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U.S. National Institutes of Health·United States of America

NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

Closes 11/16/2029$500k – $2.5MGrants Notice
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Description

The National Eye Institute (NEI) seeks applications for its Translational Research Program (TRP) to move innovative laboratory discoveries toward therapeutic products for visual system diseases. The program uses a two‑phase, milestone‑driven award structure: an R61 phase (up to 2 years) for projects with strong preliminary data but not yet ready for clinical translation, followed by an R33 phase (up to 4 years, total ≤ 5 years) to advance a single candidate through IND/IDE‑enabling studies, IND/IDE filing, and design of future clinical trials. Applicants must define SMART milestones for both phases, include manufacturing and product‑development plans, and address contingency strategies for potential delays. The award is a grant (R61/R33) limited to U.S. entities; foreign sub‑awards are prohibited. Up to five awards are anticipated. • Supports biologics, pharmaceuticals, medical devices, or combination therapies for any eye‑related disease. • R61 phase: ≤ 2 years, up to ~$250 k/year (pre‑clinical development). • R33 phase: ≤ 4 years, up to ~$500 k/year (IND/IDE preparation, filing, trial design). • Total project period ≤ 5 years; milestones must be SMART. • Eligible applicants: U.S. public, private, nonprofit, small‑business, and academic entities (see full eligibility list). • Estimated award start: Dec 1 2026; submission deadline: Nov 16 2029.

Attached files

Contact

Tony Gover, Ph.D.(Program Contact)

[email protected]

(301) 529-7320

Key dates

Opened
9/9/2025
Closes
11/16/2029
Projected award
12/1/2026
Duration
5 years

Last updated

Details

Type
Grants Notice
Industry
Healthcare and Medical Services
NAICS
541714
Solicitation №
PAR-28-072

Budget estimate

$500,000 – $2,500,000

The award combines two NIH grant mechanisms. Historically, an R61 award provides up to roughly $250,000 per year for a maximum of two years (≈ $500,000 total). An R33 award can provide up to about $500,000 per year for up to four years (≈ $2,000,000 total). Because the total combined period cannot exceed five years, the overall funding envelope per award is expected to range from the lower end of a single‑phase R61 (~$500k) to the upper end of a full R61 + R33 sequence (~$2.5 million). The exact amount will depend on the scope of the proposed milestones, the nature of the therapeutic candidate, and the budget justification submitted by the applicant.

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