Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

All of Us Research Program, Office of the Director, National Institutes of Health (PRECMED)

Funding Opportunity Title

Accelerating Discovery through Partnered Research with All of Us to Analyze Participant Biospecimens (X01 Clinical Trial Not Allowed)

Activity Code

X01 Resource Access Award

Announcement Type

New

Related Notices

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

Funding Opportunity Number (FON)

PAR-27-069

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.368

Funding Opportunity Purpose

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access stored blood plasma, blood serum, and extracted DNA from the All of Us Research Program supported Biobank to advance the program's mission of accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.

All of Us partnered research studies are collaborative initiatives funded by a study sponsor external to All of Us to collect and add new data to the All of Us Researcher Workbench in accordance with All of Us’ best practices. All of Us partnered research studies are open to the broad scientific community and require investigators to apply for and receive an X01 award under this announcement.

This will enable longitudinal follow‑up and repeat sampling, and provide multiomic data (genomics, proteomics, metabolomics, and other high‑dimensional molecular profiles), integrated clinical, environmental, and life‑course data, infrastructure designed to support future clinical‑trial recruitment, and public‑private partnership pathways.

This opportunity will enable researchers to conduct assays to evaluate associations between newly collected and existing All of Us data and add new data to the All of Us dataset for broad use by the research community. High-priority areas for biospecimen analyses may include, but are not limited to, large scale projects that propose integrated multiomics analyses, early disease detection, biomarker discovery or validation, novel risk models for incident disease, and/or novel disease stratification for chronic disease risk, diagnosis, and prognosis, in support of advancing precision medicine. For more information, please visit the All of Us X01 Partnered Research Studies Resource webpage.

Funding Opportunity Goal(s)

To provide support for initiatives funded under the 21st Century Cures Act, the All of Us Research Program will gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine.

The All of Us Research Program’s mission is to accelerate health research and medical breakthroughs, enabling individual prevention, treatment, and care for all of us. To carry out its mission, All of Us is collecting a wide range of data from participants across the country to drive discoveries that may improve overall health and the early detection, treatment, and prevention of a broad variety of diseases, while delivering one of the largest and richest biomedical datasets broadly available to the research community.

Key Dates

Posted Date

May 19, 2026

Open Date (Earliest Submission Date)

June 01, 2026

Application Due Date(s)

New (Resubmissions Not Applicable): July 1, 2026 New and Resubmissions: October 30, 2026 New and Resubmissions: March 1, 2027

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

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

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2026 February 2027 June 2027

Advisory Council Review

Not Applicable

Earliest Start Date

November 2026 March 2027 July 2027

Expiration Date

March 02, 2027

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Conformance to all requirements (both in the 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.

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 The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access the processed and stored biospecimens from the All of Us Research Program supported Biobank to advance the program's mission of accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.

This opportunity allows eligible investigators across the scientific community to access biospecimens from the All of Us Biobank to generate new assay data for subsequent analysis and to return newly generated data to the All of Us Researcher Workbench and create opportunities for engaging All of Us participants, building on All of Us resources to create rich opportunities for future research.

All of Us partnered research studies are collaborative initiatives funded by a sponsor external to All of Us to collect new biospecimens or add new data to the All of Us Researcher Workbench in accordance with All of Us’ best practices. All of Us partnered research studies are open to the broad scientific community and require investigators to apply for and receive an X01 award under this announcement. No funds are associated with awards from this announcement. The X01 will allow the NIH All of Us Research Program to prioritize applications that fit within programmatic priorities, consider collaborative opportunities between applicants, and oversee awardees’ adherence to NIH and All of Us policies and procedures during performance of All of Us partnered research studies.

Background The All of Us Research Program is a historic effort to collect data and biospecimens from at least one million people living in the United States and its territories, to accelerate health research and medical breakthroughs, and enable individualized prevention, treatment, and care. Built in partnership with participants spanning varied demographics, health statuses, and regions of the country, the All of Us dataset provides unprecedented opportunities for a wide range of studies to understand how biological, social, behavioral, and environmental factors influence health and a broad range of diseases and conditions.

As of December 2025, the All of Us Research Program has consented more than 872,000 participants, with over 613,000 participants providing biospecimens for research. At this time, only biospecimens collected at a single time point are available through this PAR.

The All of Us Researcher Workbench hosts the program’s dataset and serves as an international research resource to tens of thousands of studies, covering a wide range of health conditions. This scientific resource provides the data, tools, and cloud-based analysis infrastructure that enables interdisciplinary scientific teams to investigate complex, multidimensional, and intersecting influences on human health in collaborative workspaces.

For more information on different data types and participant characteristics including health conditions, aggregate-level data contributed by All of Us participants can be searched publicly through the All of Us Data Browser at databrowser.researchallofus.org. All of Us Researcher Workbench data is curated and updated regularly to align with the program’s data protection safeguards. Information on planned additions to the dataset is available on the All of Us Data Roadmap. With access to All of Us biospecimens, successful investigators will be able to generate new data and in combination with currently available data on the Researcher Workbench investigate how a broad range of biological, genetic, environmental, behavioral, and social factors influence health outcomes. At the time of this announcement, the All of Us Biobank manages and stores over 14.7 million aliquoted biospecimens donated by over 613,000 participants. A subset of these aliquots will be made available for this X01 opportunity.

Biospecimen Partnered Research Study Overview Investigators interested in accessing biospecimens through this partnered research study opportunity should access the All of Us Researcher Workbench to create a workspace to query existing data, develop a research question, and select a cohort of eligible participants in support of their application. See Research Strategy section for additional application information.

Applicants conditionally approved to obtain access to biospecimens will receive a provisional letter of support from All of Us, which may be utilized to secure funding for the proposed project. If funding for the proposed project is secured, All of Us will execute final partnered research study requirements in collaboration with investigators and its program partners to obtain final approval for release of de-identified biospecimens. Next, the All of Us Biobank will securely ship de-identified biospecimens to the investigator(s) and/or approved laboratory in order to carry out the approved analyses and for the generation of novel data.

As required of all partnered research studies, the investigator(s), laboratory, and/or collaborator(s), must appropriately curate and share all generated data with the All of Us Data and Research Center for privacy assessment and linkage to existing All of Us participant data in the Researcher Workbench. The investigator(s) and/or collaborator(s) will then receive exclusive access to their generated data linked to All of Us participant data, such as genomic data or electronic health records, for up to 9 months in order to conduct their proposed analyses. Following that period or at the conclusion of the proposed analyses, the All of Us Data and Research Center will release the generated data to the All of Us Researcher Workbench for all registered researchers to access in support of the mission to accelerate discovery for all.

Research Scope For this X01 announcement, the eligible cohort of All of Us participants will include those with available electronic health records, genomic data, physical measurements, baseline survey data (i.e., The Basics, Overall Health, and Lifestyle), and stored biospecimens, including plasma, serum, and/or extracted genomic DNA from blood or saliva. Applicants must propose using assays with demonstrated, repeated analytic validity in large cohorts; proposals relying on unvalidated methods will be deemed non-responsive. Applicants should propose large-scale projects that make optimal use of stored plasma, serum, and/or extracted DNA biospecimens by yielding the highest scientific value to the All of Us Research Program, with broad impacts such as advancing precision medicine, enhancing prevention and treatment strategies, and narrowing health disparities. Proposals that generate data on the entire population or large subsets will be prioritized. Applications that propose broadly applicable assays with the potential to provide insights into biological pathways that underlie common, chronic, or pressing health conditions will also be prioritized. Ideal projects will include assays that generate data that are applicable to a broad range of future scientific questions. Investigations of rare diseases will be evaluated on a case by case basis. Applications that propose adding a new biospecimen-derived data type to the All of Us dataset and/or propose expanding a data type currently available only on a small subset of All of Us participants (see All of Us Data Roadmap) are permitted. Proposals for expanding currently available data types must be compatible or compliant with those existing data.

Specific areas of interest to advance precision medicine include, but are not limited to:

Details on All of Us Biospecimen Access Up to three types of biospecimens from each participant may be made available for this X01: serum collected by Becton Dickson (BD) vacutainer serum separation tubes (SST), plasma collected by BD vacutainer plasma separation tubes (PST) or BD vacutainer EDTA tubes, and genomic DNA extracted from blood or saliva.

All of the collected biospecimens by the All of Us Research Program are processed and stored in a centralized, standardized manner at the All of Us Biobank (located in Rochester, MN) to ensure consistency and quality.

For more information on standardized sample collection processes, procedures, and storage conditions applicants may visit the All of Us X01 Partnered Research Studies Resource webpage (https://www.researchallofus.org/biospecimen-announcement/).

All biospecimens stored at the All of Us Biobank are de-identified and will be shared with successful applicants without other participant level information (e.g., age group, sex, race). If basic participant-level information is essential to the proposed assay, the investigators must provide justification as part of their proposal.

Applicants should acknowledge in their proposals that the All of Us Research Program does not release biospecimens until material transfer and data use agreements are in place.

To ensure adherence to program policies and participant protections, the All of Us Research Program reserves the right to make final cohort decisions and/or withhold the release of any biospecimen type.

Specific Application Requirements and Expectations Evidence of Funding All of Us partnered research studies require support from funding sources external to All of Us. This announcement does not provide funds for any costs related to the proposed research project. Applicants are responsible for providing their own funding to cover all costs associated with conducting the proposed research under the auspices of All of Us partnered research studies, including but not limited to:

Other costs will be specific to the needs of each study. For assistance with budget planning associated with partnered research studies, applicants are encouraged to visit the All of Us X01 Partnered Research Studies Resource webpage. Applicants who cannot provide evidence of existing funding to support the proposed research must describe a plan to secure funding within one year of receiving a provisional letter of support from All of Us. The letter of support from the All of Us Research Program may be used for securing funding. Meritorious applicants may request additional time to secure funding with appropriate justification.

Biospecimen and Assay Data Quality and Security Measures Only proposals utilizing assays that have been rigorously validated in large cohorts (i.e. data demonstrating reproducible sensitivity and/or specificity under population-scale use and robust to biobank style collection procedures) and are applicable to multiple research areas will be considered. All other applications will be deemed non-responsive. Applications must include detailed information about the proposed analytical laboratory, planned assays, and plans for implementing biospecimen and assay data quality and security measures. Investigators must adhere to the All of Us Biospecimen Access Policy. To access the policy, please visit All of Us X01 Partnered Research Studies Resource webpage. For more details, see Section IV below.

All of Us Researcher Workbench Controlled Tier Access To be eligible for this funding opportunity, applicants must register for access to the All of Us Researcher Workbench Controlled Tier. After registration, applicants will be able to access the cohort of participants with available serum, plasma, and DNA biospecimens to perform cohort selection and sample size/power calculations. For assistance with identifying cohorts with eligible biospecimens, applicants are encouraged to visit All of Us X01 Partnered Research Studies Resource webpage.

Requirement of Returning Newly Generated Biospecimen Assay Data to All of Us Newly generated assay data from approved All of Us biospecimens must be returned to All of Us Research Program. Investigators will then receive exclusive access to the data linked to requested participant data through the All of Us Researcher Workbench for up to 9 months to complete the proposed specific aims. After this embargo period, the curated, research-ready data will be released to all registered users of the All of Us Researcher Workbench.

Project proposals must include plans to return curated, release-ready biospecimen assay data to the All of Us Researcher Workbench to support broad researcher use and maximize scientific impact through publications and other outputs. Along with returning assay data, awardees will be required to create or support researcher-facing materials, such as support articles (e.g., Exploring the Mind; Physical Measurements), a featured Researcher Workbench workspace, data dictionaries, and approved code, and when appropriate, generate publications.

Requirement of Returning Value to All of Us Participants The All of Us Research Program seeks to promote and maintain long-term trust with participants as partners in All of Us. Partnered research study investigators are expected to propose return of value (ROV) plans including creation of materials, engagement and outreach techniques, or communications strategies to ensure participants receive meaningful information that engages them in the program. These plans are finalized and implemented in close coordination with All of Us.

Return of Value in the All of Us Research Program means:

In order to uphold this commitment, applicants are required to submit a ROV plan to outline strategies for meaningful contributions to All of Us participants.

Examples of ROV include but are not limited to:

To the extent possible, each ROV plan should follow the guidelines listed below in documenting the plans for return of information to participants. Given the nature of the de-identified biospecimens awarded under this X01, returning results to All of Us participants individually, i.e., contacting All of Us participants, will not be permitted. ROV materials will be limited to generalized information (i.e. not based on individual participant data). Applicants should include collaboration with All of Us as a part of their plan to coordinate interactions or communication with participants. Innovative plans for ROV are highly encouraged. Applicants must include ROV activities, including staff time, design, and dissemination in their proposed budgets and evidence of funding. Applications should consider the following guidelines in their proposals:

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

Section II. Award Information

Funding Instrument

Other: A financial assistance mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.

Application Types Allowed

New

Resubmission

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

These awards do not provide funding. The number of awards is contingent upon the number of meritorious applications and the capacity of the All of Us Research Program.

Award Budget

Not Applicable. X01 resource access awards do not provide funding.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

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

Faith-based or Community-based Organizations

Regional Organizations

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.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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:

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.

For this specific NOFO, the Research Strategy section is limited to 6 pages.

Instructions for Application Submission

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

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

Total Federal Funds Requested: Enter $0.

Total Federal & Non-Federal Funds: Enter $0.

Estimated Program Income: Enter $0.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

PHS 398 Cover Page Supplement

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

Specific Aims The Specific Aims should refer directly to the X01 request and should clearly and concisely describe the potential impact of the proposed research.

Research Strategy Applicants should propose large-scale, innovative projects that take advantage of the unique opportunities inherent in partnering with All of Us. This section should address the project's:

Significance

Investigator(s)

Approach

Applications should also address the following requirements of the announcement.

Evidence of Funding Because this announcement does not provide funding for the research project, applicants must provide evidence of existing funding or a plan to secure funding within one year of receiving a provisional letter of support sufficient to cover the following budget items:

Biospecimen and Assay Data Quality and Security Measures

Requirement of Returning Biospecimen Assay Data to All of Us Describe plans to return biospecimen assay data to the All of Us Data and Research Center.

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

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

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.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the All of Us Research Program, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Mandatory Disclosure

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

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

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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

For this 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.