It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

Background

Adolescence is a time of dramatic changes in brain structure and function, and the adolescent brain may be particularly susceptible to being altered by experiences like substance use, screen time, physical activity, sports injuries, and peer/neighborhood influences, among others. Yet there is much we still do not know about how these experiences impact the developing brain and vice versa. For example, the specific ways in which the teenage brain remains immature, particularly the less developed circuits of the prefrontal cortex relative to other brain areas, contribute to the propensity of adolescents to engage in impulsive behaviors and to take risks, which may lead to the willingness to engage in the use of alcohol, tobacco, marijuana, and other substances, which typically begins during this time period.

The fact that the brain is highly malleable during this period also theoretically makes it susceptible to being altered in the short term and perhaps also in the long term, or even permanently. Consistent with this adolescence-vulnerability concept, research has shown that adolescent substance use is associated with abnormalities in the volume of specific brain structures, the integrity of networks connecting them, brain activation related to cognitive tasks, and neuropsychological function. However, prior studies of the impact of substance use on brain development have been largely performed in cross-sectional samples of adolescents who engage in heavy episodes of substance use, including binge drinking, or those in substance use treatment. Therefore, it is not known whether observed structural and functional deficits predate the onset of substance use, are a consequence of regular use, or a combination of both.

Moreover, substance use does not exist in a vacuum. It is entwined with mental and physical health and with our social systems in myriad complex ways, as is neurodevelopment. Epidemiologic evidence indicates that substance use disorders, which often emerge in late adolescence, are highly correlated with other mental disorders (e.g., anxiety, attention deficit hyperactivity disorder, and conduct disorder). Findings suggest complexity in the temporal ordering of disorders with substance use both preceding or following symptom onset of other mental disorders. In addition, physical (e.g., hormonal, brain injuries, sleep patterns), behavioral (e.g., physical activity, screen time), and environmental (e.g., toxic exposures, discrimination, stressful events, social support systems and networks) factors contribute to the health, including brain health, of adolescents.

The Adolescent Brain and Cognitive Development (ABCD) study was launched to better understand how these experiences influence brain development, how they interact with each other, and with genetic and other biological variables to promote or interfere with later health outcomes. Its goal is to create a large, diverse, and well characterized cohort of youth beginning at ages 9 and 10 and followed into young adulthood to provide knowledge about the normal variability in adolescent brain and cognitive development and to tease apart the many factors that influence it. Recent advances in neuroimaging, informatics, and genetics technologies have made it feasible to conduct a study of sufficient size and scope to answer many outstanding questions, and to ensure that data collected as part of this project are made available to a wide research community in a timely fashion.

Objective and Organization of the Adolescent Brain Cognitive Development (ABCD) Study Consortium

This announcement is to solicit applications to renew the current ABCD Study consortium in service of a nationwide, multisite, multi-modal, longitudinal cohort study to prospectively examine brain and behavioral development from late childhood (approximately age 9-10) through adolescence into early adulthood. Current primary awardees and their subcontracting sites of the Adolescent Brain Cognitive Development (ABCD) Study Consortium will be eligible to apply and this new award period will be 7 years in duration.

The primary objective of this initiative is to design and implement a study that can collect data to address the following overarching research objectives, which are inherently interdependent and mutually informative:

• Describe individual developmental trajectories (e.g., brain, cognitive, emotional, academic), and the factors that can affect them.
• Develop national standards of healthy brain development.
• Investigate the roles and interaction of genes and the environment on development.
• Study how physical activity, sleep, screen time, sports injuries, and other experiences affect brain development.
• Examine the factors that influence the onset, course, and severity of mental illnesses.
• Understand the relationship between mental health and substance use.
• Study how use of different substances (caffeine, nicotine, alcohol, marijuana) affects developmental outcomes, and vice versa.

To accomplish these objectives, the Collaborative Research on Addiction at the NIH (CRAN) Initiative and other NIH ICs have established the Adolescent Brain Cognitive Development (ABCD) Study Consortium that consists of three highly integrated components.

Consortium Coordinating Center (CC): A single coordinating center led by the Coordinating Center Director(s) will assemble, integrate, and lead the consortium, and is directly responsible for the overall management, budget, performance, and dissemination plans and policies across the consortium. Additional information about this component can be found at: RFA-DA-20-004.

Data Analysis, Informatics, & Resource Center (DAIRC): This Funding Opportunity Announcement seeks a renewal application for a single data analysis and informatics center that will coordinate, standardize, and integrate all core data-collection, processing, storage, and analytic activities of the consortium, facilitate data sharing through the NIMH Data Archive, and serve as a resource to the scientific community to enable broad use of the ABCD data.

Research Project Sites: A set of linked research project sites will be responsible for subject retention, behavioral, self-report, and clinical assessments, biospecimen collection, and neuroimaging. Each research project site could be a single institution, or it could be formed as a central hub institution with one other institution as a spoke to the hub. In either organizational setup, the Program Director(s)/Principal Investigator(s) will have overall responsibility. Additional information about this component can be found at: RFA-DA-20-002.

It is expected that the proposed study will be designed to rigorously address the overarching objective and research questions outlined above. Each research project site 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. For additional background information regarding this study, applicants can review the website (https://abcdstudy.org/).

Purpose of the Data Analysis, Informatics, and Resource Center (DAIRC)

The Data Analysis, Informatics, and Resource Center will develop (and revise when necessary) the procedures for collection of the core neuroimaging, neuropsychological, and clinical assessment data in a manner that will maximize comparability across the individual research sites of the consortium for the longitudinal study. The center will perform quality control, data curation, and analysis for the measures collected from the research sites as well as provide data informatics tools to monitor consortium progress and performance and explore the curated data. The center will facilitate cross-site pooling of data, create a database across assessment modalities, and harmonize with existing large-scale neurodevelopmental research efforts. The center will be expected to collaborate with the NIMH Data Archive to support scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. For more information on the ABCD Data repository (hosted by the NIMH data archive), please see this link: https://data-archive.nimh.nih.gov/abcd. The DAIRC should include a director (or co-directors) and one or more associate directors to ensure that the wide scope of activities--functions of supporting the ABCD Study consortium data and informatics enterprise and acting as a resource center to scientific community at large--are seamlessly coordinated.

This renewal application should include Imaging, Informatics, Biostatistics, and Data Release Plans. Because the neuroimaging field undergoes rapid technical advances, the Coordinating Center and the DAIRC will need to plan for integrating technological advances into the longitudinal study and determine how changes in hardware and analytic approaches will be coordinated across multiple research sites. Workgroups within the Consortium will provide the DAIRC with recommendations, advice, and decisions in specific areas. At least 4 workgroups should be proposed.

The Imaging workgroup will make decisions about any changes to the image acquisition protocols for magnetic resonance (MR) imaging (T1-weighted and T2-weighted), diffusion tensor imaging, and resting-state and task-based fMRI data. The DAIRC will provide an evaluation of how any such changes would affect the imaging processing pipeline and harmonization across sites and scanners and will oversee the implementation of any such MRI acquisition protocol changes. The Imaging workgroup will also oversee image processing of the pooled data to provide post-processed data for analysis. The DAIRC will work with the Coordinating Center to ensure standardization of neuroimaging data acquisition protocols and data analysis pipelines. An Informatics workgroup will continue to support data collection and reporting infrastructure, including the incorporation of new data collection and analysis domains that emerge from various assessment workgroups (e.g., passive data, mobile technology) over the course of the longitudinal study.

A Biostatistics workgroup will provide input and consultation on statistics and experimental design.

This workgroup will recommend methods for integrating data from different levels of analysis from the neuroimaging to the behavioral levels and for linking data from different time points so that data from each study participant can readily be grouped for analysis of neurodevelopmental trajectories. The Biostatistics workgroup will leverage the ABCD Data repository (hosted by the NIMH data archive) and provide an interactive user interface for use by all research components and continue to further enhance the Data Exploration and Analysis Portal (DEAP; https://deap.nimhda.org) that allows users to analyze ABCD Study data online, while providing appropriate statistical models and tools that take advantage of the study design.? Additional refinement of bioinformatics tools (such as developing interoperable informatics software packages) to facilitate extraction and efficient dissemination of information from the database remains a priority for this longitudinal study.

The DAIRC will lead a Data Release workgroup with participation from the DAIRC, the Coordinating Center, the NIMH Data Archive staff, and other NIH and Consortium members as necessary to ensure the efficient and timely transfer of data to the NIMH Data Archive. At least an annual data release is expected for the duration of the study.

A Resources workgroup will coordinate a strategic approach to outreach, training and dissemination of ABCD data and informatics resources to the scientific field at large. They will create and execute a plan that will enable scientists from outside institutions (e.g. non ABCD study research project sites) to utilize the data, specialized tools, techniques, software packages, etc. Facets of this plan should include (but are not limited too), trainings, hackathons, workshops at scientific meetings and conferences to disseminate protocols, standards, data, and other resources to the scientific community and facilitate proper use of the datasets, and publishing white papers (or their equivalent) on best practices and considerations for data collection, pre-processing, analysis, etc.

Special Considerations

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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

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

Eligibility is limited to the existing awardee under RFA-DA-15-016.

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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. 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 NOT-OD-11-101).

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

As part of the Research Strategy, applicants must include (but are not limited to) the following functions of the Data Analysis, Informatics, and Resource Center:

• Provide leadership, overall management, and primary oversight of data management and analytics activities. Besides a director, one or more associate directors also need to be included in the developed structure of the DAIRC;
• Provide a comprehensive data-analytic strategy to address the research topics including the following:

--Analytic approaches to examine multiple and multi-level influences (e.g., individual, familial, neighborhood, social environment, macro environment) associated with the various stages of different outcomes (e.g., initiation vs. regular vs. cessation of substance use);

--Quantitative analytic and visualization tools capable of integrating data across research project sites and measures;

--Plans to address rigor and reproducibility in planned analyses, including potential concerns related to false positives, small effect sizes, etc.

--Plans and statistical approaches for handling non-response bias, attrition, missing data over assessment waves and across the study domains (e.g., interview, imaging, biospecimens, etc.);

--Rigorous analytic strategies (e.g., propensity scoring) to account for premorbid factors/characteristics that differentiate people with a condition from those without; and

--Analytical strategies to distinguish effects of true change versus practice;

• Establish and maintain the methodology for storage, retrieval, and analysis of data collected by the consortium. Certify the quality of all data generated by the study;
• Establish a plan for working collaboratively with the Consortium Coordinating Center, research project sites, NIH staff, and relevant public data/resource repositories to ensure the long-term archiving and distribution of datasets and resources developed by the ABCD Study beyond its funding period. At least one data release annually for the length of the award is mandatory;
• In conjunction with the Coordinating Center, create a technology pipeline that allows for rapid adoption of new/improved approaches that are found feasible via pilot testing, including support for consortium wide, longitudinal (if necessary) roll-out;
• A secure website and/or graphic user interface front-end should be provided to enable public data access and analytics on aggregated data, and computational workflows that can be run on restricted and secure access images and other raw study data;
• Provide and promote collaboration between ABCD study investigators, as well as research investigators at-large utilizing the ABCD Study data;
• Develop and validate MR imaging protocols and ensure capability of the MR acquisition protocol across research sites;
• Ensure standardization of image acquisition procedures across all research sites, develop and execute plan for measurement and reduction of inter-site variability in neuroimaging data acquisition and test-retest reliability for each neuroimaging site;
• Provide technical assistance to members of the consortium on neuroimaging protocols and data analysis;
• In cooperation with the Coordinating Center, provide for site visits to ensure reliability and consistency of MR imaging data collected across individual research sites;
• Produce and maintain documentation of standard operating procedures and training manuals in cooperation with the Coordinating Center;
• Standardized plan for dealing with MR imaging concerns specific to adolescent participants (e.g., contraindications due to use of dental braces);
• Work with the Consortium Coordinating Center to develop plans for replication/validation studies within the consortium;
• Develop plan for incidental findings arising from data collection;
• Develop a national resource strategy that includes outreach, training, and dissemination activities as described above;
• As the scope of the project allows, provide technical troubleshooting and disseminate best practices on the use of ABCD data to the larger neuroscience community; and
• Work with the Coordinating Center to develop metrics to ensure that the ABCD study collectively can meet its goals and to evaluate the impact of the study's data/informatics tools/scientific findings.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Please describe how the DAIRC in conjunction with Coordinating Center facilitates data sharing for the ABCD Consortium research project sites. Please describe how data will be shared with the NIMH Data Archive.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. 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

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will 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, the committee will 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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment 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. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not applicable.

For Renewals, the committee will consider the progress made in the last funding period.

Not applicable.

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.

Not applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 FOA. 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.

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.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

A results-based accountability approach will be used to support the consortium reaching its stated goals/outcomes. Additional metrics (i.e. % data quality, % missing data points, % participant withdrawals) will be added as a term and condition of the award throughout the duration of this 7-year project. If at any time an outcome is not being met, the 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 Consortium Coordinator 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The PD(s)/PI(s) will be responsible for the scientific and technical direction of the project and agrees 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 CRAN and other involved NIH ICs in those aspects of management of the project as described below. Each U01 research site project, the U24 Data Analysis, Informatics, and Resource Center (DAIRC), and the U24 Coordinating Center (CC) will receive a separate award, and the PI will have control over the project's operating budget. Awardees will be required to attend consortium meetings and participate in the cooperative nature of the consortium.
• Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees will implement the approved data 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. Awardees should comply with their institutional intellectual property policies and practices as approved in the award.

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

• The NIH Project Collaborators will have substantial programmatic involvement through technical assistance, advice, and coordination that is above and beyond the normal stewardship role in awards, as described below. The NIH Project Collaborators will not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project. If such participation is essential, this individual will seek IC waiver. An NIH Program Official will handle the normal stewardship of the award, as described below.
• The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NIH Program Official, NIH Scientific Director, and other NIH Project Collaborators.
• The NIH Project Collaborators will serve on various ABCD workgroups, providing scientific advice and guidance on the direction of the study.
• The NIH Scientific Director will have voting membership on the Steering Committee and, as determined by that committee, its subcommittees, and will serve as liaison to CRAN and other involved NIH ICs.
• The NIH Project Collaborators will assist the Coordinating Center, 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 review the scientific progress of individual components and review them for compliance with the operating policies developed by the Steering Committee, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. 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. 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.

Areas of Joint Responsibility include for the ABCD Study Consortium:

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

Consortium Coordinating Center (CC) Rights and Responsibilities: The CC is charged with coordinating the scientific and administrative activities of the consortium, and the administration and overall operation of the consortium. The CC and DAIRC Director(s) and the U01 PD(s)/PI(s) have the joint responsibility for the scientific and technical direction of the research projects. The CC is responsible for ensuring that projects awarded are fully integrated within the scientific scope and mission of the consortium. This includes assuring that all investigators have access to the resources within the resource facilities of the consortium. The CC Director(s) chair an Operations Group with representation from the CC, DAIRC, and NIH to oversee the day-to-day operations of the consortium. A Steering Committee serves to assist the CC with the governance of the consortium. The CC Director chairs this committee. In addition, the CC must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the CC agrees to accept participation of NIH staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities." The NIH Program Official may ask the CC to support sites who have challenges identified that haven't been able to be quickly resolved via technical assistance. Lastly, the CC ensures the timely dissemination of information generated by the consortium to both the consortium project members and the scientific public.

The CC will plan one or more meetings a year to which non-consortium participants will also be invited to enable the consortium to explore scientific or technologic advances and innovations that occur during the course of the project. The CC will plan a symposium or workshop to inform the research community of the progress made annually. The NIH Scientific Director and other NIH staff will provide the CC with advice on appropriate topics and participants for the workshops and symposia.

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

Observational Study Monitoring Board: This is an independent board which reports to the Director of NIDA, comprised of domain, technical, and ethics experts in areas of focus of the ABCD 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.

Steering Committee: The consortium has a Steering Committee, which is the main governing board of the consortia. This committee reviews and approves collaborative protocols, substudy proposals and consortium policies. The members of the Steering Committee for the consortium are selected by the CC Director(s) with input from the NIH program staff. The Steering Committee is primarily composed of the CC Director, several principal investigators of the research project and resource components and the NIH Scientific Director. 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 CRAN/NIH also reserves the right to augment the scientific expertise of the Steering Committee when necessary and to appoint additional NIH staff as nonvoting members of the Steering Committee and Subcommittees. Each primary member of the Steering Committee has one vote. The chairperson of the Steering Committee is the CC Director. The Steering Committee may establish subcommittees as it deems appropriate to facilitate the planning and operation of the consortia. The Steering Committee meets at least once annually.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Bethany Deeds, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1935
Email: [email protected]

Gerald McLaughlin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5819
Email: [email protected]

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6685
Email: [email protected]

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 45 CFR Part 75.