HEAL Initiative: Limited Competition for the HEALthy Brain and Plasticity Program (RFA-DA-27-013)

HEAL Initiative: Limited Competition for the HEALthy Brain and Plasticity Program (RFA-DA-27-013) is sponsored by National Institutes of Health (NIH). The NIH HEAL Initiative is focused on accelerating scientific solutions to the opioid overdose crisis and improving pain management. This specific opportunity supports research under the HEALthy Brain and Plasticity Program.

RFA-DA-27-013: HEAL Initiative: Limited Competition for the HEALthy Brain and Child Development Study - Research Project Sites (Collaborative U01- Clinical Trial Not Allowed) 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 Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute on Minority Health and Health Disparities ( NIMHD ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title HEAL Initiative: Limited Competition for the HEALthy Brain and Child Development Study - Research Project Sites (Collaborative U01- Clinical Trial Not Allowed) U01 Research Project – Cooperative Agreements Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity Resource-Related Research Project (Cooperative Agreements) See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 279, 93. 286, 93.

867, 93. 865, 93. 121, 93.

113, 93. 313, 93. 273, 93.

242, 93. 307, 93. 853 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 NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding.

This NOFO will renew the HEALthy Brain and Child Development (HBCD) Research Project Sites. The HBCD Study is a nationwide, multi-site, longitudinal study that follows children from birth through childhood. The study examines brain and behavioral development, with a focus on how prenatal substance exposure affects health outcomes.

The HBCD Consortium consists of three highly integrated components: (1) a set of linked Research Project Sites, (2) a single overall Consortium Administrative Core (HCAC); and (3) a single central Data Coordinating Center (HDCC). As such, this NOFO runs in parallel with a companion NOFO that solicits applications for the HCAC and the HDCC ( RFA-DA-27-014 ).

It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, and 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. Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information 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 application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information.

In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. The purpose of this NOFO is to renew the HEALthy Brain and Child Development (HBCD) Consortium research sites. The HBCD Study is a nationwide, multi-site, longitudinal study that follows children from birth through childhood.

The study examines brain and behavioral development, with a focus on how prenatal substance exposure affects health outcomes. The brain develops rapidly before birth and throughout childhood. This period is critical for learning and emotional growth, but it is also a time when environmental exposures can have lasting effects on health and development.

Exposure to substances during pregnancy, breastfeeding, or early caregiving can influence a child's brain and behavior. In recent years, rising substance use–especially opioids–has heightened the need to better understand these effects. For example, opioid use during pregnancy has led to an increase in infants experiencing neonatal withdrawal symptoms.

Early exposures have been associated with changes in brain development and later behavioral conditions such as ADHD, anxiety, and early substance use. Additional factors–including environmental toxins, nutrition, caregiving quality, neighborhood conditions, and access to healthcare–also play an important role in shaping child development.

However, there is limited large-scale research tracking typical brain development from birth through childhood, making it difficult to understand how early experiences shape long-term outcomes. The HBCD Study was established to address these gaps.

The study follows pregnant women and their children from the 2 nd trimester of pregnancy through childhood to develop a detailed understanding of how complex factors, including substance exposure, impact children's health, brain, and behavioral development.

Brain development (using neuroimaging and physiological tools) Genetic and biological factors Social and environmental contexts Behavioral and health outcomes Participants will include: Pregnant women from the general U.S. population A subset with prenatal exposure to substances (e.g., opioids, marijuana, stimulants, alcohol and tobacco/nicotine) A comparison group without substance exposure Data will be shared regularly with the research community to support ongoing analysis and future studies.

The goal is to better understand factors that influence child development and identify opportunities to prevent harm and promote resilience. For additional background information regarding the HBCD Study, applicants can review the HBCD Study website.

The NIH HEAL Initiative: This NOFO encourages applications in support of the NIH's Helping to End Addiction Long-term (HEAL) initiative to accelerate scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative aims to (1) improve treatment for overdose, opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.

nih. gov/ . Research sites should address key questions, including: What are typical patterns of brain development from birth through childhood?

How do they vary from person to person? How do environmental exposures affect development? How do genetic and environmental factors interact to influence brain development and behavior?

What are the effects of prenatal substance exposure on development? Are there critical windows when exposures have greater impact on development? What factors protect against negative outcomes?

How do caregiving and life transitions affect development? Program Structure and Applicant Eligibility The HBCD Consortium includes three components: 1. HBCD Research Project Sites 2.

HBCD Consortium Administrative Core (HCAC) 3. HBCD Data Coordinating Center (HDCC) This NOFO supports the renewal of the HBCD Research Project Sites. These sites will continue to follow participants and collect data using a shared protocol.

A separate NOFO ( RFA-DA-27-014 ) seeks applications for the HCAC and HDCC. HBCD Research Project Site Structure, Responsibilities, and Requirements A research project site can be either: 1. A single institution (if all functions can be accomplished at that site), OR 2.

A central hub institution with other institutions as spokes (such that all required data collection can be accomplished by contributing institutions) In either structure, PD/PIs have overall responsibility for study progress.

Each site will be responsible to: Recruit and retain participants Conduct all study assessments and measurements Collect and submit data using shared protocol Coordinate with the consortium to support combined data analysis HBCD Coordination and Data Management The HCAC manages overall coordination, performance metrics and communication.

The HDCC coordinates and standardizes data collection, processing, storage, and analysis; and provides tools to monitor study progress. Results-Based Accountability (RBA) Approach The proposed study must rigorously address the overarching objectives and research questions outlined above. To ensure the consortium reaches its stated goals and outcomes, a results-based accountability (RBA) approach will be used.

Applicants should include a Recruitment and Retention Plan describing how enrollment and retention goals will be comprehensively met throughout the course of the competitive renewal period. All linked applications must include a document titled "Recruitment and Retention Strategies" as an attachment that clearly outlines this plan (see Other Project Information section below).

Distribution of participants across linked sites Each site's staffing model Strategies for retaining participants through all study visits Note: If recruitment is complete, plans do not need to describe recruitment goals but should indicate final sample size. Research project sites will work collaboratively with the HCAC and HDCC to support the RBA approach.

Additional information about the use of RBA for HBCD can be found in Section VI. Community-Engaged Research Methods in HEAL Research Studies People with lived/living experience (e.g., patients, people in recovery, caregivers, families, community leaders) provide important insights that can improve meaningful outcomes and uptake of research findings across the research continuum from basic through implementation studies.

The NIH HEAL Initiative strongly encourages community-engaged research methods that promote bi-directional communication between researchers and the relevant community throughout the research project. See this resource for more information on community-engaged research methods. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information 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 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. Not Allowed: This NOFO only accepts 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 approximately $48 million in FY27 to fund up to 26 awards for this NOFO (RFA-DA-27-013) and up to 2 awards for the companion NOFO ( RFA-DA-27-014 ), contingent upon annual appropriations.

NIH commitments in FY28-FY31 are dependent on annual appropriations. Application budgets are not limited but need to reflect the actual needs of the proposed project. 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 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Only organizations (or their subrecipients) previously funded under RFA-DA-21-020 or RFA-DA-21-021 are eligible to apply.

Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are 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 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 the 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 .

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, Co-Investigators, or subrecipients of the currently awarded HBCD study through RFA-DA-21-020 or RFA-DA-21-021 are eligible to apply for this limited competition NOFO.

Investigators are permitted to apply for only one component of the overall HBCD Consortium (HDCC, HCAC or Research Site) as the PD/PI, but may serve as co-investigator on more than one component. This NOFO requires the use of the linked NIH Collaborative Research Project Grant (U01) award mechanism and requires a Multiple PD/PI structure with two to four PD/PIs.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms . 3.

Additional Information on Eligibility 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 ). This NOFO only accepts applications that are part of a collaborative set of multiple applications.

A linked set (i.e., set of research project sites) must contain at least two research project sites (i.e., applications). Additionally, this NOFO is limited competition and as such, PDs/PIs must have been PDs/PIs, Co-Investigators, or a subcontractor of the currently awarded HBCD study through RFA-DA-21-020 or RFA-DA-21-021 . 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 Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following exceptions or additional requirements should be noted: It is required that the Research Strategy be identical across linked collaborative U01 applications, with the exception of a section (no more than two pages) describing the specific expertise and function of each application under "Elements Unique to This Site."

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

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of linked applications, the titles for each application in the set must have the following format: a "1/N" indicator + Title (i.e., where N = the total number of linked U01 applications to this RFA e.g., "1/3", where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3, etc.).

A set of applications is defined as all applications for a single linked set submitted in response to this NOFO. Cover Letter Attachment: The Cover Letter must be one PDF file only.

The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of linked applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., "1/3"), and 3) the Applicant Institution. Each site should submit an identical listing.

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. Submit the following three PDF documents: 1.

Recruitment and Retention Strategies (5 pages maximum) This document must include: One section that is identical across all sites in the consortium One section that is specific to each site A.

The consortium-wide section (identical across all sites) must describe: The total study sample, including final projected sample size Final projected sample size distributed across main study groups Participant characteristics at the consortium level Consortium-level policy for retention metrics, including: Acceptable thresholds for withdrawals Minimum data required for visits and measures B.

The site-specific section must describe: Site's overall target or final projected enrollment across participant groups Participant characteristics at the site level Recruitment locations and types (e.g., clinic, hospital), especially sources for opioid-exposed participants Staffing model, including roles for: Recruitment and/or retention Each staffing model should include: One study navigator (or explain how these roles will be covered) If recruitment is complete, include: Final sample size (no recruitment goals or strategies required) 2.

Participant Referral Sources (1 page maximum): Provide a table of organizations that participants may be referred to for services (see Ethical and Legal Considerations below). Include services provided by site, as applicable, and services from appropriate external organizations. 3.

Community Engagement and Collaboration (2 pages maximum): Describe strategies for community engagement to obtain and incorporate input, including: Community members/organizations involved Nature of collaborative engagement (activities, frequency, duration) How collaboration enhances recruitment/retention across different groups (e.g., drug-exposed, different geographic regions or socio-economic status) Community partners should: Be compensated for their time Be included on the study team based on their expertise and role (e.g., consultant, co-investigator, MPI, or key personnel) For guidance, refer to: NIH's Community Engagement Alliance and the National Academy of Medicine's Assessing Community Engagement Conceptual Model .

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. 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.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Research Plan Requirements Linked applications from each site must include: An identical Research Strategy describing project aspects common to all consortium sites A subsection titled "Elements Unique to This Site" (limited to 2 pages) highlighting any variations between sites (even minor ones) The Specific Aims must include an Overview section that should be identical for all linked collaborative U01applications.

The Overview should provide an overall rationale for applying as a collaborative study; the role of each site; the approach to project management; and elements unique to any of the sites. The study must use a longitudinal, single-cohort design that follows participants from birth through early childhood.

The cohort must include: A general population sample of pregnant women in the U.S. Pregnant women who used opioids or other substances during pregnancy A comparison group of pregnant women with similar backgrounds who did not use substances during pregnancy The study design must describe: How the proposed sample size supports: Understanding typical brain development and person to person variability Assessing effects of substance use and environmental exposures on brain development Sample weighting, accounting for differences in various factors, such as: Rural, urban, and suburban settings Timeline for data collection that includes: Plan for completion of all study visits in order to meet enrollment targets taking into account staffing capacity Statistical justification for sample size and number of timepoints demonstrating design is adequately powered to address study aims Sustainable community partnerships that: Support retention strategies Ensure the study reflects community needs Strategies to maintain high participant retention, especially from individuals: Who used substances during pregnancy From economically disadvantaged backgrounds From varied geographic locations Ethical and Legal Considerations: Research involving pregnant individuals, children, and other vulnerable populations must address legal, ethical, and regulatory risks.

Applications must describe: Compliance with applicable regulations, including protections for prisoners (45 CFR Part 46, Subpart C), if applicable Plans to maximize benefits and minimize risks to participants Referral processes for participants needing services How the sites will work with HCAC to address these issues at both local and consortium levels Knowledge of state and local reporting requirements related to substance use during pregnancy Steps to reduce legal risks to participants Participant supports, such as: Childcare and transportation Referrals to treatment and services Case management or navigation support Partnerships with state and local agencies Measures to protect participant confidentiality Plans to involve ethics experts Plans for returning study results to participants (individual or group-level, as appropriate) Assessments and Measurements: Applications must describe all planned assessments and use of state-of-the-art tools for: Collecting and coding data across development Assessing environmental and contextual influences and factors Examining links between brain development and behavior Biospecimen collection from mothers and children Be age-appropriate and strengths-based, where possible Use modern data collection methods when feasible (e.g., geospatial data, sensors) Neurodevelopmental assessments may include: Advanced data collection methods (e.g., digital tools, wearable devices) with appropriate quality control Standardized measures that support data harmonization (e.g., NIH Toolbox, PhenX) Detailed substance use histories using multiple data sources (e.g., interviews, biospecimens, medical records) Biospecimen collection and processing (e.g., blood, saliva, hair) for substance exposure and environmental toxins Adverse and positive childhood experiences Parent stress and environmental instability Socioeconomic conditions and access to services Geographic variation and differences in healthcare access Caregiver-child interactions and social supports Neurodevelopmental conditions (e.g., autism, FASD) Cognitive, emotional, language, and physical development Neuroimaging and neurophysiology assessments should describe: Visit schedules that balance scientific value and participant burden Experience conducting imaging with infants and young children Strategies to improve scan completion and retention Access to imaging facilities, including flexible scheduling Plans to optimize and standardize imaging protocols Flexibility to adapt to new technologies and developmental changes Methods to address motion and ensure data quality Plans to harmonize data across sites If multiple scanner types are used: At least two sites must use the same scanner vendor Describe how differences across scanners and sites will be addressed A single Institutional Review Board (sIRB) is required for this multi-site study conducting non-exempt human subjects research using the same protocol at multiple domestic sites (see the Single IRB Policy for Multi-Site Research ).

The HCAC will establish and manage the sIRB. Multiple Principal Investigator (MPI) Leadership Structure This program requires a Multiple Principal Investigator (MPI) leadership structure with a maximum of four Program Directors/Principal Investigators (PD/PIs). Each PD/PI must bring unique subject matter expertise and distinct contributions necessary to achieve the stated objectives.

Applicants must include an MPI Leadership Plan that describes: Leadership structure and interactions Distribution of responsibilities across PD/PIs How the leadership team will actively engage with the Consortium Applicants must include a Leadership Succession Plan that: Identifies new leaders to replace current leaders if vacancies occur Describes how the site plans to develop new leaders to replace current leaders if vacancies occur Successor MPIs should reflect continuity in leadership structure and scientific expertise.

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 .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 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. Applications must comply with Data Management and Sharing (DMS) policies, methods and standards for scientific data and/or Genomic Data and coordinate data sharing through the HDCC.

HBCD Study data are expected to be shared through the NIH Brain Development Cohorts (NBDC) Data Hub and serve as a resource to the scientific community to enable broad use of the data. Data will be shared after basic quality assurance and at least annually.

HEAL Initiative Expectations All data from HEAL-funded projects must be shared through a HEAL-compliant data repository so the data can be accessed through the HEAL Data Ecosystem (e.g., the HBCD Data Hub). The HEAL Initiative has additional requirements for awarded applications that must be addressed in the Data management and Sharing plan (refer to HEAL Data Sharing Requirements under Section VI. 3 for details).

See guidance below for more information: Repository selection guidance 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