New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI): Clinical/Community Field Centers (UG3/UH3 - Clinical Trial Not Allowed) | RFA HL 23 015

Frequently Asked Questions (FAQs) - NIH RFA-HL-23-015 (Clinical/Community Field Centers)

1) What is RFA-HL-23-015 trying to support?

RFA-HL-23-015 is an NIH funding opportunity intended to launch a new epidemiological cohort study focused on Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI). The goal is to enroll participants and follow them over time using standardized data collection so researchers can better understand patterns of risk, resilience, disease development, and health outcomes in these communities.

2) What type of research approach is expected under this opportunity?

The opportunity is centered on an observational cohort design. This means participants are enrolled and followed longitudinally, with exposures and outcomes measured over time, rather than assigning participants to interventions.

3) Is this funding opportunity for a Coordinating Center or for Field Centers?

This specific FOA is for Clinical/Community Field Centers (CCFCs). NIH indicates there will be a companion announcement to fund a separate Coordinating Center (CC).

4) What is a Clinical/Community Field Center (CCFC) in the context of this study?

CCFCs are the on-the-ground sites responsible for community engagement and study implementation in real clinical and community settings. Based on the information provided, CCFC responsibilities include participant recruitment and retention, baseline and follow-up data collection, and implementing study protocols at the local level.

5) What does the Coordinating Center (CC) typically do, and how does that affect CCFC applicants?

NIH anticipates a separate Coordinating Center to handle cross-site harmonization, central operations, data coordination, quality control, and other study-wide infrastructure. CCFC applicants should expect to align their activities with study-wide standards and collaborate closely with the Coordinating Center and other field centers so data are comparable across locations and subpopulations.

6) What award mechanism does this FOA use?

The award mechanism is a cooperative agreement using the UG3/UH3 phased structure.

7) What does it mean that this is a cooperative agreement (UG3/UH3) rather than a typical grant?

A cooperative agreement typically involves substantial NIH programmatic involvement. Projects are expected to operate in close coordination with NIH and other funded sites, rather than functioning as fully independent investigator-initiated grants.

8) How does the UG3/UH3 phased structure work for this project?

The UG3 phase is an initial planning or start-up period that typically focuses on finalizing protocols, establishing partnerships, building staffing and workflow capacity, meeting feasibility milestones, and preparing for full implementation. If milestones are achieved, the project commonly transitions to the UH3 phase, which shifts into larger-scale operations such as full participant enrollment, longitudinal follow-up, and ongoing data and specimen collection.

9) What happens if a site does not meet UG3 milestones?

The information provided indicates that successful achievement of UG3 milestones is commonly used to justify transition into the UH3 phase. The specific consequences of not meeting milestones are not detailed here, but the phased structure implies that transition is not automatic and depends on milestone achievement.

10) Are clinical trials allowed under this opportunity?

No. The FOA states "Clinical Trial Not Allowed," meaning the funded work must remain observational in nature and cannot prospectively assign participants to interventions in a way that meets the NIH definition of a clinical trial.

11) Can the cohort study still track health outcomes and exposures over time?

Yes. The opportunity is designed to measure exposures and outcomes over time in an observational cohort framework, supporting longitudinal evidence generation about AsA-NHPI health.

12) What kinds of organizations are eligible to apply?

A wide range of organizations are eligible, including governmental and academic applicants (such as state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; and public/Indian housing authorities). Eligibility also includes federally recognized tribal governments and other tribal organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

13) Are community-centered institutions specifically called out as eligible?

Yes. The announcement explicitly highlights additional eligible applicant types often central to community-centered research, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), tribally controlled colleges and universities (TCCUs), Indian/Native American tribal governments that are not federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions.

14) Can non-U.S. (foreign) institutions apply as the main applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.

15) Are any international elements allowed at all?

Yes, within limits. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. In practical terms, the prime recipient must be a U.S.-based eligible organization, but certain project elements may involve foreign components when justified and permitted under NIH policy.

16) Which federal agency is sponsoring this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

17) How is this opportunity categorized in terms of funding type and activity area?

The opportunity is categorized under discretionary funding, and the activity area is health.

18) What Assistance Listing (CFDA) numbers are associated with this opportunity?

The associated CFDA (Assistance Listing) numbers listed are: 93.172, 93.233, 93.307, 93.837, 93.838, 93.839, 93.840, and 93.853.

19) What was the original closing date and record creation date listed?

The original closing date listed is October 13, 2022. The record creation date shown is July 7, 2022.

20) What is the listed award ceiling for this opportunity?

The listed award ceiling is $373,000. The information provided notes that this typically represents a maximum annual direct cost or total cost cap as specified in the full FOA text, and applicants generally need to confirm how the cap is defined (for example, whether it applies per year, per phase, or per budget period).

21) What does "standardized data" imply for participating Field Centers?

It implies that Field Centers will need to collect data in a consistent way across sites, following study-wide standards so that results can be compared across locations and subpopulations.

22) What is the overall purpose of building a multi-site cohort infrastructure for AsA-NHPI communities?

The opportunity is designed to build durable, collaborative cohort infrastructure that can generate high-quality longitudinal evidence about AsA-NHPI health. Field centers are positioned as community-embedded engines of recruitment, data collection, and sustained participant partnership, operating under a cooperative framework intended to ensure consistency and interoperability across multiple sites.