RFA-DA-27-002-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

National Cancer Institute (NCI)

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

Funding Opportunity Title

Limited Competition for the Adolescent Brain Cognitive Development -Extended (ABCD-E) Study-Research Project Sites (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

RFA-DA-20-002

Related Notices

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

Funding Opportunity Number (FON)

RFA-DA-27-002

Companion Funding Opportunity

RFA-DA-27-003

, U24 Resource-Related Research Project (Cooperative Agreements)

Number of Applications

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

Assistance Listing Number(s)

93.279, 93.865, 93.273, 93.399

Funding Opportunity Purpose

This is a notice of funding opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with the National Institutes of Health (NIH) standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered for funding. Only current award recipients will be eligible to apply. This NOFO seeks linked collaborative U01 applications to renew the current Adolescent Brain Cognitive Development (ABCD) Research Project Sites to extend study visits into young adulthood. This renewal, called Adolescent Brain Cognitive Development – Extended (ABCD-E) study, is critical to be able to follow these youth into emerging adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest. The structure of the ABCD-E study Consortium shall consist of three highly integrated components: (1) a set of linked Research Project Sites, (2) a single central Data Analysis, Informatics, and Resource Center, and (3) a single overall Coordinating Center. As such, this NOFO runs in parallel with a companion NOFO that solicits applications for two centers (RFA-DA-27-003). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

Funding Opportunity Goal(s)

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

Key Dates

Posted Date

June 08, 2026

Open Date (Earliest Submission Date)

June 09, 2026

Not Applicable

July 09, 2026

Not Applicable

April 2027

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

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

Due Dates for E.O. 12372

Not Applicable

Expiration Date

July 10, 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 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. Current award recipients will only be eligible to apply. The purpose of this NOFO is to renew the current Adolescent Brain Cognitive Development (ABCD) Research Project Sites. This renewal, called Adolescent Brain Cognitive Development – Extended study (ABCD-E), is critical to have the ability to follow these children through their emerging adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest.

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

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

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

Objective and Organization of the Adolescent Brain Cognitive Development - Extended (ABCD-E) Study Consortium: The purpose of this NOFO is to renew the current ABCD Research Project Sites. This renewal, the ABCD-E study, is critical to be able to follow the original pediatric cohort through their emerging adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest. Only current award recipients will be eligible to apply, and this new award period will be 5 years in duration.

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

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

Research Project Sites: This NOFO seeks applications for a set of linked research project site applications that will be responsible for subject retention, clinical assessments, biospecimen collection, neuroimaging, and neurocognitive and electroencephalogram (EEG) testing. Each research project award will represent a different site for subject follow-up, test administration, and collection of data using a common protocol established by the consortium, so that the data collected across the research project sites can be merged for integrative data analyses.

Consortium Coordinating Center (CC): A single coordinating center led by the Coordinating Center Director(s) that will assemble, integrate, and lead the consortium, and is directly responsible for the overall management, performance, and dissemination plans and policies across the consortiumis also required. Additional information about this component can be found at: RFA-DA-27-003.

Data Analysis, Informatics, & Resource Center (DAIRC): A single data analysis, informatics, and resource center that will coordinate, standardize, and integrate all core data-collection, including a centralized mobile application for survey administration and participant engagement, objective health measures, and linking extant data including electronic medical records, as well as processing, storage, and analytic activities of the consortium; facilitate data sharing through the NIH Brain Development Cohorts (NBDC) Data Hub; and serve as a resource to the scientific community to enable broad use of ABCD-E data is also required. Additional information about this component can be found at: RFA-DA-27-003.

Additional Information While current award recipients (from RFA-DA-20-002, RFA-DA-20-003, and RFA-DA-20-004) will be eligible to apply, Investigators are permitted to apply for only one component (CC, DAIRC, or research project site) as the PD/PI but may serve as co-investigator on more than one component. The Program Directors/Principal Investigators will have overall responsibility for the progress of the proposed studies. It is required that the Research Strategy be identical across these linked collaborative U01 applications, except for a short section describing the specific expertise and function of the specific research project site and personnel under "elements unique to this site."

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

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

Applicants are reminded that the use of a single Institutional Review Board (sIRB) is required for any multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site (please see the Single IRB Policy for Multi-Site Research). The sIRB will be established and managed by the CC.

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

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

Renewal

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

Clinical Trial?

Not Allowed: 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 up to $223 million in FY27-FY31 to fund up to 21 awards for this NOFO (RFA-DA-27-002) and up to two awards for the companion NOFO (RFA-DA-27-003), contingent upon annual appropriations.

Award Budget

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

Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Eligible Organizations: Only organizations previously funded under RFA-DA-20-002are eligible to apply.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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

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

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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 or Co-Investigators of the currently awarded ABCD Study through RFA-DA-20-002, RFA-DA-20-003 or RFA-DA-20-004 are eligible to apply for this limited competition NOFO through the eligible organizations. Investigators are permitted to apply for only one component of the overall ABCD-E Study Consortium (CC, DAIRC or research site) as the PD/PI but may serve as co-investigator on more than one component. This NOFO requires the use of the linked NIH Collaborative Research Project Grant (U01) award mechanism and requires a Multiple PD/PI structure with up 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).

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 (up to two pages) describing the specific expertise and function of the specific research project site under "Elements Unique to This Site"" Please include a description of the specific roles in the consortium that research project site leadership and staff hold (e.g., workgroup participation). Sites may also want to consider describing participant characteristics unique to their site and/or unique staffing or retention efforts.

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: The following three documents are required as individual PDF files:

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

Research Project Site Metrics Review: Please include aggregate site data under RFA-DA-20-002 from April 1, 2025 to April 1, 2026 to report research site performance (up to 3 pages). If the site is not within 10% of meeting the results-based metric, they have 1 additional page to articulate a plan for metric improvement.

Community engagement and collaboration (up to 2 pages): Describe how the Research Project Sites will solicit and incorporate input from the relevant community members and organizations about the appropriateness of protocols in shaping study goals and retention of study participants. Please include how the community members or organizations are involved (e.g., as members of a Community Liaison Board), a summary of the feedback provided, and how such feedback was relayed to the CC for potentially broader implementation.

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:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

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

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

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

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.

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.

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

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:

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

Investigator(s) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

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

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.

Biohazards

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

Resubmissions

As applicable, evaluate the full application as now presented.

Renewals

As applicable, evaluate the progress made in the last funding period.

Revisions

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

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.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

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…