Funder: National Institutes of Health
Due Dates: May 28, 2025 | September 29, 2025 | January 28, 2026 | May 28, 2026 | September 28, 2026 | January 28, 2027 | May 28, 2027 | September 28, 2027
Funding Amounts: Direct costs per year: $2.6M–$6.5M (tiered by institutional NIH funding); up to 7 years per award; pilot projects: $25K–$50K each; CTS Research Program: up to $500K/year.
Summary: Supports CTSA Program hubs to accelerate clinical and translational science, foster innovation, partnerships, and workforce development, and rapidly address public health needs.
Key Information: Requires concurrent K12 application; clinical trial support limited to phase IIB (except rare disease phase III); non-domestic organizations not eligible to apply.
Description
This opportunity funds Clinical and Translational Science Award (CTSA) Program hubs, which serve as central nodes in a national consortium dedicated to advancing clinical and translational science (CTS). The program aims to accelerate the development and dissemination of new treatments, improve research efficiency and effectiveness, foster innovative partnerships, address health disparities, and provide rapid response capabilities for urgent public health needs. Hubs are expected to demonstrate leadership in scientific and operational innovation, collaboration, workforce development, and community engagement.
Due Dates
- Upcoming Deadlines:
- May 28, 2025
- September 29, 2025
- January 28, 2026
- May 28, 2026
- September 28, 2026
- January 28, 2027
- May 28, 2027
- September 28, 2027 (final due date; program expires September 29, 2027)
- Letter of Intent: 30 days before the application due date
- All applications due by 5:00 PM local time of applicant organization
Funding Amount
- Award Size:
- Direct costs per year are tiered based on the 5-year average NIH direct cost funding of the applicant institution plus any partners:
- Tier A: >$385M — up to $6,500,000/year
- Tier C: $250M–$384,999,999 — up to $5,000,000/year
- Tier T: $175M–$249,999,999 — up to $3,600,000/year
- Tier G: <$175M — up to $2,600,000/year
- Project Period: Up to 7 years
- Pilot Projects: $25,000–$50,000 direct costs each, 4–8 active per year, max 12 months/project
- CTS Research Program (Element E): Up to $500,000 direct costs/year for a single project (2–3 years suggested, up to 7 years max)
- Companion Awards: Required concurrent K12 application; optional T32, R25, and RC2 applications (see NOFO for details)
Eligibility
- Eligible Applicants:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- State, county, city, township, and special district governments
- Federally recognized and other tribal governments/organizations
- Public housing authorities/Indian housing authorities
- For-profit organizations (including small businesses)
- Independent school districts
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Note: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. Foreign components as defined by NIH policy are allowed.
- Additional Requirements:
- Must include a graduate school accredited to award higher degrees related to clinical or translational science (either as applicant or partner)
- Must submit a companion K12 application (Institutional Career Development Award) concurrently
- Organizations with active CTSA UL1/UM1 awards with >16 months remaining are not eligible
- Partnering institutions may only participate in one CTSA UM1 application
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 (allow 6+ weeks for new registrations)
- Application Components:
- SF424 (R&R) forms
- Project/Performance Site Locations
- Senior/Key Person Profile
- R&R Budget (detailed, not modular)
- PHS 398 Research Plan (including Specific Aims, Research Strategy, and required attachments)
- PHS Human Subjects and Clinical Trials Information
- Letters of Support (including from all Partnering Institutions)
- Data Management and Sharing Plan
- Other required attachments as specified in the NOFO
- Page Limits: Strict limits for each section (see NOFO)
- Review Criteria: Scientific merit, innovation, significance, investigator qualifications, approach, environment, and alignment with CTSA program goals
Program Structure and Requirements
Required Elements
Each application must address five core elements:
- Overview: Vision, strategic goals, team, and anticipated impact
- Strategic Management: Leadership, governance, partnerships, continuous quality improvement, emergency response plans
- Training and Outreach: Workforce development for clinical research staff, community and stakeholder engagement
- Resources and Pilots: Core resources/services, pilot project program, data science/informatics
- CTS Research Program: At least one significant, well-defined translational science research project
Key Requirements
- Companion K12 Application: Must be submitted concurrently; optional T32, R25, and RC2 applications are available only to UM1 applicants/awardees
- Clinical Trials: Support is limited to phase IIB trials (except phase III for rare diseases); all human subjects research must be described and approved per NIH policy
- Data Sharing: Compliance with NIH Data Management and Sharing Policy is required
- Budget Tier Verification: Applicants are strongly encouraged to verify their budget tier with NCATS before submission
- Non-Responsive Applications: Will not be reviewed if missing required elements, lacking K12 companion, or not meeting clinical trial requirements
Additional Information
- Review Process: Peer review by NCATS-convened panel; scored on overall impact and specific criteria
- Award Mechanism: Cooperative agreement (UM1) with substantial NIH programmatic involvement
- Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements required
- Data and Safety Monitoring: Required for all clinical trials; see NOFO for details
- Prior Approval: Required for pilot projects and research projects involving human subjects or vertebrate animals
External Links
Contact Information