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Open (posted) · Grant

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

National Institutes of Health, Department of Health and Human Services

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name
NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
Issuing agency
National Institutes of Health (Department of Health and Human Services)
Opportunity number
PAR-28-072
Funding type
Grant
Funding purpose
Health
Status
Open (posted)
Application deadline
Closes November 16, 2029
Published award range
Not published by the agency
Cost sharing or match required
No
Eligible applicants (official categories)
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For profit organizations other than small businesses
  • Small businesses
  • Others (see Additional Information on Eligibility)
Relevant to
Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.
Geographic restrictions
None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.
Assistance Listing (CFDA)
93.867
Official source
View on Grants.gov ↗
Application URL
www.grants.gov/search-results-detail/360545 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.
Source identifier
Grants.gov opportunity ID 360545 · Funding opportunity number PAR-28-072
Posted
September 25, 2026 · Source last updated September 25, 2026
Last verified
October 29, 2026 (against Grants.gov)
Data completeness
92% of key fields published by the sourceNot published: published funding range.
Record confidence
highVerified against the official source; key fields present; no open issues.

Eligibility details (from the agency)

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Description (from the official listing)

The purpose of NEI's Translational Research program (TRP) 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 four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. 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…

Read the full description

The purpose of NEI's Translational Research program (TRP) 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 four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. 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). All projects will begin with a R61 phase regardless of therapeutic starting point.

Agency contact

NEI Extramural Programs NEI_extramural@nih.gov
NEI_extramural@nih.gov

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