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 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.

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.



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 NOFO is to seek applications for a Coordinating Center (CC) as part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network. Members of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, including the CC and separately funded research projects, will work collaboratively with the NIH to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. The MSPI Research Network will include the CC funded under this Cooperative Agreement and up to 10 Research Projects funded under the companion UG3/UH3 Phased Cooperative Agreement NOFO, PAR-24-053, Multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities.

The CC will provide overarching support and guidance to the network in three domains: (1) administration, coordination, and communication; (2) methodology, data, and analytic support and consultation; and (3) community and other collaborator engagement and dissemination support. It is important that applicants for the CC also read the companion NOFO to understand the full mission and structure of the research network.

Key Definitions for this NOFO

Preventive intervention: For the purposes of this NOFO, preventive interventions include both primary and secondary prevention. Primary prevention involves interventions or policies designed to prevent or reduce risk factors for developing a new health condition before health effects occur. Secondary prevention involves interventions or policies designed to prevent the development of a new health condition among those with identified risk factors, recurrence of a health condition, or progression of an early-stage health condition. Preventive interventions are inclusive of interventions to prevent or reduce risk factors, screen for risk factors or signs of early disease, or provide referrals or brief treatment to prevent disease onset or progression of early-stage conditions. Projects developing technologies, such as devices and algorithms, as part of risk factor screening or preventive interventions also fall within this definition.

Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Black Americans/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians/Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities, and people living with disabilities.

Social determinants of health (SDOH): The conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life. These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH Conceptualization.

Multi-sectoral intervention: An intervention involving two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.). These sectors may include neighborhood, city, county, regional, state, national, or tribal governmental or non-governmental organizations. For the purposes of this NOFO, research teams from academic institutions or research organizations are not considered as a service sector. However, institutions of higher learning would be considered as a service sector for multi-sectoral interventions directed towards students of those institutions.

Level of Influence: The socio-ecological levels (e.g., individual, interpersonal, organizational, community, or societal) at which specific determinants operate to influence risk factors and subsequent health outcomes (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence). To constitute an intervention at the interpersonal, organizational, community, or societal level, the intervention must directly alter determinants at that level, not just be delivered in a setting at that level or help individuals manage the consequences of determinants at that level. For example, an intervention to promote better nutrition among school-aged children by adjusting available food options in the school cafeterias would be an organizational-level intervention; an intervention providing nutrition information to students within the schools would be an individual-level intervention.

Background

The NIH Office of Disease Prevention (ODP) within the Office of the Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), is coordinating the new trans-NIH research effort, ADVANCE: Advancing Prevention Research for Health Equity, which grew out of the ODP’s portfolio analysis of NIH research. In an examination of NIH-funded grants and cooperative agreements between fiscal years 2012 and 2017, the ODP found that only 8.5% of all projects focused on preventing the leading risk factors or causes of death and disability (e.g., poor nutrition, low physical activity, smoking), falling well below their burden on the nation’s health. An additional analysis of the NIH research portfolio showed that between fiscal years 2016 and 2019, only 3.6% of NIH-funded prevention projects included a randomized intervention to address a leading risk factor in populations that experience health disparities.

To address this research gap, this ADVANCE initiative will support research projects to test preventive interventions addressing risk factors for chronic or acute health conditions in populations that experience health disparities. Prevention or reduction of leading risk factors in HD populations requires moving beyond addressing knowledge, attitudes, and behaviors of individuals to intervene upon social determinants of health (SDOH) that drive inequities, such as limited access to healthy food options, limited opportunities for physical activity, lack of access to healthcare, and exposure to stigma, discrimination, and violence. Multi-sectoral collaborations that span multiple service sectors and community-based organizations have great potential to develop, implement, and sustain preventive interventions that address SDOH and promote health equity. In addition, collaboration and coordination across research teams implementing these interventions can maximize impact through data harmonization and sharing that can enhance the generalizability or applicability of findings.

MSPI Research Network Structure

The MSPI Research Network will consist of a Coordinating Center (CC) and the awarded UG3/UH3 Research Projects (see PAR-24-053). The CC and each of the Research Projects will also work collaboratively with one or more Project Scientists and Program Officers from NIH Institutes, Centers, and Offices (ICOs).

The MSPI Research Network priorities and activities will be governed by a Steering Committee (SC), which at a minimum will include at least two representatives from each Research Project (e.g., research and community organizational MPI or key personnel), the CC, and at least one NIH representative. The MSPI Research Network SC will meet at least monthly and be chaired by personnel from the CC. Based on the priorities set by the SC, relevant workgroups will be established to carry out cross-project activities or consultation. For example, NIH anticipates there will be at least three workgroups (preventive intervention methodology and data analysis, measures and data harmonization, and network dissemination activities).

Scope of Work for the MSPI Research Network Structure

The CC will provide a wide range of support and guidance to the individual Research Projects as well as activities that span across Research Projects.

Specifically, support will be provided in three main areas:

1. Administration, coordination, and communication: The administrative functions include facilitating the work of the MSPI Research Network members and NIH scientific staff in the overall program management of the network. Activities include, but are not limited to:

• Leadership and project management for administrative, coordination and communication functions, including logistics and management support, such as organizing all network-related meetings and maintaining documentation (tracking and reporting) on activities of the network
• Establishing, in coordination with NIH staff, an MSPI Research Network Steering Committee to develop policies governing matters such as authorship, communications, data sharing, etc.
• Supporting collaboration and communication among the MSPI Research Project PIs, NIH program and scientific staff, Steering Committee members, and other committees, boards or groups associated with the network as appropriate
• Developing and facilitating working groups on topics of specific interest to the work of the network, such as preventive intervention methodology, measures and data harmonization, and network dissemination activities
• Developing an organizational and administrative structure to promote collaboration, provide technical assistance, and facilitate interaction across the network, including maintaining a network directory (sites, investigators, and collaborators) and a web-portal to assist with information sharing

2. Methodology, data, and analytic support and consultation. Activities may include but are not limited to:

• Providing methodological and statistical consultation for Research Projects as well as network-wide research activities. Expertise is expected in design and analytic methods appropriate for studies that evaluate prospective preventive interventions beyond the individual level. Such study designs may include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster randomized trials, rigorous quasi-experimental designs such as a group- or cluster-level regression discontinuity designs, interrupted time-series designs, or rigorous alternatives.
• Providing consultation on individual and structural SDOH measures, including, but not limited to those included in the PhenX Toolkit (www.phenxtoolkit.org).
• Assisting Research Projects with the compilation of publicly available surveillance, administrative, or other local, state, or federal data as relevant.
• Supporting data harmonization and preparing data for archival in an NIH-approved repository, as appropriate. Developing agreements across Research Projects to enable data sharing and aggregation for network-wide research efforts.
• Communicating and providing technical assistance as needed on data sharing, IRB or other human subject issues and adherence to any relevant federal data standards.

3. Community and other collaborator engagement and dissemination support. Activities may include but are not limited to:

• Creating and supporting one or more network-wide advisory boards representing appropriate members of the public, government agencies, relevant communities, systems and settings to provide support for research and dissemination activities as appropriate
• As needed, providing support in convening and exchanging best practices for engagement across communities on recruitment approaches, communications, and retention; identifying and addressing barriers to implementation; and facilitating strong community impact
• Creating public-facing communications materials (including social media) designed for study partners to promote the MSPI Research Network, including a network newsletter for research teams, communities, and participants, and coordinating with other ADVANCE or relevant NIH-funded projects as appropriate
• Providing support for dissemination activities initiated by the Steering Committee or other network partners
• Leading a multi-modal effort to rapidly and broadly disseminate information generated by the MSPI Research Network, including but not limited to project summaries and updates; lessons learned; and preliminary and overall research findings to a broad audience (e.g., academic community, practitioners, policymakers, community service providers, etc.).

Applications Not Responsive to the NOFO

• Applications that do not propose activities in all three (3) required areas (administration, coordination, and communication; methodology, data, and analytic support and consultation; and community and other collaborator engagement and dissemination support).
• Applications that include a clinical trial.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

Pre-application technical assistance

Information regarding a pre-application webinar and frequently asked questions (FAQs) will be provided in a forthcoming Notice published in the NIH Guide.

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

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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.
  • 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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov

Page Limitations

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

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

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should budget for travel to and coordination of at least one in-person meeting in the Bethesda, Maryland area per year.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

The Research Strategy should include a description of the proposed Coordinating Center (CC) structure, as well as activities, strategies, timeline, platforms and available resources. Applications should include a plan that demonstrates they have ready access to infrastructure and personnel to accomplish CC activities and processes, including relevant support services, data management and analytic support, and real-time analytic capacity. The application should describe a plan for carrying out the responsibilities of the CC in the following three areas:

1. Administration, coordination, and communication: The administrative functions include facilitating the work of the MSPI Research Network members and NIH scientific staff in the overall program management of the network. Activities include, but are not limited to:

• Leadership and project management for administrative, coordination and communication functions, including logistics and management support, such as organizing all network-related meetings and maintaining documentation (tracking and reporting) on activities of the network
• Establishing, in coordination with NIH staff, an MSPI Research Network Steering Committee to develop policies governing matters such as authorship, communications, data sharing, etc.
• Supporting collaboration and communication among the MSPI Research Project PIs, NIH program and scientific staff, Steering Committee members, and other committees, boards or groups associated with the network as appropriate
• Developing and facilitating working groups on topics of specific interest to the work of the network, such as preventive intervention methodology, measures and data harmonization, and network dissemination activities
• Developing an organizational and administrative structure to promote collaboration, provide technical assistance, and facilitate interaction across the network, including maintaining a network directory (sites, investigators, and collaborators) and a web-portal to assist with information sharing

2. Methodology, data, and analytic support and consultation.

• Providing methodological and statistical consultation for Research Projects as well as network-wide research activities. Expertise is expected in design and analytic methods appropriate for studies that evaluate prospective preventive interventions beyond the individual level. Such study designs may include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster randomized trials, rigorous quasi-experimental designs such as a group- or cluster-level regression discontinuity designs, interrupted time-series designs, or rigorous alternatives.
• Providing consultation on individual and structural SDOH measures, including, but not limited to those included in the PhenX Toolkit (www.phenxtoolkit.org).
• Assisting Research Projects with the compilation of publicly available surveillance, administrative, or other local, state, or federal data as relevant.
• Supporting data harmonization and preparing data for archival in an NIH-approved repository, as appropriate. Developing agreements across Research Projects to enable data sharing and aggregation for network-wide research efforts.
• Communicating and providing technical assistance as needed on data sharing, IRB or other human subject issues and adherence to any relevant federal data standards.

3. Community and other collaborator engagement and dissemination support.

• Creating and supporting one or more network-wide advisory boards representing appropriate members of the public, government agencies, relevant communities, systems and settings to provide support for research and dissemination activities as appropriate
• As needed, providing support in convening and exchanging best practices for engagement across communities on recruitment approaches, communications, and retention; identifying and addressing barriers to implementation; and facilitating strong community impact
• Creating public-facing communications materials (including social media) designed for study partners to promote the MSPI Research Network, including a network newsletter for research teams, communities, and participants, and coordinating with other ADVANCE or relevant NIH-funded projects as appropriate
• Providing support for dissemination activities initiated by the Steering Committee or other network partners
• Leading a multi-modal effort to rapidly and broadly disseminate information generated by the MSPI Research Network, including but not limited to project summaries and updates; lessons learned; and preliminary and overall research findings to a broad audience (e.g., academic community, practitioners, policymakers, community service providers, etc.).

In addition, the following information should be provided if not included in above descriptions:

• Without duplicating information in the biosketches, describe the applicant’s team and level of experience in coordinating large-scale and diverse research networks, including degree of scientific emphasis on preventive interventions and populations that experience health disparities.
• Describe an overall strategy for addressing the aims of the CC. Describe how the proposed CC and will interact with funded network projects to accomplish these goals. Provide a governance approach, logic model, timelines, plans for conflict resolution, and an organizational chart as appropriate.
• Describe the existing infrastructure at the applicant’s institution(s), current capacity, research activities, data platforms, and how it will support the network.
• For each of the three identified CC functions, describe specific activities that will meet the goals of the network, how the various activities will interact/intersect, and how they will interact with other relevant NIH-funded networks, centers, or programs.
• Describe plans for monitoring progress of the network and CC functions. Briefly describe how the CC will flexibly adapt or eliminate processes based on the needs of network investigators, NIH science officers, and other collaborators and the continuing need to manage the of the network.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. 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 SF424 (R&R) 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 SF424 (R&R) 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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

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

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

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

2. Review and Selection Process

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by National Advisory Council on Minority Health and Health Disparities. 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Awards issued under this NOFO will be excluded from the Streamlined Noncompeting Award Process. NIH Grants Management Officials must review and approved all carryover requests, regardless of the size and/or dollar threshold. No automatic first no-cost extension will be allowed.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

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 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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.

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

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

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

• Close coordination, cooperation, and management of the project with NIH, including establishment of the MSPI Research Network Steering Committee and any network-wide advisory boards.
• Providing salary support and travel reimbursement to the Chair of the Steering Committee.
• Participating in cooperative activities, including annual project update meetings.
• Planning and hosting the face-to-face or virtual annual meetings of the UG3/UH3 PIs/PDs.
• Facilitating comparability (e.g., common data elements) across the data from the network research projects, when feasible and appropriate to scientific research questions.
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.
• Coordinating the eventual release to the scientific, public health and other relevant methods, tools, data, results, and other resources.
• Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the network, that will be sufficient for outside users to understand and apply to their research projects with minimal assistance.
• Integrating and managing administrative or other data sets as needed. Facilitating data quality monitoring through rigorous data management and identification of data biases and errors as they arise.
• Supporting the conduct of data analyses and defining approaches, innovations, and methods related to data integration methods, metrics, and any harmonized network dataset.
• Providing expertise and leadership in addressing issues of broad scientific applicability, such as informed consent, data sharing standards, advanced analytics and methodological consultation, and dissemination of findings to NIH and UG3/UH3 recipients in the network related to methods, strategies and approaches within and between the projects.
• Making network-generated publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1 of the NIH GPS.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• Serve as a resource for specific information on NIH's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants. Similarly, the project scientist will facilitate communication involving the Coordinating Center, the UG3/UHE recipients , and others in the network as needed.
• Participate in developing innovative methodological strategies to support data collection, management, and analysis (e.g. data quality control, assessing and resolving cross project and site variation, ensuring data comparability).
• Identify research questions relevant to the network objectives based on the integrated cross-project/cross-site datasets. They may cooperate with recipients in development, design, and coordination of research plans and study reports emerging from the harmonized dataset. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH Project Scientist(s) may collaborate with recipients as coauthors in preparing publications of data resulting from the research. In this regard, they will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH staff require internal clearances.
• Additional NIH staff may participate in all cooperative-related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
• The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official will not participate in the research or the preparation of publications. The NIH Program Official carries primary responsibility for:
  • Periodic review and monitoring of the conduct and progress of the Coordinating Center in relation to their stated objectives and making recommendations regarding continuance of the award.
  • Maintaining consistent communication with the Coordinating Center PI/PD as well as communicating with the NIH Program Officials of the UG3/UH3 recipients in the network as needed for coordination activities.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) provide, with assistance from NIH staff, support necessary to ensure that sites and investigators, and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subject protection, informed consent, and reporting of adverse events.
• Recipients and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
• All recipients, with assistance from NIH, will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and relevant service systems as appropriate.
• The MSPI Research Network Steering Committee is the primary governing body of the network and is chaired by personnel from the Coordinating Center. Recipients must participate in the Steering Committee. The Steering Committee reviews and approves the agenda for collaborative research activities, develops and monitors policies and procedures guiding the research activities, and oversees communications. Recipients agree to abide by the procedures and policies established by the Steering Committee.
• The Steering Committee, with the support of the Coordinating Center, will facilitate these and other joint activities including, but not limited to: coordination of research protocols when appropriate, human subjects and other regulatory protocols when appropriate, data harmonization and archiving, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products resulting from collaborative projects across the network.

Dispute Resolution:

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

3. Data Management and Sharing

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.

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. 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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

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)

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@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

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email:Jennifer.alvidrez@nih.gov

Steve Tsang, PhD
Office of Data Science Strategy (ODSS)
Phone: 240-234-0702
Email: steve.tsang@nih.gov

Nathan Stinson, Jr., PhD, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8704
Email: stinsonn@mail.nih.gov

Center for Scientific Review (CSR)

FOAReviewContact@csr.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@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.