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.

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

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

The goal of this announcement is to support a Data Coordination and Integration Center (DCIC) as part of the NIH HEAL Initiative’s INTERACT program. The DCIC will curate, harmonize, and integrate comprehensive clinical, -omics, and other complex datasets generated by INTERACT as well as from the larger HEAL Initiative related datasets. Coordination and Integration of INTERACT multimodal data is needed to enhance capabilities of INTERACT awardees and facilitate necessary linkages to the infrastructure and support provided by the HEAL Data Ecosystem.

The INTERACT Consortium builds on the foundational HEAL BACPAC Research program and is continuing to incorporate novel analytics and technologies, and expand data collection to extensively phenotype patients with LBP, enhance an integrated model of low back pain(LBP), and produce new and improved diagnostic and treatment algorithms. The intent is to continue to advance the diagnosis and treatment of chronic LBP (cLBP) by extending an integrative whole-person approach to other HEAL pain studies and datasets to accelerate comprehensive understanding of chronic pain across musculoskeletal (MSK) diseases. For example, incorporating molecular and cellular analyses of spine and other tissues in the HEAL Program to Reveal and Evaluate Cells-to-gene Information that Specify Intricacies, Origins and the Nature of Human Pain (PRECISION) innervation mapping studies in the Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium, and putative quantitative imaging biomarkers of fascial and musculoskeletal tissues identified in the HEAL Initiative’s Myofascial program.

INTERACT is part of the multi-pronged HEAL (Helping to End Addiction Long-term) Initiative, an aggressive effort to speed scientific solutions to stem the national opioid public health crisis (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative). HEAL continues to build on extensive, well-established NIH research to address the opioid crisis and provide safer therapies for people with pain.

High-level Summary of the Anticipated Activities. During the first year, the DCIC will develop plans to finalize any remaining data coordination and data analysis activities related to the first stage of BACPAC.

In all years of funding, the DCIC will work with awarded INTERACT awardees to carry out support and integration with newly developed protocols, data, and technologies, and coordinate with the INTERACT administrative group to support activities vital for INTERACT functions. (INTERACT awarded projects can be found here (https://reporter.nih.gov/search/xfrkukccyEyz_bk5MEXD6w/projects)).

Program/Research Objectives and Scope

In alignment with the goals of the INTERACT Program, this NOFO intends to support a DCIC to enhance and promote standard terminology, data acquisition protocols, quality control metrics, and metadata requirements to facilitate data interoperability and use of data through harmonization and integration within the INTERACT Consortium. The INTERACT DCIC will be a member of a larger HEAL Initiative Data Ecosystem that functions across HEAL initiative activities to promote integration of and use of a variety of data types and to encourage a whole-person approach.

The HEAL Data Ecosystem coordinates data sharing across the NIH HEAL Initiative, including such efforts as generating a metadata standard and providing curation guidance supporting discovery, access to, and reuse of digital assets produced by HEAL-funded projects. In addition, the HEAL Data Ecosystem is generating materials to guide investigators in storing their data in appropriate long-term repositories, leveraging this aforementioned metadata to make data easily findable, accessible, and reusable within the HEAL Platform, which is a cloud-based and multi-functional web interface that provides a secure environment for discovery and analysis of NIH HEAL results and data.

It is anticipated that datasets handled by the DCIC will be of wide-ranging types - such as electronic health records, patient-reported outcomes, accelerometer/actigraphy data, Quantitative Sensory Testing, imaging, omics assays (proteomic, transcriptomic, metabolomic, etc). The DCIC should plan to be nimble and be able to shift to the coordination of other data types as needed to continue to enhance data integration and capitalize on emerging opportunities.

The specific roles of the INTERACT DCIC will include, but are not limited to:

• Managing, curating, and harmonizing data collected via INTERACT for the ultimate purpose of data sharing in the NIH HEAL Data Ecosystem. Examples of deliverables include the development and/or recommendation of tools that facilitate the curation of data using relevant data and metadata standards; and the development of data formats, such as Study Data Tabulation Models (SDTM) file data formats, for the submission of clinical trial data to relevant HEAL data ecosystems for future use and analysis.
• Providing specifications and training for the use and incorporation of all relevant data standards, including common data elements (CDEs), across INTERACT.
• Overseeing adherence and technical details of HEAL Data sharing through established NIH data repositories, study registration with the HEAL Data Platform, and other HEAL-related requirements within the HEAL Initiative programs.
• Integrating data (biologic, molecular, imaging, biomechanical, psychosocial etc.) generated in INTERACT  and other relevant data sets to accelerate development of treatment rules/algorithms and enhancement of data driven models.
• Providing opportunities for integration and collaboration and secondary analyses to progressively incorporate related datasets and future MSK HEAL and NIH whole-person pain projects to ultimately facilitate better understanding of chronic MSK pain. Ensuring data interoperability and opportunities for cross program analyses. Including management of and budget for initiating discrete, well-defined projects that can facilitate and demonstrate data interoperability with other HEAL-funded studies or datasets, and/or facilitate cross-program data integration and analysis efforts.
• Developing and providing analytic tools for integrating and interrogating data generated through INTERACT and other related MSK HEALprojects as appropriate, including facilitating hypothesis generation and secondary analyses.
• Sharing information and insights about these data with the broader biomedical research community; facilitating data use by providing user-friendly access to consortium data and by identifying or generating robust tools to enable both beginner and experienced investigators to query, integrate, analyze, model, and promote secondary analysis of the data.
• Working with the HEAL Data Ecosystem to ensure sustainability and integration of all consortium-developed data appropriately with other HEAL data and ensure synergistic and non-redundant efforts.
• Working with the INTERACT consortium PD(s)/PI(s) to analyze existing and generated data, develop analysis strategies to integrate the INTERACT datasets in synergistic ways with other relevant HEAL MSK datasets, and to share useful information and insights about these data with the broader biomedical research community.
• Coordinating with the Whole Person Research and Coordination Center (https://reporter.nih.gov/search/zhQ8fT3STU2i0mLl8eKqAQ/project-details/11224772) to ensure appropriate incorporation of CDE’s that focus on whole person health and encourage a holistic approach to data coordination across biological systems.
• Assisting INTERACT awardees with protocol sharing and publication. The DCIC should plan to develop an overall data coordination and integration plan that maximizes data transportability and data interoperability, given the rapidly changing landscapes for data access and data integration. 

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

Foreign Organizations/Foreign Collaborations

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

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. 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.

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.

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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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: The overall research strategy should address the following items:

Timeline and Milestones: Applicants should provide a timeline and detailed annual milestones throughout the funding period. If selected for funding, applicants will work with NIH staff to develop more granular quarterly milestones for each year of funding.

Data Coordination and Integration:

• Applicants should describe their plans for the performance period and how their previous experiences, for example in HEAL projects, have prepared them to succeed in carrying out the overall goals.
• Applicants should describe how the DCIC will interact with other funded components of INTERACT and engage with related HEAL MSK Pain programs and the Whole Person Research and Coordination Center (https://reporter.nih.gov/search/zhQ8fT3STU2i0mLl8eKqAQ/project-details/11224772).
• Applicants should describe how they plan to facilitate necessary data linkages and analyses of datasets, as well as hypothesis generation and additional analyses.
• It will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the consortium and the larger HEAL Initiative. Potential changes and advances in technology platforms or the assessments being performed by the consortium may alter the types and volume of data. Applicants should describe how they will prioritize activities and adjust and incorporate future datasets.
• Applicants should describe plans and budget to conduct and facilitate integration and secondary analysis of data generated in INTERACT and relevant datasets from MSK Pain Programs, for example HEAL Initiative’s Program to Reveal and Evaluate Cells-to-gene Information that Specify Intricacies, Origins and the Nature of Human Pain (PRECISION) innervation mapping studies in the Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium, and putative quantitative imaging biomarkers of fascial and musculoskeletal tissues identified in the HEAL Initiative’s Myofascial program.
• As the data storage, analysis, and dissemination needs of the consortium change with time, the DCIC may be asked to implement modifications to their workflows as agreed upon by the consortium. The DCIC should document capability and capacity to be flexible in their implementation of data coordination, analysis, and outreach workflows (including results reporting).

Management Plan: This section should describe how:

• Applicants should describe how they will manage the proposed project, including detailing who will oversee the day-to-day activities (e.g., a project manager if not the PD(s)/PI(s)), and how the management structure will support achievement of the proposed goals and milestones. Any experience coordinating large projects and budgets should be described and special strengths or capabilities should be noted.
• Applicants should describe how they will identify and interface with related HEAL investigators and programs, including the HEAL Data Ecosystem. DCIC should work closely with The HEAL Initiative Data Ecosystem and Platform teams to ensure responsible data sharing and coordination.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support should indicate the specific activities the individual or organization will perform in pursuit of the DCIC goals; letters of support from individuals or organizations without a specific role in the DCIC should not be included.

Applications are expected to include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including subcontractors) to the effect that the institution supports and agrees to abide by the resource sharing plans put forth in the application if applicable. Such letters would be clear expressions of commitment. A separate letter should be sent by each participating organization including each subcontractor. Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the relevant office handling intellectual property matters have reviewed and approved the document.

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

Other Plan(s): 

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

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.
• The HEAL Initiative has additional requirements for awarded applications that must be addressed in the Data Management and Sharing plan. Data and metadata generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant, data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Guidance is available at (https://www.healdatafair.org/resources/guidance/selection). 

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.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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

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

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols 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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Providing scientific and administrative leadership and coordination of the project at the recipient and sub-recipient institutions and among collaborators.
• Serving as a member of the INTERACT network Steering Committee.
• Accepting and implementing the common guidelines and procedures approved by the Steering Committee.
• Providing oversight to the managing, curating, and harmonizing data collected via INTERACT for the ultimate purpose of integration and analysis as well as data sharing in the NIH HEAL Data Ecosystem.
• Providing specifications and training for the use and incorporation of all relevant data standards, including common data elements (CDEs), across all of INTERACT.
• Overseeing adherence and technical details of HEAL Data sharing through established NIH data repositories, study registration with the HEAL Data Platform, and other HEAL-related requirements for funded programs within the HEAL Initiative programs.
• Providing scientific and administrative leadership and coordination for integrating data (biologic, molecular, imaging, biomechanical, psychosocial etc.) generated in INTERACT and other relevant data sets to accelerate development of treatment rules/algorithms and enhancement of data driven models.
• Providing opportunities for integration and collaboration and secondary analyses to progressively incorporate related datasets and future MSK HEAL PAIN and NIH whole-person pain projects to ultimately facilitate better understanding of chronic MSK pain. Ensuring data interoperability and opportunities for cross program analyses. May include management of and budget flexibility for initiating discrete, well-defined projects that can facilitate and demonstrate data interoperability with other HEAL-funded studies or datasets, and or facilitate cross-program data integration and analysis efforts.
• Developing and providing analytic tools for integrating and interrogating data generated through INTERACT and other related MSK HEAL PAIN projects as appropriate, including facilitating hypothesis generation and secondary analyses.
• Sharing useful information and insights about these data with the broader biomedical research community; facilitating data use by the scientific community by providing user-friendly access to consortium data and by identifying or generating robust tools to enable both beginner and experienced investigators to query, integrate, analyze, model, and promote secondary analysis of the data.
• Working with the HEAL Data Ecosystem to ensure sustainability and integration of all consortium-developed data appropriately with other HEAL data and ensure synergistic and non-redundant efforts.
• Working closely with the INTERACT consortium PD(s)/PI(s) to analyze existing data and data generated, develop analysis strategies to integrate the INTERACT datasets in synergistic ways with other relevant HEAL MSK datasets, and to share useful information and insights about these data with the broader biomedical research community.
• Coordinating with the Whole Person Research and Coordination Center (https://grants.nih.gov/grants/guide/rfa-files/RFA-AT-24-010.html) to ensure appropriate incorporation of CDE’s that focus on whole person health, including the Whole person health index: https://www.nccih.nih.gov/research/blog/the-whole-person-health-index-an-integrated-self-reported-measure-capturing-essential-components-of-health, and encourage a holistic approach to data coordination across biological systems.
• Assisting INTERACT UC2 teams with protocol sharing and publication. The DCIC should plan to develop an overall data coordination and integration plan that maximizes data transportability and data interoperability, given the rapidly changing landscapes for data access and data integration. 
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• A Program Officer will be assigned to this award and named in the award notice. 
• The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance for the overall project within the NIH HEAL Initiative.
• The Program Officer will be responsible for milestone negotiations to ensure that the milestones are achieved and goals are being met.
• The Program Officer is responsible for monitoring and implementing the NIH Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/index.htm), as well as the NIH HEAL Initiative Public Access and Data Sharing requirement - https://heal.nih.gov/about/public-access-data.
• The Program Officer may attend Steering Group meetings as a non-voting participant.
• One or more extramural NIH program staff members may be assigned as the Project Scientist(s) for this award. The same person may serve as the Project Scientist for multiple HEAL Initiative awards.
• An NIH HEAL INTERACT Project Team will be composed of Program Officials and other relevant extramural staff from NIH Institutes and Centers and the Project Scientist(s). Its primary role is to ensure that the datasets and resources generated represent the diverse interests of the participating NIH Institutes and Centers, advise activities relevant to their individual Institute/Center mission, monitor overall progress, attend Steering Group meetings as required, and report back to the NIH HEAL Initiative, as well as their Institute/Center.
• The Project Scientist(s) may interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research, including providing technical assistance, advice, and coordination for the INTERACT Consortium and its component parts. However, the role of NIH staff will be to facilitate and not to direct the activities. Close interaction among investigators will be required, as well as significant involvement from the NIH, to manage, assess, and disseminate information within HEAL
• It is anticipated that decisions in all activities will be reached by consensus of the INTERACT Steering Committee and that NIH staff will be given the opportunity to offer input to this process. One NIH Project Scientist will participate as a member of the Steering Committee and will have one vote. If additional NIH staff participate as a member in the steering committee, all NIH staff will together share one vote in support of the project.

Areas of Joint Responsibility include:

• The INTERACT Steering Committee is composed of the PD(s)/PI(s), Project Scientist(s) (experts to be named after award) from the funded recipients of HEAL Initiative: INTERACT INTEgRAtive Back Pain Longitudinal Cohort Teams (RFA-AR-25-005) and this Notice of Funding Opportunity (RFA-AR-26-002). The Steering Committee may also include designated representatives from the HEAL Data Sharing Ecosystem, as appropriate. The Steering Committee is established to help monitor progress, encourage improvements, and coordinate collaboration. A chair will be designated on a rotating basis as needed. Each PD(s)/PI(s) will have one vote each and the NIH will have one vote through the participation of the Project Scientist(s). Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of an individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. 

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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 2 CFR Part 200.301.

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).

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Email: niams_pain@mail.nih.gov

National Institute on Aging (NIA)
NIA-NOFO-Scientific@nih.gov

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

Division of Neuroscience and Behavior
NIAAA-HEAL@mail.nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov 

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
Email: NIAMSGrants@nih.gov 

National Institute on Aging (NIA)
NIA-NOFO-Grants@nih.gov

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
Email: NIAAA-GMB@mail.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.