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 Stroke (NINDS)

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)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

RFA-DA-21-020

Related Notices

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

Funding Opportunity Number (FON)

RFA-DA-27-013

Companion Funding Opportunity

RFA-DA-27-014

, U24 Resource-Related Research Project (Cooperative Agreements)

Number of Applications

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.

Key Dates

Posted Date

June 10, 2026

Open Date (Earliest Submission Date)

June 10, 2026

July 10, 2026

July 10, 2026

Not Applicable

April 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

Due Dates for E.O. 12372

Not Applicable

Expiration Date

July 11, 2026

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite 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 2nd 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:

Participants will include:

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 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 Objectives Research sites should address key questions, including:

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 Site Structure Options:

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:

HBCD Coordination and Data Management

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.

Requirements:

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).

The plan must include:

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.

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

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

Renewal

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: 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.

Award Budget

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

Award Project Period

The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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.

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.

2. Cost Sharing 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 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 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.

Page Limitations 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.

SF424(R&R) Cover 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

Other Attachments Submit the following three PDF documents:

1. Recruitment and Retention Strategies (5 pages maximum) This document must include:

A. The consortium-wide section (identical across all sites) must describe:

B. The site-specific section must describe:

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):

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

R&R or Modular Budget

R&R Subaward Budget

PHS 398 Cover Page Supplement

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

Research Plan Requirements Linked applications from each site must include:

Specific Aims 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.

Research Strategy Study Design:

The study must use a longitudinal, single-cohort design that follows participants from birth through early childhood. The cohort must include:

The study design must describe:

Ethical and Legal Considerations:

Research involving pregnant individuals, children, and other vulnerable populations must address legal, ethical, and regulatory risks.

Applications must describe:

Assessments and Measurements:

Applications must describe all planned assessments and use of state-of-the-art tools for:

Measures should:

Neurodevelopmental assessments may include:

Neuroimaging and neurophysiology assessments should describe:

IRB Requirement:

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:

Applicants must include a Leadership Succession Plan that:

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.

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 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:

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

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

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. Each application of a collaborative set must be on time. Considerations for late applications that are based on the institution of PD/PI apply only to his/her individual application.

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.

Mandatory Disclosure

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.

For this announcement, reviewers will focus on how well the linked research site applications work together as a single, coordinated study.

Reviewers will place special emphasis on whether applicants can:

Overall Impact

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Specific to this NOFO:

Reviewers will evaluate whether the application:

Factor 2. Rigor and Feasibility (Approach)

Rigor

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility

Specific to this NOFO:

Factor 3. Expertise and Resources (Investigator(s) and Environment)

Environment Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Specific to this NOFO:

Describes strategies to maintain high retention, especially from participants:

Demonstrates sustainable partnerships with community organizations

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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.

Vertebrate Animals

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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