Funder: National Institutes of Health
Due Dates: May 25, 2025 | September 25, 2025 | January 25, 2026 (New/Renewal/Resubmission/Revision/AIDS)
Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years.
Summary: Supports a Coordinating Center for large-scale, high-impact clinical trials to evaluate interventions for screening, diagnosing, preventing, or treating vision disorders.
Key Information: Clinical trial required; limited submission; contact NEI at least 6 weeks prior if requesting ≥$500,000 direct costs in any year.
Description
This opportunity, offered by the National Eye Institute (NEI) at NIH, funds a Coordinating Center (CC) to provide scientific and technical leadership for large-scale, investigator-initiated clinical trials in vision research. The CC is responsible for trial statistical and data management activities, oversight of study investigators, and ensuring rigorous performance monitoring and quality control. Projects must be designed to evaluate interventions for screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of established interventions. The CC is typically funded as part of a group of companion awards (including Chair’s and Resource Center grants) for complex, high-resource, or high-safety-risk clinical trials of significant public health importance.
Due Dates
- Upcoming Deadlines:
- May 25, 2025
- September 25, 2025
- January 25, 2026
(All for New, Renewal, Resubmission, Revision, and AIDS applications)
- Applications are due by 5:00 PM local time of the applicant organization.
- The opportunity expires May 26, 2026.
Funding Amount
- Budget: No set limit; budgets must be well-justified and reflect the actual needs of the proposed project.
- Project Period: Up to 5 years.
- Number of Awards: Contingent on NIH appropriations and the number of meritorious applications.
- Note: Applicants requesting $500,000 or more in direct costs in any year must contact NEI program staff at least 6 weeks before submission.
Eligibility
- Eligible Organizations:
- Public/State and Private Institutions of Higher Education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Native American tribal governments and organizations (federally recognized and other)
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Non-domestic (non-U.S.) entities (foreign organizations)
- Eligible agencies of the federal government
- Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD/PI(s) may apply.
- Limited Submission: Applicant organizations may submit more than one application, provided each is scientifically distinct. Duplicate or highly overlapping applications will not be accepted.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
- Required Registrations: SAM, eRA Commons, Grants.gov, and (for foreign organizations) NCAGE code.
- Application Instructions: Follow the SF424 (R&R) Application Guide and the specific requirements in the NOFO.
- Attachments Required:
- Statistical Analysis Plan (SAP)
- Data Handling, Quality Assurance, and Monitoring Plans
- Clinical Center Information
- Clinical Center Table (if applicable)
- Data Management and Sharing Plan: Required for all applications.
- Contact NEI: Strongly encouraged to contact NEI scientific/research staff as early as possible, and no later than 12 weeks before submission.
Additional Information
- Scope: Only complex, high-resource, or high-safety-risk clinical trials are eligible. Projects must directly evaluate interventions for vision disorders.
- Not Supported: Preclinical, developmental, or preparatory studies; minimal risk studies; basic experimental studies with humans (BESH).
- Companion Opportunities: Separate NOFOs exist for Chair’s Grant (PAR-23-209) and Resource Center Grant (PAR-23-201).
- Review Criteria: Scientific merit, significance, investigator qualifications, innovation, approach, environment, and appropriateness of the CC’s role.
- Data Sharing: Adherence to NIH Data Management and Sharing Policy is required.
External Links
Contact Information