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

C omplex and challenging research questions benefit from the integrated effort of multiple Program Directors/Principal Investigators (PDs/PIs) employing complementary approaches with different areas of expertise. These efforts can converge on high-impact discoveries, such as creating new disciplines, resolving longstanding questions, unraveling intractable problems, or defining new areas that challenge existing paradigms.

This NOFO invites Collaborative Program Grant (Team Science) applications from organizations that propose projects addressing complex and challenging scientific problems within the missions of participating NIH Institutes and Centers (ICs). The Team Science Grant is designed to support interdisciplinary research that offers significant advantages over supporting individual research grants or Program Project/Center grants, which often have separate aims or components. Interdisciplinary research teams must have a highly integrated approach to tackle a single, focused scientific problem and achieve anticipated outcomes. Team Science applications should demonstrate interdependent collaboration and synergy among all PD/PIs and show that the team's combined knowledge and expertise are essential to achieving program objectives and addressing unanticipated challenges.

Research involving human subjects is permitted. NIH-defined clinical trials are optional. Applicants are encouraged to identify a participating IC that supports their area of research. Applications that bridge the research interests of more than one area of science are also encouraged but must remain within the missions of participating ICs. 

Features of successful applications include:

• Each PD/PI is committed to team science and willing to devote a major part of their research effort to the team project.
• Research questions are challenging and address a single, focused scientific goal.
• The cohesive team develops an integrative structure specifically designed to achieve that scientific goal.

In addition, the following considerations may be useful in crafting an application combining multiple perspectives, experiences, and career stages:

• Encouraging regional and national participation from varied geographic areas. 

• Engaging a wide range of types of institutions or organizations to broaden participation and impact. 

  Prior Consultation with IC staff

  A limited number of Team Science applications will be funded. Applicants are strongly encouraged to consult with relevant ICs' staff as early as possible prior to submission. Staff can advise on:

  • Alignment with participating ICs' missions, priorities, and program goals.
  • Suitability for a collaborative team science program.
  • Participation of ICs in clinical research and clinical trials.
  • PD/PI's research effort requirement, including R35 awardee participation.
  • ICs' specific budget limitations.
  • Possible submission of renewal application.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Applications Not Responsive to this NOFO

The following types of applications are not responsive to this NOFO and will not be reviewed:

• Applications that propose a clinical trial and only align with the mission of an IC that does not support clinical trials.
  • ICs that do not support clinical trials under this NOFO include: 
    • National Institute of Dental and Craniofacial Research (NIDCR) 

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 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. 

Applications must be submitted as multiple PD/PI applications, with three to six PDs/PIs, all of whom must hold appointments at domestic institutions. 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.

Qualified scientists with the interest and ability to develop a team science program to address an important research question are encouraged to apply:

• NIH encourages the participation of Early Stage Investigators (ESIs) and New Investigators (NIs) as part of the multiple PD/PI team. If the Team Science Grant is awarded, ESIs and NIs who participate as a PD/PI will lose their ESI or NI status on future NIH applications.
• Scientists employed solely by foreign institutions cannot serve as one of the PDs/PIs on the multiple PD/PI team.

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, with the following exceptions or additional requirements:

The Research Strategy is limited to 20 pages and must include the following three components: A) Program Description, B) Team Integration Plan, and C) Summary Table as specified in the Research Plan instructions. If the Research Strategy exceeds 20 pages, the submitted application will be withdrawn without review. 

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.

Project Summary/Abstract: The abstract should provide an overview of a single focused goal for the next five years, and the overall vision of a collaborative research program led by an integrative team. 

Facilities and Other Resources: Describe aspects of the institutional environment and regional research resources that support team science, including how access to these resources will be ensured for team members and across institutional sites if appropriate.

SF424(R&R) Senior/Key Person Profile

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

• Applications must include at least 3 but no more than 6 PD/PIs.
• Inclusion of a scientific project manager or coordinator as a Senior/Key Person is recommended. 

R&R Budget

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

A single integrated application budget must cover research expenses, personnel, equipment, resource assignments, and other costs of the program (e.g., animal use, clinical research, Data Management and Sharing). If applicable, subcontracts may be requested. The requested budget should be consistent with the number of PDs/PIs and the scope, complexity, and resource requirements of the proposed program. Costs associated with team coordination, integration, and sharing of resources and data across team members may also be requested. 

These programs are complex and require significant effort from all PDs/PIs involved. In general, a minimum effort of 2.4 calendar months is expected from each PD/PI. Please refer to IC profile web pages for the specific effort expectations for participating ICs. Participating ICs' staff will verify that the research effort requirements are met before issuing an award. 

Do not request inflationary increases in the overall budget or in any individual budget category. Year-to-year budget changes should reflect shifts in research activities or expected ramp-up or ramp-down of the program, not cost-of-living adjustments. Equipment that duplicates institutional or regional shared facilities already available to investigators must be identified and justified.

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 Research Strategy must include three components: A) Program Description, B) Team Integration Plan, and C) Summary Table and be uploaded as a single attachment. 

A) Program Description (Must be included within the 20-page Research Strategy limit)

The proposed research must be presented as an integrated scientific program with a single, highly focused research goal or problem with sufficient scope, complexity and impact to justify significant resource investment towards a team-based approach. The single goal structure is designed to promote strong integration across interdependent or interrelated components at the conceptual, technical, and interpersonal level. The extent of integration expected for the Team Science Grant goes beyond the structure of a traditional R01 mechanism or Program Project/Center grant.  

To provide a concise overview of the whole project, an optional graphical scheme illustrating the interconnections of the proposed research and collaborative team may be included.

The Program Description should address the following:

• The problem and why it matters – What scientific issue are you addressing, and why is it important?
• Background and rationale – What are your starting assumption, scientific basis, and plan for conducting rigorous research?
• Breaking new ground – How will your project overcome existing obstacles or bring together ideas from different fields in new ways?
• Why a team – Explain why this work requires an integrated team effort and cannot be done by a single researcher or as separate projects. How will the team approach push science forward in a meaningful way?
• Creative solutions – What new or innovative methods will you use to solve scientific or technical challenges, including ones that come out of working as a team?
• Five-year plan – What are your goals for the whole project period, and what are the key milestones along the way?
• Expected impact – What major advances do you expect to make, and what results or products will your work produce?
• Technology and data needs – If you plan to develop new tools or create data-sharing systems, why are they necessary? 
• Existing data and resources – If you plan to use existing datasets or shared resources, how and why will you use them?
• Partners – Which partner agencies, private organizations, or government entities are involved in the project?

Rigor and Transparency: NIH requires researchers to follow its guidelines for rigorous and transparent research (see NIH guidance for rigor and transparency in grant applications). This means designing strong experiments, reducing bias, reporting results honestly, and interpreting findings carefully.

When writing your application, make sure to:

• Separate exploratory and confirmatory research – Clearly identify which parts of your study are exploratory (discovering new things) and which are confirmatory (testing specific hypotheses). Acknowledge the limitations of your study and plan to report all methods, analyses, and results openly, so other researchers can assess and reproduce your work.
• Evaluate your supporting data – If you cite previous research to support your proposed work, state whether that data was collected, analyzed, and reported according to NIH's rigor and transparency standards. If there are any weaknesses or gaps in that prior research, explain how you plan to address them.
• For clinical trials (if applicable) – If your application includes a clinical trial, you must also: 
  • Explain the quality and strength of the data used to justify the trial.
  • Address any gaps or weaknesses in that data.
  • Describe the reasoning behind your trial design, the population(s) you will study, the control group(s) you will use, and the hypotheses you are testing.
  • Identify potential biases and challenges in your study design, and explain how you will assign participants to groups, deliver treatments consistently, and ensure your data is accurate and complete.

B) Team Integration Plan (Must be included within the 20-page Research Strategy limit)

The Team Integration Plan should describe how all team members, including PDs/PIs, co-investigators, collaborators, and consultants, will work together effectively, sharing leadership so that no single person controls team priorities and credit. The plan must make a compelling case that the team's combined skills, integrated knowledge, and institutional context are both necessary and sufficient to achieve the project's goals and address unexpected challenges. 

Important note: A separate Multiple PD/PI Leadership Plan is also required as its own attachment to describe governance, organizational structure, and operation among the leadership team and distribution of overall available resources. Follow the How to Apply - Application Guide instructions and do not repeat the same information. Team Integration and Multiple PD/PI Leadership Plan should complement each other to address team collaboration and team operation, respectively. Both plans will be evaluated together by the reviewers.

The Team Integration Plan should discuss the following:

• Enhanced capabilities – What activities will help keep the team coordinated and balanced? How will these activities enhance the team's existing capabilities and promote team development? 
• Tracking progress and making changes – How will you measure progress, bring in new expertise if needed, and handle leadership changes? Note that any changes to team leadership require prior approval from NIH.
• Giving credit – How will you make sure all team members and contributors are fairly credited for their work and publications? 
• Working together: How does the Team Integration plan and Multiple PD/PI Leadership Plan complement each other to allow the team to build trust, stay aligned on a shared vision, and address the complex research question? 
• Program manager – Do you plan to hire a project manager to support coordination, and if so, what will their role be? 
• External Advisory Committee (EAC) – Do you plan to establish an EAC? An EAC is optional, unless your project involves clinical research, in which case it is required. If you include one, describe the role it will play but do not identify any of its members.

C) Required Summary Table (Must be included within the 20-page Research Strategy limit)

A Summary Table should illustrate the program's single focused goal, the set of research questions it addresses, the composition of the PD/PI team and how each member contributes to the integrated effort, and the anticipated milestones for project advancement. How the team will discuss and adjust plans in response to milestone achievement or unexpected challenges may be addressed elsewhere in the Research Strategy.

The Summary Table should discuss the following:

• Critical milestones and timeline for completion of each milestone.
• Expected contributions from each PD/PI toward each milestone; most milestones are expected to require substantial contributions from more than one PD/PI.
• Milestone dependencies – whether completion of one milestone depends on prior milestones
• Success metrics and criteria for anticipated outcomes and potential deliverables. 

Letters of Support: Letters of support from each collaborator should be limited to one page, must not include Biographical Sketches, and must not include figures and data. Letters of support from foreign collaborators may be subject to NOT-OD-25-098 and require Foreign Justification.  

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. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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.

For this NOFO, team science applications are expected to:

• Propose a single, focused, ambitious, and challenging scientific goal that can only be achieved through a highly synergistic and integrated team effort.
• Demonstrate strong integration across scientific areas, approaches, and team personnel.
• Study key components of the project together, rather than as separate, parallel, or sequential studies or as a multi-component program grant.
• Deliver high-impact outcomes within the funding period.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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.

Assignment of applications will be based on established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the Advisory Council of the participating IC. Funding decisions will follow the Unified NIH Funding Strategy. 

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

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.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience.

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 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. 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.

In carrying out stewardship of grant programs, NIH will periodically evaluate the program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIH may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants' subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

Characteristics of the applicant and awardee pool for the program, such as:

• Composition of research teams.  
• Participation of researchers at different career stages.
• Scientific topics of supported research.
• Institution types.
• Geographic distribution.

Indicators of scientific accomplishments/productivity, such as:

• Peer-reviewed joint research publications and citations.
• Extent of joint co-authorship among team members on publications.
• Presentations at scientific conferences (talks, posters, etc.).
• Patent activity among grantees.
• Co-authored reviews, software, protocols, or methods.

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 General Medical Sciences (NIGMS)

Email: NIGMS-TeamScience@NIH.gov

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

Email: NIDCD-TeamScience@nih.gov

NIDA Referral
National Institute on Drug Abuse (NIDA)
Email: NIDAreferral@mail.nih.gov

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

National Institute of Neurological Disorders & Stroke (NINDS)
NINDSTeamscience@ninds.nih.gov

National Human Genome Research Institute (NHGRI)
Email: nhgri-research-funding@mail.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Division of Extramural Research (DER)
Email: NCCIHDERFunding@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA Scientific Program:

NIAAA-SciContact@mail.nih.gov

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

Include the Funding Opportunity Number in the subject line
 

NLM Extramural Programs
NLMProgram@nih.gov 

NEI Extramural Programs 
NEI_extramural@nih.gov
 

National Institute of Allergy and Infectious Diseases (NIAID)
Email: NIAID_RM1@mail.nih.gov 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
 

National Institute of General Medical Sciences (NIGMS)

Email: NIGMSBBCBGABNOFO@nih.gov

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

Email: nidcdgrantsmgt@nidcd.nih.gov

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

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

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

National Human Genome Research Institute (NHGRI)
Grants Administration Branch
Email: nhgrigab@mail.nih.gov

National Center for Complementary and Integrative Health (NCCIH)
Office of Grants Management (OGM)
Email: NCCIHDERFunding@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Grants Management Contact

Email: NIAAA-GMB@mail.nih.gov

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

Include the Funding Opportunity Number in the subject line
 

NLM Grants Management
NLMGrants@nih.gov 

NEI Grants Management 
NEI_extramural@nih.gov
 

National Institute of Allergy and Infectious Diseases (NIAID)
Email: NIAIDFinancial-GrantsContact@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.