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

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

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

This Resource Access Program allows investigators to apply for access to biospecimens from the Adolescent Brain Cognitive Development^SM (ABCD) Study, the HEALthy Brain and Child Development (HBCD) Study - collectively known as the NIH Brain Development Cohorts (NBDC) - and the Population Assessment of Tobacco and Health (PATH) Study for use in conducting research consistent with study objectives. These biospecimens are stored in a temperature-controlled facility for subsequent analyses. 

NBDC

• The ABCD Study ® enrolled nearly 12,000 children ages 9-10 at 21 research sites across the country between 2016 and 2018, and has been following them longitudinally ever since. The study has examined how childhood experiences (such as sports, playing video games, social media use, 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. The ABCD study is the largest long-term study of brain development and adolescent health in the United States and will continue to follow the ABCD cohort into adulthood, when many of the outcomes of interest (e.g., substance use disorders, mental health disorders, chronic diseases, and other health conditions) will manifest. For more information on the ABCD protocol, please visit ABCDStudy.org.
• The HBCD Study is the largest long-term study of early brain and child development, tracking children from the perinatal period through 9-10 years of age. It is a nationwide study with 27 research sites across the country. The goal of HBCD is to examine how prenatal substance exposures (alcohol, marijuana, opioids, etc.), as well as other environmental exposures impact child development. The HBCD Study includes neuroimaging, toxicology, behavioral and cognitive development assessments, and the collection of a wide range of biospecimens. The HBCD Study enrollment is planned through July 2027 with a goal of ~5000 participants. For more information on the HBCD protocol, please visit HBCDStudy.org.

Specimen collection for both studies is ongoing. Available specimens include:

• ABCD Study: oral fluid, whole blood, serum, deciduous teeth, and DNA from either saliva or blood.
• HBCD Study: plasma, serum, whole blood, blood spot cards, urine, and DNA from either saliva or buffy coat from birth parents; urine, stool, and DNA from saliva from children.

The ABCD and HBCD Studies release data to the scientific community through the NBDC Data Hub. Annual releases include curated data from neuroimaging and all assessment domains, including some data from biosamples, but not the biosamples themselves. In addition, residential history derived socio-environmental data is available to contextualize primary data collected. Please visit nbdc-datahub.org for more information on the data releases.

PATH Study

The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed in June 2009, created the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and granted it the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco in order to protect public health. In 2016, CTP's authority was extended through a "deeming" rule to include all tobacco products, including electronic cigarettes or electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, hookah tobacco, and other tobacco products such as nicotine gels. A full description of the FSPTCA can be found on FDA's website (https://www.govinfo.gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf).

The PATH Study is a collaboration between the National Institute on Drug Abuse (NIDA), NIH, and the CTP and was launched in 2011 to inform FDA's regulatory activities under the FSPTCA. This ongoing longitudinal cohort study follows a nationally representative sample of approximately 46,000 participants, including youth (ages 12 to 17) and adults (ages 18+) who currently or formerly use nicotine and tobacco products as well as those who have never used these products. The goal of the study is to generate epidemiologic data on tobacco use behaviors including patterns of use, attitudes, beliefs, exposures, and related health outcomes. Starting in 2013, the study consists of annual and biennial primary waves of data collection with the multi-wave design allowing for longitudinal assessment of participants' patterns of nicotine and tobacco product use, nicotine and tobacco exposures, health, and disease risks. The study is planned to continue through 2030. 

Stored biospecimens available to researchers include urine, serum, plasma, and genomic DNA. Applicants should review the Study Biospecimen Access Program information before completing the X01 application. More information on the PATH Study data and biospecimen collection can be found here: Population Assessment of Tobacco and Health (PATH) Study Series.  

Detailed information on the policies for obtaining PATH Study biospecimens, types of biospecimens available, and the application and review processes may be found on the PATH Study Biospecimen Access Program web page at the University of Michigan's National Addiction & HIV Data Archive Program (NAHDAP), part of the Inter-University Consortium for Political and Social Research's (ICPSR). Applicants should review this information before applying for access to the PATH Study biospecimens.

Specific Areas of Research Interest 

Applications should expand the knowledge gained from these studies and advance our understanding of the multiple genetic and environmental factors that affect health and disease over the course of a lifetime. Access to samples will be limited to investigators proposing meritorious and feasible studies consistent with study objectives. Additionally, research areas of interest include, but are not limited to, those listed below:

NBDC: Genomics, including epigenetics, substance exposure, inflammation and stress, proteomics, neurotoxicants and environmental exposures, microbiome, and nutriture will be given the highest priority for access to ABCD or HBCD Study biospecimens. Studies that expand the knowledge of child and adolescent health more broadly, but not exploratory or pilot studies, will also be considered.

PATH Study: Research priorities for tobacco regulatory science will be given the highest priority for access to PATH Study biospecimens. Studies that address other objectives that expand the knowledge of tobacco use and/or tobacco related health outcomes will also be considered.

Specific Requirements and Expectations for this Opportunity

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 Drug Abuse Research Using Existing Data (R01) or (R21) funding opportunities.
• NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed)

Recipients who are granted access to NBDC or PATH Study biospecimens will be required to adhere to terms in the Data Use Certification and applicable reporting and data sharing requirements. See the Requesting Biospecimens page of the NBDC Biobank or the PATH Study BAP Overview and application guide for more information.

NBDC

Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens via the NBDC Biobank portal or contact the NBDC team at nbdc_biobank@mail.nih.gov.

PATH Study

Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens as described here: How to Apply for Biospecimens | NAHDAP. 

For further information on special considerations for NIDA applicants, please see the Resources section on the NIDA Grants and Funding page.

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 - Includes all types

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

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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

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 Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Foreign Organizations/Foreign Collaborations

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

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

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.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Describe facilities where laboratory analyses will be done in Facilities and Other Resources.

Describe instrumentation that will be used to conduct laboratory analyses in Equipment.

Other Attachments:

Availability of Biospecimens (required): Include the Resource Availability and Impact Report (NBDC Studies)/letter about the proposed study or written confirmation from the PATH Study team indicating the availability of sufficient numbers of biospecimens. To obtain this documentation: 

NBDC Studies: Interested applicants are strongly encouraged to explore available biospecimens and submit a Biospecimen Availability Inquiry via the NBDC Biobank 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. In response to the Biospecimen Availability Inquiry, a Resource Availability and Impact Report will be generated and uploaded to the Inquiry Dashboard, documenting if there is a sufficient quantity of the samples required for the proposed study, which will serve as supportive information for the application.

PATH Study: Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens as described here: How to Apply for Biospecimens | NAHDAP. Briefly, applicants should review the PATH Study Biospecimen Access Program guidelines and submit a concept statement outlining the biospecimens of interest and a short description of the proposed study. The PATH Study Biospecimen Access Committee (BAC) will review the concept statement and evaluate the proposed study for feasibility, scope, and consistency with PATH Study objectives, and/or research priorities for tobacco regulatory science. If the proposed study is approved, the notification e-mail will include a letter which indicates that the requested biospecimens are available.

Funding Source (required): 

NBDC: Applicants must identify the funding source and secured budget 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

PATH Study: Applicants must identify the proposed funding source to be used for the research project (currently available or application in process), and include relevant documentation once available (e.g., Notice of Award). Include this as a PDF file labeled Funding Source

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

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

Research Strategy

Significance: Explain how the proposed use of biospecimens relates to NBDC or PATH Study objectives, and how results will inform the scientific community, public health policy, child and adolescent health and/or tobacco regulation. The application must address the following:

• Explain how the proposed project will improve scientific knowledge of child, adolescent, or young adult health, tobacco control, and/or tobacco regulatory science.
• Describe how the study aims make use of the unique nature of the NBDC or PATH Study design and biospecimens.
• Describe how the amount of sample requested is justified by the significance and objectives of the proposed project. 

Approach: Describe how your overall research strategy and use of specific methods and analyses will accomplish the specific aims of the study. The application must address the following:

• Describe how the choice of participant variables, biospecimens, assays, and statistical analyses will answer the research questions. List challenges, and potential confounders and biases that might be encountered in conducting the proposed study and what measures will be taken to minimize these issues.

Biospecimen Information: Briefly describe participant characteristics (variables) to define participant groups for source of biospecimens, as well as the type(s), numbers and volumes of samples being requested, and the collection timeframe for samples being requested, including a clear justification for each. This should match what was entered in the Biospecimen Availability Inquiry (NBDC) or PATH Study Concept Proposal.

• NBDC and/or PATH Study biospecimens may be used to validate previous studies or used in combination with biospecimens from other studies to increase sample size and study power. If the biospecimens are used to validate previous studies or are used in combination with biospecimens from other studies, how comparable are those biospecimens from these other studies to the NBDC and/or PATH Study biospecimens?

Methodology/Assays: 

List each laboratory assay planned for the biospecimens. Provide the following information for each assay: 

• Describe to what extent the proposed assays have been validated for use with the specific types of biospecimens requested. Provide preliminary data if available; 
• Describe numbers, types and volume of biospecimen required (including justification for volume requested, and both dead and assay volumes); multiplex assay approaches that minimize volume requirements are preferred; methodologies and instrumentation (including assay kit name if commercial kit);
• Analyte stability and assay validation for the type of biospecimen requested;
• 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);
• Competency of laboratories conducting the analyses and laboratory quality control plan;
• Relevant preliminary data demonstrating experience with the assay.

Power and Effect Size: 

• Provide power calculations and anticipated size of a detectable effect for each aim. Include details on the statistical approach used to calculate power calculations and/or study size. 
• For the PATH Study only: If submitting an application for exploratory or pilot analyses, power analyses and directional hypotheses are not required, but can be included if effect sizes from related research are available.

Statistical Analyses:  

• Provide a detailed statistical analysis plan including the following: enumeration of all exposure and outcome variables (primary and secondary) and covariates; statistical models and assumptions; plans for evaluating assumptions required by the models; and other statistical issues germane to the proposed research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments.

Timeline:  

• Provide a proposed timeline for each step of the process from the receipt of biospecimens until the completion of statistical analysis of the data. Please include details that will allow evaluation of the feasibility of the timeline. Individuals conducting data analyses should include their biosketches with the application, even if they are not senior/key personnel on the project. Biosketches should include information related to the expertise and experience with the specific statistical analyses proposed.

Protection of Human Subjects:  

• Applicants must consult with their local IRB to determine whether the proposed research constitutes human subjects research or is exempt. Applicants must provide documentation of the IRB's determination if their application is approved. Note: the use of de-identified biospecimens from the NBDC or PATH Study does not meet the NIH definition of human subjects research. If these data are combined with data from other human subjects, consult with your local IRB to determine the IRB exemption status.

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

Other Plan(s): 

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

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Send proof of secured, adequate funding to pathstudyteam@mail.nih.gov or nbdc_biobank@mail.nih.gov. Resources will not be released until proof of funding is provided.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

X01 applications will be evaluated for scientific and technical merit by an internal group convened by NIDA, using the above review criteria.

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

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

 As these X01 applications are reviewed internally, 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 on the resource.
• Relevance of the proposed project to program priorities.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing (DMS) Plan is not applicable to this NOFO. An X01 does not result in a Notice of Award. Instead, successful applicants will receive instructions on accessing the resources described in this NOFO.

4. Reporting

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

Section VII. Agency Contacts

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

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

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NBDC Biospecimen Team: nbdc_biobank@mail.nih.gov

PATH Study Biospecimen Team: pathstudyteam@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIAAA-ABCD@mail.nih.gov

National Institute of Neurological Disorders & Stroke (NINDS)
Email: NINDS-BRAC@ninds.nih.gov

Division of Translational Research (DTR) 
National Institute of Mental Health (NIMH) 
Email: DTRcommunications@nih.gov  

National Institute of Dental and Craniofacial Research (NIDCR)
Email: NIDCR-Program@nih.gov

Behavioral Research Program
National Cancer Institute (NCI)
Email: NCIDCCPSBRPNOFOs@mail.nih.gov

NBDC Biospecimen Team
National Institute on Drug Abuse (NIDA)
Email: nbdc_biobank@mail.nih.gov

PATH Study Biospecimen Team
National Institute on Drug Abuse (NIDA)
Email: pathstudyteam@mail.nih.gov

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Grants Management Contact
Email: NIAAA-GMB@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Chief, Grants Management Office
National Institute of Mental Health (NIMH)
Email: NIMHNOFOGrantsManagement@mail.nih.gov   

National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
E-mail: NCIFinancialContact@nih.gov

Section VIII. Other Information

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

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