The purpose of this notice of funding opportunity (NOFO) is to support research on interventions to improve health in Native American (NA) populations. This includes 1) etiologic research, where there is a significant gap in knowledge, that will directly inform intervention development or adaptations, 2) research that develops, adapts, or tests the efficacy or effectiveness of health promotion and disease prevention interventions, 3) research that tests culturally informed treatment or recovery interventions and 4) where a sufficient body of knowledge on intervention efficacy exists, research on dissemination and implementation that develops and tests strategies to overcome barriers to the adoption, integration, scale-up, and sustainability of effective interventions. Existing data suggest that significant acute and chronic disease inequities exist for NA populations. Concurrently, NA populations experience unique sociopolitical, historical, and environmental stressors and risks that may exacerbate health conditions and/or impact the effectiveness of existing solutions to address the conditions. They also possess unique strengths and resiliencies that can mitigate stressors or inform intervention strategies. Through this initiative, intervention and related research is sought to build upon community knowledge, resources, and resilience to test science-based, culturally appropriate solutions to reduce morbidity and mortality through identification and remediation of precursors to diseases and disorders and through culturally informed treatment. Interventions should be designed with a consideration for sustainability within the communities where they are tested, and have the flexibility to be readily adapted, disseminated, and scaled up to other communities where culturally appropriate. For the purposes of this NOFO, NA includes the following populations: Alaska Natives, American Indians (whose ancestral lands fall at least partially within the U.S. main land).

PAR-25-378: Intervention Research to Improve Native American Health (R34 Clinical Trial Optional)

Posted Date: January 22, 2025 Open Date (Earliest Submission Date): September 21, 2025 Expiration Date: January 08, 2027

This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Part 1. Overview Information

Participating Organization(s)

• National Institutes of Health (NIH)

Components of Participating Organizations

• National Institute on Drug Abuse (NIDA)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Institute of Dental and Craniofacial Research (NIDCR)
• National Institute of Environmental Health Sciences (NIEHS)
• National Institute of Mental Health (NIMH)
• National Institute of Nursing Research (NINR)
• National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers:

• Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
• Office of Behavioral and Social Sciences Research (OBSSR)
• Office of Research on Women's Health (ORWH)
• Tribal Health Research Office (THRO)

Funding Opportunity Title

Intervention Research to Improve Native American Health (R34 Clinical Trial Optional)

Activity Code

R34 Planning Grant

Announcement Type

Reissue of PAR-23-285

Related Notices

• Notices of Special Interest associated with this funding opportunity
• April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON)

PAR-25-378

Companion Funding Opportunity

PAR-25-379, R01 Research Project

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.279, 93.213, 93.866, 93.121, 93.313, 93.273, 93.865, 93.242, 93.113, 93.361, 93.310

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support planning and development, including pilot or feasibility research, to improve health in Native populations. Proposed research may address health promotion, disease prevention, treatment, recovery, or services research to inform intervention implementation and dissemination. Research with Native populations requires engagement with tribal partners and communities to develop and/or adapt interventions and clinical trial protocols, understand intervention feasibility and acceptability, and identify and/or develop scientifically rigorous and culturally appropriate study designs and methods. Preparatory studies may fill information gaps, address unknowns, allow for strengthening of partnerships with Native community leaders and organizations, and pilot test the feasibility of the intervention and clinical trial design, thereby improving scientific rigor and cultural appropriateness of a future efficacy, effectiveness, or implementation trial. This NOFO is part of the Intervention Research to Improve Native American Health (IRINAH) initiative, which also includes PAR-25-379, which uses the R01 Research Project Grant mechanism. Research projects may address topics within the identified interests of any of the participating Institutes or Centers; projects are not limited to substance use and addiction research.

For the purposes of this NOFO, Native Americans are defined as people who are members of Indigenous Tribes and communities, irrespective of where they live or reside, that have been recognized as having a special political and trust relationship with the United States, including those Tribes, bands or groups terminated since 1940 and those recognized now or in the future by the State in which they reside. This includes members or up to second generation descendants of federally recognized American Indian and Alaska Native Tribes (U.S. Constitution, Article I, Section 8, Clause 3; Cherokee Nation v. Georgia, 30 U.S. 1 (1831); Worcester v. Georgia, 31 U.S. 515 (1832); 25 U.S.C. 5301(a)), and state recognized tribes and Urban Indians as described in the Indian Health Care Improvement Act (Public Law 94-437, 25 U.S.C. 1601 et seq., as amended by Public Law 117-58, November 21, 2021)). Also included for purposes of this NOFO are Native Hawaiian communities as described in the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11701 et seq.)

Funding Opportunity Goal(s)

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Key Dates

• Posted Date: January 22, 2025
• Open Date (Earliest Submission Date): September 21, 2025
• Expiration Date: January 08, 2027

The following table includes NIH standard due dates marked with an asterisk.

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.

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

• Part 1. Overview Information
  • Key Dates
• Part 2. Full Text of Announcement
  • Section I. Notice of Funding Opportunity Description
  • Section II. Award Information
  • Section III. Eligibility Information
  • Section IV. Application and Submission Information
  • Section V. Application Review Information
  • Section VI. Award Administration Information
  • Section VII. Agency Contacts
  • Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) is to support planning and development, including pilot or feasibility research, in advance of a clinical trial testing interventions to improve health in Native populations. Proposed research may address health promotion, disease prevention, treatment, recovery, or services research to inform intervention implementation and dissemination. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, recruitment challenges, intervention feasibility and acceptability, outcome measures, data and statistical challenges or operational risks necessary to finalize the trial protocol completely. Native populations experience unique sociopolitical, historical, and environmental stressors and risks that may exacerbate health conditions and/or impact the effectiveness of existing solutions to address the conditions. They also possess unique strengths and resiliencies that can mitigate stressors and inform intervention strategies. Research with Native populations requires engagement with tribal partners and communities to develop or adapt interventions and evaluate them with clinical trial protocols that are rigorous and culturally appropriate. Preparatory studies may fill information gaps, address unknowns, allow for strengthening of tribal partnerships, and pilot test the feasibility of the intervention and clinical trial design, thereby improving scientific rigor and cultural appropriateness of the future clinical trial. Research projects may address topics within the identified interests of any of the participating Institutes or Centers (see Overview Information, Components of Participating Organizations in Part 1 for a list of participating ICs).

For the purposes of this NOFO, Native Americans are defined as people who are members of Indigenous Tribes and communities, irrespective of where they live or reside, that have been recognized as having a special political and trust relationship with the United States, including those Tribes, bands or groups terminated since 1940 and those recognized now or in the future by the State in which they reside. This includes members or up to second generation descendants of federally recognized American Indian and Alaska Native Tribes (U.S. Constitution, Article I, Section 8, Clause 3; Cherokee Nation v. Georgia, 30 U.S. 1 (1831); Worcester v. Georgia, 31 U.S. 515 (1832); 25 U.S.C. 5301(a)), and state recognized tribes and Urban Indians as described in the Indian Health Care Improvement Act (Public Law 94-437, 25 U.S.C. 1601 et seq., as amended by Public Law 117-58, November 21, 2021)). Also included for purposes of this NOFO are Native Hawaiian communities as described in the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11701 et seq.).

Background

Despite tremendous strengths, Native populations have significantly varying rates of disease across many health outcomes such as chronic disease, substance use and addiction, cancer, mental illness, and sexually transmitted diseases. These disease outcomes in many cases can be traced to social and environmental challenges such as poverty, unemployment, pollution, and poor access to health care in combination with unique factors impacting Native people, such as historical trauma. In the face of these challenges, resiliencies and strengths within Native communities and individuals have been drawn upon to improve health outcomes.

A critical step towards ensuring scalable and sustainable interventions to reduce significantly varying rates of diseases and health conditions impacting Native communities is the development of scientifically rigorous and culturally appropriate clinical trials to test intervention efficacy, effectiveness, and implementation. Active and meaningful engagement of tribal communities and tribal leadership is essential to successful intervention development, adaptation, testing, implementation, and dissemination and to accelerate the translation of findings generated by the proposed research into practice. To this end, this R34 NOFO supports planning studies to strengthen community and tribal partnerships, develop and adapt interventions, collect intervention feasibility and acceptability data, test recruitment and retention strategies, and/or address clinical trial study design questions. Studies under this R34 planning grant are intended to address issues that will prepare the future clinical trial protocol for successful implementation and completion and facilitate rigorous full-scale testing of promising interventions to improve health of Native people and communities. Applicants must include specific milestones and/or study targets that, if met, will indicate readiness to conduct the planned future intervention efficacy, effectiveness, or implementation trial.

This NOFO is part of the Intervention Research to Improve Native American Health (IRINAH) initiative (see: https://cancercontrol.cancer.gov/native-american-intervention). The initiative also includes PAR-25-379, which uses the R01 Research Project Grant mechanism.

Not all NIH Institutes and Centers (ICs) participate in all three NOFOs. Please speak with the Scientific Contact for the IC listed in Section VII below for the IC you wish to target to discuss which NOFO might be the best fit for your proposed project.

Scope

The activities proposed will depend on the stage of intervention development, the delivery setting, and the type of future trial proposed (e.g., efficacy, effectiveness, or implementation). Pilot tests of feasibility and acceptability of the intervention and/or future trial protocol are within scope of this NOFO.

Research should be designed in such a way that there is a high probability that interventions delivered can be scaled and sustained if the future trial finds the intervention to be effective. To ensure sustainability of intervention designs and service delivery strategies tested, applicants should, whenever possible, partner with tribes/communities and localities that use existing programming funds (e.g., funding from CDC, SAMHSA, Indian Health Services, Medicaid, Medicare and other insurance providers, and other program funding as appropriate) to support evidence-based programs and leverage those resources as the foundation for building infrastructure.

Examples of appropriate research activities include the following, but this list is not intended to be exhaustive:

• Activities to further develop and establish meaningful and trusted partnerships with Native communities.
• Develop culturally grounded study designs in collaboration with Native community partners to ensure acceptability and feasibility in Native communities, including developing and/or selecting an intervention, defining the appropriate study population, outcome, study endpoint, and control or comparison group to use in the subsequent efficacy, effectiveness, or implementation trial.
• Determine the acceptability and feasibility of the intervention for study participants, Native communities, and tribal partners, including standardization across sites and measures of intervention fidelity when appropriate.
• Adapt, standardize, and/or validate an intervention or assessment originally designed for non-Native populations for Native populations.
• Develop a novel intervention grounded in Indigenous Knowledge, empirical and/or theoretical evidence, and/or adapt or standardize an intervention currently used in Native communities to plan for a future efficacy or effectiveness trial.
• Develop culturally appropriate recruitment and retention strategies that engage Native communities.
• Develop culturally informed study protocols, data and safety monitoring plans, analytical plans, and data management and sharing plans.
• Standardize and test the effectiveness of training tools for implementation of the intervention or clinical trial protocol.
• Employ qualitative methods, including talking circles, interviews, or focus groups as needed to address study aims and the development, testing and validation of quantitative survey tools. Qualitative or mixed methods research may also be helpful to assess community or tribal approval and commitment and to contextualize quantitative research findings as appropriate.
• Planning activities to assess the potential feasibility and acceptability of implementation strategies to be utilized in a future implementation research trial in Native communities, including planning for hybrid effectiveness implementation studies.

This R34 NOFO will not support research testing intervention efficacy or effectiveness.

Efficacy or effectiveness research could be submitted to the companion IRINAH R01 NOFO (PAR-25-379).

Preliminary data are not required for this NOFO.

Applications Not Responsive to this NOFO

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

• Applications that do not include an intervention or proposal to develop an intervention within the award period
• Applications that propose efficacy or effectiveness testing of an intervention
• Applications that only propose to write a protocol or manual
• Applications that propose research objectives that are not aligned with the mission of any of the participating ICs
• Applications that do not propose community-engaged projects

Additional Considerations for Proposed Research

Applicants are encouraged to consult American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications, which can be found at https://dpcpsi.nih.gov/sites/default/files/Critical_Considerations_for_Reviewing_AIAN_Research_508.pdf

Coordination across projects

Although the studies supported by the IRINAH initiative will not use a common study protocol, investigators are expected to meet regularly to participate in activities in support of advancing research on Native health. Such activities could include participating in cross-cutting interest groups, sharing and discussion of measures, and developing collaborative publications and products. An annual meeting will be held of all investigators with optional attendance by community partners funded by the IRINAH initiative; monthly or bi-monthly phone calls will also be held. Locations of the annual meeting will vary depending on sites funded through the initiative. Project budgets should include costs for one or more study team members to attend the annual meeting.

Conceptions of Health

While the absence of a particular disease is a critical outcome, the concept of health within many Native communities embodies wellness and is broader than the absence of disease. All four elements of life — physical, emotional, mental, and spiritual — are intricately woven together and interact to support a strong and healthy person. In this holistic perspective, illness results from imbalance and wellness from balance in these elements. For Native people who identify strongly with tribal or indigenous culture, working with traditional healers or engaging in traditional cultural practices may be a core strategy to address disease or improve wellness. For this NOFO, investigators are encouraged to consider Native concepts of health and Native traditional practices as appropriate and approved by the community.

Community Engagement

The appropriate conduct of research with Native populations has been widely documented; research must be conducted in a community-engaged manner, where the community has an equal voice as a research partner. The research should be consistent with community desires and informed by these at every step of the process. Community based participatory research (CBPR) approaches are one way to ensure appropriate engagement with communities in research and the cultural appropriateness of the intervention, study design and overall approach. Where communities desire to do so, researchers should incorporate a CBPR approach. Communities may choose to pursue approaches other than CBPR, and other forms of community-engaged research are acceptable for this NOFO. The community/tribe(s) must be appropriately involved in the study design and overall approach.

Culturally Appropriate Research and Preparatory Activities

Native communities and experts on Native research have made clear the importance of culture in addressing health outcomes. Investigators are encouraged to consider culturally unique etiological factors or targets for intervention, relying on culturally relevant theories to frame research, considering culturally specific world views and Indigenous Knowledge as they relate to the research approach and design, culturally sensitive research processes, and culturally appropriate measurement strategies and processes.

Strength-Based Focus

Since many communities place a high value on the strengths and resilience of Native peoples, investigators are encouraged to incorporate community/cultural strengths and resilience. It is appropriate to consider community resilience in addition to the resilience of individuals.

Interventions

Interventions must be consistent with community cultural values, and be supported by theory or empirical knowledge, which can originate from Indigenous Knowledge or from culturally appropriate non-Native paradigms. Interventions may include traditional health, medical, and/or cultural practices independent of or in concert with practices that have been tested in research with non-Native populations. Intervention delivery should, whenever possible and scientifically or otherwise appropriate, employ individuals from the community. Such interventionists could include behavioral professionals, community health workers, counselors, nutritionists, nurse practitioners, physician assistants, or traditional healers.

Beyond the Individual

Reflecting the importance of community and relations, researchers should consider proposing studies that address community, institutional, familial, peer network, or other factors that directly influence health outcomes or that impact individual's abilities to enact health preserving practices. This could include multi-level intervention approaches or addressing and reporting on changes in known contextual influences while intervening to create individual level change. However, the interventions should not be so intensive or time-consuming that they would exceed the resources of the participants/community to participate or affect sustainability.

Future Clinical Trial Design Considerations:

Investigators are encouraged to work with Tribal partners and communities to identify potential research designs that will provide robust evidence of intervention efficacy or effectiveness in the future clinical trial. Rigorous research designs are expected, but investigators are not required to conduct randomized controlled trials in the future trial. and to ensure that they have appropriate statistical expertise on the study team to address any non-independence or other potential sources of bias in the study design.

If participants are assigned to study arms for the future trial, other potentially appropriate study designs with randomization include parallel group or cluster-randomized trials, individually randomized group-treatment trials, and stepped wedge group or cluster-randomized trials. When it is not possible to assign participants to study arms for the future trial, alternative rigorous research designs that provide robust evidence of intervention effectiveness include, but are not limited to, multiple baseline or repeated measures designs, interrupted time series studies, or stepped-wedge cluster randomized trials in which all subjects receive the intervention.

In these studies, special methods may be warranted for analysis and sample size estimation, particularly for small samples where traditional experimental randomization is not possible without impacts on bias or contamination. Planning activities proposed under this NOFO may include working to incorporate such methods into the clinical trial protocol and research design.

Research Objectives

Participating NIH ICs have identified priority research areas (see Overview Information, Components of Participating Organizations in Part 1 for a list of participating ICs). Applicants are encouraged to speak with IC representatives for technical assistance (see Agency Contacts in Section VII). Applicant organizations with limited research experience are strongly encouraged to develop applications in collaboration with research organizations.

Applicants should ensure that the IC they wish to target participates in the IRINAH NOFO to which they wish to submit. Applications that do not align with the missions of any of the participating ICs will be considered non-repsonsive.

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

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Resubmission

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request direct costs of up to $450,000 for three years. Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000.

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

• Higher Education Institutions
  • 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 Government
  • Eligible Agencies of the Federal Government
• U.S. Territory or Possession
• Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

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

Instructions for Application Submission

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

• SF424(R&R) Cover All instructions in the How to Apply-Application Guide must be followed.
• 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.
• Milestone and Study Target Plan - Required - 2 page maximum Applicants must include an Other Attachment entitled Milestone and Study Target Plan. This R34 NOFO is intended to provide planning time for a future trial; the Milestone and Study Target Plan should describe the decision points that would justify moving to a full trial based on the planned activities in the R34 and the nature of the future trial. Such targets might include agreements reached with community and tribal partners, success metrics for recruitment strategies, measure validation metrics, thresholds for measures of intervention and/or protocol acceptability and feasibility, or any other appropriate milestone or target. These decision points should be specific, well justified and, when appropriate, should be quantified. Milestones and study targets should not be a restatement of the study aims. The justification for the milestones and study targets should be discussed in the context of the goal of the future trial (e.g., testing intervention efficacy, effectiveness, or implementation) and include the specific ways that reaching these targets will indicate readiness for a future trial of the intervention.
• SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply-Application Guide must be followed.
• R&R or Modular Budget All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
  • The combined budget for direct costs for the project period may not exceed $450,000. No more than $225,000 in direct costs may be requested in a single year.
  • Budgets should include domestic travel funds for one or more study team members to attend the annual IRINAH investigators meeting.
• 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 should describe the significance of the proposed research in the context of the future efficacy, effectiveness, or implementation trial it is meant to inform. Applicants must provide evidence that the research question addressed is relevant to and prioritized by the Native community partners for the study and that the project, if completed successfully, can improve the health of one or more Native communities. Applicants should clearly articulate how their research builds fundamental knowledge relevant to Native health. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and to use that knowledge to enhance health, lengthen life, and reduce illness and disability. Through this initiative, fundamental knowledge includes findings that may be specific to a Native American community or group of communities, even if the outcomes may not generalize broadly. Fundamental knowledge may also be defined as principles for community engaged research, or methodological innovations. Applicants must demonstrate innovation in their proposed research. Some examples of the types of innovations that may be included are the use of Indigenous Knowledge, research capacity development, novel research design and analysis, novel approaches to community engagement and/or participant recruitment, research to address the cultural appropriateness of standard measures or develop new measures, determination of culturally/clinically meaningful effect sizes for a future efficacy or effectiveness trial, or through the development or adaptation of interventions.
  • Investigators Investigators, both those from research institutions and those who work with or in the community, must show relevant proficiency to conduct the proposed research, including proficiency for working with Native partners and communities. Indications of proficiency might include research publications, efforts to build relationships and trust with communities, dissemination of information to Native communities, personal engagement in community events, provision of training to communities, knowledge of community systems and settings, leadership roles in the community, and expertise in Indigenous research and methodologies. Productivity of community-based investigators may rely on a description of their proficiency in working within the community.
  • Partnerships and collaborations The community-researcher partnership must be documented in the Research Strategy section to describe the community's support for and involvement in development, design, testing, and dissemination of the study, including establishing a Community Advisory Board. If using CBPR research methods, these must be appropriately documented. The description of the community-research organization partnership must describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. If building upon existing partnerships, the application should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, procedures for resolving disagreements, and the relative contributions to the previous and current projects.
  • Approach
    • Preliminary data: Applications to this NOFO are not required to present preliminary/pilot data in support of the proposed approaches, hypotheses and aims; rather, a well-defined theory of change, logic model, or cultural source and associated hypotheses are expected.
    • Specific justification must be provided for the necessity of all planning and intervention development activities proposed, including cultural adaptation of interventions or measures that have been used or validated with other populations. Research questions that have been addressed for other populations may still need to be specifically addressed for Native people if there is reason to believe that processes might operate differently for a Native community or Native populations more broadly. Appropriate justifications of scientific gaps areas must be provided in the applications. Justifications for the premise of the research can be established based on documentation from scientific and/or cultural sources.
    • Whenever possible, evidence should be included of the feasibility of planning and research activities proposed, including prior collaborations between the investigators and between the research team and study partners, prior experience working with the study population, and prior experience with the measures and methods to be used or tested in the research.
    • When the research involves intervention development, adaptation, or acceptability and feasibility testing, the intervention (or the process of its initial development) must be described, including the theoretical and empirical evidence informing the intervention, the proposed mechanisms of action of the intervention, the health outcomes the intervention is meant to impact, and any relevant protective factors or risk factors that the intervention acts on or through for its hypothesized effects. When appropriate, the study should include plans for assessing fidelity of intervention and/or protocol implementation and/or plans for manualization or other standardization practices. The application must describe how the approach taken will support the future sustainability of the intervention, and any implications for implementing or disseminating the intervention if it is found to be effective in the future trial.
    • The pilot studies proposed under this NOFO may or may not require a comparison condition. If included, the application should describe and justify the nature of any comparison/control group (e.g., whether the comparison group will receive information only, minimal treatment, or delayed intervention or some other design). Applicants should consult with collaborating communities to discuss the appropriateness of the selected approach to the comparison group, as tribal leaders and community members may believe that comparison group members should receive something more than usual care.
  • Letters of Support Provide all appropriate letters of support, including those from community partners, collaborators, tribal resolutions, and others. Letters of support should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects. Each Native organization that participates in the project should submit a letter of support. Applications that represent a partnership between a research organization and one or more tribes or communities should include a resolution from each tribal or community government or equivalent document, specifying that the community or tribe agrees to participate as a partner in the project and will strongly support the project for its entire duration. If the application includes a consortium of tribes or communities, applicants should provide a resolution of support from each tribe or community of the consortium. If the applicant is a tribally sanctioned non-profit tribal organization, specific tribal resolution(s) of support will not be required if the current tribal resolution(s) under which the organization operates encompasses activities proposed in the application. A copy of the current operational resolution(s) must be submitted with the application. In recognizing that Tribal governments are legal sovereign nations, potential partners should be informed that tribes may seek ownership or control of all data and all biological samples; therefore, universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements with tribes/Tribal government(s) as appropriate. If such an agreement is in place the applicant(s) should provide the letter of such an agreement with the application. Letters of Support should also explicitly stipulate that Tribes agree to respond expeditiously to requests for approval of the protocol, protocol modifications, approval of abstracts for presentation to scientific meetings, and approval of manuscripts for submission for publication in scientific journals. The time required for approving each of these (protocol, abstracts, manuscripts): 1) must be proposed and stated within the resolution of support, 2) may differ for each of these activities, 3) may be modified by study investigators only in consultation with the tribal/community leadership, and 4) should identify an individual or entity within the tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise. PD/PI(s) and tribes/communities are expected to publish scientific papers, present at scientific conferences/associations/meetings; and may also be expected to develop fact sheets/materials for dissemination to the tribe/community. If the applicant(s) is working with communities, tribes/tribal governments then community/tribal resolutions of support, or equivalent documents, should accompany the application whenever possible. However, tribal resolutions and letters of support from community collaborators may be submitted as post-submission material up to 30 days before the study section meeting. The date of the study section meeting will be posted in eRA after submission. Note that this flexibility is NOT extended to letters of support from Key Personnel and consultants with academic or research organization affiliations. Letters of support from personnel with academic or research organization affiliations must be submitted with the application (on either October due date for non-AIDs applications or the January due date for AIDs applications listed in the Key Dates table above).
  • 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:
    • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
    • Applicants should refer to the NIH Considerations for Researchers Working with AI/AN Communities page and NOT-OD-22-214 Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data.
  • 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. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

Information on the submission process and a definition of on-time submission are provided in the 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 NIDA and/or other participating NIH Institutes and Centers. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

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

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

Post Submission Materials

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

Specific to this NOFO:

Letters of Support/Tribal Resolutions sent as post submission materials must be submitted as PDFs by the Authorized Organization Representative (AOR) of the applicant organization. Although the post-submission materials may originate from the PD/PI, Contact PD/PI, or organizational officials, the AOR must send the materials directly to the SRO or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted. Please see Part 2. Section IV PHS Research Plan instructions for which letters of support are permissible as post submission materials.

Each Letter of Support submitted as post submission materials should contain the following:

• Principal Investigator(s) name(s)
• Principal Investigator(s) email(s)
• Principal Investigator(s) phone number(s)
• Title of the project
• Grant number (if available)

Section V. Application Review Information

1. Criteria

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

For this particular NOFO, note the following:

• Reviewers are encouraged to consult American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications. This document was commissioned by the NIH Tribal Health Research Office and a working group of NIH staff in order to assist reviewers in understanding the unique context of applications proposing research with American Indian and Alaska Native communities so that they can provide the most informed reviews.
• Reviewers are also asked to carefully review Part 2. Section I and Part 2. Section IV of this NOFO for important additional context for the applications.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1: Importance of the Research

• Significance Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance. Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g. prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
• Innovation Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies, or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Specific to this NOFO:

• Significance
  • Evaluate whether the project addresses research questions relevant to and prioritized by Native community partners.
  • Evaluate the extent to which the project, if completed successfully, will improve the health of one or more Native communities.
• Innovation
  • Assess innovation in the project’s approach to Native health, including incorporating Indigenous Knowledge, addressing the cultural appropriateness of new or standard measures, developing or adapting interventions, or in other ways as appropriate (see Section IV above for further examples).

Factor 2. Rigor and Feasibility

• Approach Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
  • Rigor:
    • Evaluate the potential to produce unbiased, reproducible, robust data.
    • Evaluate the rigor of experimental design and whether appropriate controls are in place.
    • Evaluate whether the sample size is sufficient and well-justified.
    • Assess the quality of the plans for analysis, interpretation, and reporting of results.
    • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
    • For applications involving human subjects or vertebrate animals, also evaluate:
      • the rigor of the intervention or study manipulation (if applicable to the study design).
      • whether outcome variables are justified.
      • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
      • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
    • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.
  • Feasibility:
    • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
    • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.
    • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Specific to this NOFO:

• Evaluate evidence of the community-research organization partnership and mutual understanding of responsibilities among the collaborators of the proposed project.
• Evaluate the scientific justification for the planning and intervention development/adaptation activities.
• Assess whether the intervention is adequately described, including its proposed mechanisms of action, considering whether a novel intervention is being developed or a current intervention is being adapted.
• Evaluate how the project addresses the future sustainability and/or implications for implementing and/or disseminating the intervention, if successful, to other Native communities/tribes.
• Assess the extent to which the milestones and study targets are specific, well justified, and, when appropriate, quantified.
• Evaluate the extent to which the proposed milestones and study targets are appropriate for informing a decision to conduct a future efficacy, effectiveness, or implementation trial of the intervention.

Factor 3. Expertise and Resources

• Investigator(s) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
• Environment Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Specific to this NOFO:

• Investigator(s) Evaluate evidence of the PD(s)/PI(s)'s proficiency to conduct the proposed research, including proficiency for working with Native partners and communities (see Section IV above for examples, including those for community members serving as an investigator).
• Environment Evaluate evidence of support from Native American tribes and community partners.

Additional Review Criteria

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

• Protections for Human Subjects For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
• Vertebrate Animals When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
• Biohazards When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
• Resubmissions As applicable, evaluate the application as now presented.
• Renewals Not Applicable
• Revisions Not Applicable

Additional Review Considerations

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.

• Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

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. 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, due 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
• HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
• 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.
• Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Successful recipients under this NOFO agree that:

• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
• Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.
• 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:
  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  2. 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. Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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.

Application Submission Contacts

• eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
  • Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
  • Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
• General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
  • Email: grantsinfo@od.nih.gov (preferred method of contact)
  • Telephone: 301-480-7075
• Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
  • Contact Center Telephone: 800-518-4726
  • Email: support@grants.gov

Scientific/Research Contact(s)

• Sarah Vidal, Ph.D. National Institute on Drug Abuse (NIDA) Phone: 301-827-5529 Email: sarah.vidal@nih.gov
• Liam O'Fallon, Ph.D. NIEHS - National Institute of Environmental Health Sciences Phone: 984-287-3298 or 919-802-6523 Email: liam.ofallon@nih.gov
• Sheila Caldwell, PhD Tribal Health Research Office Phone: 301-480-3527 email: sheila.caldwell@nih.gov
• Erin R. Harrell, Ph.D., PMP Division of Behavioral and Social Research (DBSR) National Institute on Aging (NIA) Email: erin.harrell@nih.gov
• Frank Bandiera, Ph.D. Division of Behavioral and Social Research (DBSR) National Institute on Aging (NIA) Email: frank.bandiera@nih.gov
• Dawn Morales Ph.D. National Institutes of Mental Health (NIMH) Telephone: 301-827-9668 Email: dawn.morales@nih.gov
• Melissa C. Green Parker, Ph.D. Office of Disease Prevention (ODP) Phone: 301-480-1161 E-mail: melissa.greenparker@nih.gov
• Hiroko Iida, DDS, MPH NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH Phone: 301-594-7404 E-mail: iidah@nidcr.nih.gov
• Tatiana Balachova, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Telephone: 301-443-5726 Email: tbalachova@mail.nih.gov
• Lanay M. Mudd, Ph.D. National Center for Complementary and Integrative Health (NCCIH) Phone: 301-594-9346 Email: lanay.mudd@nih.gov
• Elena K Gorodetsky, M.D., Ph.D. ORWH - Office of Research on Women's Health Phone: (301) 594-9004 E-mail: elena.gorodetsky@nih.gov
• Karen Marie McNamara, PhD National Institute of Nursing Research (NINR) Telephone: 301-337-1372 Email: karen.mcnamara@nih.gov
• Juanita J. Chinn, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-827-4901 Email: juanita.chinn@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

• Chief Grants Management Officer National Institute of Drug Abuse (NIDA) Email: NIDA_GM@nida.nih.gov
• Jenny Greer NIEHS - National Institute of Environmental Health Sciences Phone: 984-287-3332 Email: jenny.greer@nih.gov
• Ryan Blakeney National Institute on Aging (NIA) Telephone: 301-451-9802 Email: ryan.blakeney@nih.gov
• Robert Munk National Institute of Mental Health (NIMH) Telephone: (301) 443-3034 Email: munkr@mail.nih.gov
• Gabriel Hidalgo, MBA NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH Phone: 301-827-4630 E-mail: gabriel.hidalgo@nih.gov
• Debbie Chen National Center for Complementary and Integrative Health (NCCIH) Phone: 301-594-3788 Email: debbie.chen@nih.gov
• Randi Freundlich National Institute of Nursing Research (NINR) Telephone: 301-594-5974 Email: randi.freundlich@nih.gov
• Margaret Young Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-642-4552 Email: youngm@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.

Authority and Regulations

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.

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