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.

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

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 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.

Purpose:

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.

Background:

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.

HBCD Study Overview

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.

The study measures:

• 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 sharing:

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 website: HBCD Study.

The NIH HEAL Initiative: This NOFO encourages applications in support of the NIH's Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH 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 Objectives

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 HCAC and HDCC activities. A separate NOFO (RFA-DA-27-013) seeks applications for the HBCD Research Sites.

HBCD HCAC and HDCC Structure, Responsibilities, and Requirements

HBCD Consortium Administrative Core (HCAC):

• This funding opportunity supports one HCAC, led by Program Directors/Principal Investigators (PDs/PIs), to manage and lead the HBCD consortium. The HCAC will oversee the budget, performance metrics, policies, communication, outreach, and sharing of results. It will coordinate activities across the research sites and the HDCC.
• The HCAC will make sure study procedures are standardized across sites, train staff, and monitor sites to ensure data are collected consistently and correctly. It will work with the HDCC to standardize brain imaging methods and analysis and develop ways to introduce new technologies into the study. Because imaging technology changes quickly, the HCAC and HDCC will plan how to adopt new tools while keeping data consistent across sites.
• The HCAC will work with HDCC to develop and track key performance metrics to ensure the study meets its goals, including measuring scientific impact. The team should include a director (or co-directors) and associate directors (e.g., for protocol quality, training, and recruitment) to manage these activities effectively.

HBCD Data Coordinating Center (HDCC):

• This funding opportunity also supports one HDCC, which will manage all data-related activities across the consortium. This includes collecting, processing, storing, and analyzing data, and making it available to the broader scientific community.
• The HDCC will create and update standard procedures to ensure data such as brain imaging, cognitive, and clinical assessments are collected consistently across all sites. It will also manage electronic health record data and address differences between sites.
• In addition, the HDCC will handle data quality control, organization, and analysis, and provide tools (like dashboards) to track study progress and performance in real time. It will combine data across sites, build integrated databases, and align with other large research efforts.
• The HDCC will oversee annual public data releases and ensure proper data sharing, privacy, and quality standards in collaboration with the HCAC and NIH. It will coordinate data sharing through the NIH Brain Development Cohorts Data Hub and work with the HEAL data platform.
• The HDCC should include a director (or co-directors) and one or more associate directors to manage both its internal data operations and its role as a resource for the wider research community

Opportunity Fund

During this five-year award, the consortium will need to problem-solve a multitude of expected and unexpected challenges (e.g., in recruitment and retention, or in response to changing technologies). Both HCAC and HDCC will need to create a small fund to allow the consortium the ability to strengthen ongoing efforts or pursue critical new directions based on the results obtained to date. For use of these funds, the NIH Scientific Director and the NIH Program Officer should be consulted, and the NIH Program Officer must be informed in writing for prior approval to be given in advance.

Results-Based Accountability (RBA) Approach

The study should be carefully designed to address the main goals and research questions described above. To help the consortium achieve its goals, an RBA approach will be used across all components (see Section VI for more details). As part of this approach, the HCAC and HDCC are expected to work closely together as partners.

RBA responsibilities for the HCAC:

The HCAC will set goals and milestones for participant recruitment and/or retention as part of the RBA approach. An Associate Director will lead a team that tracks each site's progress and reports to HCAC and NIH leadership on successes and challenges. HCAC applications must include a "Recruitment and Retention Strategies" plan describing how the consortium will meet its enrollment and retention goals over the funding period.

RBA responsibilities for the HDCC:

The HDCC will create and maintain dashboards that track progress on all RBA metrics across research sites. It will work with HCAC leadership to ensure the dashboards reflect the right measures of progress. These dashboards will be shared with all research sites to support transparency and coordination across the consortium.

The HCAC and HDCC will work collaboratively with the Research project sites 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.

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Eligible Organizations: Only organizations (or their subcontractors) previously funded under RFA-DA-21-022 are eligible to apply for the HCAC. Only organizations (or their subcontractors) previously funded under RFA-DA-21-023 are eligible to apply for the HDCC.

Foreign Organizations/Foreign 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

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.

PDs/PIs of the HCAC must have been PDs/PIs, Co-Investigators, or a subcontractor of the currently awarded HCAC (RFA-DA-21-022), and PD/PIs of the HDCC must have been PD/PIs, Co-Investigators, or a subcontractor of the currently awarded HDCC (RFA-DA-21-023). 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 additionally requires a Multiple PD/PI structure with two to four PD/PIs. 

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).

This NOFO is a limited competition, and as such, PDs/PIs for HCAC and HDCC must have been PDs/PIs, Co-Investigators, or a subcontractor of the currently awarded HCAC (RFA-DA-21-022) or HDCC (RFA-DA-21-023), respectively.

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:

Submit the following three individual PDF files for the HCAC application only:

1. Recruitment and Retention Strategies (3 page maximum):

This document must be identical to the consortium-wide section of the "Recruitment and Retention Strategies" document submitted by applicants to RFA-DA-27-013. This section must contain: 

• 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
• The document should outline data to support selection of policies and thresholds and a description of how it will impact overall recruitment and/or retention strategies.

2. Community Engagement and Collaboration (2 page maximum):

Describe strategies for obtaining and incorporating community input, including:

• Goals of each strategy
• 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.

      3. HCAC Organizational Structure (2 page maximum):

Provide a detailed description of the HCAC leadership team and organizational structure, which must include at least three Associate Directors with leadership and decision-making authority for:

• Protocol Integrity
• Professional Development
• Recruitment and Retention
• If you include additional Associate Director positions, explain why they are needed.
• Identify who holds each leadership position, their level of effort, and the overall chain of command.
• Describe how decision-making authority is assigned across the leadership team.
• Include a communication plan that explains how information and major decisions will be shared among:
  • HCAC leadership
  • HBCD consortium
  • Working groups and committees

Submit the following individual PDF document for the HDCC application only:

         4. HDCC Organizational Structure (2 page maximum):

Provide a detailed of the HDCC leadership team and organizational structure, which must include Associate Directors with leadership and decision-making authority for key HDCC responsibilities. These may include:

• Biospecimens
• EEG/MRI
• Geocoding
• Identify who holds each leadership position, their level of effort, and the overall chain of command.
• Describe how accountability will be maintained across all oversight areas (data management, release, and QC) including plans for resolving issues, maintaining timelines, and incorporating scientific input into technical management.
• Include a communication plan that explains how information and major decisions will be shared among:
  • HDCC PDs/PIs
  • Contract personnel
  • HCAC leadership
  • HBCD consortium
  • Working groups and committees

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:

Research Strategy for HCAC

The HCAC application must include an Administrative Section that describes Administrative and Project Management Plans, and plans for addressing HCAC's key responsibilities. The HCAC will oversee training and ensure that all research sites follow the same study procedures. It will also work with key workgroups and provide logistical and administrative assistance for arrangement of meetings of the Steering Committee, National Liaison Board, Expert Scientific Board, Observational Study Monitoring Board, and HBCD Annual Meeting.

This application must describe how HCAC will work with the Expert Scientific Board, internal Steering Committee, and workgroups to evaluate study progress, recommend changes, and coordinate across sites. The application should also describe how the HCAC will implement and evaluate the study protocol to ensure it is scientifically sound, minimizes burden on sites and participants, and avoids bias.

Administrative and Project Management Plans:

The Administrative Plan should describe how the entire consortium will operate through the HCAC organizational structure. This plan should describe consortium-wide issues and outline policies and procedures for how researchers will access shared resources. It should explain how information will be shared across research sites, working groups, HCAC leadership, and the HDCC. It should also describe who makes key consortium decisions and how those decisions are communicated.

The Project Management Plan should explain how progress will be tracked and maintained over time (using the RBA approach). It should align with the Recruitment and Retention Plan and include clear goals and metrics. This plan must also describe:

• How resources will be allocated
• How recruitment and/or retention will be monitored
• How new investigators will be added (or removed, if not contributing)
• How conflicts will be resolved
• How information will be shared within the consortium and with the broader scientific community

Key HCAC Responsibilities:

• Leading and overseeing all consortium activities
• Supporting communication, outreach, and public engagement (in coordination with NIH)
• Organizing meetings, calls, and working groups
• Providing logistical support for committees and workshops
• Conducting site visits to ensure data are collected consistently
• Monitoring recruitment, retention, dropout, and adjusting plans if targets are not met
• Developing methods to predict and address participant dropout
• Monitoring data collection (e.g., imaging, clinical, cognitive data) and addressing delays
• Working with the HDCC to track and report progress, timelines, budgets, and data quality, and developing strategies to solve problems as they arise
• Clearly describing the RBA approach, including role of Associate Director, Metrics Support Team, dashboards, and communication plans
• Creating a timeline with clear milestones to track study progress
• Ensuring sampling methods will achieve the study's aims
• Setting policies for presentations and publications
• Maintaining standard procedures and training materials
• Managing a public website with consortium information and resources
• Supporting involvement of scientists at different career stages
• Providing administrative support for all major consortium meetings

Overall, the HCAC is responsible for making sure the consortium runs smoothly, stays on track, and meets its scientific and operational goals.

Research Strategy for the HDCC

The HDCC application should describe plans for addressing HDCC's key responsibilities, including plans for imaging and neurophysiology, data systems (informatics), biostatistics, and data storage and sharing and IT security for protection of personally identifiable information collected from consortium activities. Because imaging technology changes quickly, the HDCC must plan how to adopt new technologies while keeping methods consistent across research sites. The application must also explain how data collection will be standardized and how data quality and consistency will be checked.

The HDCC will lead workgroups focused on imaging and neurophysiology methods, support for new types of data (passive, biospecimen, and geolocation), and advanced analysis methods for combining different types of data over time. The HDCC will also provide leadership in tracking study progress using RBA metrics and help sites monitor their performance. The HDCC will manage annual public data releases through the NIH Brain Development Cohorts Data Hub and lead a data release workgroup with partners across the consortium.

Key HDCC Responsibilities:

• Leading and overseeing all data storage, management, quality control, and analysis
• Developing a strong data analysis strategy, including:
• Methods to combine data across sites and measures
• Approaches to reduce false positives
• Statistical approaches to handle missing data, dropout, and bias
• Methods to account for differences between exposed and non-exposed groups and other   environmental factors
• Plans for comparing findings with other similar studies
• Working with the HCAC to track recruitment and/or retention, dropout, and overall study progress using the RBA approach
• Building and maintaining systems for storing, accessing, and analyzing data, and certifying data quality
• Planning coordination with HCAC, research sites, and NIH staff to standardize data processing and support long-term distribution of HBCD datasets
• Using existing tools and systems to support data collection, integration, sharing, and analysis through a central platform
• Ensuring data access balances usability with privacy and security requirements (including working with the HEAL platform)
• Promoting collaboration within the consortium and with outside researchers
• Developing and validating MRI and EEG protocols across sites
• Linking study data with external data sources (e.g., environmental or geographic data)
• Managing different types of data (e.g., imaging, biospecimens, passive data) with appropriate staffing and flexibility
• Standardizing imaging procedures and reducing differences across sites
• Providing methods for managing any planned electronic health record data across sites
• Providing technical support for data collection and analysis
• Ensuring timely annual public data releases with proper quality and oversight
• Creating and maintaining standard procedures and training materials (with HCAC)
• Planning for replication and validation studies (with HCAC)
• Developing plans to handle incidental findings
• Sharing best practices and supporting the broader research community
• Creating and maintaining strong data security protections for sensitive information
• Overall, the HDCC is responsible for managing, analyzing, and sharing high-quality data, while ensuring consistency, security, and collaboration across the entire consortium.

Multiple Principal Investigator (MPI) Leadership Structure

Leadership Requirements:

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.

Required Plans:

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.

The document should outline clear lines of leadership and communication across all levels of the HCAC and HDCC study teams, and should reflect continuity in leadership structure and contribution to overall Consortium responsibilities.

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:

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 the NIH Genomic Data Sharing Policy (NOT-OD-14-111), as applicable.
• Awardees are expected to use the NIDA Neurodevelopmental Studies Repository (e.g., the NBDC Biobank, or another NIH-identified repository) for biospecimen storage and processing for genetic, epigenetic, and other biomarker studies.
• HBCD Study data are expected to be shared with the research community after basic quality assurance and at least annually.
• Awardees must follow data sharing policies, methods, and standards consistent with NIH policy and coordinated through the HDCC.
• Data are expected to be released through the NIH Brain Development Cohorts (NBDC) Data Hub.
• Applicants must comply with all data sharing requirements established through the HDCC.

HEAL Initiative Expectations:

All data and metadata from HEAL-funded projects must be shared through a HEAL-compliant data repository so the data can be accessed through the HEAL Data Ecosystem. 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
• HEAL data sharing policy

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.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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 policy and procedures, 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.

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

Applications will be assigned on the basis of established PHS referral guidelines 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 reside 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 primary responsibility for:

The PD(s)/PI(s) of the HCAC, HDCC 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 NIH HEAL Initiative and other involved NIH ICOs in those aspects of management of the project as described below.

• Each U01 research project site, the U24 HCAC, and the U24 HDCC 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 HBCD 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 Rights and Responsibilities: 

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.

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

The NIH Project Collaborators (Scientific Director and other Science Officers) 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.

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 HBCD 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 serve as a liaison between the Steering Committee, the consortium, and other involved NIH ICOs.

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

The NIH Program Official will handle the normal stewardship of the award, as described below:

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 HCAC 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.

Areas of Joint Responsibilities:

HBCD Consortium Administrative Core (HCAC)

The HCAC is charged with coordinating the scientific and administrative activities of the consortium, and the administration and overall operation of the consortium. The HCAC 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 HCAC Director(s) chair an Operations Group with representation from the HCAC, HDCC, and NIH to oversee the day-to-day operations of the consortium. A Steering Committee serves to assist the HCAC and HDCC with the governance of the consortium. The HCAC Director(s) chairs this committee. In addition, the HCAC must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the HCAC 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 HCAC 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 virtual meeting of the HBCD centers and site PIs to discuss progress and plan for the future.

HBCD Data Coordinating Center (HDCC)

The HDCC 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 Sharing Platform. In addition, the HDCC must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the HDCC agrees to accept participation of NIH staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities."

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 HCAC Director(s) with input from the NIH program staff. The Steering Committee is primarily composed of the HCAC Directors and Associate Directors, HDCC Directors and Associate Directors, a rotating set of principle investigators from research project sites who serve staggered terms, and the NIH Scientific Director and Associate Director (one vote). 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 HCAC 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 twice annually.

Expert Scientific Board

The consortium includes an expert scientific board whose purpose is to meet with the HCAC and HDCC 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 HCAC 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, comprising domain, technical, and ethics experts in areas of focus of the HCBD 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.

Collaborative decision-making:

The HBCD HCAC, HDCC, 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.

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. 

NIDA HBCD Data Sharing Requirements

Awardees are expected to share HBCD Study data with the research community as soon as possible after basic quality assurance is completed and at least annually. Awardees must follow data sharing policies, methods, and standards that are consistent with NIH-wide data and resource sharing policies and coordinated through the HDCC. Data are expected to be released through the NIH Brain Development Cohorts (NBDC) Data Hub.

HEAL Data Sharing Requirements

1. Study Registration and Metadata (within 1 year of award)

• Register the study with the HEAL Platform
• Provide study information, including:
• Update the registration:
• Some required study-level metadata will be automatically added during registration.

2. Data and Metadata Submission

Awardees must submit data, metadata, and code (if applicable) to a HEAL-compliant repository.

Before final data submission:

• Ensure study registration is complete

Required submissions may include:

• Data files
• Data dictionaries (variable-level metadata)
• Code (if applicable)

Data dictionaries can be submitted by:

• Following repository-specific submission processes, or
• Using HEAL Data Ecosystem utility tools to create a compliant data dictionary and submitting it to the HEAL Platform
• Or sending materials to: HEALStewards@RENCI.org

Timeline requirements (NOT-OD-21-013):

• Share data as soon as possible
• No later than:
  • The time of publication, or
  • The end of the project period (whichever comes first)

3. Additional Requirements for Human Subjects Research

• Studies involving human participants must meet the following:
• ClinicalTrials.gov Registration
• If required to register:
• Include the term "the HEAL Initiative" in the Study Description Section
  • The time of publication, or
  • The end of the project period (whichever comes first)

Use of Common Data Elements (CDEs)

Pain studies (required):

• Use HEAL-required core questionnaires
• Consider additional questionnaires from the HEAL Common Data Elements (CDE) Program

To access supplemental questionnaires used by other HEAL studies:

• Email: heal_cde@hsc.utah.edu

All other HEAL studies (expected, when applicable):

• Use HEAL CDE questionnaires when relevant
• Report use of CDEs as required

If proposing new questionnaires:

• Consult with the program officer and HEAL CDE team
• Provide justification for inclusion

If using copyrighted questionnaires:

• Obtain licenses before data collection
• Provide licenses to the HEAL CDE team and program officer

Informed Consent

When possible:

Include language that allows for broad data sharing

Guidance and tools are available at:

https://www.healdatafair.org/

Data Protection and Confidentiality

All HEAL data are protected under a Certificate of Confidentiality.

Awardees and partner institutions must:

• Use data only for approved purposes
• Follow all applicable federal and state laws
• Follow informed consent requirements

Comply with NIH policies, including:

• NOT-OD-17-109
• 42 U.S.C. 241(d)

Failure to comply may result in enforcement actions.

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.

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.

Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication:

"This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov/)" under award number, [include specific grant/contract/award number; for NIH grant number(s) use full format for the grant number, which includes application type, activity code, institute code, serial number, support year, and other suffixes as defined in Deciphering NIH Application/Grant Numbers. Example: 5R01GM987654-03S]." 

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).

HBCD
National Institute on Drug Abuse (NIDA)
Email: hbcd@nida.nih.gov

Email: NOFOReviewContact@csr.nih.gov

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