Part 1. Overview Information

Key Dates

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

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

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

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Purpose

This Resource Access Program allows investigators to apply for access to the Adolescent Brain Cognitive Development^SM (ABCD) Study biospecimens for use in conducting research studies on adolescent health. The ABCD Study is a collaboration between 10 Institutes, Centers, and Offices at the National Institutes of Health (NIH) and other Federal Partners.

The ABCD Study has been funded to continue until all subjects have completed 10 years of data collection. Available specimens include oral fluid, whole blood, serum, deciduous teeth, and DNA from either saliva or blood. These biospecimens are stored in a temperature-controlled facility for subsequent analyses. By making these specimens available to the greater scientific community, this resource award seeks to maximize the scientific potential of the biospecimens collected in the ABCD Study and expand the scope of ABCD’s open science model, allowing scientists from around the world to utilize these specimens to enrich the child and adolescent health data being obtained from the ABCD Study and further our understanding of adolescent health more broadly.

Detailed information on the policy for obtaining study samples and the application and review processes can be found on NIDA's funding opportunity page. Applicants should visit this page and the NBDC portal before applying for access to ABCD Study biospecimens to query available samples using the Biospecimen Explorer, submit a Biospecimen Availability Inquiry to determine the resource availability and impact on existing samples, and learn more about this resource.

Background

The ABCD Study enrolled nearly 12,000 children ages 9-10 at 21 research sites across the country between 2016 and 2018. Researchers will examine how childhood experiences (such as sports, playing video games, social media use, unhealthy sleep patterns, smoking, and drug use) interact with each other and with a child’s changing biology to affect brain development and social, behavioral, academic, health, and other outcomes through adolescence into young adulthood.

To address these objectives, the ABCD Study collects data related to physical and mental health, culture and environment, substance use, and neurocognitive function, as well as bio-assays for hormones, cardiovascular and hematologic health, genetics, environmental toxins, and substance use analysis, and multimodal brain imaging to track changes in brain structure and function as participants transition from childhood through adolescence into adulthood. These assessments are done annually (non-imaging, some biospecimens) or biannually (imaging, some biospecimens) for 10 years. For more information on the ABCD protocol, please visit the NIDA page for the ABCD Study.

The ABCD Study releases fast-track data to the scientific community containing unprocessed neuroimaging data from ABCD Study participants to date. Curated data from all assessment domains, including some data from biosamples (e.g., gene array data, pubertal hormone analyses), but not the biosamples themselves, are released annually. In addition, residential history derived socio-environmental data is available to contextualize primary data collected. Please visit the data sharing page of the ABCD Study website for more information on the data releases.

Research Scope

Access to ABCD Study samples will be limited to investigators proposing meritorious and feasible studies consistent with ABCD Study objectives (above) or studies that expand the knowledge of adolescent health more broadly.

Specific Requirements and Expectations for this Opportunity

Interested applicants are strongly encouraged to explore available biospecimens and complete a Letter of Intent in the form of a Biospecimen Availability Inquiry via the NBDC portal at least 4 weeks prior to the submission deadline to determine whether there is a sufficient quantity of samples required for the proposed study and to determine whether the proposed use of samples is consistent with the limitations of the participant's informed consents. Applicants may apply for access to samples from multiple time-points if they are proposing a feasible longitudinal design and can demonstrate adequate storage capabilities. Applicants who are attempting to find biospecimens for specific participants based on other available ABCD Study data should contact the NIH Brain Development Cohorts (NBDC) team at devstudybiosamples@nida.nih.gov. In response to the Biospecimen Availability Inquiry, the NBDC Biospecimen Team will provide a Resource Availability and Impact Report, documenting if there is a sufficient quantity of the samples required for the proposed study, which will serve as supportive information for the application. Applicants must include the Resource Availability and Impact Report as a PDF file labeled Resource Availability and Impact Report in Other Attachments . For more information on the procedures to determine biospecimen availability, visit the NBDC portal and the NBDC Biospecimen Access Program page.

No funds will be provided through this opportunity. Applicants will be responsible for costs associated with conducting the research and sample distribution. Several NIH funding opportunities may be of interest:

• Accelerating the Pace of Child Health Research Using Existing Data from the Adolescent Brain Cognitive Development (ABCD) Study R01 (Clinical Trials Not Allowed) or R21 (Clinical Trials Not Allowed).
• Accelerating the Pace of Drug Abuse Research Using Existing Data (R01) or (R21) funding opportunities.
• For applicants proposing to conduct studies about environmental exposures, see more information on funding through the Human Health Exposure Analysis Resource (HHEAR) laboratories for chemical analysis of banked biological samples.

Additional opportunities for funding may be sought from NIH parent announcements supported by the relevant institute(s) for the proposed research.

Applicants will need to submit proof of sufficient funding at the time of application.

Note: Recipients who are granted access to the ABCD biospecimens will be required to adhere to the separate award conditions noted in the ABCD data use agreement, including signing the NBDC Specimen and Data Use Agreement and ABCD Study data archives' Data Use Certification, and referencing the Research Resource ID associated with the ABCD study.

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.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• 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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

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

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. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants should submit a letter of intent in the form of a Biospecimen Availability Inquiry via the NBDC portal that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Participating institution(s)
• Number and title of this funding opportunity
• Detailed information on the requested biospecimens: the type and quantity of biospecimen requested, from which biospecimens study timepoint(s) they are requesting samples, and relevant demographic variables (e.g. sex, race/ethnicity)

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 NOFO.

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

Please follow these additional instructions as this is not an application for funding:

Total Federal Funds Requested: Enter $0

Total Federal and Non Federal Funds: Enter $0

Estimated Program Income: Enter $0.

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.

Other Attachments

Applicants must include the Resource Availability and Impact Report as a PDF file labeled Resource Availability and Impact Report .

Applicants must identify the funding source to be used for the proposed studies and include relevant documentation (e.g., Notice of Award). Include this as a PDF file labeled Funding Source .

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

In the biosketches, highlight the investigator’s familiarity with the study that produced the samples being requested.

R&R Budget

Not Applicable.

R&R Subaward Budget

Not Applicable.

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:

Research Strategy

Significance

Explain how the proposed use of biospecimens relates to adolescent health objectives, and how results will inform the scientific community and/or public health policy.

Explain how the proposed project will enhance scientific knowledge about child or adolescent development.

Describe how the study aims to make use of the unique nature of the ABCD Study design and biospecimens.

Discuss how the impact on the amount of sample that will remain in the NBDC Biorepositories matches the significance of the proposed project, such that studies that will substantially deplete the collection are appropriately significant.

Approach

Provide relevant details on the proposed study design to justify the request:

• Provide a justification for the choice of specimens and analyses and how they will answer the proposed research questions.
• Describe how the proposed study will take advantage of the ABCD study design, and how the requested samples will maximize the benefits of this design.
• Provide a rationale for how race- and ethnicity-related constructs will be used in analyses (including the use of contextualizing variables). Include a discussion of potential harms that may be posed to marginalized individuals, groups, or communities whose biospecimens are being requested, and propose strategies to mitigate any potential harms.

Biospecimens Information: List participant characteristics (including sex, race/ethnicity, or other relevant variables) to define participant groups for source of biospecimens, the type(s), numbers and volumes of samples being requested, and the collection visit timepoints for samples being requested, including a clear justification for each. This should match what was entered in the Biospecimen Availability Inquiry.

Additional phenotypic information is available through the ABCD Study data archive. Learn more about ABCD Study data releases here.

ABCD Study samples may be used to validate previous studies or used in combination with biospecimens from other studies to increase sample size and study power. If applicable, describe how the biospecimens from the ABCD Study and other studies are comparable.

Methodology/Assays: List each laboratory assay planned. Provide the following information for each assay:

• Volume required (include both dead and assay volumes); multiplex assay approaches that minimize volume requirements are preferred;
• Methodologies and instrumentation (include the assay kit name if using a commercial kit);
• Analyte stability and assay validation;
• Assay performance (precision, specificity, accuracy, linearity of range, limits of detection);
• Quality control (QC) plan (proportion of QC samples, estimated batch size, use of a pooled sample or individual replicates, plan for evaluating assay performance, and the source of QC samples);
• Storage plan for each biomaterial;
• Competency of laboratories conducting the analyses;
• Relevant preliminary data demonstrating experience with the assay, as well as accuracy and robustness of the proposed assays.

Power and Effect Size: When appropriate, provide power calculations and anticipated size of a detectable effect for each aim. Based upon these calculations, demonstrate how the requested sample size is adequate to detect significant effects for each aim, or if additional samples are required from another source.

Statistical Analyses: Provide a detailed statistical analysis plan, including stratifying the data by sex or race/ethnicity when appropriate, in accordance with NOT-OD-15-102, and other statistical issues germane to the proposed research. Include a brief summary of the team’s expertise and experience and evidence that they have the required expertise to perform the proposed analyses. Describe the data that will be analyzed and the statistical methods that will be used. Address statistical issues germane to the research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments.

Letters of Support: The NBDC Biospecimen Team will provide a standardized report which will indicate sample availability, ensure that the proposed usage is consistent with participants' informed consents, and will report by how much the proposed research (if approved) will deplete the resource. Include this Resource Availability and Impact Report in the application as a Letter of Support in Other Attachments . If using biospecimens from other studies, provide letters of commitment from collaborators.

Resource Sharing Plan:

Not Applicable.

Other Plan(s):

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

• A Data Management and Sharing Plan is not applicable for this NOFO.

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

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 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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

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 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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

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.

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 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 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NBDC Biospecimen Team by email at devstudybiosamples@nida.nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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.

Section V. Application Review Information

1. Criteria

The NIH awarding component will convene a federal review panel who will evaluate applications for scientific and technical merit. The review criteria described below will be considered in the review process.

For this particular announcement, note the following:

The X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 NOFO. This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research. Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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.

Significance

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?

Specific to this NOFO: How adequately does the impact on the amount of sample that will remain in the NBDC Biorepositories match the significance of the proposed project, such that studies that will substantially deplete the collection are appropriately significant?

Investigator(s)

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?

Specific to this NOFO: How adequately has the Investigator demonstrated familiarity with the study that produced the samples being requested?

Innovation

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?

Approach

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?

Specific to this NOFO:

• How adequately can the study aims be accomplished using ABCD Study samples and data?
• How sufficient is the applicant's secured funding to conduct the proposed study?
• To what extent does the proposed study take advantage of the ABCD study design, and how fully will the requested samples maximize the benefits of this design?
• How sufficient are the preliminary data in demonstrating accuracy and robustness of the proposed assays? How adequate is the laboratory quality control plan?
• Based on the power calculations and effect sizes provided, how adequate is the requested sample size to detect significant effects for each aim, or are additional samples required from another source?
• How adequate is the statistical analysis plan in describing the data that will be analyzed and the statistical methods that will be used? How adequately does the plan address statistical issues germane to the research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments?
• How sufficiently justified is the use of race- and ethnicity-related constructs in the analyses? How appropriately is the use of these constructs contextualized? How adequate is the discussion of potential harms that may be posed to marginalized individuals, groups, or communities whose biospecimens are being requested? How appropriate are the proposed strategies to mitigate any potential harms?
• How appropriate is the expertise and experience of the team proposed to conduct the statistical analyses?

Environment

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?

Additional Review Criteria

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.

X01s requesting facility access do not receive peer review. A committee with the appropriate expertise comprised of NIH staff will evaluate requests to determine their overall merit."

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, 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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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 Animals Section.

Biohazards

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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).

Resource Sharing Plans

Not applicable.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

Not applicable.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by a federal review panel with appropriate expertise, convened by the NIH awarding component, using the above review criteria.

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

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

As these X01 applications are reviewed by a federal review panel, they will not undergo Advisory Council review. The following will be considered in making award decisions:

• Scientific and technical merit of the proposed project, with consideration for the impact to the resource, as determined by a federal review panel convened by the NIH awarding component. .
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the review of the application is completed, the PD/PI will be able to access his or her written critique via the?NBDC portal.?Refer to Part 1 for dates for 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

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.

An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources described in this NOFO. Successful applicants will receive instructions for next steps.

2. Administrative and National Policy Requirements

An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

Not applicable. An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

Additional information about the requirements for the access program may be found at https://nida.nih.gov/funding/nida-funding-opportunities/nih-brain-development-cohorts-biospecimen-access-program. Additional required documentation will be submitted via the NBDC portal.

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Kimberly LeBlanc, Ph.D
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-4102
Email: kimberly.leblanc@nih.gov

Joseph Ciccolo, PhD
National Cancer Institute (NCI)
Telephone: 301-639-0943
Email: ciccolojt@nih.gov

David A Thomas, Ph.D.
ORWH - Office of Research on Women's Health
Phone: 301-435-1313
E-mail: david.thomas@nih.gov

Laura A. Thomas, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-1624
Email: laura.thomas@nih.gov

Kimberly A Gray, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-3262
E-mail: gray6@niehs.nih.gov

Deborah E. Linares, PhD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: deborah.linares@nih.gov

John Matochik, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-7319
Email: jmatochi@mail.nih.gov

Applications submitted to this NOFO will not undergo peer review. Questions should be directed to the Scientific/Research Contact(s).

Not applicable

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Jenny L Greer
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.