, for responding to and reporting incidental findings arising from data collection;
• In conjunction with the CC, develop policies and procedures for returning individual results to participants, where appropriate, including providing counseling as needed;
• Develop predictive models to guard against differential attrition and evaluate the impact of such attrition, solicit appropriate epidemiological expertise as needed;
• Provide a comprehensive data-analytic strategy to address the research topics including the following:
  • Analytic approaches to examine multiple and multi-level influences (e.g., individual, familial, neighborhood, social environment, macro environment) associated with the various stages of different outcomes (e.g., initiation vs. regular vs. cessation of substance use);
  • Quantitative analytic and visualization tools capable of integrating data across research project sites and measures;
  • Plans to address rigor and reproducibility in planned analyses, including potential concerns related to false positives, small effect sizes, etc.
  • Plans and statistical approaches for handling non-response bias, attrition, missing data over assessment waves and across the study domains (e.g., survey, imaging, biospecimens, etc.);
  • Rigorous analytic strategies (e.g., propensity scoring) to account for premorbid factors/characteristics that differentiate people with a condition from those without; and
  • Analytical strategies to distinguish the effects of true change versus practice effects;
• 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; 
• Provide and maintain consistent variable naming and value structures, user-friendly data dictionaries, and data documentation;
• Provide and maintain a secure website and/or graphic user interface (i.e., Data Exploration and Analysis Portal) to enable public data access and analytics, and computational workflows that can be run on restricted and secure access images and other raw study data;
• As the scope of the project allows, provide technical troubleshooting and disseminate recommended practices on the use of ABCD-E study data to the larger scientific community;
• In conjunction with the CC, create a technology pipeline that allows for rapid adoption of new/improved approaches that are found feasible via pilot testing, including support for consortium wide, longitudinal (if necessary) roll-out.

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 (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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.

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 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. 

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 grantdisclosures@oig.hhs.gov. 

Post Submission Materials

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), 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.

The application will be peer-reviewed and if it is not a meritorious application, it will not be funded.

Requests for reconsideration 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 National Advisory Council on Drug Abuse. 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.

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 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 funding.

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, 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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

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:

The PD(s)/PI(s) of the CC, DAIRC, and Research Project Sites will be responsible for the scientific and technical direction of the project and agree to abide by the policies and guidance set up by the consortium. This includes accepting the actions and recommendations approved by the Steering Committee and the Observational Study Monitoring Board. In addition, each PD/PI will agree to accept close coordination, cooperation and participation of the Collaborative Research on Addiction at NIH (CRAN) and other involved NIH ICs in those aspects of management of the project as described below.

• Each U01 research project site, the U24 DAIRC, and the U24 CC will receive a separate award. Each award recipient will be responsible for the fiscal management of their award's operating budget, with the oversight of the Authorized Organization Representative (AOR) and guidance of the PI.
• Recipients will be required to attend consortium meetings and participate in the cooperative nature of the consortium.
• Recipients will retain custody of, and have primary rights to, the data developed under these awards, and any software developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies.
• Recipients will implement the approved Data Management and Sharing plan (see Submitting an Application), which will be incorporated as an additional term of award and will be expected to share (make available) these data both within the consortium and with the scientific community. Recipients will comply with their institutional intellectual property policies and practices as approved in the award.
• While recipients will provide updates annually regarding meeting ABCD-E Study consortium metrics, they will be responsible for problem-solving and corrective action throughout the duration of award to ensure the result-based accountability metrics are being strived for and successfully met. 

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

The NIH Project Collaborators will have substantial programmatic involvement through technical assistance, advice, and coordination that is above and beyond the normal stewardship role in awards, as described below. The NIH Project Collaborators will not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project. If such participation is essential, this individual will seek IC waiver. An NIH Program Official will handle the normal stewardship of the award, as described below.

The dominant role and prime responsibility for the activity resides with the recipients for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the recipients, the NIH Program Official, NIH Scientific Director, and other NIH Project Collaborators.

The NIH Scientific Director and NIH Science Officers will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. The NIH Scientific Director will coordinate and facilitate the ABCD-E Study, will attend and participate as a voting member in all meetings of the Steering Committee on behalf of participating NIH Institutes, Centers, and Offices, and will provide liaison between the Steering Committee, the consortium, and other involved NIH ICOs. 

The NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official may elect to attend the Steering Committee meetings, but not as a member of the committee. The NIH Program Official will review the scientific progress of the individual award components. A results-based accountability management approach will be utilized to ensure achievement of stated consortium goals/outcomes and the policies and guidance developed by the consortium need to support these outcome measures defined by NIH. Additional metrics will be added as a term and condition of the award throughout the duration of the project. If at any time, an outcome is not being met, the NIH Program Official will ask the PD/PI for a resolution plan and increased progress reporting to ensure compliance. If scientific progress is not met, the NIH Program Official may ask the CC to provide technical assistance and can recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to these award conditions.

The NIH Project Collaborators will serve on various ABCD-E workgroups, providing scientific advice and guidance on the direction of the study. The NIH Project Collaborators will assist the CC, workgroups, and other committees in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.

Areas of Joint Responsibility for the ABCD-E Study Consortium include:

Consortium Data Analysis, Informatics, and Resource Center (DAIRC) Rights and Responsibilities: The DAIRC is charged with coordinating, standardizing, and integrating all core data collection, processing, storage, quality control, and analytic activities of the consortium, and facilitating data sharing through the NBDC Data Hub. In addition, the DAIRC must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the DAIRC agrees to accept participation of NIH staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities."

Consortium Coordinating Center (CC) Rights and Responsibilities: The CC is charged with coordinating the scientific and administrative activities of the consortium, and the administration and overall operation of the consortium. The CC is responsible for ensuring that projects awarded are fully integrated within the scientific scope and mission of the consortium. This includes assuring that all investigators have access to the resources within the resource facilities of the consortium.

The CC Director(s) chair an Operations Group with representation from the CC, DAIRC, and NIH to oversee the day-to-day operations of the consortium. A Steering Committee serves to assist the CC and DAIRC with the governance of the consortium. The CC Director chairs this committee. In addition, the CC must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the CC agrees to accept participation of NIH staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities."

Lastly, the CC ensures the timely dissemination of information generated by the consortium to both the consortium project members and the scientific public. This will include an annual meeting of the ABCD-E centers and site PIs to discuss progress and plan for the future.

Collaborative decision-making: The ABCD-E CC, DAIRC, Project Site PIs, workgroups, and NIH Project Collaborators must all work together to advance its goals. Significant decisions about protocols, analysis pipelines, workflows, and policies, must be vetted through workgroups, the Operation Group, and the Council of Investigators, with the ultimate decision made by the Steering Committee. 

Steering Committee: The consortium has a Steering Committee, which is the main governing board of the consortia. This committee reviews and approves collaborative protocols, study enhancement proposals, and consortium procedures and policies. The members of the Steering Committee for the consortium are selected by the CC Director(s) with input from the NIH program staff. The Steering Committee is primarily composed of the CC Directors and Associate Directors, DAIRC Directors and Associate Directors, a rotating principal investigator from each research project site and the NIH Scientific Director and Associate Director. The centers, sites, and the NIH each have one vote.

The Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. The NIH also reserves the right to augment the scientific expertise of the Steering Committee when necessary and to appoint additional NIH staff as nonvoting members of the Steering Committee and Subcommittees. Each primary member of the Steering Committee has one vote. The chairperson of the Steering Committee is the CC Director. The Steering Committee may establish subcommittees as it deems appropriate to facilitate the planning and operation of the consortia. The Steering Committee meets at least once annually.

Expert Scientific Board: The consortium includes an expert scientific board whose purpose is to meet with the CC and DAIRC to assess progress and provide feedback to the investigators and NIH on proposed goals for the next year of support. The panel members are designated by NIH in consultation with the CC and consist of research scientists not actively involved with the consortia. The Expert Scientific Board should meet at least once a year.

Observational Study Monitoring Board: This is an independent board which reports to the Director of NIDA, comprised of domain, technical, and ethics experts in areas of focus of the ABCD-E study. Their charge is to provide broad and independent review of study safety and the impact of data quality issues on participants of this national research effort. The Observational Study Monitoring Board should meet at least once a year.

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

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

ABCD Program Staff
National Institute of Drug Abuse (NIDA)
Email: NIDA-27-003@mail.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichd_cdbb_nofos@mail.nih.gov 

Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Email: NIAAA-ABCD@mail.nih.gov

NCI DCCPS BRP NOFOs 
Email: NCIDCCPSBRPNOFOs@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Chief, Grants Management Officer
National Institute of Drug Abuse (NIDA)
Email: nidagmbemail@nida.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdgrantsmanagement@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
Email: NIAAA-GMB@mail.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@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.

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.