NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1- Clinical Trial Required) | PAR 21 043

Opportunity Information: Apply for PAR 21 043

The National Eye Institute (NEI), part of the National Institutes of Health (NIH), is soliciting applications under Funding Opportunity Announcement PAR-21-043 for the "NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1 - Clinical Trial Required)." This opportunity uses the UG1 cooperative agreement mechanism, which is designed for large, complex, and higher-risk clinical research where NIH staff have substantial involvement in oversight and coordination. The central focus is on investigator-initiated clinical trials and other demanding clinical studies in vision science, including large-scale multi-center trials, human gene-transfer trials, stem cell therapy trials, and similarly complex studies that require robust organization, careful monitoring, and strong patient safety protections.

A key requirement is that the proposed work must be a clinical trial (or part of a clinical trial enterprise) intended to evaluate interventions related to vision disorders. That includes interventions aimed at screening, diagnosing, preventing, or treating eye and vision conditions, as well as studies that compare the effectiveness of two or more established interventions. Because the trials supported through this mechanism tend to be large and multifaceted, the FOA emphasizes the need for clearly defined study organization, including roles and responsibilities across the overall trial structure, and highlights the expectation for active performance oversight and safety monitoring appropriate to the level of risk and complexity.

This particular FOA is specifically oriented toward the Resource Center component of an NEI UG1-supported clinical trial program. In NEI's typical model for these large collaborative trials, the overall effort may be funded as a set of linked companion awards that can include (1) a Chair's Grant to provide scientific leadership, (2) a Coordinating Center to manage operations such as data systems and trial logistics, and (3) one or more Resource Centers when specialized centralized services are needed. The Resource Center grant is meant to provide required shared services for a multi-center or otherwise complex/high-risk clinical trial. Examples of the kinds of services implied by the FOA include imaging support (such as standardized acquisition, grading, and quality assurance), laboratory services (such as centralized specimen processing, biomarker assays, or specialized testing), or other essential resources that must be consistent across participating sites to ensure data quality, participant safety, and interpretability of results.

The FOA also notes that not every project will need separate companion awards for all functions. For less organizationally complex studies, some functions that might otherwise be handled by a separate Coordinating Center or Resource Center (for example, data management, statistical analysis planning, recruitment support, or certain centralized activities) could be included within a Chair's Grant application. In contrast, this Resource Center FOA is geared toward situations where a dedicated, centralized service unit is necessary to execute the trial properly, especially when the trial spans multiple sites or involves advanced procedures that require standardization and oversight.

Eligibility is broad and includes many types of domestic institutions and organizations, reflecting NIH's general approach to expanding participation across sectors. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA additionally highlights other eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations. This signals that NEI is open to resource centers with specialized expertise or infrastructure, including those outside the United States, provided they can meet NIH requirements and effectively support the clinical trial.

Administratively, this is a discretionary funding opportunity under the health activity category, associated with CFDA (now often referred to as Assistance Listing) number 93.867. The instrument type is a cooperative agreement, which generally means the awardee is expected to work closely with NEI/NIH staff throughout the project, particularly on issues like trial governance, milestone-based progress, data and safety oversight, and adherence to regulatory and quality standards. The opportunity was created on 2020-11-18, and the original closing date listed in the provided source data is 2023-05-07. The source information does not specify an award ceiling or the expected number of awards in the excerpt provided, which typically means applicants would need to consult the full FOA text and NIH guidance to understand budget expectations, project period norms, and anticipated funding levels.

In practical terms, applicants considering this FOA should think of a Resource Center as a backbone unit for a major vision clinical trial: it is not simply a supporting lab or imaging core in the ordinary sense, but an organized, trial-integrated service center with the staffing, SOPs, quality management, and coordination capacity to deliver consistent, auditable, high-quality outputs across many clinical sites. The overall intent is to ensure that high-stakes clinical studies in vision research, especially those involving advanced therapies or elevated safety considerations, have the centralized technical capabilities and oversight structure needed to protect participants and produce reliable, actionable results.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1- Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2020-11-18.
• Applicants must submit their applications by 2023-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 21 043

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: