Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and organizations developing therapeutics to treat visual system diseases. The R61 phase supports research with strong preliminary data not yet ready for clinical translation. The R33 phase supports near-clinical products targeting FDA approval pathways.
Eligible applicants include universities, research institutes, hospitals, and biotechnology companies with the expertise to advance drug candidates or medical devices toward clinical use. Non-U.S. organizations may also apply if they have U.S. locations.
The program covers biological, pharmaceutical, medical device, and combination therapies for any eye disease or disorder. Projects must demonstrate clear milestones and a path to FDA submission within the award period.
Not the right fit? Find grants for your organization in 5 questions →
Key dates
- Sep 9, 2025 Applications open
- Feb 16, 2026 Application deadline
- Dec 1, 2026 Award announced
- Dec 1, 2026 Project start
Program description
The purpose of NEI’s Translational Research program is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.
The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to three years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an IND/IDE application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product.
Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). Mature efforts that do not require the R61 phase resources may apply directly to the R33 phase. However, evidence of a pre-IND/IDE meeting with the FDA is required to submit an R33 application directly.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 Research and Related Senior Key Person Profile (Expanded)
- Project Narrative (Research Strategy)
- Budget and Budget Justification
- Biosketch (all key personnel)
- Letters of Support (if applicable)
- Preliminary Data Documentation
- FDA Pre-IND/IDE Meeting Summary (R33 only)
Program contact
- 👤 Tony Gover, Ph.D.
- 📧 tony.gover@nih.gov
- 📞 301-529-7320
Funding track record
Recent awards under CFDA 93.867 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$73,768,606
-
$61,555,044
-
$35,249,682
-
$27,603,179
-
$27,051,746
-
$22,003,615
-
$20,411,581
-
$19,986,536
-
$18,098,351
-
$16,012,672
Top States by Funding
- MA 13 awards $157.7M
- FL 4 awards $153.5M
- CA 11 awards $121.1M
- PA 8 awards $114.0M
- NY 10 awards $109.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.867). How funding has trended year over year.
| 2024 | $696,472,579 | |
| 2025 | $702,696,370 | |
| 2026 est. | $863,753 |
FAQ
Who can apply for the NEI Translational Research Program?
Research institutions, universities, hospitals, and biotech companies developing therapeutics for eye diseases can apply. You must have relevant expertise and preliminary data.
What is the difference between R61 and R33 phases?
R61 (up to 2 years) supports early-stage translational research with preliminary data. R33 (up to 3 years) supports products ready for IND/IDE filing and FDA submission.
What are milestones and why do they matter?
Milestones are scheduled, measurable events marking major project stages. They are required for both phases and must be SMART (Specific, Measurable, Achievable, Relevant, Time-bound).
Can I apply directly to R33 without R61?
Yes, mature projects can apply directly to R33. You must provide evidence of a pre-IND/IDE meeting with the FDA.
What happens if I receive R33 funding?
You must submit or obtain an IND/IDE application with the FDA, or transition the product to clinical practice, within the award period.
💡 Tips for applicants
- Develop clear, realistic milestones for each phase with specific timelines and measurable deliverables. Vague goals will weaken your application.
- Include contingency plans showing how you will address potential delays in meeting milestones. Reviewers value proactive risk management.
- For R33 applicants, demonstrate evidence of FDA engagement through pre-IND/IDE meetings. This strengthens feasibility and shows regulatory readiness.
- Provide strong preliminary data showing your therapeutic candidate is ready for the proposed phase. Preliminary data quality directly impacts competitiveness.
- Align your budget and timeline with your milestones. Mismatched budgets or unrealistic timelines will raise reviewer concerns.
⚠️ Common mistakes
Weak or vague milestones that lack specificity, measurability, or realistic timelines. Underdeveloped preliminary data or insufficient evidence of translational progress. Missing or weak contingency plans for potential setbacks in the development pathway.
Similar grants
- OPEN Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Optional) — National Institutes of Health
- OPEN Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 – Clinical Trial Not Allowed) — National Institutes of Health
- OPEN INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) — National Institutes of Health
- OPEN Research Projects to Enhance Applicability of Mammalian Models for Translational Research (R01 Clinical Trial Not Allowed) — National Institutes of Health