About this opportunity
AI summaryThe National Institutes of Health requires translational research program services to rapidly translate laboratory findings into biological, pharmaceutical, medical device, or combination therapies for visual system diseases. Applicants must execute an R61 phase of up to two years for preliminary research, followed by an R33 phase of up to four years focused on preclinical development, FDA IND/IDE filing, and clinical trial design. Work will occur offsite in Washington, DC. Only USA organizations, including various government entities, nonprofits, educational institutions, and businesses, are eligible to apply. Non-domestic entities, non-domestic components of U.S. organizations, and applications involving foreign subawards or subcontracts are ineligible. Applicants must submit proposals through www.grants.gov by the closing date of November 16, 2029. The contract term spans a bi-phasic period of performance where the total combined duration of the R61 and R33 phases cannot exceed five years. The solicitation does not state specific budget amounts or evaluation criteria, but note that cost sharing or matching is not required.
Buyer and opportunity details
- Client
- National Institutes of Health
Scope of work
- Translation of laboratory research findings into therapeutics for visual system diseases or disorders
- Product development of biological, pharmaceutical, medical device, and combination therapies
- R61 phase research supporting preliminary data not yet advanced to clinical translation
- R33 phase research focusing on final stages of preclinical development
- Advancing a single therapeutic candidate through IND or IDE enabling studies
- Filing an IND or IDE package with the FDA
- Designing future clinical trials
- Transitioning the product to clinical practice within the period of performance
Minimum qualifications
- Must be a USA onshore organization
- Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply
- Applications involving foreign subawards or subcontracts are not allowed
Documents to include with your response
- R61 and R33 phase milestone plan addressing manufacturing and product development goals
- IND or IDE application package to FDA (required during R33 phase)
Key dates
- Last Updated
- September 25, 2026
- Posted date
- September 25, 2026
- Closing
- November 16, 2029
- Archive date
- January 15, 2030
How to submit
- Method
- Electronic via Grants.gov
- Instructions
- Go to www.grants.gov to apply, track application status, and subscribe to updates.
Contract details
- Term
- Up to 2 years for R61 phase, up to 4 years for R33 phase, total duration cannot exceed 5 years
- Place of performance
- Offsite / Washington, DC
- Funding
- Assistance Listings: 93.867 -- Vision Research
