1. What is the purpose of the ComPASS Program?

The first overall goal of the ComPASS Program is to catalyze, develop, and rigorously assess Community-led, Health Equity Structural Interventions that leverage multisectoral partnerships to advance health equity. A second overall goal of ComPASS is to develop a new health equity research model for community-led, multisectoral structural intervention research across NIH and other federal agencies.

2. What are the specific initiatives of ComPASS?

ComPASS is comprised of three initiatives as outlined below.

• The Community-Led, Health Equity Structural Interventions (CHESIs) will develop, implement, assess, and disseminate co-created community-led, health equity structural interventions in partnership with research organizations, by intervening upon structural factors that produce and perpetuate health disparities. Approximately, 20-25 CHESIs will be awarded in FY 2023.
• The ComPASS Coordination Center (CCC) will lead overall program management and coordination of administrative, data, capacity-building, partnership, training, and the National Health Equity Research Assembly (HERA) activities. One Coordination Center will be awarded in FY 2023.
• The Health Equity Research Hubs (Hubs) will provide localized technical assistance and scientific support, as well as partnership support and research capacity-building and training previously designed in collaboration with the CCC. Up to five Hubs will be awarded in FY 2024.

3. Why is ComPASS funded through the NIH Common Fund?

The Common Fund supports programs that are intended to have a transformative impact on biomedical research conducted across all NIH Institutes and Centers. Common Fund programs encourage highly innovative approaches to broadly relevant challenges, coordination among awardees, and rapid dissemination of results and lessons learned. These programs represent NIH-wide priorities, and program areas are selected with input from all Institute and Center Directors and from extramural scientists. ComPASS is catalytic and cross-cutting in its integration of multisectoral partnerships, comprised of community organizations; local, state, and federal government; academic institutions, and the private sector. The Common Fund support of the ComPASS program is indicative of the recognition by NIH Leadership of the importance of addressing structural inequities by dismantling the systems and policies that enable them to exist and persist. This program is a high priority for NIH as a whole.

4. Where does funding for the ComPASS program come from?

ComPASS funding comes from the NIH Common Fund. The funding opportunities will be administered by a NIH-wide team, led by the Office of the Director (OD), Office of Strategic Coordination (OSC), National Cancer Institute (NCI), and the National Institute for Nursing Research (NINR) together with a group of NIH staff from several Institutes, Centers, and Offices across the NIH.

5. Have the CHESI projects and the Coordination Center been selected yet? If not, do you know when they will be selected?

Announcements of the recipients of the CHESI projects and the Coordination Center will occur by October 1, 2023. The recipients of these awards will be posted on the ComPASS website and will be disseminated also via the ComPASS listserv, ComPASS website and Common Fund social media platforms.

6. Can you tell me where to find a description of the CHESI project themes that are referred to in RFA-RM-23-012?

The CHESI project themes include Community Health Care Access and Quality, Economic Development, Neighborhood and Built Environment, Social and Cultural Context, and Nutrition and Food Environment. The CHESI project themes map onto the Healthy People 2030 goals. Those goals include: Community Health Care Access and Quality - Increase access to comprehensive, high-quality health care services; Economic Development - Help people earn steady incomes that allow them to meet their health needs; Neighborhood and Built Environment - Create neighborhoods and environments that promote health and safety; Social and Cultural Context - Increase social and community support; and Nutrition and Food Environment - Improve health by promoting healthy eating and making nutritious foods available.

More information regarding the social determinants of health domains that inform the list of themes can be found on the Healthy People 2030 website: https://health.gov/healthypeople/priority-areas/social-determinants-health.

7. When the CHESI project details are revealed in October, should Hub applicants reach out to relevant CHESIs and identify which CHESIs to include in the Hub?

No. Hub applicants are discouraged from reaching out to CHESI awardees during the application development and submission process. CHESI projects will be assigned to the Hubs by NIH staff after the Hubs are awarded. Hub assignments to CHESI projects will be informed by identified scientific, capacity building, training, resource, and partnership needs, as well as any emerging scientific opportunities as determined by the ComPASS Program recipients and NIH Program Staff.

8. Is it acceptable to get a letter of support for our application from a CHESI we have an existing relationship with?

Hub applicants are discouraged from reaching out to CHESI awardees during the application development and submission process.
 

9. Are we eligible to apply, even if we do not have a letter of support from a ComPASS CHESI Project awardee?

Letters of support from CHESI awardees are not a requirement listed in the NOFO. In fact, Hub applicants are discouraged from reaching out to all ComPASS awardees during the application development and submission process. For more information regarding eligibility, see Section III. Eligibility Information the NOFO.
 

10. Is the ComPASS Coordination Center awardee allowed to provide letters of support to Hub applicants?

Hub applicants are discouraged from reaching out to all ComPASS awardees during the application development and submission process. Similarly, the ComPASS Coordination Center awardee is discouraged from writing letters of support for Hub applicants. The CCC will support all awarded Hubs.

1. What are the main goals of the ComPASS Health Equity Research Hubs (Hubs)?

The Hubs will support the research efforts of their assigned CHESI projects and extend the work of the CCC. The primary responsibilities of the Hubs are to 1) enhance the scientific rigor of their assigned CHESI projects; 2) support effective partner engagement by leveraging a multidisciplinary expert panel; and 3) collaborate with the CCC to provide localized and tailored scientific, technical, and collaborative support based on the needs of their assigned CHESI projects.

2. What is the composition of the ComPASS Consortium?

The consortium is comprised of the three ComPASS initiatives (described above), the ComPASS Coordination Center (CCC), Community-Led, Health Equity Structural Interventions projects, and the Health Equity Research Hubs as well as the ComPASS Steering Committee. The PDs/PIs and NIH Program Staff will form the ComPASS Steering Committee (SC) immediately following the CCC award. Specifically, the ComPASS Steering Committee will be coordinated and administrated by the CCC and Consortium governance rests with the SC. The SC will work cooperatively and interactively, during all phases to promote collaborations, as well as information and resource sharing across the ComPASS Program.

3. What are the Multidisciplinary Expert Panels (MEPs)?

Each Hub will convene a Multidisciplinary Expert Panel (MEP) that will be comprised of broad scientific, methodological, statistical, and ad hoc CHESI-relevant subject matter experts. MEPs will be integrated within the Hub structure to support all Hub functions and activities and will serve as an integral resource for the Hub’s assigned CHESI projects. Core subject matter expertise will include structural and multilevel intervention study design, sampling and data collection, implementation science, team science, data science, biostatistics and econometrics, community engagement, and health disparities research. Additional expertise will be obtained based on identified needs of the assigned CHESI projects and may come from other Hubs and/or from researchers within and outside the ComPASS Program. Key personnel listed on ComPASS awards, may be named as a member of the MEP (in an attachment which is described in the Multidisciplinary Expert Panel (MEP) Resource section under SF424(R&R) Other Project Information of the NOFO). But keep in mind that naming all individuals for the MEP is not required at the time of application submission.

4. How do the roles of the ComPASS Hubs (UC2) relate to the roles of the Community-led Health Equity Structural Interventions?

The primary role of the ComPASS Hubs will be to provide tailored scientific, technical, and collaborative support for sustainable community engagement, research capacity building, and training during the implementation and assessment phases of the CHESI projects (Phase II) and will employ strategies that are responsive and adaptive to the needs of the projects and the diverse communities they serve.

The Hubs will be responsible for connecting their assigned CHESI projects with expertise from relevant sources, including the MEP, other Hubs, the local or national HERAs. CHESI projects will have access to a wide range of scientific and technical expertise within and beyond the ComPASS Program.

5. How do the roles of the ComPASS Hubs (UC2) relate to the roles of the Coordination Center?

The Hub investigative team will collaborate with the CCC to facilitate scientific progress, data compliance, and reporting of ComPASS activities including the measurement and evaluation of community engagement and health equity practice. In coordination with the CCC, Hubs will leverage, expand, and deploy subject matter expertise from multiple sources, including within the MEP and ComPASS, to provide localized scientific and technical assistance, skills training, and sustainability planning.

6. Will the ComPASS Hubs be responsible for collecting common data elements or any other data?

Yes, but it should be noted that the Hubs will have two roles pertaining to common data elements:

• The Hubs will provide CHESI specific data management support and facilitation by developing and/or adapting processes for CHESI investigators to help the investigators execute their specific project data collection (including standardized common data elements), data safety monitoring, data handling, data access, data annotation, data quality assurance, and data sharing, as needed, to ensure effective coordination with the CCC and harmonization across the ComPASS Program.
• In coordination and collaboration with the CCC and other Hubs, each Hub may generate their own data and/or Hub-specific common data elements. This could include data related to ongoing needs, assets, and resource assessments across CHESIs; administrative processes and outcomes; aggregated CHESI project decision science, value of information, and health economic analyses; research capacity building and training activities; and community engagement and health equity metrics.

7. The funding opportunity review criteria noted that clinical trials are not a requirement, is that accurate?

Yes, a clinical trial is optional and not required for this funding opportunity.

8. What will the Administrative and Coordinating Unit do?

The Administrative and Coordinating Unit will provide leadership, expertise, and organizational infrastructure to support the entire scope of Hub activities. This Unit is charged with assuring active, systematic, and responsive engagement with assigned CHESI projects. Examples of responsibilities include, but are not limited to:

• Providing leadership, administrative infrastructure, management, and operational support for all Hub activities,
• Developing a plan for actively engaging with assigned CHESI projects and relevant partners to support their activities and establish the Hub as an accessible, valuable and trustworthy research resource, and
• Collaborating with the CCC to ensure efficient, timely, and responsive coordination, communication, and reporting of ComPASS activities, as needed.

9. What will the Research Methods & Data Management Unit do?

The Research Methods & Data Management Unit will be responsible for collaborating with the assigned CHESI projects to provide tailored scientific support and intervention-related technical guidance for all research activities (including study design and adaptations, as needed; intervention implementation; data collection and management; data quality; data security; data analysis & interpretation; research dissemination).

10. What will the Research Capacity Building and Training Unit do?

The Research Capacity Building and Training Unit will coordinate, design, and deliver tailored research and training support for their assigned CHESI projects. Based on needs identified throughout the planning, implementation, and assessment phases of the CHESI projects and in collaboration with the CCC, each Hub will leverage, expand, and deploy the subject matter expertise available within their established MEP to provide localized scientific and technical assistance, skills training, and sustainability planning. The activities of this Unit will strengthen the capacity of the CHESI projects to sustainably identify and address the conditions that affect the health and well-being within their local communities.

11. What will the Community Engagement and Health Equity Practice Unit do?

The Community Engagement and Health EQuity (CEEQ) Practice Unit will provide scientific, technical, and collaborative support for their assigned CHESI projects and liaise with the national, local HERAs, and Hub MEP to facilitate and assess active and meaningful community engagement, research collaboration, and community translation using a health equity lens. By leveraging or expanding their established MEP, activities conducted within this Unit will also seek to ensure sustainability of community-led interventions that are informed by, responsive to, and ultimately serve the individuals and communities most affected by structural inequities. This Unit will also be responsible for designing, implementing, and assessing a mentored CEEQ Scholars Program.

12. What are the expectations regarding the eligibility criteria, number of CEEQ Scholars, and budget allocations for the CEEQ Scholars Program?

The applicant has flexibility to design the CEEQ Scholars Program as they see fit, while addressing the required elements outlined in RFA-RM-23-012.

13. Will Hubs be distributed across the country geographically?

Hub location is not a review criterion.

14. In our application, should we refer to the CHESI projects we think we are best suited to work with, or should we focus on a particular theme(s)?

The NOFO requests applicants to address the required elements outlined in RFA-RM-23-012 which includes but is not limited to describing the social determinants of health/structural factor theme(s) for which the applicant can serve as a centralized research resource to assigned CHESI projects (see Overview under PHS 398 Research Plan in Section IV. Application and Submission Information). The NOFO does not request applicants refer to or specify specific CHESI projects.

15. What are milestones?

Milestones are intermediate steps towards the completion of concrete goals. They must include clear and quantitative criteria for success. Yearly specific and quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review, but also in consideration of the awarded project for funding of non-competing award years. The application should include clearly specified, well-defined milestones, quantitative go/no go decision points, and timelines for assessing progress. An example of a poorly defined milestone is "have an external panel in 2020" whereas a well-defined milestone would be "have an external panel in 2020 that concludes which approaches are feasible". The milestones and timeline should be included as an attachment, filename labeled as "Milestones and Timeline” and submitted under the Other Attachment section of the R&R Other Project Information form. See related Notice of Clarification: NOT-RM-23-024.

16. How can I use the PhenX Toolkit for measurement?

The PhenX Toolkit offers a way to standardize the collection of data to allow cross- comparison. The web-based catalog offers recommended measurement protocols in 29 research domains, including a collection of measurement protocols in the social determinants of health domain.

17. How many letters of support can I include in my application?

Letters of support are not restricted to a number. Include letters of support from partnering institutions, appropriate leaders of institutional component services, Tribal communities, or outside collaborators/subcontractors with clear statements of roles/responsibilities. Submitted letters should directly demonstrate the ability of the proposed Hub to fulfill the roles and responsibilities specified in the NOFO.

18. Do I need to include a Resource Sharing Plan in my application?

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan will be evaluated as part of the Approach criterion. Applicants are asked to describe a vision for how the valuable resources generated by the Hubs can be maintained beyond the funding period as part of the application.

19. Do I need to include a Data Management and Sharing Plan in my application?

In accordance with NIH Policy for Data Management and Sharing all applications, regardless of the amount of direct costs requested for any one year, must include a Data Management and Sharing Plan. For elements to include in the Data Management and Sharing Plan, please see the SF424 (R&R) Application Guide. Additionally, as described in the additional instructions listed in “Other Plan(s)” under PHS 398 Research Plan, the Data Management and Sharing Plan should include components related to public access; data security; and Findable, Accessible, Interoperable, Reusable (FAIRness).

20. Do we need to have ready to implement community training curriculum or will this come from the Coordinating Center?

No. Research capacity building, training, and curricula will be developed by the Hubs, once awarded, based on needs identified throughout the planning, implementation, and assessment phases of the CHESI projects and in collaboration with the CCC. Leadership and experience in research capacity building and training is expected and will be reviewed and scored, however, ready to implement curriculum itself is not an itemized component or review criteria. For more information, see the Research Capacity Building and Training Unit description in Section I. Notice of Funding Opportunity Description as well as all relevant “Specific to this NOFO” subsections in Section V. Application Review Information under Scored Review Criteria that mention expectations and review criteria for capacity building, trainings, and curricula.

1. What is a cooperative agreement?

A cooperative agreement is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. It requires a level of involvement from NIH staff that is higher than for a typical research project (R) grant. After award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. In many cases these are milestone-driven and in order to receive subsequent years of funding, milestones in the notice of award must be met which demonstrates the resource continues to have clear value to the ComPASS Program.

2. What are the main features of this UC2 mechanism?

This UC2 is a research infrastructure cooperative agreement. Investigators are required to foster new approaches to improve the interactions among multi- and interdisciplinary research teams. This mechanism supports research teams to propose the creation of a unique infrastructure/resource designed to accelerate scientific progress and advance public health in the future.

3. Should the UC2 application document the applicant institution’s research expertise and resources in the Units listed in the funding opportunity or will the areas of research be determined by the composite research agendas of the funded ComPASS Health Equity Research Hubs?

The UC2 application should provide information on the institution’s research expertise and resources that will contribute to addressing the specific areas of research noted in the funding opportunity and the process for how you envision your team to work together to accomplish the study objectives by developing the common protocols.

1. What organizations are eligible to apply for this funding opportunity?

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
• American Indian/Alaska Native Tribal Governments (Federally Recognized)
• American Indian/Alaska Native Tribal Governments (Other than Federally Recognized)

Federal Government

• U.S. Territory or Possession

2. Are Foreign Institutions able to apply?

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

3. Is there a limit to the number of applications that can be submitted by an institution?

No, there is no limit to the number of applications an institution can submit.

4. Can an investigator on the CCC award or a research partner of a CHESI award also be listed as key personnel on a ComPASS Health Equity Research Hub?

No. An investigator can only be listed as key personnel on one ComPASS award: either on the Hub, the CCC award, or as a research partner on the CHESI award. Key personnel listed on ComPASS awards, may be named as a member of the MEP (in an attachment which is described in the Multidisciplinary Expert Panel (MEP) Resource section under SF424(R&R) Other Project Information of the NOFO). But keep in mind that naming all individuals for the MEP is not required at the time of application submission.

5. How will a situation in which a co-investigator is listed on two different Hub applications be handled?

If Hub applications include overlapping key personnel and both applications are determined as meritorious for funding, then, as described in the NIH Grants Policy Statement, any scientific, budgetary, or effort overlap for investigators (i.e. PD/PI(s), senior/key personnel) would need to be reported and addressed in the Just-In-Time submission.

6. Would Hubs located in close proximity to the CHESI projects have an advantage in being awarded?

No. Funding decisions for the Hubs will be informed by the scientific and technical merit of the applications as determined by scientific peer review, availability of funds, and the relevance of the work proposed to the Hub objectives outlined in RFA-RM-23-012.

1. When may I submit an application?

The application due date is October 31, 2023. All applications are due by 5:00 PM local time of the applicant organization. The earliest submission date is September 30, 2023.

2. Who may I contact if I have questions about my application?

If you have questions prior to submission or after summary statement release, please contact Amanda Acevedo ([email protected]).

For questions about the review process after submission and before summary statement release, please contact the Center for Scientific Review at [email protected].

3. How do I submit my application?

For instructions on how to submit an NIH grant application, please visit the NIH Office of Extramural Research How to apply-Application Guide” at: How to Submit, Track and View Your Application | grants.nih.gov.

4. Do all collaborators need to have a Commons registration and ID?

Any individual participating for at least 1 month or more should be registered in eRA Commons. Information on how to obtain eRA Commons credentials can be found here: eRA Commons – User Registration | grants.nih.gov.

5. Is a Letter of Intent Required for Submission?

A letter of intent (LOI) is not required, is not binding, and does not enter into the review of a subsequent application. The information that it contains allows NIH staff to estimate the potential review workload and plan the review. The LOI is due on September 30, 2023 and should be submitted to [email protected].

6. What information should be included in the Research Strategy?

The Research Strategy must include the Overview section, Section 1: Administrative and Coordinating Unit, as well as Sections 2-4 with Sub-sections A-E as described in Section IV. Application and Submission Information under PHS 398 Research Plan. Please note that an overall Specific Aims page is not included in the Research Strategy. See NOT-RM-23-024 for more details.

7. What are the page limits for a UC2 application?

The Table of Page Limits that includes the UC2 Activity Code must be used to inform the page limits (see: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and…) with the following exception: for this specific NOFO, the Research Strategy section is limited to 24 pages. Please note that an overall Specific Aims page is not included in the Research Strategy section. See NOT-RM-23-024 for more details.

8. Do we need a separate Specific Aims page (since this is following the SF424 R component applications). Or should the aims be fully folded into the 24-page Research Strategy?

Yes, a separate overall Specific Aims page is required for this application and should not be included in the Research Strategy. Additionally, please note that Sub-Sections A-E are specific to Sections 2-4 of the Research Strategy and are not expected for Section 1: Administrative and Coordinating Unit.

9. Could you confirm that there are no page limits for the 1) resource sharing plan and the 2) multidisciplinary expertise panel (MEP) resources document?

Correct, there are no page limits for the resource sharing plan and the multidisciplinary expert panel (MEP) resources document. Note that as described on the Table of Page Limits website, “If no page limit is listed in the table below, in Section IV of the NOFO under Page Limitations, or in a related notice, you can assume the attachment does not have a limit”.

10. We are not proposing a clinical trial. However, given that all teams will be proposing a Community Engagement and health EQuity (CEEQ) Scholars program, does that mean we have to fill out human subjects forms?

If any of the work proposed in a Hub application qualifies as Research Involving Human Subjects then the NOFO states that applicants “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.” See the PHS Human Subjects and Clinical Trials Information section of the SF424 (R&R) Application Guide for more guidance on completing that part of the application.

11. Are we expected to upload biographical sketches for all of the Multidisciplinary Expertise Panel (MEP) members? Or will a letter of support from each of these individuals suffice?

The NOFO states that applicants should “Include letters of support from partnering institutions, appropriate leaders of institutional component services, MEP members, potential CEEQ mentors, or outside collaborators/subcontractors with clear statement of roles/responsibilities. However, any named member of a MEP in a Hub application would either be considered key personnel or an other significant contributor and must submit a biosketch (for more detail, see the R&R Senior/Key Person Profile (Expanded) Form in the SF 424 (R&R) Application Guide for instructions for biosketches). But keep in mind that naming all individuals for the MEP is not required at the time of application submission.

1. Are the standard project review criteria for “Significance,” “Investigator(s),” “Innovation,” “Approach,” and “Environment” not applicable and superseded by the RFA-specific criteria?

View Section V of the funding opportunity. The standard review criteria for these sections still apply, including specific review criteria.

2. How will applications be reviewed?

Applications will be reviewed by NIH staff for completeness and responsiveness. All applications determined to be complete and responsive will be reviewed by scientific experts convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures and using review criteria outlined in the funding opportunity announcement. All applications received in response to the funding opportunity announcement will be reviewed in a single special study section. Applications may undergo a 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.

3. When will my application be reviewed and by whom?

The Scientific Merit Review for this funding opportunity will convene in Spring 2024. Following initial peer review, applications will receive a second level of review by the National Cancer Institute (NCI) Advisory Council. The Advisory Council Review will convene in May 2024. Questions about the review should be directed to the Center for Scientific Review at https://public.csr.nih.gov/.

4.  How will awards be selected for funding?

Applications will compete for available funds with all other applications submitted in response to this funding opportunity. 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.

5. How many total awards will be made?

This funding opportunity seeks to fund up to five Health Equity Research Hubs as an integral part of the ComPASS Program.

1. ComPASS is a 10-year program, so why is there a 5-year budget period?

NIH policy limits each competitive segment to a maximum of 5 years. A single award covering the entire period of support generally is used only if the project is solely for construction or modernization of real property, if the total planned period of support will be less than 18 months, or if the project is awarded under a special support mechanism.

2. Are the funding amounts listed in the RFA direct costs or total costs (i.e., are they inclusive of indirect costs)?

The amounts listed in Section II. Award Information under Funds Available and Anticipated Number of Awards are the intended total cost commitment of the NIH Common Fund’s Office of Strategic Coordination for each fiscal year, across approximately five awards. These amounts are contingent upon NIH appropriations and submission of a sufficient number of meritorious applications. There is not a limit on the direct costs that can be requested in the applications As noted in the NOFO, application budgets must reflect the actual needs of the proposed project.

1. What are key components of a CHESI application?

Successful applications must be 1) community-led, 2) relate to health equity and prioritize population(s) experiencing health disparities 3) demonstrate strong partnerships and collaborations with other community partners and researchers, and 4) propose a structural intervention that addresses root causes (broader system and societal factors and conditions) that contribute to health disparities.

2. Can you provide an example of structural interventions? This terminology is new to me.

Structural interventions are interventions that attempt to alter the social, physical, economic, and/or political environments that influence health behaviors and outcomes are critical (Brown, et al., 2019). These structural interventions provide opportunities to address the broader system and societal factors and conditions that influence the ability to live healthy lives. Structural interventions might include addressing the root causes of economic instability, limited educational and employment opportunities, and lack of community resources. Because structural factors span multiple sectors and systems, structural interventions must be created in partnership with organizations such as those within the areas of education, housing, transportation, commerce, agriculture, economic and urban development, justice, human and social services, clinical care, and public health.

3. Examples of structural interventions that have the potential to influence health outcomes include, but are not limited to:

• Criminal justice system policy changes to address structural racial/ethnic and socioeconomic discrimination (e.g., in police stops, arrests, bail systems, and pre-trial detainment/diversion, sentencing, and probation and parole practices);
• Universal basic income programs and policies to address issues of economic instability;
• High-speed broadband internet expansion to enhance internet connectivity and telehealth access in rural and other underserved communities;
• Child tax credits to address access to early childhood education;
• Housing voucher programs to improve access to safe, quality housing;
• Community revitalization investment projects to enhance neighborhood and community resources and facilitate health-promoting behaviors;
• Food program policies to improve access to and affordability of fresh produce; and
• Opportunities that leverage changes to policies, programs, and practices at the local, state, and/or federal levels.

4. Is ComPASS focused on a specific health condition?

Since health equity structural interventions have the potential to impact a variety of health outcomes, ComPASS is not focused on a specific health condition or disease.

5. What are key dates in the timeline for planning our application?

Research Opportunity Announcement Released	September 12, 2022
Applicants Register in eRA Commons*	September – mid-November
Letter of Intent Due	November 18, 2022;
Invitation to Submit Full Application	December 16, 2022
Full Application Office Hours (2)	December/January (exact dates TBD)
Application Submission Due	February 6, 2023

* Note that all applicants must be registered in eRA Commons, which may take up to six (6) weeks or more to complete. Applicants should therefore begin the registration process as soon as possible even before receiving the invitation to submit the full application.

1. What organizations are eligible?

Community organizations are eligible to apply. For the purposes of this opportunity announcement, a community organization is defined as a non-Federal, non-academic or non-research organization that provides goods, services, support, resources, or advocacy to members of a defined community.

The following organizations are eligible:

Non-profits Other Than Institutions of Higher Education

• Non-profits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Non-profits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), including but not limited to:
  • Faith-based or community-based organizations
  • Tribal serving organizations
  • Patient or consumer advocacy groups
  • Social service organizations
  • Healthcare systems and providers (including Federally Qualified Health Centers)
  • School districts
  • Law enforcement and criminal justice agencies
  • Neighborhood associations
  • Labor unions

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• American Indian/Alaska Native Tribal Governments (Federally Recognized)
• American Indian/Alaska Native Tribal Governments (Other than Federally Recognized)

2. Are independent research organizations eligible?

For-profit or non-profit, independent research organizations are not eligible to apply.

3. Is a community organization that has a research and development unit still eligible?

Yes, if an organization meets the definition of a community organization but also conducts research, it would be eligible.

4. Does the organization need a history of NIH funding or current NIH funding to apply?

No, applicant organizations nor their partner organizations do not need to have a history of NIH funding or current NIH funding to apply successfully to the ROA. Prior funding would give the experience that could affect success. However, it does not affect their ability to apply and be successful at applying.

6. Are foreign institutions eligible?

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

7. Are healthcare organizations permitted to participate as collaborating, subcontracted institutions? What about academic institutions?

Yes, healthcare organizations and academic institutions are allowed to be identified as collaborating, subcontracted institutions on the invited full application. While individuals from academic institutions and certain healthcare organizations (i.e., academic healthcare organizations, private healthcare organizations) cannot serve as Principal Investigators (PIs) on the full application, they may serve as Senior/Key Personnel, Other Significant Contributors, Co-Investigators, Collaborators, Consultants, Sub-Awardees, etc.

8. Are healthcare systems eligible to apply?

If the healthcare system is a non-profit, it is eligible to apply for this opportunity. For example, Federal Qualified Health Centers (FQHCs) are eligible to apply.

9. Would a public health department at the local level be eligible to apply?

Yes, state, county, city, or township governments are eligible to apply, including affiliated departments (e.g., public health departments, health and human services, etc.)

10. What areas constitute the United States for this opportunity? Are territories of the United States eligible?

For this opportunity, the United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia.

11. Are Federal Qualified Health Centers (FQHCs) eligible to apply for the opportunity?

Yes, Federal Qualified Health Centers are eligible to apply for this opportunity.

12. Can an individual from an academic institution or research organization be one of the Multiple Principle Investigators (MPIs)?

No, only individuals who are employed at organizations that meet the eligibility criteria may serve as one of the MPIs. Individuals from academic institutions or research organizations may be identified as partners in the application and may serve as Senior/Key Personnel, Other Significant Contributors, Co-Investigators, Collaborators, Consultants, Sub-Awardees, etc.

13. Am I eligible to serve as a PI on an application if my primary employment is an eligible community organization, but I also have an academic appointment?

Yes, if your primary employment is with a community organization eligible for this opportunity and you have an academic appointment that is not full-time, you would be eligible to serve as a PI or MPI on an application. If you are employed full-time by an academic institution, you may serve as Senior/Key Personnel, Other Significant Contributors, Co-Investigator, Collaborators, Consultants, Sub-Awardee, etc. on the application.

14. Would a public health department at the local level be eligible to apply?

Yes, state, county, city, or township governments are eligible to apply, including affiliated departments (e.g., public health departments, health, and human services)

15. Would a non-profit organization that focuses on health equity that includes faculty from academic institutions as leaders and who works with multiple community organizations be eligible to apply?

Yes, a non-profit organization that focuses on health equity that includes faculty from academic institutions as staff leaders would be eligible to apply. These individuals would not be eligible to serve as the Principal Investigator on the application, however. Additionally, applicant organizations are encouraged to work in collaboration with other community organizations and researchers as partners in the development of health equity structural interventions.

16. If a non-profit, non-academic organization has a research department are they eligible?

Yes. A non-profit, non-academic organization that has a research department is eligible. However, if the organization is an academic research center, academic healthcare organization, or a private healthcare organization, the organization would not be eligible for this opportunity.

17. May two or more community organizations apply as a team for the ComPASS ComPASS Community-Led, Health Equity Structural Interventions (CHESI) initiative?

Applications involving a team of community organizations or other collaborators are strongly encouraged. However, only one organization can serve as the applicant institution. Collaborating organizations can have their representatives serve as key personnel on the project (including Multiple PI), and the organization can be supported with award funds via subcontracts.

18. If your application includes Multiple Principal Investigators, do both organizations need to demonstrate the capacity for management program cost > $250,000?

Yes, both organizations would need to demonstrate the capacity for managing program costs of >$250,000.

19. Is there a limit to the number of applications that can be submitted by an organization?

No. Applicant organizations may submit more than one application, provided each is scientifically distinct.

20. Who can serve as a PI on an application?

PIs must be employed by or affiliated with community organizations that meet eligibility requirements.

21. May multiple PIs from different community organizations apply as a team?

More than one individual, affiliated with different community organizations, may be named Principal Investigators (PIs) in the application. However, all PIs must be employed by or affiliated with community organizations that meet eligibility requirements. One individual must be identified as the Contact PI. If a multiple PI proposal is submitted, a leadership plan is required.

22. Do I have to be a U.S. citizen to serve as the PI?

No, there are no citizenship or residency requirements. Foreign scientists are eligible if they apply from a U.S.-based institution.

23. Can individuals employed by government agencies, non-academic, and/or for-profit organizations serve as the PI?

Yes, State, county, city or township, special districts, and Tribal Governments are eligible to apply as well as non-academic, non-profit, and for-profit organizations.

24. Is the award transferable if I change organizations?

The award is made to an organization, not an individual person. A transfer of award would need to be requested by the organization and approved by NIH according to the current policy and terms of an award at that time.

25. I work at a private, for-profit healthcare system, is my organization eligible to apply?

Private, for-profit healthcare systems/organizations are not eligible for this opportunity. Academic research centers and academic healthcare organizations are also not eligible to apply. These organizations may be identified as partners in the application, however. Partners may serve as Senior/Key Personnel, Other Significant Contributors, Co-Investigators, Collaborators, Consultants, Sub-Awardees, etc.

26.My organization partners with several organizations in our region/city, is it viable for us to partner with all representatives from these organizations?

Yes, multi-sectoral teams of community organizations are highly encouraged. Note that more than one individual may be named as the Principal Investigator (PI) in the application, however, all PIs must be employed by or affiliated with non-profit community organizations that meet eligibility requirements. Employment or affiliation with institutions or organizations not eligible for this opportunity (i.e., academic research centers, academic healthcare organizations, institutions of higher education, etc.) prevents an individual from being named as a PI on the application. If you are submitting a multiple PI proposal, a leadership plan is also required.

If you are not submitting a multiple PI application, your partner organizations can be included as partners in your application and should provide letters of support in your full application. Partners may serve as Senior/Key Personnel, Other Significant Contributors, Co-Investigators, Collaborators, Consultants, Sub-Awardees, etc.

27. Is a board member or volunteer with our organization allowed to be a PI on the full application?

The identified PI on your full application must be employed by the organization to meet the eligibility criteria. Therefore, a board member or volunteer may not be allowed to serve as a PI on the full application.

28. Can a research partner on a Community-Led, Health Equity Structural Intervention (CHESI) Initiative (OT2) award also be listed as key personnel on the Community Partnerships to Advance Science for Society (ComPASS): Coordination Center (U24) award or the ComPASS Health Equity Research Hub? If not, is it acceptable for the research partner’s institution to be listed on both awards?

No, a research partner cannot be listed as key personnel on both a CHESI award and the Coordination Center award and must decide to serve on one award. Similarly, a research partner cannot be listed as key personnel on both a CHESI award and the ComPASS Health Equity Research Hub award and must decide to serve on only one award. However, the research partner’s institution is allowed on both a CHESI award and the Coordination Center award or the CHESI award and the Health Equity Research Hub award.

29. Can a research partner serve on more than one submitted application?

Yes, a research partner can serve on more than one submitted application. However, a research partner can only serve on one CHESI award. If a research partner is on more than one CHESI award, the research partner must decide to serve on only one CHESI award. Community organizations may want to name more than one research partner on their application, to address this possible situation.

General Budget

1. For our 10-year budget, how do community organization’s do forecasting and account for “to-be-named” community partners, inflation, cost-of-living adjustments and other unknown expenses for the 10-year budget?

A 10-year budget is needed including combined/summary budget. The applicant organization is responsible to ensure all community partners' detailed budget and justification be included as subs (either subaward or subcontract).  To-Be-Named partners' budget and justification are allowed. To-be-named Personnel budget and justification are allowed. Research costs are allowable as long as they satisfy the definition of "allowable cost" per the NIH Grants Policy Statement.

For out years, we do expect a reasonable approximation of what you intend to spend. Be thorough enough to convince the reviewers that you have a good sense of the overall costs. In general, NIH does not have policy on salary escalation submitted in an application. We advise applicants to request in the application the actual costs needed for the budget period and to request cost escalations only if the escalation is consistent with organizational policy.

Applicants should see "Understanding the Out Years" section at the following link: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm#years

2. Is a Memo of Understanding (MOU) or Memo of Agreement (MOA) required for research partners and the financial intermediary?

No. A MOU or MOA with research partners and or the fiscal sponsor/fiscal agent is not required for submitting the full application. However, prior to award, a MOU or MOA may be something NIH would recommend having in place.

3. Is a project timeline and payment milestones required/encouraged?

A project timeline and payment milestones are not required for submitting the full application. The project timeline and payment milestones will be negotiated with the award recipient.

4. How should an in-kind contribution be reflected in the budget? For example, if the PI's proposed effort on the project is 40%, but 20% will be provided in-kind and 20% requested from the NIH funding?

Cost share/match is not required for this research opportunity. The total allowable costs (both direct costs and F&A costs) are incurred by the recipient to carry out an award-supported project or activity. Total project costs include costs charged to the NIH award and costs borne by the recipient to satisfy a matching or cost sharing requirement.

5. Are applicants encouraged to have experience managing federal awards?

Applicants are not required to have experience managing federal awards. They are required to have the organizational capacity and fiscal experience and/or expertise available to manage a program greater than $250,000.

6. Will reducing my budget increases the likelihood of funding?

No, we encourage applicants to develop budgets that are realistic and most importantly meet the goals and activities outlined in the application. The applicant’s budget is not considered during the review process for this opportunity.

7. Who should attend the annual ComPASS consortium meeting and how many days should we budget for this annual meeting?

Applicants should budget for the Principal Investigator(s) and the research partner(s) to attend the annual ComPASS consortium meeting. Applicants may choose different individuals and partners over the 10-year period of the award to attend, but budgeting for at least two attendees for up to three days would be a reasonable estimate.

Indirect Cost (F&A) Rate

8. Are indirect costs (or F&A/Facilities and Administrative) required?

No. Indirect costs or F&A (Facilities and Administrative) are not required for this opportunity. Any indirect costs are included in the total budget and in the total award amount.

9. Can you provide guidance on indirect costs?

Applicants with an indirect/F&A (Facilities and Administrative) cost rate agreement with the Federal Government should include that amount in the total budget and in the total award amount as specified in the Research Opportunity Announcement (ROA) OTA-22-007.

Applicants without an indirect cost or F&A rate agreement with the Federal Government should use the de minimis rate of 10% of modified total direct costs (MTDC) as explained in the NIH Grants Policy Statement (Section 7.4 Reimbursement of Facilities and Administrative Costs) and 2 CFR 200.

Modified Total Direct Cost (MTDC) means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward in excess of $25,000. Other items may only be excluded when necessary to avoid a serious inequity in the distribution of indirect costs, and with the approval of the cognizant agency for indirect costs. (References: 2 CFR 200 and NIH Grants Policy Statement)

10. Are applicants locked in for the 10-year duration of the ComPASS Program with the current indirect cost rate included in the applicants proposed budget?

For awardees, changes in the budget, including indirect cost rate over the 10-year ComPASS Program will be determined on a case-by-case basis.

11. Which federally negotiated indirect cost (F&A) rate should the university-based research partner for our project use in calculating their subaward budget?   Should it be the approved “research”, “other sponsored programs”, or some other rate?

The Community-led Health Equity Structural Intervention (CHESI) is a research project. Applicants should follow their internal organization’s rate agreement in calculating their research partners subaward budget.

12. Our research partner’s Federally negotiated indirect cost (F&A) rate is 57.5% through 6/30/2023 and 55.5% beginning 7/1/2023. Is the research partner allowed to use these rates in their proposal for their subaward?

The NIH is not requiring any specific indirect cost rate. The applicant organization should follow their internal organization’s policies and procedures in negotiating their research partners subaward budget.

Budget Form

13. I am having an issue accessing the budget forms. Can you please advise?

Please visit the Common Fund Other Transactions Forms page and click on the links to the budget forms to automatically download the PDFs. After you have downloaded it to your computer, you should be able to open it. If the file is still opening in your browser automatically and not displaying correctly, right click on the file in your “Downloads” folder and click “Open with Adobe Reader.”

14. For the budget, in the "total funds requested" should this be for 5 years or 10 years?

In ASSIST, the “Total Funds Requested” section, enter the total federal funds estimated to fund the project, including Direct Costs requested for the project period of 5 years. The project period for this opportunity is 5 years. Thus, the “total funds requested” entered should be no more than $6,000,000.00.

15. Is the budget summary table required? What budget categories should the budget summary table include?

One, 10-year budget is required. Including a budget justification is required. A budget summary is strongly recommended. The 10-year budget should provide the overall expected cost for each of the following categories: personnel, travel, subawards/subcontracts/consultants (as appropriate for research partners and community partners), IRB costs, other direct costs, and total costs (with indirect costs included). Provide a budget justification for all budget items for all 10 years of the project. Subawards/subcontracts/consultants need to provide details of cost breakdown. In addition, provide a budget summary. Annual budgets are expected not to exceed the total costs detailed in OTA-22-007. The table below is provided as an example of one way a budget summary could be presented in the full application:

16. In the R&R Budget Form, there is a box titled “Subaward/Consortium”, do our subaward partners have to complete this form and check that box? An example of our subaward partners include intervention sites, local health institutions and academic institutions that will support our IRB and provide technical support for the intervention.

Yes. For a subaward, partners should check the box title, “Subaward/Consortium” and complete the budget form for all 10 years of the project. For the budget form, the applicant organization is to provide a budget justification for all budget items for all 10 years of the project. Subawards/subcontracts need to provide details of cost breakdown. The areas specified in the research opportunity announcement are: Personnel, Travel, Sub-awards, Sub-contracts, Consultants, IRB Costs, Other Costs and Total Costs.

17. For the budget, I’ve seen something about “flattening” a PDF for uploading to eRA Commons. What does that mean and how do I do it?

A PDF that has fillable fields, electronic signatures, text boxes or images inserted, becomes layered with each of these elements representing a layer. Flattening a PDF merges these separate elements into one flat layer. There are a number of methods to flatten a PDF, the easiest of which is to print it as a PDF.

To do this, go to File>Print, select the printer option from the menu that has says PDF, such as "Adobe PDF". Depending on the software available to you, the specific option may vary but should contain "PDF". Click the Print button and name the file. This will "print to a PDF" and the file will be flattened.

Fiscal Sponsor/Fiscal Agent

18. Are applicants allowed to have a fiscal sponsor or fiscal agent arrangement?

Yes, an applicant is allowed to have a fiscal sponsor/fiscal agent arrangement. However, prior to making an award, NIH will require supporting documentation from the applicant. Specifically, a copy of the agreement between the applicant and the fiscal sponsor/fiscal agent would need to be submitted. NIH will conduct a financial capability review to ensure that the applicant, working with the fiscal sponsor/fiscal agent, is able to meet all the requirements for proper fiscal stewardship of the award.

19. Can fiscal sponsors and fiscal agents serve in the Signing Official role in eRA commons for the community organization?

Yes, the fiscal sponsor/fiscal agent can serve as the Signing Official in eRA commons for the community organization.

Budget Justification

20. For the Budget Justification, is there a guidance on how to write this? Are there any templates?

There are no budget justification templates. Applicant organizations should provide a budget justification for all budget items for all 10 years of the project. Subawards/subcontracts need to provide a 10-year budget with details of cost breakdown. Subawards/subcontracts can use the same budget forms provided here: https://commonfund.nih.gov/OTforms. Budget justification/narrative is listed as a section in the Budget form to be uploaded as a PDF attachment. To-Be-Named partners' budget and justification are allowed. To-be-named Personnel’s budget and justification are allowed.

21. After “flattening” and uploading the NIH provided R&R Budget forms, that included a PDF of our budget justification, I was not able to preview the budget justification in ASSIST. NIH said in the ASSIST webinar that if I could not see the file in the preview, then NIH could not see the file. What should I do, so that I see the budget justification pdf in ASSIST?

Applicants should NOT use the “Budget Justification” field on the R&R Budget form to attach their budget justification. Instead, applicants should select, “Add Attachment” and upload their PDF budget justification as a separate file. Label this file, “BudgetJustification”. There is no page limit for budget forms and there is no page limit for the budget justification.

Cost Allowability

22. Is an academic partner's salary allowed to be included in the budget?

Yes. An academic partner's salary can be included in the budget.

23. Do salary caps apply to community groups? If so, what percentage of the community person’s salary be allotted? Are we able to pay a full portion of the PI’s salary as supervision of all the parts maybe full time?

As noted in the research opportunity announcement, NIH salary limitations apply to this Other Transactions Authority (OTA) mechanism in addition to other NIH funding mechanisms. For guidance on salary limitations, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-056.html

24. Should research incentives for research participants be included in our proposed budget?

Incentive payments to volunteers or patients participating in a grant-supported project or program are allowable. Incentive payments to individuals to motivate them to take advantage of grant-supported health care or other services are allowable, if within the scope of an approved project.

25. In terms of budget, is it ok for the research costs (personnel, data collection costs, etc.) to be a subaward to a research organization?

Research costs are allowable as long as they satisfy the definition of "allowable cost" in the NIH Grants Policy Statement. Allowable costs is defined as A cost incurred by a recipient that is: (1) reasonable for the performance of the award; (2) allocable; (3) in conformance with any limitations or exclusions set forth in the Federal cost principles applicable to the organization incurring the cost or in the NoA as to the type or amount of cost; (4) consistent with regulations, policies, and procedures of the recipient that are applied uniformly to both federally supported and other activities of the organization; (5) accorded consistent treatment as a direct or indirect cost; (6) determined in accordance with generally accepted accounting principles; and (7) not included as a cost in any other federally supported award (unless specifically authorized by statute).

For additional information on each, see the NIH Grants Policy Statement: 7 Cost Considerations 7.2 The Cost Principles.

26. Should the members of the local Health Equity Research Assembly be compensated?

Local HERA members may be compensated as allowed for their time and travel to participate in meetings to provide consultation on the project. HERA members must manage any conflict of interests by their position and roles in serving on the HERA and receiving travel and consultation fees.

27. Are capital assets an allowable cost?

Capital assets are an allowable cost under certain conditions as guided by the NIH Grants Policy Statement and 2CFR200. Applicants should apply cost principles to make a determination of this item. Provide a detailed justification for this and all items to align with program goals and performance.

28. Is paying for a community organization’s rent an allowable cost?

Rental costs are an allowable cost under certain conditions as guided by the NIH Grants Policy Statement and 2CFR200. Applicants should apply cost principles to make a determination of this item. Provide a detailed justification for this and all items to align with program goals and performance.

Project Period

29. What is the Project Period for this opportunity?

The Project Period is for 5 years. In the ASSIST platform, when it asks for the Start Date and End Date, please enter the following dates: Start Date 9/30/2023 and End Date 9/29/2028

30. Why is the Project Period 5 years, but the opportunity asks for a 10-year budget?

The NIH approves the budget for Other Transaction Authorities in 5-year increments. However, ComPASS was designed to be a 10-year program, therefore all full applications must include budget details for the entire 10-year period.

31. It states that the initial project duration is expected to be 5 years, yet the full application requires a 10-year budget covering all 3 phases, can you clarify this?

The NIH approves the budget for Other Transaction Authorities in 5-year increments. However, ComPASS was designed to be a 10-year program, therefore all full applications must include budget details for the entire 10-year period.

Budget Period

32. Can you clarify the annual budget costs for the length of this opportunity?

• Year 1: $750,000 total costs
• Year 2: $750,000 total costs
• Year 3: $1.5 million total costs
• Year 4 $1.5 million total costs
• Year 5: $1.5 million total costs
• Year 6: $1.5 million total costs
• Year 7: $1.5 million total costs
• Year 8: $1.5 million total costs
• Year 9: $750,000 total costs
• Year 10: $750,000 total costs

33. For the budget, what are the budget period start and end dates? On the R&R Budget Form, how do I add more budget periods to equal 10 budget periods?

The budget period reflects one year. Below are the following budget period start dates and end dates for each budget period over the course of the 10-year program for the application submission. During the award negotiations, these dates are subject to change:

• Year 1: 9/30/23-9/29/24
• Year 2: 9/30/24-9/29/25
• Year 3: 9/30/25-9/29/26
• Year 4: 9/30/26-9/29/27
• Year 5: 9/30/27-9/29/28
• Year 6: 9/30/28-9/29/29
• Year 7: 9/30/29-9/29/30
• Year 8: 9/30/30-9/29/31
• Year 9: 9/30/31-9/29/32
• Year 10: 9/30/32-9/29/33

On the budget form, to add another budget period, select, “Add Period”.

34. Do we submit 1, 10-year budget or 2, 5-year budgets? Could you clarify each?

We have posted on our website the 10-year R&R Budget Forms and the 5-year R&R Budget Forms. You can submit 1, 10-year budget, or 2, 5-year budgets. On the R&R Budget form, to add another budget period, select, “Add Period” button to add another budget period.

Sub-Recipients (Sub-Award/Sub-Contract) & Consultants

35. Please explain the difference between a subaward, sub-contract, and a consultant.

Definitions for sub-award and consultant, along with reference links, are as follows:

Sub-award: An award provided by a pass-through entity to a subrecipient for the subrecipient to carry out part of a Federal award received by the pass-through entity. It does not include payments to a contractor or payments to an individual that is a beneficiary of a Federal program. A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract. The term includes consortium agreements. https://grants.nih.gov/grants/glossary.htm#S and https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-A/subject-group-ECFR2a6a0087862fd2c/section-200.1

Sub-contractor: Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders (reference: https://www.acquisition.gov/far/part-44#FAR_44_101%C2%A0)

Consultant: An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, recipients and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants also include firms that provide professional advice or services. https://grants.nih.gov/grants/glossary.htm#Consultant

36. Are research partners considered sub-awards or sub-contracts?

The mechanism of payment to their research partner is up to the community organization (Prime) and sub-award/sub-contractor/consultant, etc. Applicant organizations should follow their internal policies and procedures for establishing such awards.

37. Are subawards considered "pass-through" and, do "pass-through" amounts count toward the $750K expense per year single audit threshold for our organization?

Applicants should follow their internal policies and procedures. A sub-award is defined as an award provided by a pass-through entity to a subrecipient for the subrecipient to carry out part of a Federal award received by the pass-through entity. It does not include payments to a contractor or payments to an individual that is a beneficiary of a Federal program. A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract. The term includes consortium agreements. https://grants.nih.gov/grants/glossary.htm#S and https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-A/subject-group-ECFR2a6a0087862fd2c/section-200.1

38. For direct consultant services, if the consultant is a specialized expert and we list them in the application, can we pay them with award funds without Federal OMB procurement policy such as competitive bidding?

Applicants should follow their organization’s internal policies and procedures regarding negotiations with consultants, sub-contractors, sub-awardees and other key personnel.

Carryover and Payment

39. If awarded, how will my community organization be paid?

All NIH award payments will use the Payment Management System (PMS) operated by the DHHS Program Support Center. Payments by PMS may be made by one of several payment methods, including SMARTLINK II/ACH, cash request, or by cash request on a reimbursement basis as specified in the terms of the Agreement. Generally, payments align with achievement of milestones and a payment schedule will be negotiated prior to issuance of the award to minimize the amount of time elapsing between the transfer of funds from the Federal Government and disbursement by the recipient. This is noted in OTA-22-007, “Payment” section.

40. If the awardee does not use all the money in one fiscal year, can it roll over to the next year?

Although the expectation is not to anticipate a carryover of funds, approval to carryover previous year unspent money will be determined on a case-by-case basis.

41. How should applicant organizations expect to pay our sub-awardee(s)/sub-contractor/consultants? Are we expected to make it be a fixed rate or reimbursement?

Applicant organization should follow their internal policies and procedures. Payment to sub-awardee/sub-contractor/consultants, etc. is between the applicant organization (Prime) and sub-awardee/sub-contractor/consultant.

1. What are the important dates for the full application?

Invited full applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by February 6, 2023 at 5:00 pm (based on the local time of the applicant organization)

2. Are applicants encouraged to have prior experience facilitating Health Equity Research Assemblies or similar collaborative efforts?

No, applicants do not need to have prior experience facilitating health equity research assemblies, however, applicants should have existing collaborations in their communities.

3. Does the funded organization develop the local Health Equity Research Assembly (HERA) or does NIH develop HERA?

The funded community organization and its research partners are expected to establish the local HERA of relevant collaborators.

4. Can you elaborate on the concept of the local HERA and how these relate to the CHESI programs?

Community organizations and their research partners are also expected to establish a local HERA of relevant collaborators, which may include but are not limited to, regional federal agency representatives (e.g., Housing and Urban Development (HUD), Substance and Mental Health Services Administration (SAMSHA), Indian Health Service (IHS), Department of Justice (DOJ), Department of Transportation (DOT), Department of Education), non-governmental partners, policymakers, community organizations, non-profit organizations, foundations, public and private sector organizations, and health care organizations. Members of the local HERA will provide tailored and contextualized guidance and advice to community organizations and their research partners throughout all phases of the project.

5. Does the proposed intervention have to have a control group?

For the full application, applicants may propose a study design that includes a control or comparison group.

6. Can we propose more than one structural intervention in our application and use the Planning Phase to prioritize which structural intervention to implement?

No. We suggest that you propose one structural intervention. The Planning Phase is for projects to refine their overall structural intervention and prioritize feasible intervention activities as part of their submission of a draft structural intervention research strategy.

7. What support and resources are available to develop and implement the community-led health equity structural intervention?

ComPASS was designed to provide support to organizations in the development of their community-led health equity structural interventions. The ComPASS Coordination Center will provide technical assistance in the areas of intervention planning and research capacity-building and training to the community organizations and their research partners during Phase I. Beginning in Year 2 of Phase I, the Health Equity Research Hubs will also extend the scientific and partnership support and services previously designed in collaboration with the ComPASS Coordination Center and provide community organizations and the research partners with technical assistance in the areas of research study design, statistical analysis and outcome assessment.

8. Can the lead community organization complete the full application with support from their other partners?

Yes, the lead community organization should seek input from their partners, keeping in mind that this community organization-led award.

9. Can Phase 1 include a community-led assessment to inform the planning and eventual implementation of the community-led health equity structural intervention?

Phase 1 is expected to include plans to conduct a structural intervention-related community assessment. The assessment plan is part of the required draft structural intervention research strategy.

10. For each phase of the program, would community-based organizations be involved in each phase or just in Phase I?

Community-based organizations should be involved in each phase of the structural intervention.

11. Would an applicant with a more sophisticated financial infrastructure have an advantage over an equally qualified organization with a lesser financial infrastructure?

The minimal requirement is for the submitting organization to have the capacity and fiscal experience or expertise available to manage a program greater than $250,000. See the review criteria in the opportunity.

12. What is NIH's expectation about the sustainability of effective interventions?

NIH expects successful structural interventions to be sustainable beyond the term of the award. In preparation for Phase III, awardees will be required to develop intervention sustainability activity plans.

13. Can the proposed intervention be conducted across multiple states, or does it have to be in just one state?

Yes, the proposed intervention can be conducted in one or more states.

14. What type of plan for the structural intervention is required for the full application?

If invited to submit a full application, applicants will be required to submit a research plan which includes a description of the structural intervention and research planning process. This section should include plans for the sustainability of research capacity and structural intervention efforts post-NIH funding. Please review the ROA for further details.

15. What must be done before I submit an application to the NIH eRA Commons ASSIST system?

To submit an application via ASSIST, the applicant organization must be registered in eRA Commons (See Submission Instructions). If you are invited to submit a full application, you must be registered in eRA Commons, which may take up to six (6) weeks or more to complete, applicants should therefore begin the registration process as soon as possible. See “Resources only for Other Transactions Authority (OTA) Users of ASSIST for the Instruction Guide for OTA Submissions via ASSIST (version 11/03/2022) at this website: https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm.

16. Is an Entity Identification Number (EIN) required to register in eRA Commons and apply for the full application in ASSIST?

No. If you do not have an EIN when you register for eRA Commons and/or apply via ASSIST, you may enter 111111111111. However, an EIN will be required should an application be considered for award.

17. Can a research partner on a Community-Led, Health Equity Structural Intervention (CHESI) Initiative (OT2) award also be listed as key personnel on the Community Partnerships to Advance Science for Society (ComPASS): Coordination Center (U24) award? If not, is it acceptable for the research partner’s institution to be listed on both awards?

No, a research partner cannot be listed as key personnel on both a CHESI award and the Coordination Center award and must decide to serve on only one award. However, the research partner’s institution is allowed on both a CHESI award and the Coordination Center award.

18. Will late applications be accepted?

No, as stated in the Research Opportunity Announcement, late applications will not be accepted.

19. What are Other Transactions (OT) and where can I find more information about the funding mechanism for this initiative?

The Other Transaction (OT) is a unique type of legal instrument other than a contract, grant, or cooperative agreement that NIH uses to fund awards. For more information, click here.

20. How should full application documents be formatted? What is the page limit for the Application Research Plan?

Full applications must be in text-recognizable PDF (Adobe) format, use an 11-point font with 1” margins, be single-spaced, and the file size must be no greater than 20 MB. For tables and images, the font size can be less than 11-point and should be legible by reviewers. We generally recommend one of the following fonts: Arial, Georgia, Helvetica, Palatino Linotype, or Times New Roman. The full application consists of the items listed in the Application Submission Instructions and Contact Information section of the Research Opportunity Announcement.

The Application Research Plan should be no more than 10 pages, including any charts and figures. The page limits of the remaining items are stated in the Research Opportunity Announcement. The sections of the application should be loaded as separate attachments and titled as specified in each section (title included in parentheses following each section) of the full application.

21. Should I submit Letters of Support? If so, how many should be submitted and how should the Letters of Support be assembled for the full application?

Yes, letters of support are encouraged and shoul dbe addressed to the applicant organization. As appropriate, letters of support should be included from proposed research partners, collaborators, consultants, Tribal communities and partnering community organizations, with a clear statement of roles/responsibilities on the project. These Letters of Support should be individual letters from each supporting entity. There is no limit to the number of Letters of Support. There are no page limits associated with the Letters of Support. It is understood that the number and type of partners and supporting entities may change over the 10-year ComPASS Program.

Please combine all Letters of Support into one PDF attachment. The file should be named, “LettersofSupport”.

22. What documentation and explanations should I include to describe my current partnerships to support the success of my application?

Current partnerships to support the success of the application can be included in the “Application Research Plan” and the letters of support submitted with your application.

23. How does the administration of the OT2 mechanism differ from the R01 mechanism?

A R01 application is a research grant application. The administrative and funding instrument used for this program will be the Other Transactions, OT2 mechanism, in which active oversight and management by the NIH are expected during the performance of the activities. The format used for an NIH grant application is acceptable, but not a required format, as Other Transactions are not grants. For additional information on an application, format see sections “developing application” and “Application Submission Instructions and Contact Information.” For more information, click here.

Other Transactions Authority

Support or acquisition mechanism	Type of funding	Research directed by	Responsive to changing priorities	Grant or procurement laws and regulations apply?	Governed by overarching Federal research laws, regulations, policies	Review of applications
Grant	Financial assistance mechanism to support research for the public good	Investigator	No	OMB Uniform Guidance and NIH Grants Policy Statement	Yes	Peer review of broad criteria
Cooperative Agreement		Investigator with significant government involvement	Some		Yes
Contract	Legally binding instrument to acquire goods or services for the direct use or benefit of the government	Government	Not really	Federal Acquisition Regulation (FAR)	Yes	Award based on stated evaluation factors
Other Transactions Authority	Legally binding instrument that may be used for a broad range of research and activities based on an OT Authority	Government/Investigator Collaboration	Yes	Federal laws and NIH policy applicable to all award instruments and Cognressional authorizing language	Yes	Scientific evaluation or objective research

24. Do I need to submit a Specific Aims page?

Yes, specific aims should be included and no more than 1 page. The specific aims should not include specific objectives of the proposed research. Instead, the specific aims page must contain a section entitled, “Significance, Innovation and Impact." The section should provide a cogent overview of your proposed structural intervention and answer the following questions:

• What is the challenge or opportunity that is the focus of your proposed structural intervention?
• Why is this significant for health disparities or health equity research?
• What is the overall approach you are proposing?
• What are the most original or innovative aspects of your application?
• What would the impact be on our scientific understanding of health disparities and advancing health equity?

25. What details about the structural interventions in Phase 2 and Phase 3 should be included in the full application? How much detail is required for Phase 2 and Phase 3?

While Phase I (Years 1 -2) of the community-led health equity structural intervention will be devoted to intervention planning development and partnership building, the application should include as much detail as possible about Phase 2 and Phase 3 to respond to the elements outlined in the Application Research Plan sections. This detail will facilitate the objective review of your full application. Reviewers will know and understand that your structural intervention may further evolve during Phase I.

26. Do I need to include preliminary data in my application?

No, preliminary data is not required for the application.

27. My community organization was not invited to submit a full application. Will OTA-22-007 funding opportunity be re-issued?

No. The funding opportunity, OTA-22-007, will not be re-issued.

28. If I am partnering with an academic institution, can they submit on behalf of my organization?

No, the application must be submitted by the applicant organization.

29. Can the research partner, who is not employed by our community organization, also serve as the Signing Official?

No, the research partner, who is not employed by the applicant organization, cannot serve as the Signing Official. The Signing Official is the applicant organization’s designated business official with the authority to legally bind your organization in award administration matters.

30. Can advocacy and lobbying for policy change be included as an activity in the full application?

No, NIH funds may not be used for advocacy and lobbying. Structural interventions that may be supported include natural experiments that examine the potential impact of upcoming or enacted policy changes. As indicated in the research opportunity announcement, these may include policy changes to address structural racial/ethnic and socioeconomic discrimination, policies to address issues of economic instability, and food program policies. Further, OTA-22-007 requirements regarding lobbying align with 2 CFR Part 418, New Restrictions on Lobbying. Full applications that include intervention activities described in the aforementioned regulation will not be reviewed.

31. Is the recording of the January 3 Technical Assistance Webinar available?

Yes. For more information on the full application process, watch the Technical Assistance Webinar presentation and view the slides.

32. What are the ComPASS reporting requirements for awardees and their partners?

Reporting will be required for each awardee, which will include details of partner activities. Reporting details and frequency will be determined during the negotiation process. There is no separate reporting by partners to the NIH.

33. How does the Community Organization satisfy the IRB requirement? Where in the application do we describe details about the IRB?

In the application, the community organization should provide as much detail as possible regarding what entity will or may serve as the IRB for their proposed intervention research project. Community organizations are encouraged to leverage their research partner in identifying an IRB or utilize the services of an independent IRB. The application should provide the reviewer an understanding of current IRB capacity. If a tribal organization is the applicant, discuss the process in the application by which the community organization and its research partner will need to undertake to obtain IRB approval and describe the entity that will serve as IRB for your proposed research project. Additionally, the budget should also address costs and fees associated with the research partner’s organization/institution providing support for administration of the project’s institutional review board (IRB) review or utilizing the services of an independent IRB. This information should be included in the “Human Subjects” attachment.

34. Should the specific aims include aims for establishing the HERA/planning and other Y1-2 aims in addition to the larger aims for the project?

Specific aims may include planning for the HERA during Y1-2 as part of the aims based on the scope and timing of the project.

35. Can you talk about the responsibility of the CHESI to develop the local HERA and the relationship between the three initiatives?

The CHESI should develop a local HERA to build the necessary collaborations and relationships for the execution of the structural health equity intervention and its sustainability. There is a national level HERA to address national level collaborations to support interventions and their sustainability through the ComPASS Coordination Center.

36. If we do not have solid contacts with federal agencies in our local area for the local HERA, could NIH eventually help us facilitate these during year one of the project?

As a collaborative initiative, NIH may facilitate processes during year 1 of the project to build a representative HERA based on the intervention planned.

37. Does the HERA need to include federal agencies even if they don't make sense for the project?

The HERA should include federal, local, private, non-profit, and other entities on the HERA that make sense for successful facilitation of the structural intervention outcomes and sustainability.

1. Where can I find help in submitting my application to the NIH eRA Commons ASSIST system?

All applications must be submitted via the NIH eRA Commons ASSIST system. See specific instructions under the “Resource only for Other Transactions Authority (OTA) Users of ASSIST” section for an Instruction Guide for OTA Submissions via ASSIST (version 11/03/2022): https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm.  Follow this guidance to submit your application.

If the above resources do not answer your question, contact customer support at  1-866-504-9552 (Toll-free )(Press 1 for eRA Commons or ASSIST) or 301-402-7469 (Press 1 for eRA Commons or ASSIST). If you need immediate help (i.e., you are within two days of a deadline or in the event of a security emergency), call customer support. Note that the Service Desk’s busiest hours are between 10 am ET and 3 pm ET, and hours of operation are Monday through Friday, 7 am to 8 pm Eastern Time (closed on federal holidays)

2. Where can I find help in registering my community organization in eRA Commons?

Register your organization, as well as the Business Official/Signing Official and Principal Investigator roles, within eRA Commons: https://www.era.nih.gov/register-accounts/register-in-era-commons.htm

If an individual is to be listed on an application as a Co-Investigator, Senior/Key Personnel, Other Significant Contributor, Collaborator, Consultant, Sub-Awardee, etc.  (i.e., research partners, community partners, consultants, etc.), they will need to have a valid eRA Commons username (Commons ID).  The Business Official/Signing Official roles of the applicant organization have the authority to create and edit eRA Commons accounts.

For questions regarding the eRA Commons registration process, contact the eRA Service Desk at 1-866-504-9552 (Toll-Free) or 301-402-7469 from Monday–Friday, 7:00 am to 8:00 pm (Eastern Time). Please let them know you are applying to OTA-22-007. If you need immediate help (i.e., you are within two days of a deadline or in the event of a security emergency), call customer support.  Note that the Service Desk’s busiest hours are between 10 am ET and 3 pm ET, and hours of operation are Monday through Friday, 7 am to 8 pm Eastern Time (closed on federal holidays)

3. Which key personnel needs to have an eRA Commons account?

The applicant organization, Signing Official and Principal Investigator (PI) must have an eRA Commons account. Once the “Signing Official” has been designated in eRA Commons, they can establish new accounts for individuals at their organization and add roles to an existing account. Detailed instructions can be found in the Instruction Guide for OTA Submissions via ASSIST (version 11/03/22) at: https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm

Other key personnel can also have eRA Commons accounts, but it is not required at the time of application submission.

4. Do all of the Key Personnel (i.e., Co-Investigator, Senior/Key Personnel, Other Significant Contributor, Collaborator, Consultant, Sub-Awardee, etc.) listed on our application need an eRA Commons ID to submit our application?

No. For submission, at a minimum, there must be the Signing Official (SO), with signature authority for the organization, and there must be at least one person with the role of Principal Investigator (PI) with the organization. The application must be submitted by the individual with Signing Official credentials.

5. Can one individual serve in both the Signing Official role and the Principal Investigator role in eRA Commons.

Yes. However, the individual will need both the Signing Official role (admin) and a separate username and password for the Principal Investigator (science) role in eRA Commons.

6. My organization has registered with SAM.gov, but will not have a Unique Entity Identifier (UEI) in time for submitting our full application. Can we still register our organization in eRA Commons?

Yes. To register your organization in eRA Commons you will not need a UEI. However, a UEI must be obtained prior to receiving an NIH award.

7. I registered as my organization’s Signing Official on our eRA Commons registration and want to know what happens next?

Once the registration is submitted and approved by eRA, the Signing Official (SO) will receive an e-mail to verify before the registration is completed and any account information is sent out. So please check for that e-mail. Registrants should follow the process for eRA Commons registrations outlined at (https://www.era.nih.gov/register-accounts/register-in-era-commons.htm) to help ensure a successful Commons registration.

8. If I need help with eRA or ASSIST, what should I do?

Users should clearly identify that they are Other Transactions Authority (OTA) applicants for OTA-22-007 when they call Toll-free: 1-866-504-9552 (Press 1 for eRA Commons or ASSIST) Phone: 301-402-7469 (Press 1 for eRA Commons or ASSIST) or in their ticket (web ticket requests are preferred over calls for easier tracking) https://public.era.nih.gov/submithelp/

9. When I register in eRA Commons, what type of opportunity should I select? There are many options.

When OTA applicants submit their eRA Commons registration, they should select (NIH Other Transaction Authority (OTA) Opportunities) only.  There are two other options, but only select (NIH Other Transaction Authority (OTA) Opportunities)

1. Is a letter of intent (LOI) required to apply for this award? If so, how do I submit the LOI?

Yes, all applicants must submit a letter of intent (LOI) by November 18 at 11:59 ET to be considered. All LOIs should be emailed to Yvonne Owens Ferguson, Ph.D., M.P.H. at [email protected]. Only select LOI submitters will be invited to submit a full application.

2. What needs to be included in the LOI?

The LOI must include the following in no more than four pages, single-spaced, using an 11-point font with 1” margins:

• Descriptive Information
• Community organization’s mission statement
• Description of the community organization’s research and/or programmatic experience (e.g., program evaluation).
• Name and description of the established community or other partnerships that will help conduct the proposed structural intervention, including the date at which the established partnership came into existence
• Description of at least one project/strategy/significant initiative that the community organization has participated in related to addressing health disparities with the community and other partners
• Project Information
• The project’s descriptive title
• Name of project’s Principal Investigator(s)
• NIH-designated population(s) experiencing health disparities in the U.S. to be the focus of the proposal
• Project’s geographic area(s) where the proposed structural intervention would take place
• Health outcomes impacted by the proposed structural intervention
• Structural factors for potential intervention as part of a full application
• At least one potential research organization/research investigator, who has agreed to support and participate in the community organization’s full application. The research organization(s)/research investigator(s) can be academic or non-academic institutions and must include the individual researcher’s name, title, institution/organization, phone number, and email address
• Fiscal Management Information
• Description of the community organization’s organizational capacity and fiscal experience, and/or expertise available, with managing program costs of over $250,000. 

3. What if I have questions during the LOI preparation?

If there are additional questions about the LOI, please email [email protected](link sends e-mail).

4. Do I need to include letters of support with my LOI?

No, letters of support should not be included with your LOI. If invited to submit a full application, letters of support should be included.

5. How do I work with community partners to build the best LOI for this funding opportunity?

Designing and implementing structural interventions to change systems, policies, and/or practices takes a multi-sectoral approach. It is recommended that you work collaboratively with your other community partners in the development of the LOI to ensure a diversity of ideas to build the most effective proposal. Engagement of all community partners at all stages of the process will also facilitate sustainability once the intervention is complete.

6. What type of role is an academic partner allowed to have for this opportunity?

For this opportunity, the academic partner may serve as Senior/Key Personnel, Other Significant Contributor, Co-Investigator, Collaborator, Consultant, Sub-Awardee, etc.  In these roles, we expect the research partner to be involved in co-creating the health equity structural intervention.

7. What is the primary intent of the research partner?

Research partners are expected to have the requisite expertise and experience to scientifically inform the development, implementation, and assessment of the community-led health equity structural intervention.

8. Does the research partner have to be 100% confirmed before submitting the LOI?

The research partner in the LOI should have agreed to support and participate in the community organization’s full application. For the LOI, the research organization(s)/research investigator(s) can be academic or non-academic institutions and must include the individual researcher’s name, title, institution/organization, phone number, and e-mail address.

10. Will all LOIs that are deemed responsive move forward to the full application phase, or is there a limit to the number of applicants you expect to be invited to submit a full application?

Yes. All LOIs that are deemed responsive and meet the LOI eligibility criteria will be invited to submit a full application. There will be no limit placed on the number of applicants invited to submit a full application.

11. Is any budget information required to be included in the LOI?

No. Budget information for the proposed structural intervention is not required for the LOI. However, budget information is a requirement for the full application.

12. For the LOI, do I need to outline the entire 10-year plan?

No, applicants are not required to outline an entire 10-year plan at the LOI stage.

13. What does it mean to have experience in managing budgets of > $250,000? For example, is there a specification on how long, what type of projects, etc.?

To demonstrate organizational capacity and fiscal experience, eligible organizations should have experience managing budgets of >$250,000. There is no specification on the time period of the project nor the type of project.

14. Is there any disadvantage to applications that focus on one population rather than multiple populations?

No. Your identified priority population(s) should align with the proposed project and health outcomes of interest.

15. Do I need to include letters of support with my LOI?

No, letters of support should not be included with your LOI. If invited to submit a full application, letters of support should be included.

16. How will the LOI be reviewed?

An NIH internal subject matter expert panel will be convened to review LOIs for responsiveness based on the below criteria. Only eligible and responsive LOI submitters will be invited to submit a full application. LOIs that are non-responsive to indicated criteria will not be invited to submit a full application for this opportunity. The NIH is not responsible for providing feedback on the LOI and will not accept an appeal of the decision.

17. What happens after I submit the LOI?

After submitting your LOI, you will receive a notification by December 8 if you are invited to submit a full application.

1. What are the main goals of the ComPASS Coordination Center (CCC)?

The CCC will be responsible for managing cross-consortium functions, including management of the National Health Equity Research Assembly (HERA); and effective communication, collaboration, and coordination across the Community-Led, Health Equity Structural Interventions and Health Equity Research Hubs. The CCC will comprise three core functions, 1) administration and coordination; 2) data collection, management, and assessment, and 3) research capacity-building and training.

2. What is the composition of the ComPASS Consortium?

The consortium comprises the three ComPASS initiatives, the ComPASS Coordination Center (CCC), Community-Led, Health Equity Structural Interventions projects, and the Health Equity Research Hubs. Immediately following the CCC award, the PDs/PIs and NIH Program Staff will form the ComPASS Steering Committee (SC). Consortium governance rests with the Steering Committee. The ComPASS Steering Committee will be coordinated and administrated by the CCC. The SC will work cooperatively and interactively, during all phases to promote collaborations, as well as information and resource sharing across the ComPASS Program.

3. What is the National Health Equity Research Assembly (HERA)?

The National HERA will comprise an invited group of federal and non-federal representatives from sectors including, but not limited to transportation, housing, urban planning, and public health to provide vital consultation on the development and implementation of the Community-Led, Health Equity Structural Interventions projects. These national-level representatives will facilitate successful research collaborations and opportunities as well as advise on the sustainability of the interventions and their potential policy levers.

4. How do the roles of the ComPASS Coordination Center (U24) relate to the roles of the Community-led Health Equity Structural Interventions?

The primary role of the ComPASS Coordination Center (CCC) will be to provide overall management, coordination, communication, and relevant support to the ComPASS consortium across all initiatives of the program. The NIH requires that the CCC and Community-Led, Health Equity Structural Interventions awardees work collaboratively in all phases of the ComPASS Program.

5. Will the ComPASS Coordination Center (CCC) be responsible for collecting common data elements or any other data?

The CCC is not responsible for primary data collection. The CCC is however tasked with coordinating the development of, collecting, and managing common measures/data collected by the Community-Led Health Equity Structural Intervention research projects.

6. The funding opportunity review criteria noted that clinical trials are not a requirement, is that accurate?

Yes. The funding opportunity is designated as "clinical trial optional" to demonstrate the need for clinical trial expertise for the ComPASS Coordination Center. However, the clinical trial elements are not a requirement for this funding opportunity.

7. What are milestones?

Milestones are objective measures of progress toward research goals and should represent the completion of specific tasks that are projected to have a significant impact on the completion of the project. Milestones must provide objective and quantitative outcomes by which to justify advancing the project, and must be measurable, have appropriate endpoints, and have specific due dates. An example of a poorly defined milestone is "have an external panel in 2020" whereas a well-defined milestone would be "have an external panel in 2020 that concludes which approaches are feasible". Another example of a well-defined milestone is “The Coordinating Center will create standards-based phenotype definitions for common comorbidities by end of Year 1”.

8. Should the milestones be included in the application page count or uploaded as an attachment?

The milestones and timeline should be included as an attachment, filename labeled as "Milestones and Timeline” and submitted under the Other Attachment section of the R&R Other Project Information form. (See related Notice of Clarification: NOT-RM-22-019).

9. Where might I find a sample milestone document?

A sample milestone document can be found here.

10. How can I use the PhenX Toolkit for measurement?

The PhenX Toolkitoffers a way to standardize the collection of data to allow cross-comparison. The web-based catalog offers recommended measurement protocols in 29 research domains.

11. How many letters of support can I include in my application?

Letters of support are not restricted to a number. Include letters of support from partnering institutions, appropriate leaders of institutional component services, Tribal communities, or outside collaborators/subcontractors with clear statements of roles/responsibilities. Submitted letters should directly demonstrate the ability of the proposed coordination center to fulfill the roles and responsibilities specified in this funding opportunity announcement.

12. Do I need to include a Resource Sharing Plan in my application?

In accordance with NIH Policy for Data Management and Sharing all applications, regardless of the amount of direct costs requested for any one year, must include a Data Management and Sharing Plan. The plan should include components related to public access; data security; and Findable, Accessible, Interoperable, Reusable (FAIRness). The Data Management and Sharing Plan will be evaluated as part of the Approach criterion. For elements to include in the Data Management and Sharing Plan, please see Writing a Data Management & Sharing Plan | Data Sharing (nih.gov) and NOT-OD-21-014: Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan.

13. Can an investigator on the Coordination Center award also be listed as key personnel on a ComPASS Community-Led Health Equity Structural Intervention (CHESI) Initiative (OT2) award or a ComPASS Health Equity Research Hub?

 

No, an investigator cannot be listed as key personnel on both the Coordination Center award and a CHESI award. If an investigator is listed on both applications and both are funded, the investigator will need to decide on which award to remain. Similarly, key personnel on the Coordination Center award cannot be listed as key personnel on the ComPASS Health Equity Research Hub award and must decide to serve on only one award.

1. What is a cooperative agreement?

A cooperative agreement is a support mechanism used when there will be substantial Federal scientific or programmatic involvement. It requires a level of involvement from NIH staff that is higher than for a typical research project (R) grant. After the award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. In many cases these are milestone-driven and in order to receive subsequent years of funding, milestones in the notice of award must be met which demonstrates the resource continues to have clear value to the ComPASS Program.

2. What are the main features of this U24 mechanism?

This U24 is a milestone-driven cooperative agreement. Investigators are required to propose quantitative milestones for each year of requested support in their applications. When an application is suggested for funding, the NIH staff and investigators negotiate milestones prior to award. Milestones will then be included in the notice of award and would be used to assess the success of the project. Investigators are required to meet all milestones and provide a milestone completion report in their annual progress report submitted to the NIH.

3. Should the U24 application document the applicant institution’s research expertise and resources in the Core Functions listed in the funding opportunity or will the areas of research be determined by the composite research agendas of the funded ComPASS Coordination Center?

The U24 application should provide information on the institution’s research expertise and resources that will contribute to addressing the specific areas of research noted in the funding opportunity and the process for how you envision your team to work together to accomplish the study objectives by developing the common protocols.

1. What organizations are eligible to apply for this funding opportunity?

• 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
• American Indian/Alaska Native Tribal Governments (Federally Recognized)
• American Indian/Alaska Native Tribal Governments (Other than Federally Recognized)

Federal Government

• U.S. Territory or Possession

2. Are Foreign Institutions able to apply?

• Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

3. Is there a limit to the number of applications that can be submitted by an institution?

No, there is no limit to the number of applications an institution can submit.

1. When may I submit an application?

The application's due date is January 27, 2023. All applications are due by 5:00 PM local time of the applicant organization. The earliest submission date is December 27, 2022.

2. Who may I contact if I have questions about my application?

If you have questions prior to submission or after summary statement release, please contact [email protected](link sends e-mail).

For questions about the review process after submission and before summary statement release, please contact the Center for Scientific Review at [email protected](link sends e-mail).

3. How do I submit my application?

For instructions on how to submit an NIH grant application, please visit the NIH Office of Extramural Research How to apply-Application Guide” at How to Submit, Track and View Your Application | grants.nih.gov.

4. Do all collaborators need to have a Commons registration and ID?

Any individual participating for at least 1 month or more should be registered in eRA Commons. Information on how to obtain eRA Commons credentials can be found here: eRA Commons – User Registration | grants.nih.gov.

5. Is a Letter of Intent Required for Submission?

A letter of intent (LOI) is not required, is not binding, and does not enter into the review of a subsequent application. The information that it contains allows NIH staff to estimate the potential review workload and plan the review. The LOI is due on December 27, 2022 and should be submitted to [email protected](link sends e-mail).

6. Do I use FORMS-G or FORMS-H to submit my applications?

FORMS-H is required for grant application due dates on or after January 25, 2023. See NOT-OD-22-195: New NIH "FORMS-H" Grant Application Forms and Instructions for additional detail.

 

7. For the Coordination Center human subjects designation, should we select delayed onset?

Yes, you should select delayed onset for the HS designation. Delayed onset means you can't fully define your plans for human subjects in your application at the time of submission.

1. Are the standard project review criteria for “Significance,” “Investigator(s),” “Innovation,” “Approach,” and “Environment” not applicable and superseded by the RFA-specific criteria?

View Section V of the funding opportunity. The standard review criteria for these sections still apply, including specific review criteria.

2. How will applications be reviewed?

Applications will be reviewed by NIH staff for completeness and responsiveness. All applications determined to be complete and responsive will be reviewed by scientific experts convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures and using review criteria outlined in the funding opportunity announcement. All applications received in response to the funding opportunity announcement will be reviewed in a single special study section. Applications may undergo a 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.

3. When will my application be reviewed and by whom?

The Scientific Merit Review for this funding opportunity will convene in Summer 2023. Following initial peer review, applications will receive a second level of review by the National Institute of Nursing Research (NINR) Advisory Council. The Advisory Council Review will convene in September 2023. Questions about the review should be directed to the Center for Scientific Review at https://public.csr.nih.gov/.

4. How will awards be selected for funding?

Applications will compete for available funds with all other applications submitted in response to this funding opportunity. The following will be considered in making funding decisions: o Scientific and technical merit of the proposed project as determined by scientific peer review. o Availability of funds. o Relevance of the proposed project to program priorities.

5. Can I appeal my peer-review decision?

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

6. How many total awards will be made?

This funding opportunity seeks to fund a single Coordination Center as an integral part of the ComPASS Program.

1. What budget and project period should I request?

The budget should reflect the needs of the Center to perform the duties as outlined in the funding opportunity, up to $3,000,000 in FY 2023 and 2024 and up to $6,000,000 per year for years FY2025 through FY2027.

2. ComPASS is a 10-year program, so why is there a 5-year budget period?

NIH policy limits each competitive segment to a maximum of 5 years. A single award covering the entire period of support generally is used only if the project is solely for the construction or modernization of real property, if the total planned period of support will be less than 18 months, or if the project is awarded under a special support mechanism.

3. Is the expectation of the Coordinating Center to budget for potential consultant fees/stipends/financial support to individuals, organizations, or other entities in relation to their role on the National Health Equity Research Assembly (HERA)? 

Applicants should include costs for consultant fees for HERA participation and travel to attend the ComPASS kick-off and annual meetings for non-federal members. For federal HERA members, travel costs will be provided by the employee’s agency.

1. Are there annual meetings I am required to attend?

Yes, awardees will be expected to attend the annual ComPASS consortium meetings held in Bethesda, MD (or the surrounding area) or virtually.

2. Do I need to submit an annual progress report?

Yes, a progress report is due annually.

1. Why is this ComPASS Program funded through the NIH Common Fund?

The NIH Common Fund supports programs intended to have a transformative impact on biomedical research conducted across all NIH Institutes and Centers. Common Fund programs encourage highly innovative approaches to broadly relevant challenges, coordination among awardees, and rapid dissemination of results and lessons learned. These programs represent NIH-wide priorities, and program areas are selected with input from all Institute and Center Directors and from extramural scientists. ComPASS is catalytic and cross-cutting in its integration of multi-sectoral partnerships, comprised of community organizations; local, state, and federal government; academic institutions, and the private sector. The Common Fund support of the ComPASS program is indicative of the recognition by NIH Leadership of the importance of addressing structural inequities by dismantling the systems and policies that enable them to exist and persist. This program is a high priority for NIH as a whole.

2. What are the goals of ComPASS?

There are two overall goals of ComPASS. The first goal is to catalyze, develop, and rigorously assess community-led, health equity structural interventions that leverage multi-sectoral partnerships to advance health equity. A second overall goal of ComPASS is to develop a new health equity research model for community-led, multi-sectoral structural intervention research across NIH and other federal agencies.

3. Where does funding for the ComPASS Program come from?

ComPASS funding comes from the NIH Common Fund. The ComPASS Program will be administered by an NIH-wide team, led by the Office of the Director (OD), Office of Strategic Coordination (OSC), National Cancer Institute (NCI), and the National Institute for Nursing Research (NINR) together with a group of NIH staff from several institutes, centers, and offices across the NIH.

4. What are the initiatives of the ComPASS Program?

ComPASS comprises three initiatives described below:

• The Community-Led, Health Equity Structural Interventions (CHESIs) will develop, implement, assess, and disseminate co-created community-led, health equity structural interventions in partnership with research organizations, by intervening upon structural factors that produce and perpetuate health disparities.
• The ComPASS Coordination Center (CCC) will lead overall program management and coordination of administrative, data, capacity-building, partnership, training, and the National Health Equity Research Assembly (HERA) activities.
• The Health Equity Research Hubs (Hubs) will be funded in FY 2024 (pending the availability of funds) and provide localized technical assistance and scientific support, as well as partnership support and research capacity-building and training previously designed in collaboration with the CCC.

Note that each initiative above has a unique timeline for release. Please check the ComPASS website for additional details.